Wednesday, December 3, 2025

Pharma Lobbyists to EU: Cut Deals With Trump

(12/2, Amanda Chu, POLITICO) ...Dorothee Brakmann, general manager of Pharma Deutschland, Germany’s industry lobby, warned that if Germany did not pursue a similar path to the U.K., Trump’s tariffs presented a “real geopolitical risk.”...Alex Schriver, senior vice president of public affairs at the Pharmaceutical Research and Manufacturers of America, the U.S. industry lobby for brand-name drugmakers, echoed the German pharma group’s call for similar country deals... Full

Editorial: Trump Strikes a Good Drug Deal

(12/2, The Wall Street Journal) ...If Mr. Trump is going to wield tariffs as a tool of diplomacy, the goal should be to fix longstanding trade irritations, not merely ameliorate the negative side effects caused by his tariff barrage... Sub. Req’d

The Economics Behind U.S. Generic Drug Manufacturing

(12/2, Andy Lundin, Pharma Manufacturing) ...In the latest episode of Off Script: A Pharma Manufacturing Podcast, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, to unpack what's working, what's not, and what must change to secure the future of generic drug production in the U.S... Full

Repricing Fairly: Balancing MFN and Domestic Reforms

(12/2, Franklyn Rocha Cabrero, AJMC) ...The path to sustainable drug pricing reform does not lie in choosing between MFN and domestic strategies—it lies in blending their strengths while addressing their shortcomings. A hybrid model guided by equity-conscious valuation tools can deliver affordable medications, maintain incentives for innovation, and reduce systemic disparities. Health policy cannot rely on imported benchmarks or legacy cost-effectiveness tools alone; it must evolve with frameworks that align economic rationality with ethical responsibility. Reduction of spending while preserving access and innovation should be a shared goal of public policy officials and their constituents... Full

Lawmakers Dig in on Biopharma Manufacturing With Bill Proposing US Center of Excellence

(12/2, Zoey Becker, Fierce Pharma) ...Lawmakers are proposing a new effort to strengthen biopharma manufacturing in the U.S., leveraging a bill that seeks to create a dedicated center of excellence in the country...In essence, the legislation seeks to reduce U.S. dependence on foreign supply chains and to ensure a smoother road to commercialization through a national public-private biopharmaceutical manufacturing center of excellence. The production hub would be designed to “facilitate and accelerate manufacturing innovation, support good manufacturing practices” and provide training for workers to “bolster talent” throughout the industry, according to the bill... Full

Q&A: TrumpRx Could Change the Way Pharmacies, PBMs Do Business

(12/2, Brian Nowosielski, Drug Topics) ...While the rollout of TrumpRx is still being prepared, we caught up with [John C. Goodman, PhD, senior fellow at the Independent Institute and president of the Goodman Institute for Public Policy Research] to tap into his expertise as a health care economist. With extensive insights into the roles of PBMs, insurance plans, manufacturers, pharmacies, and drug pricing in general, Goodman shared his thoughts on the unprecedented new avenues of drug dispensing TrumpRx could be introducing... Full

TrumpRx Could Be a Gamechanger

(12/2, Merrill Matthews, The Hill) ...The key to this model is bypassing the pharmacy benefit managers that for decades have served as middlemen between the drug manufacturers and pharmacies...TrumpRx also builds on the trend of people who are increasingly comfortable shopping online and having their purchases delivered to the home... Full

Top Drug Regulator Richard Pazdur Set to Leave The FDA

(12/2, Lizzy Lawrence, STAT+) ...Top drug regulator Richard Pazdur has filed papers to retire from the [FDA] at the end of this month, adding to the turmoil atop the agency...A spokesperson for the FDA confirmed the news and said Pazdur's decision is final... Sub. Req’d

Pazdur to Retire Weeks after Assuming Leadership of CDER

(12/2, Elizabeth S. Eaton, FirstWord PHARMA) ...Reports on Tuesday suggested that Pazdur's reservations about the CNPV scheme played a part in his decision to retire, alongside frustrations with Makary and Vinay Prasad, chief of the FDA's biologics division... Full

Lawmakers Invited to FDA Meeting for Patrick Soon-Shiong's Drug

(12/3, Charles Gorrivan, Rachel Cohrs Zhang, Gerry Smith, Bloomberg Law) ...The invitation was unusual for the FDA, whose regulatory process is supposed to be dictated by science rather than politics. Lawmakers have generally not been allowed to attend drug approval meetings to prevent the appearance of political interference in the review process, though the practice is not banned outright. It was unclear who extended the invitation to the lawmakers... Sub. Req’d

Department of Banking and Insurance Adopts Final Regs Capping Copays for Certain Prescription Drugs

(12/3, John Harrington, ROI-NJ.com) ...The New Jersey Department of Banking and Insurance on Dec. 2 said it has adopted final rules outlining requirements for state-regulated insurers to cap certain out-of-pocket costs on critical prescription medications... Full

Illinois to Cap Prescription Inhaler Costs at $25 Starting in 2026

(12/2, John Clark, WTVO) ...Starting January 1st, 2026, Illinois residents will see new limits on what they pay for certain prescription drugs, a move lawmakers say could ease financial strain on families managing chronic conditions. Under the law, health insurance policies must cap out-of-pocket costs for prescription inhaler cost-sharing at $25 for a 30-day supply... Full

List Price Reductions Will Deflate the Gross-to-Net Bubble–and Threaten Pharmacy and 340B Profits from IRA-Negotiated Drugs

(12/2, Adam J. Fein, Drug Channels) ...As I show below, retail pharmacies risk becoming collateral damage from significant deflation in the gross-to-net bubble for drugs subject to an MFP. Welcome to our bonkers healthcare system—where everyone wants lower prices, until they actually get them... Full

FDA Approves Amneal's Albuterol Sulfate Inhalation Aerosol

(12/2, Danielle Valletti, Pharmacy Times) ...This marks Amneal's consecutive major respiratory approval after the beclomethasone dipropionate inhalation aerosol (Qvar RediHaler; Amneal), received FDA approval in November 2025.¹ Together, these wins represent significant progress in the company's long-term strategy to expand its inhalation-based therapeutics and establish a competitive presence across both maintenance and rescue respiratory therapies... Full

Amneal Scores Dual FDA Wins In High-Value Complex Generics

(12/3, Dean Rudge, Generics Bulletin) ...Both of Amneal's products will enjoy relatively limited competition. According to the FDA's database of approved drugs, Amneal is the fifth abbreviated new drug application sponsor to receive approval for cyclosporine 0.5% ophthalmic solution, following nods for Viatris' Mylan and Teva, as well as Deva Holding A.S. and partners Saptalis Pharmaceuticals/Taejoon Pharmaceutical...Meanwhile, the competition pool for generic ProAir is smaller still, with Teva's reference product joined by ANDA products registered by Padagis, Lupin, Armstrong Pharmaceuticals, and now Amneal... Global Sub. Full

Celltrion's Eydenzelt Becomes Third Aflibercept Biosimilar Approved In Canada

(12/2, Dean Rudge, Generics Bulletin) ...The authorization covers all indications currently approved for the reference product, with the biosimilar to be made available in both vial and pre-filled syringe formats... Global Sub. Full

Fresenius Kabi Expands Operating Room Portfolio with New Simplist® Prefilled Syringes

(12/2, Fresenius Kabi ) ...Fresenius Kabi...announced today it has introduced two new products in its Simplist® portfolio of ready-to-administer prefilled syringes: Simplist® Ephedrine Sulfate Injection, USP and Simplist® Succinylcholine Chloride Injection, USP. Both medications are used in anesthesia and critical care, and their introduction extends the Simplist line's use into operating rooms, supporting clinicians with safe, efficient and reliable medication delivery... Full

Upstart PBMs Chip Away at Market Leaders as ‘Big 3' Pivot

(12/2, Noah Tong, Modern Healthcare) ...Should the largest PBMs convince skeptical employers they are now similarly transparent, alternative PBMs will be tested as to whether they can still make compelling cases to employers. Alternative PBMs argue the onus is on big players to prove they've truly changed and that, even if they have, the transition may not be easy... Sub. Req’d

EU Countries Clinch Fragile Deal on Drug Shortages Plan

(12/3, Emma Pirnay, Euractiv) ...EU health ministers agreed the Council's position on the Critical Medicines Act (CMA) on Tuesday, but divisions persist over funding and the level of ambition needed to secure the medicines supply for each EU country, particularly among smaller states... Full

NHS Will Not Receive Extra Money From Treasury to Cover Cost of Inflated Drug Prices Resulting From New US Trade Deal

(12/2, Shaun Wooller and Jason Groves, Daily Mail) ...Number 10 today admitted medicines will cost taxpayers an additional £1billion over the next three years but was unable to say how they would be paid for. The Prime Minister's spokesman said the Department of Health and Social Care will have to find the money from what it was allocated in June's spending review... Full

Can The UK Become A First Approver Of New Drugs, Rather Than A Fast Adopter?

(12/2, Francesca Bruce, Pink Sheet) ...The UK's medicines regulator, the MHRA, should offer more clarity to pharmaceutical companies on which types of medicines would be suitable for UK-first global approvals and which would be more appropriate for regulatory reliance procedures, according to Dan O'Connor from the Association of the British Pharmaceutical Industry. However, asked if it had any plans to publish guidance on which products were more appropriate for first approvals, the MHRA told the Pink Sheet that it was up to companies to choose the regulatory pathway that best fits their circumstances... Global Sub. Full

EMA Considers New Biomarkers, Patient Populations in Proposed Parkinson's Disease Guideline Update

(12/2, Jeff Craven, Regulatory Focus) ...The European Medicines Agency (EMA) has released a concept paper proposing discussion questions about what should be contained in a future clinical guideline revision for Parkinson's disease, the first revision in more than a decade... Full

India Doubles Down on Domestic Active Pharmaceutical Ingredient Manufacturing

(12/3, The Hans India) ...The PLI scheme for Bulk Drugs is aimed at avoiding disruption in supply of critical Active Pharmaceutical Ingredients (APIs) used to make critical drugs for which there are no alternatives by reducing supply disruption risk due to excessive dependence on single source. The scheme has a budgetary outlay of Rs 6,940 crore... Full

Indian Pharma Eyes US Biosimilars Boom as USFDA Eases Rules

(12/3, Viswanath Pilla, Moneycontrol) ...Indian drugmakers are recalibrating their biosimilars strategy, seizing on a fresh opportunity created by recent US FDA draft guidelines and a booming American biosimilars market. Companies that were sitting on the fence are now thinking about how to get into the biosimilar race; some are even considering acquisitions to get to market faster, industry sources told Moneycontrol... Full

South Korea: Government, Pharma Clash Over Generic Drug Prices

(12/3, Kwak Soo-keun, The Chosun Daily) ...The conflict between the government and the pharmaceutical and bio industry over the pricing calculation rate for generic drugs (copy drugs) developed with the same ingredients and content as expired patented new drugs is expected to intensify... Full

Japan to Lower Official Drug Prices in FY 2026

(12/3, Jiji Press) ...The Japanese government is expected to lower the state-set prices of drugs in its fiscal 2026 revision after a health ministry survey found that market prices are lower than the official prices. The survey results, presented Wednesday to the Central Social Insurance Medical Council, which advises the health minister, showed that prices of drugs purchased by medical institutions from wholesalers were 4.8 pct lower than official prices on average as of September... Full

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