Thursday, February 26, 2026

Trump Wants Congress to Make His Drug Pricing Deals Law. It Won't Be Easy.

(2/25, David Lim, Robert King, Politico) ...Conservative groups have already been exerting pressure against codification, with more than 50 leaders of GOP and free-market groups signing a letter to Congress arguing that turning the drug pricing deals into law would "import socialist price controls and values into our country. " And while some Republican lawmakers appear willing to consider the idea, they also say the secrecy around the deals presents an obstacle... Full

‘They May Do It': Trump's Call For Congress To Codify MFN Deals Suggests Challenges

(2/25, Cathy Kelly, Pink Sheet) ...In a response to the speech, Public Citizen disputed Trump's claims, including the savings from TrumpRx. "Nearly half of the drugs listed on TrumpRx (20 out of 43) have generics already approved by [the US Food and Drug Administration] that can be purchased more cheaply than the ‘discount' prices on TrumpRx," the group said. "Most of the products listed on TrumpRx are decades old. The median time on the market of the listed drugs is 26 years."..."For insured patients, going through TrumpRx could provide a double whammy of higher drug costs and those costs not counting toward insurance deductibles or out of pocket maximums," Public Citizen argued... Global Sub. Full

Worried Trump's MFN Push Will ‘Destroy Biotech Innovation,' Midsize Companies Form Coalition to Fight Back

(2/25, Will Maddox, Fierce Biotech) ...MBAA members, which consist of companies like Acadia Pharmaceuticals, Madrigal Pharmaceuticals and Travere Therapeutics, feel vulnerable to MFN, which seeks to lower U.S. drug prices by aligning them with the lowest prices paid by comparable nations. The midsized members are fearful if MFN targets their drugs, the resulting loss in profits could spell the end of their enterprises... Full

TrumpRx Drug Savings for Insured Are Limited by US Discount Laws

(2/26, Lauren Clason, Bloomberg Law) ..."If manufacturers wanted to give these prices to health plans right now, they could," said Anna Kaltenboeck, president of Verdant Research and a former Senate Finance Committee staffer under Sen. Ron Wyden (D-Ore.). "That's the punchline. They absolutely could do that. The distinction here is that they don't want to."... Sub. Req’d

AAM Touts Tariff Exemptions As Trade Pressure For Pharma Could Return

(2/25, Jessica Karins, Inside Health Policy) ..."As trade policy became a front-page issue, and tariffs threatened to ripple through already strained supply chains, we made the case clearly and consistently that generics and biosimilars must be treated differently because they are different," [President and CEO John Murphy] said, addressing members at AAM's annual conference Tuesday (Feb. 24). "And we succeeded. In every trade agreement announced by the White House, generic and biosimilar medicines were treated uniquely protected from tariffs to ensure robust patient access to affordable medicines."... Sub. Req’d

What Trump Got Right and Wrong about Drug Pricing During State of the Union

(2/25, Mary Kekatos, Liz Neporent, and Dr. Ishani D. Premaratne, ABC News) ..."It's impossible to make a blanket saying about prices being lowered. It really depends on where any individual sits in their circumstance," Kaye Pestaina, vice president at KFF, a nonpartisan health policy research organization, told ABC News. "For one individual, they might get some discounts and some significant ones. For another individual, that has employer coverage, it might be cheaper to use their insurance and then nothing has changed for them."... Full

AAM CEO: Trump's Drug Pricing SOTU Message Overlooks Generic Benefits

(2/25, Jessica Karins, Inside Health Policy) ...AAM president and CEO John Murphy told Inside Health Policy Wednesday (Feb. 25) policies that facilitate rapid access to generics and biosimilars offer broader affordability benefits than initiatives Trump highlighted, like the "most favored nation" deals with branded drug companies he is seeking to codify or switching prescription drugs to over-the-counter access. Murphy said Rx-to-OTC switching mainly benefits patients with savings in a flexible spending or health savings account... Sub. Req’d

PCMA Statement on Drug Pricing in President Trump's State of the Union Address

(2/25, PCMA) ..."President Trump has been bold in taking on the drugmakers that have gamed the system to keep prices high. But now Congress must get involved. Big Pharma continues to abuse patent laws and is waging a war on generic medicines in order to avoid competition. It must be stopped..."... Full

FDA's CDER Agenda Includes New Guidance on Digital Health Technologies and AI in Manufacturing

(2/25, Joanne S. Eglovitch, Regulatory Focus) ...The agenda includes 81 guidelines that are scheduled for release, many of which are carried over from the January 2025 agenda. It covers 12 topics, including biosimilars, clinical and medical issues, compounding, generics, labeling, and pharmaceutical quality, chemistry, manufacturing, and controls (CMC). As in previous years, this year's agenda emphasizes generic drugs, with 26 of the topics focusing specifically on them... Full

Pharmacies To Face Low Cash Flow For MFP Drugs Until Fixes Emerge

(2/25, Gabrielle Wanneh, Inside Health Policy) ...A bill introduced last year aiming to ensure long-term care (LTC) pharmacies can continue to supply and dispense Medicare Part D drugs despite lower prices resulting from the price negotiation program will need to be tweaked to ensure the intended relief is retroactive, according to Alan Rosenbloom, executive director of the Senior Care Pharmacy Coalition (SCPC)... Sub. Req’d

'Biology Is Dirty': HHS's Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA

(2/25, Nielsen Hobbs, Pink Sheet) ..."So on the biosimilar side, I think it's really important that the regulator, and the attorneys that advise them, understand that the biosimilar world or biology is just slightly different, or in many ways different, than the drugs and the chemistry side," [Health and Human Services Principal Deputy General Counsel Robert Foster] said. "I think starting conversations as early as possible, and submitting and sharing great sets of comparative analytical data is really important because industry should be teaching the regulator to a degree."... Global Sub. Full

Senate Leaders Warn Defense Department About Procuring Generic Drugs Overseas

(2/26, Zara Norman and Naisha Roy, ProPublica) ...Senate leaders are urging the Department of Defense to prioritize the purchase of generic drugs manufactured in the United States, warning that the country's overreliance on foreign factories poses an "existential risk" to the military... Full

Analysis: FTC Pharma Settlement Furthers Drug Pricing Priorities

(2/25, Laura Travis, Bloomberg Law) ...One settlement stipulation, however, has created an unexpected twist: Express Scripts' standard offering to plan sponsors must ensure that members receive the benefit of direct-to-consumer pricing through TrumpRx. This stipulation raises the likelihood that the Trump administration will use this and future potential PBM FTC settlements to implement TrumpRx requirements into the drug pricing market... Sub. Req’d

Access 2026 Meeting: More from Day One

(2/25, Bob Pollock, The Lachman Blog) ...The Association of Accessible Medicines (AAM) continued Day 1 with a discussion of what's happening on Capitol Hill and how we can be working to position industry priorities with policymakers to make the most positive impact on patient access... Full

Meet the New AAM Board Chair: Bob Hoffman

(2/25, AAM Blog) ...Bob Hoffman, Chief Commercial Officer of U.S. Generics at Lupin Pharmaceuticals, was introduced as the incoming AAM Board Chair at ACCESS! 2026 in Miami, succeeding Keren Haruvi. With more than 34 years of experience in the generic pharmaceutical industry and a deep history of service to AAM, Hoffman brings both operational expertise and a personal commitment to expanding patient access to affordable medicines... Full

Aurobindo Pharma Gains as Arm Gets USFDA Final Nod for Everolimus Tablets

(2/26, Business Standard) ...The approval covers Everolimus tablets in strengths of 0.25 mg, 0.5 mg, 0.75 mg and 1 mg. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zortress Tablets, marketed by Novartis Pharmaceuticals Corp... Full

Positive PK Data Positions Formycon's Keytruda Biosimilar For Regulatory Submission

(2/25, Dean Rudge, Generics Bulletin) ...Formycon is entering the final stretch of its FYB206 pembrolizumab biosimilar development program after reporting positive clinical data from its pivotal Dahlia pharmacokinetic study, shifting its strategic focus toward completing all remaining development activities and preparing the regulatory dossiers required for approval... Global Sub. Full

Sandoz To Lift Capital Spending Beyond $1Bn To Fuel Biosimilar Ambitions

(2/26, Dean Rudge, Generics Bulletin) ...The nine newly revealed assets include proposed biosimilars to Keytruda Qlex (pembrolizumab) and Opdivo Qvantig (nivolumab) subcutaneous versions of Merck & Co's and Bristol Myers Squibb's blockbuster PD-1 inhibitors; AstraZeneca's Soliris (eculizumab) follow-on, Ultomiris (ravulizumab); and Roche's VEGF-A/Ang-2 inhibitor Vabysmo (faricimab) for wet age-related macular degeneration... Global Sub. Full

Novo Nordisk Licenses Technology From Vivtex in $2.1 Billion Deal

(2/26, Adria Calatayud, The Wall Street Journal) ...Novo Nordisk and Vivtex said Wednesday that their collaboration aims to develop next-generation biologic medicines for obesity, diabetes and associated diseases in oral formulations. By bringing together Vivtex's technologies with Novo Nordisk's experience, the collaboration seeks to enable the oral delivery of drug candidates traditionally limited to injectable administration due to poor gastrointestinal absorption, the companies said... Sub. Req’d

Hikma Pharma Tumbles on Softer Guidance as Buyback Fails to Soften Pill

(2/26, Oliver Haill, Proactive Investors) ...Hikma Pharmaceuticals PLC shares fell almost 16% to 1,390p after the drugs group delivered results for 2025 in line with forecasts but disappointed with weaker than expected guidance for 2026. Executive chair Said Darwazah will become full-time chief executive for the next two years, with current chief financial officer Khalid Nabilsi becoming deputy chief executive with responsibility for North America and Europe. Group finance chief Areb Kurdi will serve as acting chief financial officer while a search for a permanent CFO is underway... Full

Call to ‘Stop the Clock' on UWWTD – Urgent Reassessment Needed to Protect Competitiveness and Supply

(2/25, Medicines for Europe) ...Cosmetics Europe, EFPIA, AESGP, and Medicines for Europe, representing the European cosmetics and pharmaceutical sectors are today calling on Ministers of Economy to ask the European Commission to stop the clock on the implementation of the EPR scheme under the Urban Wastewater Treatment Directive (UWWTD), and to revise it... Full

Manufacturing Drift To Distribution-Chain Risks: Denmark Sets New Inspection Priorities

(2/25, Vibha Sharma, Pink Sheet) ...For GMP inspections, the DMA said the focus would be on verifying that manufacturers continue to comply with the manufacturing requirements detailed in a product's marketing authorization dossier, which sets out the approved processes and conditions for the drug's manufacture. Inspectors will assess whether companies' procedures remain aligned with the dossier to ensure the product's quality, safety and efficacy... Global Sub. Full

Medication Shortage Hits UK as Statins and Aspirin 'Disappear From Shelves'

(2/26, Katie-Ann Gupwell, Mirror) ...A pharmacist has warned people the UK has been hit with a medication shortage. Even popular medicines like statins and aspirin could "disappear from shelves"...A pharmacist, known as Pharmacist Anum, recently drew attention to the issue in a candid video explaining exactly what's happening, and it's expert advice worth knowing... Full

India's Weight-Loss Drugs to Get Cheaper as Semaglutide Patent Expires

(2/25, The Economic Times) ...The patent for semaglutide, which is the key ingredient in these injectable medications is going to expire on March 20. This clears the path for more than half a dozen players, including Sun Pharma, Zydus Lifesciences, Dr Reddy's, and Natco Pharma, to enter the market from Day 1 (March 21). More entrants are expected over the coming months, which could drive prices down in a segment long dominated by premium innovator brands... Full

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