Wednesday, February 11, 2026

Teva's Strategic Pivot: A Critical Assessment

(2/11, Ad Hoc News) ...The coming months will be defined by the execution of Teva's biosimilar strategy. Market observers are closely monitoring planned product launches, which are intended to secure market share within the lucrative biological medicines space. Successful expansion in this division is viewed as a key lever for increasing the company's presence in specialized therapeutic areas. Concurrently, Teva's portfolio of innovative branded products is gaining emphasis. While treatments in neurology and respiratory medicine are already demonstrating growth, investor attention is increasingly focused on newer psychiatric therapies and long-acting injectable formulations... Full

Drug Industry Leaders Await Election-Year Grilling in House

(2/11, Victoria Knight, Bloomberg) ...Lawmakers on a major GOP-led House health panel are set to question top drug supply-chain industry group leaders Wednesday, as economic anxieties are already shaping up to be a major theme in the 2026 midterms...The hearing is a sign that congressional Republicans in particular increasingly are willing to take aim at the drug industry, following in the footsteps of President Donald Trump... Full

Oz Pitches TrumpRx Plan as White House Affordability Crisis Fix

(2/11, Mica Soellner, Bloomberg) ...Dr. Mehmet Oz, the administrator for the Centers for Medicare and Medicaid Services and cardiovascular surgeon, called the high price of health care and prescription drugs the number one cost issue facing Americans. "I want eggs to cost less and milk to be more affordable, but if you have diabetes and your doctor sends you to a pharmacy, one in three times you don't pick up the pills or meds because you can't afford it," the former television host said in an interview with Bloomberg Government... Full

Medicare Negotiation Cycle Two: More Dynamic Offer Process, Better Public Input

(2/10, Cathy Kelly, Pink Sheet) ...Whether the process led to more favorable prices from the manufacturers' perspective is unclear. CMS guidance for the second round modified the process to allow more time for exchanges of offers between manufacturers and the agency... Global Sub. Full

GLP-1s Likely TrumpRx Savings Focus Over Old, Genericized Products

(2/10, Jessica Merrill, Pink Sheet) ...Lilly's Zepbound (tirzepatide) and Novo Nordisk's Wegovy, Wegovy pill and Ozempic, all versions of semaglutide, the GLP-1 agonists approved for diabetes and obesity, are among those available. But Zepbound and Wegovy have a unique business model based on widespread cash-paying customers, which better lends itself to a direct sales model... Global Sub. Full

Warren, Hawley Introducing Legislation to Break up ‘Big Medicine'

(2/10, Max Rego, The Hill) ...Warren and Hawley's "Break Up Big Medicine Act" proposes prohibiting parent companies from owning a medical provider or management services organization and a PBM or insurer. It also proposes prohibiting parent companies of prescription drug or medical device wholesalers from owning a medical provider or management services organization... Full

Dose of Reality: Lawmakers Have Opportunity to Hold Big Pharma Accountable for Egregious Pricing and Anti-Competitive Practices Driving Health Care Costs

(2/10, CSRxP) ...Big Pharma's egregious pricing practices and anti-competitive tactics are the root cause of high prescription drug prices in the United States and a major driver of rising health care costs for millions of hardworking Americans. There are bipartisan, market-based reforms that Congress can enact today to crack down on Big Pharma's egregious pricing practices, boost competition and lower prices for American patients... Full

How Can We Stop High Drug Prices at the Source? | Opinion

(2/10, David Merritt, Newsweek) ...There's more Congress can do right now to expand competition and address the root causes of rising costs. There is bipartisan legislation already on the table—from cracking down on patent thickets to ending pay-for delay schemes—that would give patients more choices at lower costs. By acting on these targeted, bipartisan proposals, lawmakers can deliver meaningful relief to Americans who are tired of paying more every year for the same medicines... Full

Trump Administration Revives Effort to Launch Pilot Initiative Reworking Drug Discount Program

(2/10, Ed Silverman, STAT+) ...In a little-noticed posting, the Health Resources and Services Administration indicated it is pursuing a rule for a rebate model, although details were not disclosed. A previously proposed pilot program would have allowed drugmakers to offer rebates to hospitals after a medicine is dispensed, instead of providing discounts at the time of purchase... Sub. Req’d

Moderna Accuses FDA of Shifting Trial Standard after Agency Refuses to Review Flu Shot

(2/11, Max Bayer, Endpoints News) ...Monday's action by the agency is one of the harshest steps it can take on an application. In an unusual disclosure of what are typically confidential communications between companies and the regulator, Moderna published the refuse-to-file letter that was signed by vaccines and biologics chief Vinay Prasad... Sub. Req’d

PDUFA VIII Could Boost US FDA Biomarker Qualification Program Resources, Incentives

(2/10, Sue Sutter, Pink Sheet) ...The FDA and industry have agreed on proposed draft commitment letter language for drug development tools (DDTs), including biomarker qualification, according to Jan. 8 Premarket Subgroup meeting minutes in the PDUFA VIII negotiations... Global Sub. Full

Biotechs, Wary of Being Tied to Big Pharma, Form New Industry Group as Hedge Against Trump Policies

(2/11, Elaine Chen, STAT+) ...Unlike the early-stage biotech startups that make up much of the trade group BIO, the members of the Midsized Biotech Alliance of America, or MBAA, already have one or two medicines on the market and are focused on policies that affect drugs available commercially. But unlike the pharma giants in the lobbying group PhRMA, the midsized biotechs don't have vast portfolios of medicines that would make it easier to be flexible on pricing for certain products... Sub. Req’d

Immunotherapy Regimen Approved for Recurrent Ovarian Cancer

(2/10, Mike Bassett, Medpage Today) ...The FDA approved pembrolizumab (Keytruda) plus paclitaxel for recurrent ovarian cancers that express PD-L1, the agency announced on Tuesday. Approval stipulates use of the combination, with or without bevacizumab, in adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas, with PD-L1 positivity defined as a Combined Positive Score (CPS) of 1 or above... Sub. Req’d

Blockbuster Ambitions Grow as AstraZeneca Moves Oral GLP-1 into Pivotal Studies

(2/10, Matthew Dennis, FirstWord PHARMA) ...The decision to advance elecoglipron — in-licensed from Eccogene in 2023 — follows positive results from the Phase IIb VISTA and SOLSTICE studies, which evaluated the drug in obesity and type 2 diabetes, respectively. AstraZeneca disclosed Tuesday that VISTA met its primary endpoints of change in body weight from baseline at 26 weeks and proportion of participants achieving weight loss of 5% or more from baseline at 26 weeks... Full

The Knockoff GLP-1 Market Is Still the Wild West

(2/10, Lisa Jarvis, Bloomberg) ...Consumers can't be blamed for their confusion over, or interest in, these copycat GLP-1s. Some companies had been describing their compounded drugs as "generics," and too many experts casually use that erroneous term. And when the public is bombarded with ads for cheap, easily accessible alternatives to FDA-approved drugs, it's no wonder some people are eager to buy them... Sub. Req’d

Celltrion Outlines Plan To Quadruple Biosimilar Portfolio By 2038

(2/11, Dean Rudge, Generics Bulletin) ...By 2038, Celltrion outlined, the targeted markets for its biosimilars will increase from around $55bn today to $278bn, in line with IQVIA data. One of those targeted biosimilars has just been revealed as ixekizumab, referencing Eli Lilly's IL-17A inhibitor Taltz for the treatment of plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and related inflammatory conditions... Global Sub. Full

Lotus Pharmaceutical Becomes Commercialization Partner for Formycon's Keytruda® Biosimilar Candidate FYB206 Across Major Parts of the Asia-Pacific Region

(2/10, Lotus Pharmaceutical) ...Formycon AG and Lotus Pharmaceutical today announced the conclusion of an exclusive license agreement for Formycon's Keytruda® biosimilar candidate FYB206 (Pembrolizumab). Lotus, a multinational pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines will commercialize FYB206 across major parts of the Asia-Pacific ("APAC") Region... Full

Lupin Strikes $90M Settlement With Astellas On Myrbetriq

(2/10, Vibha Ravi, Generics Bulletin) ...Following the settlement announced by Lupin today, it will pay Astellas $90m, including a prepaid option payment of $75m and a prepaid per unit license fee for each unit of Lupin product sold from the date of the settlement through Sept. 2027, the Indian company said while adding that the terms of the settlement are confidential... Global Sub. Full

J&J Prevails as Stelara Buyers' Antitrust Claims Are Dropped

(2/10, Randi Love, Bloomberg Law) ...A federal judge entered a final judgment that allows Johnson & Johnson to shed claims from third-party purchasers of the Stelara drug. The judgment came in a Tuesday order by the US District Court for the Eastern District of Virginia after plaintiff Carefirst of Maryland Inc. jointly agreed with J&J that a series of December and January orders effectively disposed of the claims... Sub. Req'd

Royalty Pharma Reports Q4 and Full Year 2025 Results

(2/11, Royalty Pharma) ...Positive Phase 3 results for Teva's TEV-‘749 in schizophrenia, Gilead's Trodelvy in 1L metastatic triple negative breast cancer, Emalex's ecopipam in Tourette's syndrome and Pharvaris' deucrictibant in hereditary angioedema... Full

Gilead's 2026 Forecast Falls Short of Wall Street's Expectations

(2/10, Robert Langreth, Bloomberg) ...Gilead struck a deal with President Donald Trump in December to lower the price of some of its medicines in exchange for a three-year reprieve on threatened tariffs. The company's 2026 sales guidance reflects a 2% negative impact from new policies, including the tariff deal and changes to the Medicare prescription drug program, Chief Financial Officer Andrew Dickinson said in an interview... Sub. Req'd

AstraZeneca Sets Sights on 25+ Blockbusters by 2030 to Fuel $80B Revenue Ambition

(2/10, Angus Liu, Fierce Pharma) ..."It's great to have one or two big products. [It] makes you very profitable and makes you look good," [CEO Pascal] Soriot said. "But if you lose one of those, as we've seen happen to some actors in the industry lately, it really becomes very painful, very quickly. So this diversification, both product-wise, but also geographically, is suddenly becoming more apparent as we drive growth through therapy areas but also through regions."... Full

AstraZeneca Targets Global Obesity Market With Low-Cost Weight-Loss Drugs

(2/10, Ashleigh Furlong, Bloomberg) ...Lower prices and high volumes are an unusual approach for Big Pharma, but harsh competition in the US, combined with pressure from the Trump administration, prompted other companies like the once market leader Novo Nordisk A/S to adopt this approach. Soriot, who turned Astra into a cancer-drug powerhouse, is looking to bring several next-generation weight-loss medicines to market... Sub. Req’d

Aurobindo Growth to Be Led by Penicillin G Business; US Not a Key Driver Near Term, Says Analyst

(2/11, CNBC-TV18) ...[Vishal Manchanda, Pharma Analyst at Systematix Group,] struck a cautious note on the US generics outlook. On the near-term trend in the US market, he said, "the US generic business will be on a downturn for most." On the overhang from the India-US trade and Section 232 investigation, Manchanda said the US has limited alternatives. He added, "I don't think the US has any other option but to keep outsourcing generic drugs from other countries."... Full

German Drugmakers Lobby Says US Price Rules Will Challenge Domestic Market

(2/11, Reuters) ...In a statement on Wednesday, the Pharma Deutschland association, which counts 400 member companies, said that drugmakers active in both nations would have to re-evaluate their pricing and launch strategies. As a result, "Germany could fall behind or miss out entirely when it comes to the introduction of new medicines", it added... Sub. Req'd

USTR Greer Calls India a Potential "Way Station" for US Supply Chains as Alternative to China

(2/11, The Hindu BusinessLine) ...In an interview with Fox News, Ambassador Greer, when asked whether India could be the right place for US companies to move supply chains out of China, said India was a viable option for companies seeking to diversify away from China, noting its manufacturing capacity and workforce strength... Full

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