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DATA COMPILATION #PharmaFlow

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FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments
This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  

Impressions: 5584

https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

#PharmaFlow by PHARMACOMPASS
11 Jul 2024

STOCK RECAP #PipelineProspector

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Pipeline Prospector February 2026 highlights: Gilead buys Arcellx for US$ 7.8 bn; FDA okays Vanda’s psychotic pill
February was a month of upheavals. In the US, the Supreme Court ruled that President Donald Trump exceeded his authority by imposing broad tariffs. Soon after the ruling, Trump imposed a temporary 15 percent global tariff under a separate trade law. The month ended with the US and Israel launching a major military operation against Iran, and the region now appears headed for a prolonged conflict.Despite the turbulent geopolitical environment, the biotech indices continued to grow steadily. The Nasdaq Biotechnology Index (NBI) rose 3.68 percent, moving from 5,852.67 to 6,041.31. The SPDR S&P Biotech ETF (XBI) gained 2.4 percent, rising from 124.75 to 127.27, and the S&P Biotechnology Select Industry Index (SPSIBI) increased 2.4 percent, rising from 9,746.25 to 9,954.51. In comparison, the S&P 500 fell by 0.55 percent — from 6,916.64 to 6,878.88.  Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)Gilead buys Arcellx for US$ 7.8 billion; Lilly acquires Orna for its circular RNA therapeutics The month’s biggest acquisition was made by Gilead Sciences, which acquired its cancer therapy partner Arcellx for US$ 7.8 billion. The two companies have been collaborating on cell therapy development since 2022 through Kite Pharma, Gilead’s subsidiary. The centerpiece of the deal is Arcellx’s investigational CAR-T therapy for multiple myeloma — anitocabtagene autoleucel.Eli Lilly announced the acquisition of Orna Therapeutics for up to US$ 2.4 billion in cash. The deal will give Lilly access to a new class of therapeutics, known as circular RNA, that allows patients’ own cells to generate therapies (to treat underlying diseases) inside the body, doing away with the need for cell extraction.Among other deals, GSK acquired Canadian biotech 35Pharma for US$ 950 million in cash. The acquisition includes HS235, an investigational therapy being studied for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with heart failure with preserved ejection fraction. GSK’s stock was up 14 percent in February.  Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)FDA approves Vanda’s antipsychotic pill Bysanti; Dupixent okayed for allergic fungal rhinosinusitisThe month saw several key approvals. The US Food and Drug Administration (FDA) approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) tablets, a first-line therapy for acute bipolar I disorder and schizophrenia. This marks the company’s third FDA approval in recent months.The agency also approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adults and pediatric patients with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. AFRS is a chronic inflammatory condition that can cause nasal polyps, persistent congestion, and loss of smell. This is Dupixent’s ninth FDA approval.Merck’s Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with paclitaxel, with or without bevacizumab, were approved for treating a form of ovarian cancer. This marks Keytruda’s first FDA approval in ovarian cancer.Pfizer’s Braftovi (encorafenib) was granted full approval when used in combination with Erbitux (cetuximab) and fluorouracil-based chemotherapy to treat adults with a type of metastatic colorectal cancer. The combo therapy had received accelerated approval in 2024.FDA also approved AbbVie’s supplemental new drug application for the combination regimen of Venclexta (venetoclax) and AstraZeneca’s Calquence (acalabrutinib) for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). Venclexta is manufactured by AbbVie and Genentech.  Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)Lilly in another oncology deal with Innovent worth up to US$ 8.85 bn; Novo inks obesity deal with VivtexLilly entered into a strategic collaboration with Chinese drugmaker Innovent Biologics to advance novel medicines in oncology and immunology. This is the seventh collaboration between the two drugmakers. Lilly will pay US$ 350 million upfront and as much as US$ 8.5 billion in milestone payments.Madrigal Pharmaceuticals entered into a global license agreement with Suzhou Ribo Life Science and its subsidiary Ribocure Pharmaceuticals for six preclinical small interfering RNA programs targeting metabolic dysfunction-associated steatohepatitis (MASH). Madrigal will pay US$ 60 million upfront and US$ 4.4 billion in milestone payments.Novo Nordisk has inked a deal worth up to US$ 2.1 billion with privately-held American company Vivtex Corp to develop next-generation oral drugs for obesity and diabetes.Astellas Pharma (stock up 16 percent) has entered into a global strategic collaboration with Vir Biotechnology to advance a T-cell engager targeting prostate-specific membrane antigen and CD3 proteins for the treatment of prostate cancer. The deal involves an upfront payment, milestone payments and royalties that could together add up to US$ 1.7 billion.There were also a few AI deals. Takeda Pharmaceutical has entered into a multi-year partnership that could be worth over US$ 1.7 billion with San Diego-headquartered Iambic to use AI to design small-molecule drugs for cancer and gastrointestinal diseases. And, Novartis (stock up 13 percent in February) signed a research collaboration and licensing deal worth up to US$ 1.8 billion with American biotech Unnatural Products (UNP) to develop therapeutics with potential applications in cardiovascular diseases. Novartis will license UNP’s AI-enhanced macrocycle platform.  Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)Roche’s Gazyva scores phase 3 win in rare autoimmune kidney disorder; Novo’s CagriSema beats WegovyIn a phase 3 trial, Roche’s Gazyva (obinutuzumab) met its primary endpoint, holding the potential to become the first approved therapy for primary membranous nephropathy, a rare autoimmune kidney disorder. According to top-line results, significantly more patients achieved complete remission at two years with Gazyva, compared to immunosuppressant tacrolimus. Novo Nordisk said its experimental next-generation weight-loss drug CagriSema (cagrilintide and semaglutide) delivered greater reductions in body weight and blood sugar than its blockbuster Wegovy (semaglutide) in a late-stage trial in patients with type 2 diabetes. Novo has positioned CagriSema as a successor to Wegovy and a potential rival to Eli Lilly’s Zepbound (tirzepatide).Eli Lilly’s Retevmo (selpercatinib), an FDA-approved drug for lung and thyroid cancers that have RET gene alterations, has demonstrated statistically significant improvement in event-free survival in patients with early-stage (2-3A) RET fusion-positive non-small cell lung cancer.In a phase 3 trial, Bayer’s experimental blood thinner — asundexian — reduced the risk of recurrence of stroke by 26 percent. And Compass Pathways’ psilocybin-based therapy — COMP360 — eased symptoms in treatment-resistant depression. This is the second such late-stage trial win for the therapy.  Access the Pipeline Prospector Dashboard for February 2026 Newsmakers (Free Excel)Our viewThe rapidly shifting geopolitical landscape, particularly the conflict in the Middle East and rising trade tensions, is adding a fresh layer of uncertainty for the industry. If the deal-making momentum and progress in clinical trials are maintained, we can safely assume that the innovation pipeline is resilient, the geopolitical turbulence notwithstanding. 

Impressions: 1028

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-february-2026-highlights-gilead-buys-arcellx-for-us-7-8-bn-fda-okays-vanda-s-psychotic-pill

#PharmaFlow by PHARMACOMPASS
05 Mar 2026

NEWS #PharmaBuzz

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https://www.fiercebiotech.com/medtech/after-local-tumor-approval-novocure-touts-positive-data-metastatic-pancreatic-cancer

FIERCE BIOTECH
27 Mar 2026

https://www.globenewswire.com/news-release/2026/03/26/3263438/0/en/Onco360-Has-Been-Selected-as-the-National-Pharmacy-Partner-for-LIFYORLI-relacorilant.html

GLOBENEWSWIRE
26 Mar 2026

https://www.globenewswire.com/news-release/2026/03/23/3260322/0/en/Theriva-Biologics-Announces-Positive-End-of-Phase-2-Meeting-with-U-S-FDA-Regarding-the-Design-of-a-Phase-3-Trial-of-VCN-01-in-Metastatic-Pancreatic-Ductal-Adenocarcinoma.html

GLOBENEWSWIRE
23 Mar 2026

https://www.businesswire.com/news/home/20260227462624/en/KEYTRUDA-pembrolizumab-Plus-Paclitaxel-With-or-Without-Bevacizumab-Significantly-Improved-Key-Secondary-Endpoint-of-Overall-Survival-OS-Versus-Paclitaxel-With-or-Without-Bevacizumab-in-Patients-With-Platinum-Resistant-Recurrent-Ovarian-Cancer

BUSINESSWIRE
27 Feb 2026

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or

FDA
12 Feb 2026

https://www.globenewswire.com/news-release/2026/02/12/3237583/0/en/FDA-Approves-First-of-Its-Kind-Device-to-Treat-Pancreatic-Cancer.html

GLOBENEWSWIRE
12 Feb 2026