Friday, March 6, 2026

Democrats Ask Trump For Copies Of MFN Deals

(3/5, Maaisha Osman, Inside Health Policy) ...Senior congressional Democrats are demanding President Donald Trump turn over unredacted copies of the administration's "most favored nation" drug pricing agreements with pharmaceutical companies, after receiving no response from HHS Secretary Robert F. Kennedy Jr. to an earlier request for details... Sub. Req'd

Democrats Seek Details On GLOBE, GUARD, GENEROUS Models, Warn Of Pharma Deal Loopholes

(3/5, Maaisha Osman, Inside Health Policy) ...In a letter to HHS Secretary Robert F. Kennedy Jr. Thursday (March 5), Senate Finance ranking Democrat Ron Wyden (OR), House Energy & Commerce ranking Frank Pallone (NJ), and House Ways & Means ranking Democrat Richard Neal (D-MA) said the administration has provided little public information about how the models would function or whether they would meaningfully lower drug prices for beneficiaries... Sub. Req'd

Deeper Views on TrumpRx (the Direct-to-Patient Channel), MFN and MFP, and Biosimilars

(3/5, Stanton Mehr, Biosimilars Review & Report) ...Takeaways from discussions on the Trump administration's drug price controls with leaders at last week's Association for Accessible Medicines' Access 2026 conference... Full

Chairman Rick Scott's CLEAR LABELS Act Garners Bicameral Support With Rep. McCormick in the U.S. House

(3/5, United States Senate Special Committee on Aging) ...Chairman Rick Scott's bipartisan Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act received bicameral support with Congressman Rich McCormick leading the effort in the House of Representatives... Full

Novo Nordisk, Eli Lilly Tighten 340B Oversight as Providers Fume

(3/5, Bridget Early, Modern Healthcare) ...Novo Nordisk issued a notice to hospitals and other 340B participants on Monday saying providers will be required to submit comprehensive claims-level data in order to receive discounts on medications starting April 1. A similar Eli Lilly policy took effect last month... Sub. Req’d

The Drug Supply Chain's Hidden Giants

(3/5, Megan R. Wilson, The Washington Post) ...Rep. Kat Cammack (R-Florida) pointed out at a recent congressional hearing that distributors have spent $16 billion acquiring or partnering with physician management service companies that invest in doctors' practices...Overall, the complex ties make it even less likely that doctors' offices will skip the wholesaler middleman to buy drugs directly from manufacturers. The cemented connections also make it harder for other wholesalers to compete for business. The relationships also raise questions about whether investments from a wholesaler in physician practices influence doctors' treatment decisions... Sub. Req'd

FTC Seeing 'Progress' in Discussions With Optum, Caremark in Insulin Case

(3/5, Paige Minemyer, Fierce Healthcare) ...In a court filing (PDF) posted this week, the agency disclosed that it is making "significant progress" in talks with both CVS Health's Caremark and UnitedHealth Group's Optum Rx on the heels of a broad settlement with Cigna's Express Scripts... Full

PDUFA VIII: US FDA Willing To Risk One-Time Potential Revenue Reduction In Five-Year Cycle

(3/5, Derrick Gingery, Pink Sheet) ...Sponsors have argued that given the agency's current staffing situation and its difficulties hiring, annual user fee revenue increases should not be automatic. They proposed changing several of the base revenue adjustment formulas to potentially allow for revenue, and by extension application and other user fees, to decline if appropriate based on staffing levels. FDA officials opposed the idea, in part because PDUFA revenue would be less predictable for annual budgeting... Global Sub. Full

Highlights of the February 4, 2026 GDUFA IV Negotiation Meeting

(3/5, Bob Pollock, The Lachman Blog) ...Some movement towards agreement appears to have been made as the FDA indicated it would consider that "original ANDAs could qualify for a priority review under this new prioritization factor during the first three years of GDUFA IV (i.e., until October 1, 2030) if they met two of the three following criteria... Full

As FDA Decisions Get Harder to Predict, Top Official Blasts Outside Advisory Panels

(3/5, Max Bayer, Endpoints News) ...When asked why the agency hasn't convened them to discuss debatable product applications, the official questioned their value. The official also claimed that companies whose product is under discussion often use "an extremely skilled orator [and] a very slick presentation."... Sub. Req’d

Federal Health Officials Attack Rare-Disease Drug, Say Company Lied

(3/5, Liz Essley Whyte, The Wall Street Journal) ..."The recent statements made by anonymous FDA sources to the press have been highly irregular, unprecedented, and are incomplete or entirely incorrect," the company said in a statement. "We do not believe they reflect a fair and faithful reading of the documents we have submitted or those we have received from the agency."..."It feels like an unprecedented attack on a company and other companies while there's still active consideration going on," said Raymond James analyst Chris Meekins... Sub. Req’d

US FDA's Third Commissioner's NPV Nod Gives Clearer Indication Of Review Timelines

(3/6, Manas Mishra, Pink Sheet) ...The approval of Johnson & Johnson's Tec-Dara multiple myeloma (MM) regimen arrived after roughly three months of review activity, giving new insight into how long CNPV designated applications may take from the point a sponsor publicly discloses a submission to the final action... Sub. Req’d

Ga. Bill Targets Pharmacy Benefit Managers Over Drug Pricing

(3/4, Abby Kousouris, WRDW) ...House Bill 810 would set a ceiling preventing PBMs from charging above a national market price, set a floor so they cannot pay pharmacies less than the cost of a drug, and add a roughly $10 to $11 dispensing fee to help pharmacies cover costs... Full

FDA Gives a Speedy OK to J&J's Tecvayli-Darzalex Faspro Duo in MM

(3/5, Elizabeth S. Eaton, FirstWord PHARMA) ...The agency on Thursday cleared anti-BCMA bispecific Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) to treat adults with relapsed or refractory MM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent... Full

FDA Official Calls UniQure's Gene Therapy a ‘Failed' Treatment for Huntington's Disease

(3/5, Angelica Peebles, CNBC) ...The official, who requested anonymity before discussing sensitive information, confirmed the agency has asked the company to run a placebo controlled trial of its treatment, which is administered directly into the brain. UniQure has said that type of study isn't ethical because it would require putting people under general anesthesia for hours, a characterization the official disputed... Full

AEON Biopharma Abstract Accepted for Presentation at 2026 American Academy of Neurology (AAN) Annual Meeting

(3/5, AEON Biopharma) ...AEON Biopharma, Inc., a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) to achieve accelerated and full-label U.S. market entry, today announced a poster presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026... Full

J&J's Janssen Targets Accord Simponi Biosimilars in Patent Suit

(3/5, Christopher Yasiejko, Bloomberg Law) ...Janssen asked the court to seal the complaint and an exhibit because they reference "highly sensitive business information" about the proposed biosimilar products that the parties exchanged during the Biologics Price Competition and Innovation Act's patent-dispute process, including material subject to a confidentiality agreement, according to the J&J units' motion. Judge Richard G. Andrews granted the request Wednesday, with a redacted version of the sealed complaint to be filed within seven days... Sub. Req'd

Gedeon Richter's Biotech Business Breaks Into Profit For The First Time

(3/5, Dean Rudge, Generics Bulletin) ...[Richter CEO Gábor Orbán] also cautioned to investors that, in broad terms, the commercial environment for biosimilars remains uncertain. "Biosimilar pricing is highly volatile," he said. "Tenders are unpredictable, and there is considerable uncertainty about where market pricing will ultimately settle. As a result, the opportunities for us to capture profitable market share," while expanding patient access to biological therapies remain difficult to forecast. Meanwhile, Orbán stated, biosimilars are also "complicated because competition is intense, particularly from Asia, including India and South Korea."... Global Sub. Full

Insmed Holds Off Ex-US Brinsupri Launches Amid MFN Uncertainty

(3/5, Francesca Bruce, Pink Sheet) ...Insmed is pausing launch plans for its potential mega-blockbuster Brinsupri (brensocatib) in Europe and Japan. The company says it wants more clarity on US President Trump's Most Favored Nations policy that ties US drug prices to those in lower-priced markets before it proceeds... Global Sub. Full

Pfizer Secures China Nod for Obesity Drug as Generics Loom

(3/6, Amber Tong, Bloomberg) ...China has approved a new obesity treatment from Pfizer Inc., heightening competition in a market poised to become even more crowded with the looming entry of generics. The drug, ecnoglutide, is approved for chronic weight management in overweight or obese adults, Pfizer announced Friday via WeChat. The company secured China rights to the therapy from local startup Hangzhou Sciwind Bioscience Co. in a $495 million deal in late February... Sub. Req'd

Breaking Down The Pharmaceutical Regulatory (R)evolution With Medicines For Europe

(3/5, Urte Fultinaviciute, Generics Bulletin) ...Medicines for Europe's Beata Stepniewska and Adrian van den Hoven outlined how the regulatory trinity - EU pharmaceutical legislation, Critical Medicines Act, and Biotech Act - will reshape the industry... Global Sub. Full

Japan To Start Foreign Drug Priority Reviews, Clarifies Conditional Approvals

(3/6, Lisa Takagi, Pink Sheet) ...Among the key changes is a priority review system for certain foreign drugs to help address urgent demand, which allies with the country's recent moves to ease regulation around foreign products to fill market gaps. More specific criteria for conditional approval filings and a clarified view on the use of real-world data (RWD) in approval filings have been laid out... Global Sub. Full

Warning Issued Over New Shortage of Common Medicine – ‘Something Needs to Be Done'

(3/5, Hanna Geissler, Express.co.uk) ...A common painkiller is among the latest drugs to be affected by shortages in the UK, according to a top pharmacist. Dr Leyla Hannbeck, chief executive of the Independent Pharmacies Association, said codeine 15mg tablets had been out of stock from wholesalers recently, along with supplies of pregabalin used for chronic neuropathic pain...The shortage is part of a wider trend of medicine shortages in the UK which has also affected blood pressure medication, drugs for epilepsy and antidepressants... Full

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