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The US Food and Drug Administration (FDA) has flagged quality control issues at Novo Nordisk’s Clayton, North Carolina plant. This plant makes active pharmaceutical ingredients (APIs), including semaglutide used in Novo’s popular weight loss drug Wegovy and diabetes drug Ozempic.Eli Lilly has
filed multiple lawsuits against US medical spas, wellness centers and
compounding pharmacies for fraudulent sale of non-FDA approved products falsely
claiming to contain tirzepatide, the API in its diabetes medication Mounjaro.Johnson & Johnson has updated its brand and has united its medtech and pharmaceutical segments under its brand name.In approvals, GSK has received FDA approval for its oral therapy, Ojjaara (momelotinib), for the treatment of myelofibrosis, a rare bone marrow cancer. BieGene’s cancer drug Tevimbra (tislelizumab) has received authorization in Europe as a monotherapy for adults with esophageal squamous cell carcinoma (ESCC) following chemotherapy. Meanwhile, BeiGene has regained full global rights to Tevimbra as it has ended its 2021 agreement with Novartis.After news about deaths due to contaminated cough syrups, India has decided to make it mandatory for drugmakers to audit their raw material suppliers at least once a year. And, FDA has declined approval to ARS Pharmaceuticals’ nasal spray Neffy, an alternative to EpiPen.FDA flags quality issues at Novo’s Clayton facility that makes API for WegovyFor sometime now,
Novo Nordisk has been facing supply-side challenges
in meeting demand for its hugely popular obesity med Wegovy and diabetes drug
Ozempic, both of which contain the API semaglutide. Reuters has now reported that FDA had found lapses in quality control at Novo Nordisk’s Clayton, North Carolina plant, back in May 2022. The Clayton facility produces semaglutide.According to
reports, FDA inspected the plant once again, in July. During both the inspections, FDA found issues with the factory’s control systems to prevent microbial contamination. According to Endpoints News, Novo’s US facility has had at least four quality control issues related to
microbes in the past two years. It is not clear how the FDA citations will
impact the supply of Ozempic and Wegovy.In 2022, there
were production problems at the Brussels (Belgium) plant operated by its first
contract manufacturer Catalent. Novo then took some Wegovy
manufacturing into its own hands. Novo has also hired Thermo Fisher to do the filling of Wegovy injections
at its Greenville, North Carolina plant.Meanwhile, Novo
Nordisk has hired US private contract manufacturer PCI Pharma Services for assembly and packaging of Wegovy in
order to meet its growing demand. Novo has also partnered with Aspen Pharmacare to manufacture insulin on its behalf in South Africa for export
to African countries through a government tender initiative.FDA issues Form 483 to Aurobindo
subsidiary:
Indian drugmaker Aurobindo Pharma’s subsidiary, APL Healthcare Limited, has received a Form 483 with one observation from the FDA for lapses at its plant in
Tirupati in south India.Lilly files lawsuits over entities
selling knockoff Mounjaro in USEli Lilly has filed four lawsuits against US medical spas, wellness centers and
compounding pharmacies for fraudulent sale of non-FDA approved products falsely
claiming to contain tirzepatide, the API in its diabetes medication
Mounjaro. The drug was originally approved for treating type 2 diabetes and is
exclusively produced and available through Lilly. It has also shown benefit in weight loss. Lilly’s lawsuits seek to halt the distribution of tirzepatide and have sought unspecified damages for alleged violations of consumer protection laws.GSK bags FDA approval for Ojjaara, its
rare bone marrow cancer therapyGSK has received FDA approval for its oral therapy, Ojjaara (momelotinib), for the treatment of myelofibrosis, a rare bone marrow cancer that disrupts the body’s normal production of blood cells, in patients with anemia regardless of prior myelofibrosis therapy. This makes it the first and only approved medicine for both newly
diagnosed and previously treated myelofibrosis patients who have anemia and splenomegaly (enlarged spleen).EU regulator suggests withdrawal of GSK’s blood cancer drug: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended against renewing the conditional marketing authorization granted to GSK’s multiple myeloma drug Blenrep (belantamab mafodotin-blmf). Last year, GSK withdrew Blenrep from the US market, following outcomes of a phase 3 confirmatory trial.J&J in makeover mode; gets new visual identity after 135 yearsJohnson & Johnson has announced a makeover of its iconic signature script, in use
since 1887, with a modern design that reflects its enhanced focus on pharmaceuticals and medical devices.
The updated look, featuring a different shade of red, signifies J&J's transformation. Its pharmaceutical division will be
rebranded as Johnson & Johnson Innovative Medicine, while the medical devices unit will continue to be named Johnson & Johnson MedTech.FDA rejects approval of first nasal spray
alternative to EpiPenFDA has issued a complete response letter (CRL) to ARS Pharmaceuticals for Neffy, an epinephrine nasal spray, to treat allergic
reactions, including anaphylaxis in adults and children weighing 30 kg or more.
The agency has requested a study that evaluates repeated doses of
Neffy as compared to repeated doses of an epinephrine injection product,
specifically under allergen-induced allergic rhinitis conditions, to support
its approval. ARS Pharma plans to resubmit the application to the FDA in the
first half of 2024.India mandates annual audit of raw material suppliers by
drugmakersAfter news of contaminated India-made cough syrups causing deaths of children in The Gambia, Uzbekistan and Cameroon, the country has decided to tighten rules to improve the quality of drugs being manufactured by its drugmakers. India will make it mandatory for drugmakers to audit their raw material suppliers at least once a
year. According to a Reuters report, India’s regulator conveyed the decision on mandatory audits for raw material and packaging material suppliers in a meeting with industry representatives held on September 15.BeiGene’s Tevimbra gets authorized in Europe; terminates deal with NovartisThe European
Commission (EC) has authorized BeiGene’s cancer drug Tevimbra (tislelizumab) as a monotherapy for the treatment of adults with
unresectable, locally advanced, or metastatic esophageal squamous cell
carcinoma (ESCC) following chemotherapy. Additionally, FDA has also accepted
the biologics license application (BLA) for tislelizumab, considering it as a potential first-line therapy for patients with unresectable,
recurrent, locally advanced, or metastatic ESCC.Meanwhile,
BeiGene and Novartis have ended their 2021 agreement to jointly develop Tevimbra,
marking the second such termination in just over two months. BeiGene will regain
full global rights to the drug without any royalty payments to Novartis, which
will continue its manufacturing.
Impressions: 691
https://www.pharmacompass.com/radio-compass-phisper/fda-flags-quality-issues-at-novo-s-clayton-plant-j-j-renews-identity-after-135-years
#Phispers by PharmaCompass
21 Sep 2023
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In this week’s Phispers, the US Department of Health and Human Services (HHS) has attacked Merck over the lawsuit it had filed in June pertaining to the provisions in the Inflation Reduction Act. In a court filing, HHS has argued that it can’t be sued by Merck as the drugmaker isn’t the primary manufacturer of Januvia.In deals, Moderna and Immatics have inked a research and development collaboration for developing cancer vaccines and therapies with high unmet medical need. And Sandoz has partnered with Samsung Bioepis for the development and commercialization of its biosimilar to Johnson & Johnson’s blockbuster anti-inflammatory med Stelara.In regulatory news, a group of external experts to the US Food and Drug Administration (FDA) has declined to endorse the efficacy of over-the-counter (OTC) medicines containing phenylephrine, a commonly used active pharmaceutical ingredient (API) found in cold and cough syrups. The agency has also issued warnings to eight companies cautioning them against manufacturing or marketing unapproved eye products.And in trial news, AstraZeneca’s cancer drug Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38 percent compared to Tagrisso alone in a late-stage trial.Merck can’t sue US govt over drug pricing plan, HHS argues in new court filingMerck, the first drugmaker to sue the US government over Medicare’s price negotiation provisions in the Inflation Reduction Act (IRA), was assailed by the US Department of Health and Human
Services (HHS). In a new filing, HHS has said Merck can’t sue the US government as the drugmaker isn’t the primary manufacturer of the diabetes med Januvia—one of 10 medications up for the first round of price negotiations in 2026.It merely markets Januvia, HHS has said, pointing out that Merck’s subsidiary — Merck Sharp & Dohme (MSD) — is the company set to face the legal obligations “that Merck supposedly fears”.The agency said
the price negotiation program does not constitute a physical taking of property in violation of the American constitution. “If a manufacturer is unwilling to sell its selected drugs to Medicare at the price that the government is willing to pay, it is free to withdraw from the Medicare program,” the motion says.After Merck sued the US government in
June, several other drugmakers and trade groups had filed similar lawsuits. The pharmaceutical industry was concerned that the drug pricing plan might lead to reduced profits, potentially causing them to scale back their efforts in developing innovative treatments and imposing excessive fines on those that don’t negotiate.Moderna partners Immatics for cancer
jabs; its flu shot succeeds late-stage trialModerna and Immatics have inked a research and development
collaboration for cancer vaccines and therapies with high unmet medical need. The deal will combine Immatics’ TCR platform with Moderna’s mRNA technology. Under the terms, Immatics will receive an upfront payment of US$ 120 million and milestone payments that could exceed US$ 1.7 billion. Moderna will also explore the potential combination of its own cancer vaccine with Immatics’ cancer therapy, IMA203.In other news
from Moderna, its flu vaccine has generated a stronger immune response against all four A and B strains of the influenza virus in a late-stage trial, when compared with traditional flu shots. The Moderna flu shot was effective in all age groups, and was found to be safe and tolerable even in older people.Meanwhile,
Moderna has scaled down the manufacture of its Covid 19 vaccine whose updated version was approved by the US regulators this week, to keep pace with decreased demand post-pandemic.AbbVie’s Skyrizi beats J&J’s Stelara in head-to-head phase 3 Crohn’s disease trialIn a late-stage, head-to-head trial in patients with Crohn’s disease, AbbVie’s Skyrizi (risankizumab-rzaa) outperformed Johnson & Johnson’s blockbuster arthritis therapy Stelara (ustekinumab).For the first primary endpoint of clinical remission at week 24, the
remission rates stood at 59 percent and 40 percent for those who received
Skyrizi and Stelara, respectively. For the second primary endpoint of endoscopic remission, the remission rates for the two groups reached 32 percent and 16 percent, respectively, indicating statistically significant superiority for Skyrizi over Stelara at week 48.Sandoz-Samsung Bioepis tie-up for Stelara
copycat: Novartis’ Sandoz unit announced a partnership with Samsung Bioepis to develop and commercialize its biosimilar to J&J’s Stelara. This agreement will provide Sandoz exclusive rights to commercialize the biosimilar SB17
ustekinumab in the US, Canada, and almost all European countries. With Stelara’s patent exclusivity expiration nearing, there is currently no approved biosimilar for ustekinumab.FDA panel terms popular nasal decongestant used in OTC cough syrups ineffectiveA group of external experts advising the FDA declined to endorse the
efficacy of over-the-counter (OTC) medicines containing phenylephrine, a commonly used API in cold and cough
syrups. The panel unanimously rejected the notion that orally administered phenylephrine is effective as a nasal decongestant and stated that further trials were unnecessary to establish this fact.FDA issues warning letters to eight firms over eye products: FDA has
issued warnings to eight companies, including CVS Health Corp, Boiron, DR
Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and
Walgreens Boots Alliance, cautioning them against manufacturing or marketing unapproved eye products. As per the warning letter, these eye
products are being marketed illegally for the treatment of conditions such as conjunctivitis, cataracts, and glaucoma.CDC okays broad use of updated Covid-19
vaccines: The US Centers
for Disease Control and Prevention (CDC) has okayed broad use of updated Covid-19 vaccines from Pfizer-BioNTech and Moderna, that were approved by the FDA. The shots are part of a push by
public health officials to align the next Covid vaccines more closely with the
actual circulating variant of the virus.Astra’s Tagrisso-chemo combo reduces risk of death by 38% in lung cancerIn May, AstraZeneca’s blockbuster cancer drug Tagrisso in combination with chemotherapy showed
promise in a late-stage clinical trial in patients with locally advanced or
metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung
cancer (NSCLC). This week, the trial details were shared at a conference in Singapore. The trial showed Tagrisso plus chemotherapy reduced the
risk of disease progression or death by 38 percent compared to Tagrisso alone.
Tagrisso is already established as the trusted first-line standard of care for
EGFRm NSCLC.
Impressions: 644
https://www.pharmacompass.com/radio-compass-phisper/hhs-assails-merck-over-ira-lawsuit-moderna-partners-immatics-for-cancer-jabs
#Phispers by PharmaCompass
14 Sep 2023
Novartis has sued the US government in a bid to halt the Medicare drug-price negotiation program. The first list of drugs for price negotiation was released last week, and included Novartis’ heart failure treatment Entresto.The Federal Trade Commission (FTC) has given its approval to Amgen’s US$ 27.8 billion acquisition of Horizon, albeit with anti-competition restrictions.In trial news, Roche announced promising findings from a late-stage study evaluating Alecensa (alectinib) as an adjuvant treatment for patients with early lung cancer. Similarly, J&J’s Janssen unit has announced positive topline results from a late-stage study that evaluates Rybrevant in combination with chemotherapy in patients with a type of non-small cell lung cancer (NSCLC).Viatris has secured tentative FDA approval for a fixed-dose combination (FDC) of three drugs for the treatment of HIV-1 infection in pediatric patients.Sage Therapeutics
plans to reduce its workforce by 40 percent after the US Food and Drug
Administration (FDA) rejected its drug in a larger indication while approving
it as the first postpartum depression pill. And CSL Vifor, the merged entity
after CSL acquired Vifor Pharma last year, will be laying off 85 staff members.Post release of first list, Novartis sues
US govt over Medicare drug price regulationNovartis has sued the US government over Medicare drug price negotiations. This is the first lawsuit that has been filed by a drugmaker after the Biden administration released the first list last week. The list includes 10 drugs that will be subject to price negotiations and includes Novartis’ blockbuster heart-failure medication, Entresto.Through this lawsuit, Novartis joins companies such as Bristol Myers Squibb, J&J, and Merck that had filed lawsuits in
July, aiming to block the Medicare drug-price negotiation program.
In a statement, Novartis said the negotiations are unconstitutional.Meanwhile, Japanese drugmaker Astellas Pharma has withdrawn its lawsuit against the US government after its prostate cancer drug got spared from the first list.Roche
touts positive late-stage results for its targeted early-stage lung cancer drugRoche’s unit Genentech has announced promising findings from a late-stage study on people with early non-small cell lung cancer (NSCLC) that was driven by a well-known cancer gene, known as anaplastic lymphoma kinase (ALK). The patient population was given Roche’s Alecensa (alectinib) as an adjuvant treatment.
Compared to chemotherapy, Alecensa successfully achieved its
primary goal of improving disease-free survival. This makes Alecensa the first and only ALK inhibitor to demonstrate a
decreased risk of recurrence or mortality in early-stage ALK-positive NSCLC.Seagen-Genmab’s drug for cervical cancer: An antibody-drug conjugate (ADC)
co-developed by Seagen and Genmab — Tivdak (tisotumab vedotin-tftv) — has successfully achieved its primary goal of overall survival in a late-stage
trial involving patients with recurrent or metastatic cervical cancer who had
experienced disease progression following front-line therapy as compared to
chemotherapy alone. Tivdak is the first and only approved ADC for the treatment of this
patient population. It received accelerated approval in 2021.GSK
invests in Belgium plant: GSK plans to invest over €250 million (US$ 273 million) in constructing a new facility at its Wavre site in Belgium, set to become operational in 2027. The new unit will manufacture freeze-dried vaccines, including GSK’s new RSV jab Arexvy, shingles vaccine Shingrix and malaria vaccine Mosquirix.FTC
okays Amgen-Horizon deal, albeit with anti-competition restrictionsThe Federal Trade Commission (FTC) in the US has granted approval to Amgen’s US$ 27.8 billion acquisition of Horizon Therapeutics. However, the commission has
imposed restrictions that seek to prevent Amgen from using anti-competitive
tactics to extend its control over two drugs owned by Horizon. This agreement clears the uncertainty
surrounding the deal, which stemmed from FTC taking legal action in May over
concerns that Amgen may leverage rebates from its successful drugs to exert
influence over insurance companies and pharmacy benefit managers.Viatris bags FDA’s tentative approval for treatment of HIV in pediatric patientsViatris has secured tentative FDA approval for
a fixed-dose combination (FDC) of abacavir 60 mg, dolutegravir 5
mg, and lamivudine 30 mg tablets in oral suspension
form for the treatment of HIV-1 infection in pediatric patients weighing at
least 6 kg. This approval is anticipated to lessen the medication burden for children with HIV.Sage
lays off 40% staff after FDA rejects its major depressive disorder drugSage Therapeutics plans to reduce its workforce by approximately 188 employees,
which constitutes around 40 percent of its staff. This decision comes shortly
after FDA declined to approve Sage and Biogen’s drug for the treatment of major
depressive disorder last month, while approving it as the first postpartum
depression (PDD) pill.Meanwhile, CSL Vifor, the merged entity
created after CSL acquired Vifor Pharma for US$ 11.7 billion in August
last year, is laying off 85 staff members based in
California.J&J posts positive data from late-stage lung cancer trial; stops hypertension trialJohnson & Johnson’s Janssen unit has announced positive topline results from a late-stage study that evaluates Rybrevant (amivantamab-vmjw) and chemotherapy (carboplatin-pemetrexed) in combination with and without lazertinib, in patients with previously treated EGFR-mutant NSCLC. The drug combination plus chemo met its dual primary endpoint of progression-free survival as opposed to chemotherapy alone. Rybrevant is currently approved for subset of NSCLC. These results could move the drug to a larger area of NSCLC.Meanwhile, J&J has decided to stop a late-stage study that tests its experimental drug — macitentan — on patients with chronic thromboembolic pulmonary hypertension, a type of hypertension. Janssen has also pulled out of its deal with Idorsia
to develop an experimental hypertension drug, known as aprocitentan. Janssen has returned the rights for aprocitentan to
Idorsia. It had licensed rights to the drug in 2017.FDA rejects Astra’s Ultomiris for use in rare autoimmune disorderFDA has handed AstraZeneca a complete response letter (CRL) for its Ultomiris application in a rare autoimmune disease affecting the central
nervous system, known as neuromyelitis optica spectrum disorder (NMOSD). While the rejection didn’t raise safety or efficacy concerns, it has asked AstraZeneca to make modifications to its proposed Ultomiris risk evaluation and mitigation strategy (REMS).BioCardia’s cell therapy for heart failure fails to meet its primary endpoint In July, an independent data safety monitoring board had recommended pausing enrollment in a late-stage trial involving BioCardia’s CardiAMP cell therapy for heart failure. And now, the company says it has reported disappointing interim efficacy findings
from this late-stage trial. BioCardia says the therapy
did not meet its primary endpoint.
Impressions: 745
https://www.pharmacompass.com/radio-compass-phisper/novartis-sues-us-govt-over-medicare-drug-price-regulation-ftc-okays-amgen-horizon-deal
#Phispers by PharmaCompass
07 Sep 2023
After a year of signing the landmark Inflation Reduction
Act (IRA), this week the US government released the long-awaited list of 10 prescription
medications that will now be open to initial price negotiations under the US
Medicare health program.In approvals, Bristol Myers Squibb’s Reblozyl received US FDA (Food and Drug Administration) approval for first-line treatment of anemia in patients diagnosed with myelodysplastic syndromes (MDS) who may require regular RBC transfusions. Additionally, Sandoz’s biosimilar for BMS’ multiple sclerosis (MS) drug Tysabri also bagged FDA approval.In trial news, Novo Nordisk’s Wegovy injection resulted in significant reductions in heart failure in obese adults in a late-stage trial.In regulatory news, FDA issued a Form 483 to Gland Pharma
with two observations after a pre-market inspection of its Pashamylaram
facility in Hyderabad, India. The US agency rejected Outlook Therapeutics’ experimental eye disease drug due to manufacturing issues observed during pre-approval inspections. And, FDA issued a warning letter to California-based
eye drop manufacturer K.C. Pharmaceuticals, citing significant violations of
current good manufacturing practices (cGMP).US
releases list of first drug for price negotiations under MedicareBiden administration has released the long-awaited list of 10
prescription medications that will now be open to initial price negotiations
under the US Medicare health program
that caters to 66 million Americans, predominantly above the age of 65. The list comprises several prominent medications,
such as BMS and Pfizer’s widely sold blood thinner Eliquis, and its rival med from Johnson & Johnson Xarelto, Merck’s diabetes drug Januvia, and AbbVie’s treatment for leukemia Imbruvica. Other medicines chosen for
negotiations include Amgen’s rheumatoid arthritis drug Enbrel, Boehringer Ingelheim and Eli Lilly’s diabetes medication, Jardiance, J&J’s solution for arthritis and Crohn’s disease, Stelara, as well as insulin provided by Novo Nordisk. The revised prices of these
drugs will become effective in
2026. With this initiative, the US government hopes to save US$ 25 billion
annually on pharmaceutical expenses by 2031.Novo’s Wegovy reduces heart failure in obese patients in late-stage studyNovo announced encouraging outcomes from a late-stage study
involving their weekly Wegovy injection that showed significant reductions in
heart failure in obese adults. The trial compared Wegovy’s efficacy to a placebo in patients dealing with both obesity and heart failure with preserved ejection fraction (HFpEF) for one year. Earlier this month, in a separate late-stage study, Wegovy cut the risk of heart attacks and strokes by 20 percent.Catalent’s Indiana plant to make Novo’s Wegovy: Catalent’s plant in Bloomington, Indiana,
became the third facility to fill injection pens for Novo Nordisk’s Wegovy as part of the two companies’ expanded supply agreement, according to Reuters. Catalent’s factory in Brussels is the first site, with Thermo Fischer’s North Carolina facility joining it earlier this month. In response to surging demand in the US, the Danish drugmaker is putting concerted efforts to ramp up the drug’s production.Novo
acquires Embark Biotech for its diabetes, obesity treatments:
Novo Nordisk has bought Embark Biotech for €15 million upfront (US$ 16.3 million) and has agreed to pay up to €456 million (US$ 494.2 million) in milestones to maintain its dominance in the lucrative field of obesity and diabetes. The companies agreed to a three-year collaborative
effort in research and development aimed at discovering and creating innovative
pharmaceuticals for the treatment of obesity and associated conditions.Lilly’s diabetes drug to face shortage in Europe: The
European Medicines Agency (EMA) has announced shortage of Trulicity, Eli Lilly’s sought-after diabetes
medication, throughout September. Austria, Finland, Greece, Poland, and Sweden
are currently affected with a shortage of
Trulicity, with Denmark and Norway also expected to experience temporary
supply gaps.FDA expands use of BMS’ anemia med; Sandoz’s Tysabri biosimilar bags approvalBristol Myers Squibb’s
Reblozyl (luspatercept-aamt) received FDA approval as first-line treatment of anemia without prior
erythropoiesis stimulating agent (ESA) usage among adult patients diagnosed
with myelodysplastic syndromes (MDS) with very low-to intermediate-risk MDS who
may require regular red blood cell (RBC) transfusions. BMS had gained the drug
through the acquisition of Celgene in 2019 and marks Reblozyl’s third US approval in an anemia subgroup. The company targets US$ 4 billion in peak sales for the drug.FDA also approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster multiple sclerosis (MS)
treatment Tysabri, developed by Polpharma Biologics.
Tyruko is the first and only biosimilar approved as a mono-therapy to treat all indications covered by reference medicine Tysabri for relapsing forms of MS. Tysabri accounted for nearly 25 percent of Biogen’s revenue in 2022 by generating US$ 2.03 billion in sales.MHRA approves first seven-minute cancer jab: The
Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval to Roche’s Tecentriq SC (atezolizumab) injection, making it the first subcutaneous anti-PD-(L)1 cancer immunotherapy accessible to patients in the United Kingdom. Tecentriq’s SC injection utilizes Halozyme’s ENHANZE drug delivery technology, enabling an administration process that takes around seven minutes, in contrast to the 30 to 60 minutes required for intravenous infusion. Tecentriq’s subcutaneous variant will be accessible to eligible patients in Great Britain suffering with specific forms of lung, bladder, breast, and liver cancer.Pfizer’s RSV vaccine authorized in Europe: The European Commission (EC) has authorized Pfizer’s Abrysvo, a vaccine for respiratory syncytial virus (RSV) to protect newborns through maternal immunization during pregnancy. It has also been approved for adults 60 years of age and older in the European Union.The European Union has also recommended authorizing an
updated Covid vaccine from Pfizer and BioNTech which targets the dominant
XBB.1.5 variant of Omicron.FDA issues Form 483 to Gland’s India plant; rejects Outlook’s experimental eye drugFDA has issued a Form 483 with two observations
to Gland Pharma after a pre-market inspection of
its Pashamylaram facility in Hyderabad, India, conducted from August 23 to 26.
The observations reported
pertained to the ANDA filed for the product to be manufactured in a pen device.
There was no data integrity observation.The US agency has also declined to approve Outlook Therapeutics’ experimental eye disease
drug, in part due to manufacturing issues observed during pre-approval
inspections. Moreover, FDA has issued a warning letter to
California-based eye drop manufacturer K.C. Pharmaceuticals, citing significant violations
of current good manufacturing practices (cGMPs).
Impressions: 578
https://www.pharmacompass.com/radio-compass-phisper/us-names-first-10-drugs-to-face-price-negotiations-novo-s-wegovy-reduces-heart-failure-in-obese
#Phispers by PharmaCompass
31 Aug 2023
Like last week, this week too saw several drug approvals. The US Food and Drug Administration (FDA) approved Regeneron’s Veopoz for the treatment of CHAPLE disease (CD55-deficient protein-losing enteropathy) in both adults and pediatric patients aged one year and above. The agency also approved the company’s higher dose Eylea for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Pfizer’s RSV vaccine also bagged FDA’s nod for use in pregnant women to protect babies.In news from clinical trials, Merck announced positive results from a late-stage trial of belzutifan in advanced renal cell carcinoma. Eli Lilly’s Retevmo also posted positive results from a late-stage study for the treatment of thyroid cancer.Novo
Nordisk has hired Thermo Fisher as the second contract manufacturer for its
immensely popular weight-loss drug Wegovy.Meanwhile, FDA commissioner Robert Califf has termed drug shortages in the US as a ‘national security threat’ and has cited the low prices of generic drugs as the key reason behind these shortages. And FDA has issued a partial clinical hold on Gilead Sciences’ late-stage clinical trials evaluating magrolimab in acute myeloid leukemia (AML) patients.FDA chief says drug shortages due to low-priced generics; terms it a ‘security threat’FDA
commissioner Robert Califf has pointed out low generic drug prices in the US as a key contributor to the ongoing drug shortages. Speaking at a webinar hosted by the Alliance for a Stronger FDA, Califf said US drug shortages now constitute a “national security threat”.Califf said drug shortages aren’t good for society. The “fundamental problem,” according to him, stems from the fact that the US essentially has “two drug industries.” There’s the “innovator industry,” where Califf said he thinks “the prices are too high,” and then there’s the generics industry, where “a lot of the prices are too low.”Twin wins for Regeneron — ultra rare disease drug, higher
dose Eylea bag FDA nodsIt was a good week for Regeneron as two of its drugs
bagged FDA approvals. The agency granted approval to Regeneron Pharmaceuticals’ Veopoz (pozelimab) for the treatment of CHAPLE disease (CD55-deficient protein-losing enteropathy) in both adults and pediatric patients aged one year and above. This approval makes Veopoz the first and only treatment for CHAPLE, an ultra-rare hereditary immune disorder characterized by
excessive activation of the complement system, leading to severe health risks.
Fewer than 10 patients suffer with CHAPLE disease in the US.The other drug that was okayed by the FDA was Regeneron’s Eylea HD (aflibercept) injection 8 mg — a higher dose version of Eylea 2 mg. Developed in collaboration with Bayer, Eylea HD is the first and only treatment
approved in wet age-related macular degeneration (wAMD), diabetic macular edema
(DME) and diabetic retinopathy (DR) for immediate dosing at eight-week and up
to 16-week intervals following three initial monthly doses.FDA approves Pfizer’s RSV vaccine for maternal use to protect babiesFDA has approved Pfizer’s Abrysvo as the first and only respiratory syncytial virus (RSV)
vaccine for infants through active immunization of pregnant women to prevent lower respiratory tract
infection and severe disease in infants lesser than six months of age. The
vaccine was approved for use in adults aged 60 and older in May 2023.Novo hires Thermo Fisher as second
contract manufacturer for WegovyNovo Nordisk has been struggling to
boost supplies of its immensely popular weight-loss drug Wegovy ever since production problems emerged at Catalent’s Brussels facility in 2021. According to a Reuters news, Novo has now hired Thermo Fisher as the second contract
manufacturer to manufacture the drug. According to the report, Thermo Fisher is doing the filling of the Wegovy injection pens at its factory in Greenville, North Carolina.Merck
reports positive late-stage trial results for Welireg in advanced renal cancerIn a recent late-stage study, Merck’s Welireg (belzutifan) met the primary goal of progression-free
survival in patients with advanced renal cell carcinoma (RCC), a stage of
cancer that spreads from the kidneys to distant parts of the body, compared to Novartis’ Afinitor. With this, the company is looking to expand the drug into broader RCC use
and turn it into a blockbuster.Lilly’s Retevmo scores win in late-stage thyroid cancer trial: In
a late-stage study, Eli Lilly’s FDA-approved RET kinase inhibitor drug,
Retevmo (selpercatinib), successfully achieved its
primary goal of progression-free survival in the initial treatment of patients
with advanced or metastatic rearranged during transfection (RET)-mutant
medullary thyroid cancer (MTC). The trial involved a comparison between Retevmo and the physician’s choice of multikinase inhibitors, namely Exelixis’ Cabometyx (cabozantinib) and Sanofi’s Caprelsa (vandetanib).Boehringer to begin three late-stage studies on its obesity drug: Boehringer Ingelheim will conduct three late-stage
trials on its glucagon/GLP-1 receptor dual agonist drug, survodutide, in individuals dealing with excess weight and/or
obesity. This decision is supported by results from a mid-stage trial, which
revealed weight loss of up to 19 percent in overweight/obese individuals
after undergoing 46 weeks of treatment with survodutide.Roche inadvertently discloses positive interim trial data: Roche accidentally published positive late-stage trial data on its lung cancer drug from an interim analysis, thereby boosting the company’s share price. The study evaluates its investigational immunotherapy tiragolumab in combination with its established immune-oncology drug Tecentriq versus Tecentriq alone for people with
lung cancer. The analysis published is not yet statistically significant.FDA puts Gilead’s leukemia trials on hold: FDA
has issued a partial clinical hold on Gilead Sciences’ late-stage clinical trials for magrolimab, the company’s investigational drug for acute myeloid leukemia
(AML). This decision comes subsequent to
the discontinuation of the late-stage combination study of magrolimab and azacitidine in higher-risk myelodysplastic
syndromes (HR-MDS) in July 2023.Spanish agency identifies 63 deficiencies at Serra Pamies’ Spain facilityThe Spanish Agency of Medicines and Medical Devices has identified multiple issues at Serra Pamies’ Reus, Spain, facility. According to the European Directorate for the Quality of Medicines (EDQM), the company did not meet the standards of cGMP during an inspection in May and June 2023. The inspection findings revealed a total of 63 deficiencies, out of which 19 were categorized as “major”. The European Medicines Agency (EMA) has suspended production at the plant.FDA warning over contaminated eye drops: FDA has issued a warning against buying or using certain eye drops from Dr Berne’s and LightEyez due to microbial contamination. The drops contain methylsulfonylmethane or MSM. The products containing MSM as
an active ingredient, are unapproved drugs and illegally marketed in the U.S.
Impressions: 885
https://www.pharmacompass.com/radio-compass-phisper/two-regeneron-drugs-bag-approval-fda-chief-links-drug-shortages-to-low-priced-generics
#Phispers by PharmaCompass
24 Aug 2023
This was a week of drug approvals. The US Food and Drug Administration (FDA) granted accelerated approvals to two cancer therapies — Talvey by Johnson & Johnson (J&J) and Elrexfio by Pfizer. The agency also approved Ipsen’s rare bone disorder drug Sohonos, and Janssen’s Akeega (niraparib and abiraterone acetate) for the treatment of adult patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). Additionally, the agency approved Revance Therapeutics’ Daxxify as the first long-acting treatment for cervical dystonia.Following last week’s promising update on Novo’s obesity drug Wegovy, which lowers heart attack risks by 20 percent, there are more updates this week from the drugmaker. The company is acquiring Canadian obesity drugmaker Inversago for up to US$ 1.08 billion. Its obesity drug Wegovy’s sales increased by over 30 percent during the last quarter to touch Danish Krone (DKK) 7.5 billion (US$ 1.1 billion).In dealmaking news, Gilead has entered into three multi-year collaborations with Tentarix Biotherapeutics to develop novel therapies for cancer and inflammatory diseases. And a combination of Seagen’s therapy Tukysa and Roche’s Kadcyla met the main goal in some breast cancer patients in a late-stage study. Seagen was bought over by Pfizer for US$ 43 billion in March this year.J&J, Pfizer’s cancer therapies bag FDA’s accelerated approvalsJohnson & Johnson’s pharmaceutical unit Janssen has received FDA’s accelerated approval for Talvey (talquetamab-tgvs), a first-in-class bispecific antibody therapy designed to treat adult patients dealing with relapsed or refractory
multiple myeloma (RRMM) who have received at least four prior lines of therapy.
Talvey, a weekly or biweekly subcutaneous injection, works by targeting a
protein GPRC5D. The company expects the therapy to be accessible to patients
within a span of three weeks. Talvey will be marketed at a list price of US$
45,000 per month.FDA has also
granted accelerated approval to Pfizer’s blood cancer treatment, Elrexfio
(elranatamab-bcmm). This therapy is the first ready-to-use subcutaneous B-cell maturation
antigen-directed agent in the US designed for adults with RRMM, a
difficult-to-treat type of blood cancer. Elrexfio will carry list prices of US$
7,556 and US$ 13,051 for the 44 mg and 76 mg vials respectively.In addition, the
agency has also granted approval to Janssen’s Akeega (niraparib and abiraterone acetate), a fixed dose combination given with prednisone, for the treatment of adult patients
with deleterious or suspected deleterious BRCA-positive metastatic
castration-resistant prostate cancer (mCRPC), as detected by an FDA-approved
test.Novo to acquire Inversago Pharma for up
to US$ 1.08 billionNovo Nordisk will acquire Canada-based Inversago for
up to US$ 1.075 billion in cash, contingent upon the achievement of specific development and commercial
goals. Through this acquisition, Novo will gain access to Inversago’s primary developmental asset INV-202, an
oral cannabinoid receptor blocker. In an early stage
trial, INV-202 displayed the potential for weight loss and is presently
undergoing a mid-stage trial to address diabetic kidney disease. The company
aims to explore the possible applications of INV-202 in treating obesity and
its associated complications. Furthermore, Inversago is actively working on
additional pipeline assets designed for metabolic and fibrotic disorders.In its second quarter (Q2) results, Novo Nordisk reported 158
percent sales growth in the segment of obesity, with Wegovy contributing DKK 7.5 billion
(approximately US$ 1.1 billion). The total revenue increased 30 percent, reaching DKK 107.7 billion (US$ 15.8
billion) as compared to the previous year.Meanwhile, Novo
is further evaluating results from Wegovy’s five-year trial for additional health advantages in areas such as kidney disease, heart failure, and the likelihood of hospitalization. The company plans to seek regulatory approval for incorporating the cardiovascular advantage into the drug’s label.FDA okays Ipsen’s rare bone disorder drug — SohonosFDA
has approved Ipsen’s drug to treat fibrodysplasia ossificans progressiva (FOP), a rare genetic connective tissue disorder that causes progressive loss of mobility and reduced life expectancy. The drug — Sohonos — was approved in adults and pediatric
patients with FOP.Meanwhile, Peter Marks, FDA’s biologics center director told Endpoints
News that “the agency plans to encourage sponsors to use the accelerated approval pathway”, particularly for rare disease treatments, as the agency also moves ahead with an Operation Warp Speed-like pilot for rare diseases later this year.FDA approves Revance’s Daxxify as first long-acting treatment for cervical dystoniaFDA has approved Revance Therapeutics’ Daxxify (daxibotulinumtoxinA) as the first long-acting treatment for cervical dystonia, a rare condition in which the neck muscles
involuntarily contract into abnormal positions in
adults. It is the first and only peptide-based, long-acting neuromodulator designed to address patients’ needs for improved treatment outcomes. Daxxify received orphan drug designation from the FDA for treating cervical
dystonia in adults in 2017. It was further approved as an anti-wrinkle
injection in September 2022, competing with AbbVie’s Botox.Seagen’s Tukysa meets main goal in breast cancer study: A
combination of Seagen’s therapy, Tukysa and Roche’s Kadcyla (ado-trastuzumab emtansine) met the primary endpoint of progression-free survival in a late-stage study on some breast cancer patients. The study reported that the combination extended the patient’ lives without their disease worsening. Seagen was bought over by Pfizer for US$ 43 billion in March this year.Gilead partners with Tentarix for cancer,
inflammatory treatmentsGilead Sciences has entered into three multi-year collaborations with Tentarix Biotherapeutics to develop novel therapies for cancer
and inflammatory diseases. Tentarix will get upfront payments and equity worth US$ 66 million from
Gilead. The latter also has the option to acquire up to three select Tentarix
subsidiaries containing the programs developed under the collaborations for US$ 80 million per subsidiary. The agreement provides Gilead access to Tentarix’s proprietary drug development platform known as Tentacles, dedicated to the discovery and formulation of multi-functional, conditional protein therapeutics for both cancer and inflammatory diseases.Harmony to acquire Zynerba for US$ 200 million: Harmony Biosciences will acquire Zynerba Pharmaceuticals for up to US$ 200 million upfront, in a bid to deepen and diversify its
portfolio, particularly in rare neuropsychiatric disorders. This buyout gives Harmony access to Zynerba’s lead asset Zygel, the first and only pharmaceutically manufactured, synthetic non-euphoric cannabidiol gel for transdermal delivery. It is currently in a late-stage trial for Fragile X syndrome, a genetic disorder for which there are no approved therapies.
Impressions: 593
https://www.pharmacompass.com/radio-compass-phisper/fda-grants-accelerated-nods-to-j-j-pfizer-s-blood-cancer-therapies-ipsen-s-rare-disease-drug-approved
#Phispers by PharmaCompass
17 Aug 2023
This week, we bring you news about Nektar Therapeutics filing a lawsuit against Eli Lilly for undermining the potential of a drug the two drugmakers were jointly developing to treat autoimmune diseases.A late-stage study conducted by Novo Nordisk on Wegovy showed that the obesity med lowers the risk of cardiovascular death, heart attack, or stroke by 20 percent. Eli Lilly’s diabetes drug Mounjaro, on the other hand, saw its sales rise by over 72.3 percent during the last quarter to touch US$ 979.7 million.In approvals, Biogen and Sage Therapeutics’ oral pill, Zurzuvae (zuranolone), bagged US Food and Drug Administration’s (FDA) nod to treat postpartum depression (PPD). However, Zurzuvae got rejected as a treatment for major depressive disorder (MDD). And, Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) received FDA approval to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).Meanwhile, the World Health Organization (WHO) has identified yet another Indian manufacturer producing contaminated common cold syrup, this time in Iraq. AstraZeneca inked an mRNA manufacturing deal with China’s CanSino Biologics for the supply of mRNA products. And Emergent BioSolutions has revealed plans to downsize its contract development and manufacturing organization (CDMO) services business at select facilities and cut 400 jobs.Nektar sues Lilly for botching up analysis of formerly
partnered drug rezpegNektar Therapeutics has filed a lawsuit against Eli Lilly, accusing the company of undermining the potential of rezpegaldesleukin, a drug they were jointly developing to treat autoimmune diseases. In 2017, both companies had formed a partnership to develop and potentially market the drug. The complaint, submitted in a federal court, alleges breach of contract, negligent misrepresentation, unfair
competition, and other misconduct by Lilly. The lawsuit seeks various remedies,
including compensatory and punitive damages.Nektar, which
regained full control of the drug this year after the partnership ended in
April, also highlighted that Lilly had inaccurately reported data from two
early-stage studies involving rezpegaldesleukin for treating eczema and
psoriasis.Novo’s obesity drug Wegovy lowers heart attack risks by 20 percentNovo Nordisk’s recent late-stage study on Wegovy (semaglutide 2.4 mg) to prevent major cardiovascular
events met its primary goal by reporting a 20 percent drop in the risk of cardiovascular death,
heart attack, or stroke in overweight and obese patients. These findings hold
potential to sway insurers in the US and cost-conscious health authorities in
Europe to extend coverage for Wegovy to a wider patient group.Mounjaro Q2 sales skyrocket: Eli Lilly’s diabetes drug, Mounjaro, witnessed significant growth in second quarter (Q2) and is likely to
be approved soon to treat obesity. Sales of Mounjaro leaped by 72.3 percent to reach US$ 979.7 million in Q2 of this year. Lilly’s global revenue for Q2 2023 reached US$ 8.31 billion, marking an increase of 28 percent.Biogen, Sage’s Zurzuvae approved for postpartum depression, rejected for MDDBiogen and Sage Therapeutics’ oral pill, Zurzuvae (zuranolone) received FDA approval for treating postpartum depression
(PPD) in women, making it the first and only daily oral treatment for
PPD with rapid efficacy. The pill is likely to become available for
commercial use in Q4 2023.The drug’s approval, however, was overshadowed by its
rejection to treat another, more common condition known as major depressive
disorder (MDD).Vistagen’s social anxiety nasal spray achieves late-stage study goals: Vistagen Therapeutics reported positive data from its late-stage trial evaluating its investigational nasal spray — fasedienol — for the treatment of social anxiety disorder.Astellas eye drug Izervay bags FDA nod: Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) received FDA approval to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Izervay is the first GA treatment proven to significantly slow progression in two late-stage trials, even at six months.CDC okays Sanofi-Astra’s RSV therapy for infants: Centers for Disease Control and Prevention (CDC) has endorsed the use of Sanofi and AstraZeneca, Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) in infants and toddlers. Beyfortus will be available before the 2023-2024 RSV season.FDA rejects Mesoblast’s cell therapy for kids: FDA has rejected Mesoblast’s biologics license application (BLA) resubmission for remestemcel-L, a cell therapy for children under 12 years of age for treating a
type of complication that occurs after a stem cell or bone marrow transplant. Mesoblast had received a CRL for the same BLA in October 2020.
Currently, there are no approved treatments for this condition in children.WHO flags yet another contaminated India-made cough syrup,
this time in IraqThe WHO has identified yet another Indian manufacturer
producing contaminated common cold syrup. The agency found a batch of Cold Out
(paracetamol and chlorpheniramine maleate) cough syrup in Iraq that was found to be substandard. It was
manufactured by Fourrts (India)
Laboratories for Dabilife Pharma. The batch contained high levels of contaminants,
specifically diethylene glycol and ethylene glycol.Astra, CanSino sign mRNA deal: AstraZeneca has signed an mRNA manufacturing deal with China’s CanSino Biologics for the supply of unspecified mRNA
products aimed at supporting its mRNA vaccine initiative. The
financial details of the deal were not disclosed.Emergent to downsize, cut 400 jobs: Emergent BioSolutions has revealed plans to downsize its CDMO services business
at select facilities and cut 400 jobs. These changes, along with other initiatives, are projected to save over US$ 100 million annually.Mirati CEO steps down: In its Q2 report, Mirati Therapeutics made public the departure of its CEO, David Meek. The report revealed
that their non-small cell lung cancer (NSCLC) drug, Krazati, generated a net revenue of US$ 13.4 million, in contrast to Amgen’s Lumakras, which achieved sales of US$ 77 million during
the same period. The report also stated that Mirati plans to commence a
late-stage study by the end of 2023, evaluating the combination of Krazati with
Merck’s Keytruda (pembrolizumab) in first-line
NSCLC.
Impressions: 1047
https://www.pharmacompass.com/radio-compass-phisper/nektar-sues-lilly-over-incorrect-analysis-of-rezpeg-data-novo-s-wegovy-reduces-heart-attack-risk-by-20
#Phispers by PharmaCompass
10 Aug 2023
In this week’s Phispers, we bring you news on Biogen’s US$ 7.3 billion acquisition of Texas-based biotech Reata Pharmaceuticals to strengthen its rare disease portfolio. AstraZeneca’s rare diseases unit Alexion has bought Pfizer’s gene therapy portfolio for up to US$ 1 billion.In approvals, the US Food and Drug Administration (FDA)
has granted approval to GSK's Jemperli in combination with chemotherapy as
first-line treatment for endometrial cancer.GSK has sued Pfizer over violation of four of its respiratory syncytial virus
(RSV) vaccine patents. Pfizer and Roche have reported decline in second quarter (Q2) revenues due to a sharp drop in sales of their Covid products.In news from clinical trials, Merck has announced positive results from late-stage trial of Keytruda in combination with chemotherapy for the treatment of high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. Lilly’s experimental obesity drug, Mounjaro, has helped patients lose 26 percent of weight on average in two late-stage studies.In regulatory news, the US Food and Drug Administration
(FDA) has issued a warning letter to Intas Pharmaceuticals’ Gujarat facility in India for violations of current
good manufacturing practices (cGMPs). And India has found violations of both
manufacturing and laboratory practices at Riemann Labs, the company that made Naturcold cough syrup. A batch of Riemann’s cough syrup was linked to the death of at least six children in Cameroon.Biogen
to acquire Reata for US$ 7.3 billion to boost rare disease portfolioBiogen has agreed to acquire rare disease drugmaker Reata Pharmaceuticals for approximately US$ 7.3 billion. The acquisition will give Biogen access to Reata’s FDA-approved drug Skyclarys, the first and only treatment
approved for Friedreich’s ataxia, a rare genetic disorder that damages the nervous system in adults and adolescents aged 16 years and older. Skyclarys was approved in the US in February this year. Analysts expect the drug to touch US$ 1.3 billion in sales by 2029.Astra’s rare disease unit to buy Pfizer’s gene therapies: AstraZeneca’s rare disease subsidiary, Alexion Pharmaceuticals, has reached an agreement to buy Pfizer’s portfolio of preclinical gene therapy programs and
enabling technologies for up to US$ 1 billion. The deal will give Alexion access to Pfizer’s novel adeno-associated virus (AAV) capsids, known for their effectiveness in delivering therapeutic gene cargos for gene therapy and gene editing.GSK
sues Pfizer over violation of four of its RSV shot patentsGSK has taken Pfizer to court in the US alleging that the New York-headquartered drugmaker’s RSV vaccine Abrysvo violates GSK’s patent rights in its rival RSV shot Arexvy. The British pharma giant states that Abrysvo infringed on four patents the company has for Arexvy. The lawsuit alleges that Pfizer knowingly used a number of vaccine ingredients developed by GSK and protected under GSK’s patents “without permission.” GSK also noted that its vaccine was in development seven years prior to Pfizer’s. Both Pfizer and GSK’s vaccines were approved by the FDA for patients 60 years or older in May this year.Pfizer, Roche report drop in Q2 revenues
due to fall in sales of Covid productsPfizer reported a
significant decline in the second quarter (Q2) sales with revenue of US$ 12.7 billion,
a decline of 54 percent compared to Q2 2022. Sales of its Covid-19 vaccine
Comirnaty fell 83 percent to US$ 1.49 billion, and its antiviral
treatment Paxlovid fell 98 percent to US$ 143 million.
Pfizer has said it is prepared to cut costs if Covid-related revenue continues to
disappoint this year.Meanwhile, Roche’s Q2 group sales also fell by two percent due to a falling demand
for Covid-19 products. However, excluding Covid-19 products, there is an eight
percent rise in group sales.GSK’s Jemperli bags FDA nod as first-line treatment for endometrial cancerGSK has received FDA approval for its oncology drug Jemperli (dostarlimab) combined with chemotherapy (carboplatin and paclitaxel) as the first frontline treatment option for adult patients with
primary advanced or recurrent endometrial cancer. A marketing authorization
application is also under review by the European Medicines Agency (EMA). This
approval positions Jemperli ahead of Merck’s Keytruda as the potential first-line treatment for endometrial cancer.Merck’s Keytruda shows gains in ER+/HER2- breast cancer trial: Merck announced positive late-stage study results of its
blockbuster drug Keytruda (pembrolizumab) along with chemotherapy in the treatment of high-risk, early-stage estrogen receptor-positive,
human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
The study showed that the combination of Keytruda and chemotherapy was able to
help clear all signs of tumor in patients compared to neo-adjuvant placebo plus
chemotherapy.Meanwhile, Merck’s investigational 21-valent pneumococcal conjugate vaccine – V116 – has achieved positive outcomes in two late-stage trials. If approved,
V116 will be the first pneumococcal conjugate vaccine specifically designed for adults.Lilly’s Mounjaro leads to 26% weight loss: Eli Lilly has reported positive results from two late-stage trials of its
experimental obesity drug, Mounjaro (tirzepatide), being tested in overweight and obese patients without type 2
diabetes. Patients experienced an average weight reduction of 26.6 percent
after intensive lifestyle changes or with continued treatment before stopping
the drug. Mounjaro had bagged FDA approval to treat adults with type 2 diabetes in
May 2022.FDA issues warning letter to Intas’ India facility for cGMP violationsFDA has issued a warning letter to Intas Pharmaceuticals’ drug manufacturing facility in Sanand (Gujarat, India) for multiple violations of cGMPs. The letter highlights several
issues related to data, quality, and the failure to establish and follow
necessary laboratory control procedures. Prior to this
warning letter, FDA had issued a Form 483 with 11
observations to the same facility in December 2022, alleging that its employees
had destroyed manufacturing-related documents.India
finds violations at Riemann Labs in Cameroon cough syrup caseIndia has found violations of both manufacturing and laboratory practices at Riemann Labs, the company that made Naturcold cough syrup. A batch of Riemann’s cough syrup was linked to the death of at least six children in Cameroon.Regulators inspected the company’s production unit in the state of Madhya Pradesh in India and issued a notice after finding lapses, the state’s drug controller said. The Indian government has directed Riemann Labs to stop all manufacturing
activities. Riemann Labs is the fourth Indian cough syrup maker to stop production after regulators found lapses.Meanwhile, India
has found multiple deficiencies among drugmakers following wide-ranging inspections across the country’s pharmaceutical industry, including a lack of raw materials testing.
Impressions: 1009
https://www.pharmacompass.com/radio-compass-phisper/biogen-to-acquire-reata-for-us-7-3-billion-gsk-sues-pfizer-for-violation-of-its-rsv-jab-patents
#Phispers by PharmaCompass
03 Aug 2023
Pfizer’s manufacturing facility in Rocky Mount, North Carolina, suffered significant damage due to last week’s tornado. The company has notified
hospitals of the possibility of supply disruptions of over 30 drugs produced at
the plant.After bagging two drug approvals during the last quarter, Biogen has embarked on a ‘Fit for Growth’ cost-cutting program wherein 1,000 employees will be laid off to save US$ 1 billion.FDA has okayed Daiichi Sankyo’s Vanflyta for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML). And Emergent’s anthrax vaccine — Cyfendus — was granted FDA approval in adults.Meanwhile, Mirati’s Krazati received the European Medicines Agency’s (EMA) negative opinion for lung cancer. And Gilead has halted a late-stage trial of a combination of two drugs to treat a rare type of blood cancer.In regulatory news, Biocon’s Malaysia facility and Aurobindo’s Telangana facility in India received FDA’s Form 483s.Pfizer
warns of supply disruptions after tornado damages its NC facilityPfizer’s manufacturing facility in Rocky Mount, North Carolina, suffered significant damage from a tornado, completely
destroying the warehouse that stored raw materials, packaging supplies, and
finished medicines awaiting release. The production facilities at the site did not report of major damage. Pfizer notified
hospitals of the possibility of supply disruptions of over 30 drugs produced at
the plant, including crucial drugs used in surgery and critical care.
FDA is closely working with Pfizer to assess the damage and is
taking mitigation steps to avoid immediate supply shortages.Ends agreement with Syros: Pfizer has decided to terminate
its license agreement with Syros Pharmaceuticals,
which involved working together on innovative therapies for sickle cell disease and beta-thalassemia. This decision also marks the end of Syros’ three year old partnership with Global Blood Therapeutics
(GBT), a sickle cell disease drugmaker that Pfizer acquired for US$ 5.4 billion in August 2022.Biogen to cut 1,000 jobs as part of its
US$ 1 billion expense saving programDuring the last
quarter, Biogen had bagged two FDA approvals — Leqembi for Alzheimer’s disease and Qalsody for ALS. Now, Biogen plans to shift its
resources to these areas of higher value creation. Therefore, the company plans to cut 1,000 jobs, out of a worldwide employee strength of 8,725, as part of its “Fit for Growth” cost-cutting program that seeks to achieve US$ 1
billion in gross operating expense savings. Approximately US$ 300 million of this will be reinvested in product launches and R&D programs.Mirati’s lung cancer drug Krazati receives EMA’s negative opinionMirati Therapeutics’ Krazati (adagrasib), a non-small cell lung cancer (NSCLC) KRAS inhibitor, received a negative opinion on its application for conditional marketing authorisation from the EMA’s Committee for Medicinal Products for Human Use (CHMP). It expressed concerns about the lack of comprehensive data and uncertainties regarding the medicine’s effectiveness.UK reviews safety data of diabetes,
weight loss meds sold by Novo, Astra, Sanofi, LillyBritain’s Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing a class of drugs known as GLP-1 receptor agonists used for weight management and to treat diabetes after some patients reported suicidal or self-harming thoughts. Similar action was taken by the European Union two
weeks back. The drugs being reviewed are Novo’s Ozempic and Saxenda, AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide and Eli Lilly’s dulaglutide.Gilead halts late-stage blood cancer trial: Gilead
Sciences has decided
to halt a late-stage trial of
the combination
treatment of magrolimab and azacitidine for the treatment of a rare but severe form of blood cancer, known as higher-risk myelodysplastic syndromes (HR-MDS), in adults. The decision came after an analysis revealed that the drug combination would not be effective for treating the condition.Bavarian Nordic ends RSV vaccine trial: Bavarian Nordic will discontinue its late-stage trial for respiratory
syncytial virus (RSV) vaccine candidate, MVA-BN RSV, intended for adults aged 60
and above. The vaccine did not meet all the primary objectives of preventing
lower respiratory tract disease caused by RSV. Based on this outcome, Bavarian
Nordic will discontinue its RSV program.Verrica Pharma’s Ycanth bags FDA nod for viral skin infectionVerrica Pharmaceuticals’ Ycanth (cantharidin) has bagged an FDA approval, making it the first approved
drug-device combination product for the treatment of Molluscum contagiosum, a
viral skin infection that affects both adults and children. Ycanth is expected
to be available by September. Prior to the approval, the drug had faced
rejections in 2020, 2021 and 2022.FDA okays Daiichi’s Vanflyta for newly diagnosed leukemia: Daiichi Sankyo’s Vanflyta (quizartinib) was granted FDA approval for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. This is an aggressive form of leukemia. Vanflyta will be available in the coming weeks. In 2019, an FDA advisory panel had voted 8-3 against Vanflyta’s approval, as they believed the safety risks for AML patients outweighed the potential efficacy benefit. The drug got approved in Japan in May 2023. FDA approves Emergent’s anthrax vaccine: Emergent BioSolutions has bagged FDA approval of its anthrax vaccine, Cyfendus, for post-exposure prophylaxis
of disease following suspected or confirmed exposure to Bacillus anthracis in adults aged between 18 to 65 years. Emergent
has been supplying Cyfendus to the US Department of Health and Human Services
since 2019 under pre-emergency use authorization status.Biocon’s Malaysia facility, Aurobindo’s India facility receive FDA’s Form 483FDA has issued a Form 483 with six observations to Biocon Biologics’ Malaysia insulin facility. The inspection of the facility was conducted from July 10 to 20. The company said the observations were primarily related to enhancing operational procedures and strengthening training programs. FDA has also issued a Form 483 with three observations to Aurobindo Pharma’s Unit III formulation manufacturing facility in
Telangana, India. The inspection of the facility was conducted from July 14 to
21, and has ended with three observations. The company said the observations
were procedural in nature.
Impressions: 1390
https://www.pharmacompass.com/radio-compass-phisper/pfizer-s-nc-facility-damaged-by-tornado-may-worsen-drug-shortages-biogen-to-cut-1-000-jobs
#Phispers by PharmaCompass
27 Jul 2023
Last week, Biogen-Eisai’s Leqembi became the first med for Alzheimer’s to bag FDA’s full approval. And this week, there is news that Eli Lilly’s Alzheimer’s drug, donanemab, has shown greater benefit in earlier stages of Alzheimer’s disease in a late-stage trial.The US Food and Drug Administration (FDA) has granted approval to Sanofi-AstraZeneca’s respiratory syncytial virus (RSV) antibody therapy, Beyfortus (nirsevimab-alip), for newborns and infants.In deals, Eli Lilly acquired New York-headquartered
biopharma Versanis for a potential US$ 1.93 billion to boost its weight-loss
portfolio. And Roche is reportedly in talks with Roivant to buy its bowel
disease treatment for over US$ 7 billion.In regulatory news, new draft guidelines on merger and acquisitions were unveiled in the US to draw up a tougher framework on mergers and acquisitions. And FDA has issued Form 483 to Indian drugmaker Gland Pharma for violations at its Dundigal facility in Hyderabad, India.In news from clinical trials, BridgeBio’s experimental heart drug — acoramidis —demonstrated significant effectiveness in a late-stage trial for transthyretin amyloid cardiomyopathy, a rare heart disease. And results from early stage Alzheimer’s trials on Alnylam’s RNAi therapy and Acumen’s experimental drug have shown promising results.Lilly’s donanemab slows early stage Alzheimer’s by 60% for mildly impaired patientsThis fortnight, there has been a lot of news on Alzheimer’s drugs. Last week, Biogen-Eisai’s Leqembi became the first med for Alzheimer’s to bag FDA’s full approval. And this week, there is news from a late-stage trial on Eli Lilly’s donanemab — the med has shown significant reduction in cognitive and functional decline in early symptomatic Alzheimer’s disease patients.Donanemab slows progression of memory and thinking problems by
about a third, but that rate doubles to 60 percent if the drug is started when
patients are only mildly impaired.Lilly has submitted its application for full approval to the FDA and expects regulatory action by the year-end. Submissions to other global regulatory bodies are currently in progress and are likely to be finalized by the year-end. Like Biogen-Eisai’s Leqembi, donanemab is an intravenous antibody targeting beta amyloid protein in Alzheimer’s patients’ brains.Promising results for Alnylam’s RNAi therapy: Alnylam Pharmaceuticals has shared promising early-stage findings for ALN-APP
(amyloid precursor protein), the first experimental RNAi therapy designed to
silence genes in the human brain. ALN-APP has demonstrated rapid and sustained
reduction in amyloid precursor protein levels in the cerebrospinal fluid,
indicating effective targeting. ALN-APP has been developed by Alnylam in
collaboration with Regeneron Pharmaceuticals. Meanwhile, Acumen Pharmaceuticals’ ACU193, an experimental Alzheimer's
drug, has also shown compelling safety profile in an early-stage trial.FDA approves Sanofi-AstraZeneca’s RSV therapy for newborns, infantsSanofi-AstraZeneca’s respiratory syncytial virus (RSV) antibody therapy, Beyfortus
(nirsevimab-alip), has received approval from the FDA. It is a
long-acting treatment that can be given once per season. The approval is
specifically developed for newborns and infants and is given before or
during their first RSV season. It can also be given to children up to 24 months who remain
vulnerable to severe RSV disease through their second RSV season.Opill now an OTC birth control pill in US: Opill (norgestrel), Perrigo’s oral
contraceptive pill, has bagged FDA approval and will be available over the counter (OTC) in the US. This makes Opill the first daily non-prescription
contraceptive pill available in the US for all ages.Lilly to buy Versanis for US$
1.93 billion to boost weight-loss portfolioEli Lilly has bolstered its weight-loss
portfolio with the acquisition of New York-headquartered
biopharma Versanis for a potential value of US$ 1.93 billion. Through this deal, Lilly will get access to Versanis’ lead asset, bimagrumab, an experimental obesity drug currently being assessed in mid-stage study alone and in combination
with semaglutide, a rival Novo Nordisk weight-loss
treatment marketed as Wegovy and Ozempic. Bimagrumab is a monoclonal
antibody that acts directly on fat cells without reducing appetite and without prompting loss of lean mass.Roche in talks to buy Roivant’s bowel disease treatment for over US$ 7 bn, says WSJA report in the Wall Street Journal says Roche is nearing a deal worth over US$ 7 billion to acquire RVT-3101, an
experimental bowel disease treatment developed by Roivant Sciences focused on addressing conditions such as ulcerative colitis and Crohn’s disease.Europe declines authorization to Ipsen’s drug to treat rare genetic muscle disorderThe European Commission has followed guidance provided by the Committee
for Medicinal Products for
Human Use (CHMP) in May this year, and has not granted marketing
authorization for palovarotene, an
investigational treatment for fibrodysplasia ossificans progressiva (FOP). Ipsen’s Palovarotene is the first treatment to be submitted anywhere
in the world for regulatory approval for FOP, an ultra-rare disease with
approximately 900 known cases worldwide.BridgeBio’s heart drug meets study goal: BridgeBio Pharma’s acoramidis, an experimental drug, has demonstrated
significant effectiveness in a late-stage trial for transthyretin amyloid
cardiomyopathy. The drug showed an 81 percent improvement in patient survival compared to a placebo and presented a 92 percent improvement on heart failure tests. BridgeBio plans to seek regulatory approval from the FDA by 2023-end.FTC unveils new draft guidelines, implies tougher stance on pharma M&AsIn
the US, the Federal Trade Commission and Department
of Justice unveiled new draft merger and acquisitions
guidelines with 13 principles to determine compliance with federal antitrust laws. This move is towards providing a regulatory framework for the agency’s tougher stance on mergers, including those in the pharmaceutical sector. “The goal of this update is to better reflect how the agencies determine a merger’s effect on competition in the modern economy and evaluate proposed mergers under the law,” a statement issued by FTC said.Gland Pharma’s second Hyderabad facility in India receives FDA’s Form 483The
US FDA issued Form 483 to Gland Pharmaceuticals’ Dundigal facility at Hyderabad, India. The inspection of the facility conducted from July 3 to July 14 ended
with one observation. Gland has said the observation is neither a repeated observation nor related to data integrity.Earlier this June, Gland Pharma’s Pashamylaram facility in Hyderabad, India, had received another Form 483 with one observation.
Impressions: 932
https://www.pharmacompass.com/radio-compass-phisper/lilly-s-donanemab-slows-early-alzheimer-s-by-60-fda-okays-sanofi-astra-s-rsv-therapy-for-babies
#Phispers by PharmaCompass
20 Jul 2023
