Friday, February 27, 2026

Trump's Drug-Pricing Hurdle

(2/26, Kelly Hooper and Sophie Gardner, Politico) ...Nick Shipley, a longtime drug industry lobbyist, questioned whether Republicans on Capitol Hill will have much appetite to take Trump up on his request. Trump "only devoted three minutes to drug pricing out of 107 minutes total, and like a lot of the traditionally left-leaning ideas he has embraced, it's just hard to see the congressional GOP getting on board without a better sales pitch, especially if you're openly saying, ‘I'm not sure it matters,'" said Shipley. But some Trump loyalists say they are willing to work with Trump to pass legislation... Full

Trump Bets His Affordability Ideas Will Win Over Anxious Voters

(2/27, Mica Soellner, Bloomberg) ...Kevin Hassett, director of the White House Economic Council, said Trump is well prepared to sell his agenda on the campaign trail as a mix of what he's already put out including existing platforms like Trump RX and other emerging ideas... Sub. Req’d

Big Pharma Lying to Trump — And the American People

(2/26, Mike Feuz, The Washington Times) ...If we want drug prices to fall, then there's something else Washington can do, and it's the stuff Big Pharma fears most: easier entry for competitors, faster approval pathways, less protectionism, fewer artificial barriers, fewer sweetheart arrangements, more transparency and real consumer choice. In other words, a freer market... Full

Trump Admin Takes Pro-Patient Approach to Drug Prices | Opinion

(2/26, Joe Grogan, Newsweek) ...For the uninsured, those navigating health savings accounts or enrollees facing coverage gaps in their insurance plans, TrumpRx represents a lifeline. It empowers patients to take the reins of their drug expenditures, bypassing the opaque machinations of intermediaries. In some cases, prices could rival those negotiated by Medicare itself—and, in rare but telling instances, undercut what insured patients might pay through their own plans... Full

Americans Don't Need Announcements, They Need Lower Drug Prices

(2/26, Sen. Ruben Gallego, The Hill) ...When you look past the headlines, TrumpRX is effectively a bad knock-off of GoodRx, except with fewer options. Worse, if families use it, what they pay doesn't count toward their deductible or their annual out-of-pocket maximum. For most insured Americans, that doesn't mean relief — it means paying more over the course of the year, not less... Full

IRA Price-Setting Is 'Not a Negotiation'

(2/26, The Washington Post) ...On a recent WP Intelligence Live Briefing, "Washington's new push on drug pricing," PhRMA Executive Vice President Elizabeth Carpenter outlined the pharmaceutical industry's concerns with the Inflation Reduction Act — including why manufacturers argue the current framework functions more as price-setting than negotiation... Full

Senate HELP Report Maps US FDA Reform Agenda Ahead of User Fee Reauthorizations

(2/26, Sue Sutter, Generics Bulletin) ...While Congress must pass reauthorizing legislation encompassing the user fee agreements, lawmakers like to tack on new policies, or codify existing programs, as part of the must-pass legislation... Global Sub. Full

Generic Drug Advocates Seek To Codify FDA Reforms

(2/26, Jessica Karins, Inside Health Policy) ..."We at AAM and in the generic and biosimilar industry in general have a great story to tell on affordability," Mark Ratner, AAM's senior vice president for government affairs, said. Hull said Republicans are eager to pass policies that can save Medicare money on drug purchases and the solvency of the Medicare trust fund is a prominent concern generics advocates can point to in their pitch for the lower-priced medicines. The biggest concern for Republicans about passing generics-focused policy, she said, will be whether the bills have the Trump administration's endorsement... Sub. Req’d

HHS Official: Whole-Of-Government Effort Needed To Onshore Essential Medical Products

(2/26, Jessica Karins, Inside Health Policy) ...Separately, a Democratic strategist and lobbyist on generic drug issues, Cristina Antelo of Ferox Strategies, said at the conference that a possible "Buy America" requirement for drugs in the National Defense Authorization Act (NDAA) for 2026 would be a problem for the generic industry and advocates should aim to "kill it in the cradle."... Sub. Req’d

FDA to Give Staff Bonuses for Speeding Up Drug Reviews

(2/26, John Tozzi, Robert Langreth, Bloomberg) ...The initiative will give staff scientists who perform high quality, efficient reviews bonuses of around a few thousand dollars per quarter, said the person, who didn't specify as the figures are still being finalized. The agency plans to announce it today at an internal meeting. The FDA didn't immediately respond to a request for comment... Sub. Req’d

FDA's Makary Says Agency Is Facing a Media 'Smear Campaign'

(2/26, Madison Muller, Bloomberg) ...US Food and Drug Administration Commissioner Marty Makary defended against accusations his top deputy is unfairly rejecting promising drugs, in a combative television interview with CNBC on Thursday that added to pressure the agency is facing over how it's run. Makary called Vinay Prasad, the FDA's medical and scientific chief and head of its biologics center, a "genius" who is facing a "fatwa" and a "smear campaign" by certain media outlets... Sub. Req’d

FDA Probes Internal Prasad Complaints With Outside Help

(2/26, Max Bayer and Zachary Brennan, Endpoints News) ...The outside firm, called Professional EEO Services, has been assisting with the FDA's probe, according to the first source, who spoke to Endpoints on condition of anonymity. The source said that Prasad was expected to meet with the investigator this week, though travel issues during an East Coast blizzard may have delayed that, the source added... Sub. Req’d

GLOBE, GUARD Demos' Approach To Licensed Drugs Alarms Small, Mid-Size Firms

(2/26, Cathy Kelly, Pink Sheet) ...CMS' decision not to exclude drugs from the GLOBE and GUARD models that are out-licensed to other entities is alarming to small and mid-size companies...The decision indicates a "significant misunderstanding" of the role of licensing to advance biotech innovation, BIO said... Global Sub. Full

DOJ Urges Supreme Court to Undo Revival of Hikma ‘Skinny Label' Case 

(2/26, Nicole DeFeudis, Endpoints News) ...In an amicus brief filed Wednesday, DOJ attorneys wrote that the skinny label mechanism "cannot function as Congress intended if a generic manufacturer's anodyne descriptions of its product create a serious risk of massive patent-infringement liability."... Sub. Req’d

New Report by IQVIA Institute for Human Data Science Outlines ASP Policies to Support Prescription Drug Affordability and Lower-Cost Biosimilars

(2/26, Biosimilars Forum) ...The report, Modeling Policy Proposals for Medical Benefit Biosimilar Reimbursement in the U.S., assesses five policy approaches designed to address these challenges through modifications to ASP-based reimbursement for medical benefit biosimilars... Full

Day 2 Highlights at AAM Access 2026

(2/26, Bob Pollock, The Lachman Blog) ...The newly named Board Chair of the Association of Accessible Medicines (AAM), Bob Hoffman, Chief Commercial Officer of U.S. Generics for Lupin Pharmaceuticals, provided his view of the current state of the generic and biosimilar industry and some of the issues he is concerned about... Full

DOJ Supports AbbVie in Suit Over Colorado's Drug Discount Law

(2/26, Nyah Phengsitthy, Bloomberg Law) ...The amicus brief filed by the US government argues that federal law prohibits the enactment of Colorado's 340B Contract Pharmacy Protection Act. The statute prevents pharmaceutical companies from restricting, limiting, or denying discounts for drugs distributed through contract pharmacies under the federal 340B Drug Pricing Program... Sub. Req’d

Teva's Olanzapine And Duvakitug Updates Test Valuation Gap Narrative

(2/26, Bailey Pemberton, Simply Wall St.) ...The olanzapine long acting injectable and duvakitug data both support Teva's effort to lean further into branded central nervous system and gastrointestinal therapies alongside its existing generics base... Full

Bristol Myers Says ADC Licensed from China Hits Mark in Aggressive Breast Cancer

(2/26, Kristin Jensen, BioPharma Dive) ...Researchers tested the drug, iza-bren, in patients with advanced triple-negative breast cancer whose disease had progressed after previous therapy. They found that the experimental medication improved the chances of progression-free survival and overall survival, compared with chemotherapy... Full

Camber Launches Sodium Oxybate Oral Solution

(2/26, Chain Drug Review) ...Sodium Oxybate Oral Solution 0.5 g/mL is available in 180 mL bottles and is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy... Full

Aurobindo Launches Brivaracetam Tablets

(2/26, Sandra Levy, Drug Store News) ...The product is available in 50 mg and 100 mg dosage strengths... Full

Glenmark Pharma US Arm to Launch Sodium Phosphate Injection, Begin Distribution in April

(2/27, Shloka Badkar, CNBC-TV18) ...Glenmark Pharmaceuticals Ltd. on Friday, February 27, said its US subsidiary is launching the sodium phosphates injection USP in the 15 mM P/5 ml, 45 mM p/15 ml and 150 mM P/5 ml, single-dose vials... Full

Zydus Lifesciences Moves Closer to US Launch of Key Cancer Drug Biosimilar

(2/27, CNBC-TV18) ...The randomised, double-blind, multi-centre study demonstrated pharmacokinetic equivalence between FYB206 and Keytruda (pembrolizumab), an immuno-oncology therapy. Zydus has in-licensed the product from Formycon AG for the US and Canadian markets, the company said in a regulatory filing... Full

Omalizumab Biosimilar Entry Linked to Expanded Patient Access, Reduced Spending

(2/26, Skylar Jeremias, The Center for Biosimilars) ...A newly published budget impact analysis in the Journal of Medical Economics projected that the introduction of an omalizumab biosimilar could generate substantial savings for public payers over the next 5 years, with the potential to expand access to tens of thousands of additional patients... Full

AI Drug Discovery: How Roche Accelerates Health Innovation

(2/27, Georgia Collins, AI Magazine) ...Through its Genentech division, Roche has developed what it calls a 'lab in a loop' approach, integrating AI models directly into the drug discovery pipeline. This methodology could fundamentally change how pharmaceutical companies develop treatments, potentially reducing both the time and cost associated with bringing new therapies to patients... Full

Viatris to Cut 10% of Workforce in 3-Year Overhaul, Discloses Fire at India Plant

(2/26, Eric Sagonowsky, Fierce Pharma) ...After kicking off an enterprisewide strategic review a year ago, Viatris on Thursday said it plans to cut its global workforce by about 10% over the next three years. The company expects restructuring-related charges to come in between $700 million and $850 million, but it aims to save $600 million to $700 million annually once the plan is complete... Full

Canadian Pharmaceutical Company Reinforces Mexico Strategy

(2/26, Jose Escobedo, Mexico Business) ...André Soresini, Vice President, Apotex Latin America, said the milestone underscores the company's confidence in Mexican manufacturing capabilities. "This fiscal year we will make history by delivering more medicines than ever before, produced by Mexican hands with Canadian-quality standards, benefiting millions of patients in Mexico and nine other Latin American countries," Soresini said... Full

Amneal Reports Fourth Quarter and Full Year 2025 Financial Results

(2/27, Amneal) ..."We are extremely pleased with Amneal's sixth consecutive year of consistent execution and strong growth. Our full year 2025 performance highlights the durability of our diversified portfolio and the successful execution of our strategy. In Specialty, CREXONT® continues to see strong uptake, and we successfully launched our newest branded product, the BREKIYA® autoinjector. In Affordable Medicines, we delivered a robust cadence of new product approvals, including our first two inhalation products and our fourth and fifth biosimilars. Looking ahead, we believe Amneal is very well positioned to deliver substantial growth and create long-term value for years to come," said Chirag and Chintu Patel, Co-Chief Executive Officers... Full

Cigna, Extending Reach Into Prescription Drugs, Acquires Major Pharmacy Used by Hospitals

(2/26, Bob Herman, STAT+) ...The acquisition, discovered by STAT in a review of Cigna's financial filings, reinforces the company's push to control more of the lucrative flow of pharmaceuticals through the U.S. health care system. Cigna executives have repeatedly told investors that managing prescription drugs has been one of their highest priorities since the company acquired Express Scripts for $54 billion in 2018... Sub. Req’d

The Estrogen Patch Surged in Popularity. Now It's in Shortage.

(2/26, Nina Agrawal, The New York Times) ...It's a sign of just how much attitudes about the patches, and about menopause, have changed. After a report in 2002 suggested that hormone therapy increased the risks of breast cancer and cardiovascular disease, its popularity plummeted — and stayed low even after further research debunked that concern... Full

He Needs an Expensive Drug. A Copay Card Helped — Until It Didn't.

(2/27, Elisabeth Rosenthal, KFF Health News) ...Copay assistance programs are part of a "tug-of-war between drug manufacturers and insurers," said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies the pharmaceutical industry. The value of drugmakers' copay cards has become more unpredictable as insurers try to restrict their use. Many insurance plans, for instance, do not count the money from a copay program toward a patient's deductible... Full

New EU Pharma Legislation to Safeguard Patient Access and Boost Off-Patent Medicines Efficiency

(2/26, Medicines for Europe) ...Speaking at Medicines for Europe's 2026 Regulatory and Scientific Affairs Conference, the Association's Director General, Adrian van den Hoven, said "The European Union cannot sit on the sidelines while the US, Japan, India and China are heavily investing in and clearly supporting their off-patent pharmaceutical industry. As we build the pharmaceutical regulatory framework of the future, we need bold reforms to encourage investments in EU medicines development and production. The digitalisation of the regulatory network and pharmaceutical regulation offers hope for a dynamic and efficient single market for medicines..."... Full

Wastewater Directive: Industry Calls For EU Ministers To Press Commission After Legal Defeat

(2/26, Francesca Bruce, Pink Sheet) ...European economy ministers should press the European Commission to pause implementation of, and revise, extended producer responsibility (EPR) provisions in the updated Urban Wastewater Treatment Directive, says EFPIA, the European federation of pharmaceutical industry groups. The call comes days after the EU's General Court dismissed EFPIA's case against the directive on procedural grounds... Global Sub. Full

Keep EU Drug Price Agreements Confidential or Risk Market Disruption

(2/27, Aneta Zachová, Euractiv) ...According to Czech health economist Tomáš Doležal, tying US prices to European benchmarks may put particular pressure on lower-priced markets such as Czechia and Slovakia. Countries in the region frequently use international price referencing to secure competitive prices. "We really try in public prices to be among the cheapest," Doležal, founder of the Institute for Health Economics and Technology Assessment (iHETA), told Euractiv... Full

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