Tuesday, December 2, 2025

U.K. Pushed to Spend More on Medicines in Deal to Avoid Tariffs

(12/2, Rebecca Robbins and Eshe Nelson, The New York Times) ...''For too long, American patients have been forced to subsidize prescription drugs and biologics in other developed countries by paying a significant premium for the same products in ours,'' Jamieson Greer, the U.S. trade representative, said in a news release announcing the deal. Under the deal with the United States, Britain would pay 25 percent more for new medicines...''This vital deal will ensure U.K. patients get the cutting-edge medicines they need sooner, and our world-leading U.K. firms keep developing the treatments that can change lives,'' said Liz Kendall, Britain's secretary of state for science, innovation and technology... Full

US, UK Agree Deal on Pharmaceutical Tariffs, Drug Pricing

(12/1, Ashleigh Furlong, Lucy White, Bloomberg) ...But Diarmaid McDonald, executive director at the Just Treatment patient lobby group, called the deal a "betrayal" of NHS patients. "Big Pharma have got what they want. Donald Trump has got what he wants," he said in a statement. "The government has folded and thousands of patients will pay for this with their lives, as precious funds get stripped from other parts of the health service to line the pockets of rich pharmaceutical execs."... Sub. Req’d

US Pharma Manufacturing Investments Reaching Unprecedented Levels: Report

(12/1, Greg Slabodkin, Pharma Manufacturing) ...Despite rising costs, aggressive schedules, and unpredictable market conditions, large pharmaceutical companies have committed to investing more than $370 billion over the next five years in U.S. pharma manufacturing - a sector poised for growth amid significant challenges, according to DPR Construction's Life Sciences Market Trends Q4 2025 report... Full

AAM Applauds Q1/Q2 House Bill Passage

(12/1, AAM) ...The Association for Accessible Medicines today applauded passage of Q1/Q2 legislation in the U.S. House of Representative...The legislation will authorize FDA to cut through the bureaucratic red tape and disclose to a generic manufacturer the ingredient or ingredients that cause a proposed generic drug formulation not to be quantitatively and qualitatively, or Q1/Q2, the same as the brand-name reference product formulation... Full

Hospitals Sue HHS Over New Drug Discount Rebate Pilot Program

(12/1, Nyah Phengsitthy, Bloomberg) ...The complaint and temporary restraining order filed Monday in the US District Court for the District of Maine by the American Hospital Association, the Maine Hospital Association, and four safety-net health systems seeks to block the implementation of the 340B Rebate Model Pilot Program... Full

Annual US FDA User Fees Proposed For Sponsors With No Domestic Clinical Development

(12/1, Derrick Gingery, Pink Sheet) ...Sponsors developing drugs outside the US could be charged an annual user fee by the [FDA]. Among the FDA's top priorities for the prescription drug and generic drug user fee program reauthorizations is to encourage more onshoring of drug development and manufacturing, a major goal of the Trump Administration... Global Sub. Full

FDA Launches Agentic AI Tools Agency-Wide in Latest AI Push

(12/1, Marta Rybczynski, FirstWord PHARMA) ...The tools are meant to support what the agency described as more complex tasks such as meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance, as well as administrative functions. The agentic AI system is designed to plan and carry out multi-step actions while operating under guidelines that require human oversight, according to the FDA... Full

À La Carte Clinical Trials? DCTs Promise Flexibility, But Reality Is Complex

(12/1, Vibha Sharma, Pink Sheet) ...While several companies are focused on improving the patient experience in clinical trials through innovative solutions, such as DCTs, offering such choice is far from straightforward. This issue was highlighted during discussions at a conference organized by the public-private Trials@Home consortium in Amsterdam, the Netherlands... Global Sub. Full

Postmarket Optimization Can Give Companies A ‘Competitive Advantage' In Oncology

(12/1, Eliza Slawther, Pink Sheet) ...Companies that run postmarket optimization studies for their cancer drugs can benefit from greater use of their drugs by clinicians due to improved safety and efficacy, according to expert professor Sahar Barjesteh van Waalwijk van Doorn-Khosrovani... Global Sub. Full

AbbVie Moves to Widen Aquipta's EU Label After Pivotal Success in Acute Migraine

(12/1, Pavan Kamat, FirstWord PHARMA) ...Results — detailed ahead of presentation at the European Headache Congress this week — showed that 24.3% of Aquipta recipients achieved the primary endpoint of pain freedom at two hours post treatment of the first attack versus 13.1% on placebo. Additionally, 12 of 16 key secondary goals were met, including freedom from most bothersome migraine symptom at two hours... Full

Lilly Direct to Offer Lower-Priced Single-Dose Zepbound Vials

(12/1, Elizabeth S. Eaton, FirstWord PHARMA) ...The low, 2.5-mg single-dose Zepbound vial will also carry the $299 self-pay price tag, while the 5-mg dosage will be priced at $399 per month. All other single-dose vials will have a monthly cost of $449... Full

Four Firms Fire Starting Pistol On European Denosumab Competition

(12/1, Dave Wallace, Generics Bulletin) ...Fresenius Kabi, Samsung Bioepis, Sandoz and Zentiva have confirmed market entry, against a backdrop of more than 20 individual denosumab products having been given the green light by the European Medicines Agency – meaning the market may struggle to support all of the competitors that will be vying for share... Global Sub. Full

Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05%

(12/1, Amneal Pharmaceuticals) ...Amneal...today announced the U.S. Food and Drug Administration (FDA) has approved the Company's cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The product is the generic equivalent of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan, an AbbVie company... Full

Can Biosimilars Take Root In Cell And Gene Therapy?

(12/2, Dean Rudge, Generics Bulletin) ...In an exclusive interview, Generics Bulletin spoke with Duke-Margolis Center for Health Policy professionals Brian Canter, Steven Colvill and Nitzan Arad to discuss the formidable challenges that must still be overcome before biosimilar cell and gene therapies become a reality... Global Sub. Full

Zydus Builds On US Specialty Portfolio With A 505(b)(2) Deal

(12/1, Urte Fultinaviciute, Generics Bulletin) ...Under the agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the application submission and commercialization in the US. The undisclosed oncology supportive care product is being developed for submission via the US Food and Drug Administration's 505(b)(2) pathway, with the filing expected in 2026... Global Sub. Full

Top Contributors to Leading Psychiatry Journals Fail to Disclose Industry Payments, Analysis Finds

(12/1, Ed Silverman, STAT+) ...Amid ongoing concern over conflicts of interest that may affect medical practice, a new study found that 14% of the $4.5 million paid to authors in two leading psychiatry journals was undisclosed and nearly all of the payments were made to researchers conducting randomized controlled trials for pharmaceuticals... Sub. Req’d

Medicines ‘Never More Expensive in Switzerland'

(12/2, Swissinfo.ch) ...According to the Helsana report, in 2023 drug costs in Switzerland had already risen by 5.9% to CHF9.02 billion in the outpatient sector. And for the first time, they represented the largest expenditure item in basic insurance. In the last ten years, the prices of new medicines have almost doubled. This is also true for products with no innovations, adds Helsana, according to which rapid and consistent implementation of the cost monitoring model adopted by parliament is indispensable... Full

Patients Promised Groundbreaking New Drugs on NHS in Deal with US

(12/1, Richard Fletcher, Alex Ralph, Oliver Wright, The Times) ...As a result of the move, NHS spending on medicines is forecast to rise from about 9.5 per cent of its budget to 12 per cent over the next decade. The Office for Budget Responsibility, the fiscal watchdog, said last week that a 25 per cent rise in medicine prices would cost the NHS £3 billion a year — but as the deal only applies to new drugs this increase will be gradual. One industry source said that the cost to the NHS over the next few years was expected to be about £700 million a year... Full

Commerce Ministry Seeks Inputs on Pharma Trade Related Issues Being Faced with Japan

(12/2, Shardul Nautiyal, Pharmabiz.com) ...Indian pharma exporters face numerous non-tariff barriers, particularly in the form of Japan's stringent technical, sanitary, and phytosanitary (SPS) standards. Implementing and agreeing upon ROO for goods traded under the Comprehensive Economic Partnership Agreement (CEPA) is another contentious area. India is pushing for a review of the 2011 CEPA to address the perceived imbalance and the NTBs faced by Indian exporters... Full

Generic Drug Price Cuts Risk Collapsing Korea's Pharma Ecosystem, Industry Warns

(12/1, Park Gi-taek, Korea Biomedical Review) ...The government highlights the positive aspects of the reforms, such as improving access to innovative new drugs and offering preferential treatment to companies investing in R&D. But the industry argues that the proposed sharp reduction in the pricing calculation standards for generic drugs (excluding new drugs) from 53.55 percent of the original drug price to around 40 percent would eliminate essential funding for the pharmaceutical and biotech sector, threatening the sustainability of the industry's ecosystem... Full

Broad Korea Pricing Reforms Aim To Promote Innovation, Ensure Essential Drug Supply

(12/2, Jung Won Shin, Pink Sheet) ...Generics and off-patent drugs will be priced at 40% of the current reimbursement price of the original, down from the current 53.55%, sparking industry warnings over R&D investment, delays in new drug development, reduction in capital investment and reduced global competitiveness... Global Sub. Full

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