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DATA COMPILATION #PharmaFlow

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FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs
This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).  Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 296 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.

Impressions: 3337

https://www.pharmacompass.com/radio-compass-blog/fda-s-december-2025-opoe-list-features-784-prescription-drugs-73-otc-drugs

#PharmaFlow by PHARMACOMPASS
22 Jan 2026

STOCK RECAP #PipelineProspector

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Pipeline Prospector March 2026 highlights: Lilly to acquire Centessa for US$ 7.8 bn; Merck buys Terns Pharma for US$ 6.7 bn
The raging war in the Middle East has disrupted global pharmaceutical supply chains, which are dependent on both sea and air routes. Major airports, such as Dubai, Abu Dhabi and Doha, are operating far below capacity due to strikes by Iran in response to attacks by the US and Israel. This has impacted the flow of critical medicines to the region. The closure of the Strait of Hormuz is pushing up crude oil prices.Given the geopolitical turbulence, the industry displayed grit, with March witnessing a flurry of high-value acquisitions.However, the war impacted pharma indices, which had been rising steadily since June 2025. The Nasdaq Biotechnology Index (NBI) fell by 2.12 percent in March, moving from 5,965.89 to 5,839.40. The SPDR S&P Biotech ETF (XBI) rose by 2.49 percent, from 124.63 to 127.73, and the S&P Biotechnology Select Industry Index (SPSIBI) inched up by 0.23 percent — from 9,954.55 to 9,977.73. In comparison, the S&P 500 fell by 4.34 percent — from 6,824.36 to 6,528.52. Access the Pipeline Prospector Dashboard for March 2026 Newsmakers (Free Excel)Lilly acquires Centessa for its sleep disorder treatments; Merck buys Terns Pharma to strengthen oncology pipeline On the last day of the month, Eli Lilly announced the acquisition of British drugmaker Centessa Pharmaceuticals in a deal worth up to US$ 7.8 billion. Centessa is developing a new class of treatments designed to target orexin, a molecule in the brain that regulates the sleep-wake cycle.On the same day, Biogen announced the acquisition of Apellis Pharmaceuticals for about US$ 5.6 billion in cash, adding approved immunology medicines Empaveli and Syfovre (both pegcetacoplan) to its portfolio.Meanwhile, Merck announced a US$ 6.7 billion acquisition of American biotech Terns Pharmaceuticals. The biotech is developing treatments for rare blood and bone cancers, and is expected to strengthen Merck’s oncology pipeline, as its blockbuster Keytruda (pembrolizumab) faces a patent cliff.Novartis made a significant move by acquiring Pikavation Therapeutics, a subsidiary of US biotech firm Synnovation Therapeutics, and its portfolio, which includes an experimental breast cancer drug candidate — SNV4818 — for up ‌to US$ 3 billion. Novartis also deepened its focus on immunology through the up to US$ 2 billion acquisition of Excellergy, a private biotech company developing next-generation anti-IgE therapies.French pharmaceutical group Servier announced the acquisition of Day One Biopharmaceuticals for ‌about US$ 2.5 billion. This buyout gives Servier access to FDA-approved Ojemda (tovorafenib), a monotherapy for pediatric low-grade glioma, the most common form of brain tumor in children.Gilead Sciences is acquiring Ouro Medicines for up to US$ 2.18 billion to expand its presence in autoimmune diseases. Luxembourg-based CVC Capital Partners made a €10.9 billion (US$ 12.6 billion) offer to acquire Italian drugmaker Recordati, where it already holds a 47 percent stake.In other deals, Insilico Medicine entered into a US$ 2.75 billion global licensing and research collaboration with Eli Lilly to leverage generative AI to accelerate R&D and improve pipeline efficiency. And Tenaya Therapeutics tied up with Alnylam Pharmaceuticals to work on disease-modifying treatments for cardiovascular diseases in a deal worth up to US$ 1.14 billion. Access the Pipeline Prospector Dashboard for March 2026 Newsmakers (Free Excel)Biogen’s Spinraza approved for spinal muscular atrophy; J&J’s pill okayed for plaque psoriasisThe month witnessed multiple FDA approvals and label expansions. Biogen secured FDA approval for a higher-dose regimen of Spinraza (nusinersen) for spinal muscular atrophy (SMA), a genetic disorder that causes muscle weakness.The agency also approved Johnson & Johnson’s oral pill Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older.Besides these, FDA granted accelerated approval to Denali Therapeutics’ Avlayah (tividenofusp alfa), which was approved for the treatment of children with Hunter syndrome, ‌a rare genetic disorder. And it expanded the labels of Bristol Myers Squibb’s Sotyktu (deucravacitinib), Novo Nordisk’s Sogroya and GSK’s RSV vaccine Arexvy. Access the Pipeline Prospector Dashboard for March 2026 Newsmakers (Free Excel)Merck’s drug cuts LDL cholesterol by 64.6%; Xenon’s epilepsy med meets main goal in late-stage trialMerck reported that its oral cholesterol drug enlicitide decanoate reduced low-density lipoprotein (LDL) cholesterol by approximately 64.6 percent in a head-to-head late-stage trial, outperforming non-statin therapies.Xenon Pharmaceuticals’ experimental epilepsy drug azetukalner met its main goal by significantly reducing seizure frequency, while United Therapeutics’ ralinepag reduced disease progression risk by 55 percent in pulmonary arterial hypertension.Bristol Myers Squibb’s mezigdomide demonstrated improved survival outcomes in relapsed or refractory multiple myeloma when used in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone.Another therapy that posted a trial win was Pfizer and Astellas’ Padcev (enfortumab vedotin) when used in combination with Keytruda. In a phase 3 trial, it significantly improved outcomes in patients with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy.Roche reported positive phase 3 data for its multiple sclerosis drug fenebrutinib, though safety concerns (including patient deaths during trials) could complicate regulatory review. Eli Lilly’s atopic dermatitis drug Ebglyss (lebrikizumab) achieved both primary and secondary endpoints in a phase 3 trial in children aged six months to 18 years. The drug is already approved for people over 12 years with eczema who weigh over 40 kg. Access the Pipeline Prospector Dashboard for March 2026 Newsmakers (Free Excel)FDA lifts hold on Intellia’s gene therapy, hands Aldeyra’s dry eye disease med its third rejection FDA lifted the clinical hold placed on Intellia Therapeutics’ gene therapy for transthyretin amyloidosis with cardiomyopathy, a fatal heart condition. The clinical holds on two trials of the therapy were imposed in October after a patient developed severe liver complications.Some drugmakers faced setbacks. For instance, FDA asked for additional data for uniQure’s Huntington’s disease gene therapy (a fatal, inherited neurodegenerative disorder). Similarly, the agency handed Aldeyra’s reproxalap a third rejection. The drug was being developed to treat dry eye disease, a chronic condition characterized by insufficient tear production.Australian biotech Immutep discontinued a crucial phase 3 trial for Efti (eftilagimod alfa), which is administered along with Keytruda and was being developed as a first-line treatment for advanced non-small cell lung cancer (NSCLC). And Roche said its breast ‌cancer pill, giredestrant, failed to meaningfully help newly diagnosed patients with breast cancer in a phase 3 trial. Access the Pipeline Prospector Dashboard for March 2026 Newsmakers (Free Excel)Our viewWhile geopolitical disruptions have exposed vulnerabilities in global supply chains, they have not dented the industry’s appetite for growth and innovation. That said, a prolonged conflict could alter this trajectory, forcing pharma leaders to reassess strategic priorities.

Impressions: 2249

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-march-2026-highlights-lilly-to-acquire-centessa-for-us-7-8-bn-merck-buys-terns-pharma-for-us-6-7-bn

#PharmaFlow by PHARMACOMPASS
02 Apr 2026

WEEKLY NEWS RECAP #Phispers

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Lilly to invest US$ 3 bn in China to boost supply of new obesity drug; Servier acquires Day One Biopharma for US$ 2.5 bn
In Phispers this week, Eli Lilly announced its plans to invest US$ 3 billion in China over the next decade in order to build production capacity for its experimental ‌type 2 diabetes and obesity treatment orforglipron. Servier acquired Day One Biopharma for US$ 2.5 billion to boost its oncology pipeline. Swiss contract drug manufacturing organization (CDMO) Lonza sold its capsules business to Lone Star Funds for US$ 3 billion. And BioNTech founders said they are quitting the firm to start a new venture. In drug approvals, the US Food and Drug Administration (FDA) okayed Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The agency also expanded the labels of Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, and of Wellcovorin (leucovorin calcium) to treat a rare genetic condition.In trials, Bristol Myers Squibb’s experimental drug mezigdomide in combination with Amgen’s cancer drug Kyprolis (carfilzomib) and dexamethasone met a phase 3 study’s primary goal by improving survival in patients with relapsed multiple myeloma, a form of blood cancer. Xenon Pharmaceuticals’ experimental epilepsy drug, azetukalner, significantly reduced focal-onset seizures in a late-stage trial. And Roche’s giredestrant failed to meaningfully help newly diagnosed patients with breast cancer in a phase 3 trial.The FDA issued a warning letter to Novo Nordisk over issues with its procedures for reporting potential side effects of its diabetes drug Ozempic (semaglutide), which is also prescribed for weight loss. And Vinay Prasad, the controversial head of FDA’s Center for Biologics Evaluation and Research (CBER), ‌will leave the agency next month.Lilly to invest US$ 3 billion in China to build capacity for its new obesity medEli Lilly plans to invest US$ 3 billion in China over the next decade to build production capacity for its experimental ‌type-2 diabetes and obesity treatment orforglipron. This drug is under FDA review, with a decision expected in April. Lilly has also filed for marketing authorization for the pill in China.BioNTech founders to start new venture: BioNTech’s co-founders and leading executives — CEO Ugur Sahin and chief medical officer Özlem Türeci — are quitting the company by the end ‌of the year to start a new venture. BioNTech said it had initiated a search for their successors.Servier acquires Day One Biopharma for US$ 2.5 bn to boost its oncology pipelineFrench pharmaceutical group Servier has announced the acquisition of US-based Day One Biopharmaceuticals for ‌about US$ 2.5 billion. This buyout will expand Servier’s brain tumor portfolio and give it access to FDA-approved Ojemda (tovorafenib), a monotherapy for pediatric low-grade glioma, the most common form of brain tumor in children.Lonza sells its capsules business: Swiss CDMO Lonza has announced the sale of its capsules and health ingredients business to private equity fund Lone Star Funds for an enterprise value of CHF 2.3 billion (US$ 3 billion).J&J’s Tecvayli-Darzalex combo wins approval under FDA’s voucher programFDA has approved Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This decision was issued 55 days after filing and marks the third approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. The new approval is for second-line treatment of the blood cancer.Sotyktu okayed for psoriatic arthritis: FDA has expanded the label of Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. Sotyktu is the first and only tyrosine kinase 2 (TYK2) inhibitor to be approved for this indication.Leucovorin approved for rare genetic disorder: FDA has expanded the use of decades-old drug Wellcovorin (leucovorin calcium) to treat cerebral folate transport deficiency, a rare genetic condition in adult and pediatric patients that prevents folate from properly reaching the brain. People with this condition have severe developmental delays, movement disorders, seizures, and other serious neurological complications. The move comes months after the Trump administration touted leucovorin as a potential therapy for a broader group of patients with symptoms of autism spectrum disorder.Bristol Myers’ mezigdomide enhances survival rates in late-stage blood cancer trialBristol Myers Squibb’s experimental drug — mezigdomide — for a rare form of blood cancer met a phase 3 study’s primary goal by improving survival. Mezigdomide, when used in combination with Amgen’s cancer drug Kyprolis (carfilzomib) and dexamethasone, showed significant improvement in patients with relapsed or refractory multiple myeloma without the disease worsening, compared to carfilzomib and dexamethasone alone.Xenon’s epilepsy drug meets main goal: Xenon Pharmaceuticals’ experimental epilepsy drug, azetukalner, significantly reduced focal-onset seizures in a late-stage trial. Azetukalner also demonstrated a safety and tolerability profile consistent with prior studies.Roche’s breast cancer drug combo fails trial: Roche said its breast ‌cancer pill, giredestrant, failed to meaningfully help newly diagnosed patients with breast cancer in a phase 3 trial. The investigational drug was being tested in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.FDA issues warning letter to Novo Nordisk over reporting Ozempic side effectsFDA has issued a warning letter to Novo Nordisk over issues with its procedures for reporting potential side effects of its diabetes drug Ozempic (semaglutide), which is also prescribed for weight loss. The agency has cited three deaths among patients receiving semaglutide. Novo Nordisk violated its protocols for reporting adverse symptoms that could potentially be tied to the drug, the letter said. Meanwhile, the company has undertaken an action plan to address the gaps.Rise in dementia in diabetes patients: According to a study published in The Lancet, newer diabetes medicines, including GLP-1 drugs, provide heart protection along with blood sugar control. Analyzing data from 10 wealthy countries on 2.7 million deaths of patients with type 2 diabetes between 2000 and 2023, the researchers noted overall declines in mortality rates from cardiovascular disease, cancer, and diabetes. However, they reported increases in mortality rates and proportions of deaths from dementia and other causes.Vinay Prasad to leave CBER in April: Vinay Prasad, the controversial head of FDA’s Center for Biologics Evaluation and Research, ‌will leave the agency next month, FDA commissioner Marty Makary said. A search is currently underway for Prasad’s successor. 

Impressions: 2556

https://www.pharmacompass.com/radio-compass-phisper/lilly-to-invest-us-3-bn-in-china-to-boost-supply-of-new-obesity-drug-servier-acquires-day-one-biopharma-for-us-2-5-bn

#Phispers by PHARMACOMPASS
12 Mar 2026

NEWS #PharmaBuzz

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https://ir.corcept.com/news-releases/news-release-details/corcept-presents-new-data-ada-improved-outcomes-patients

PRESS RELEASE
07 Jun 2026

https://www.prnewswire.com/news-releases/new-tecvayli-teclistamab-cqyv-data-demonstrate-superior-progression-free-and-overall-survival-as-early-as-first-relapse-in-multiple-myeloma-302785621.html

PR NEWSWIRE
29 May 2026

https://endpoints.news/asco26-bristol-myers-details-phase-3-trial-win-for-pomalyst-successor/

ENDPOINTS
29 May 2026

https://www.pharmiweb.com/press-release/2026-05-21/study-confirms-use-of-pepaxti-in-a-broader-population-with-strong-data-in-the-50-of-rrmm-patients-that-suffer-from-reduced-kidney-function

PHARMIWEB
21 May 2026

https://www.prnewswire.com/news-releases/upsher-smith-launches-generic-version-of-ciprodex-ciprofloxacin-0-3-and-dexamethasone-0-1-sterile-otic-suspension-302734882.html

PR NEWSWIRE
06 Apr 2026

https://www.businesswire.com/news/home/20260331718599/en/CellCentric-Initiates-DOMMINO-1-a-Pivotal-Phase-2-Clinical-Trial-of-Inobrodib-in-Combination-with-Pomalidomide-and-Dexamethasone-InoPd-in-Relapsed-or-Refractory-Multiple-Myeloma

BUSINESSWIRE
31 Mar 2026