Wednesday, December 17, 2025

Sagimet Biosciences, TAPI Announce Global License Agreement for Resmetirom

(12/17, The Fly) ...Under the agreement, TAPI has granted Sagimet a global, exclusive license to certain intellectual property rights covering innovative forms of TAPI's resmetirom active pharmaceutical ingredient for Sagimet's technical evaluation and manufacture, and, if elected by Sagimet, further development of a fixed-dose combination product containing denifanstat and resmetirom. Pending patent applications filed by Sagimet and TAPI cover the FDC and the innovative resmetirom forms, respectively... Sub. Req’d

Teva Pharma (TEVA) PT Raised to $35 at JPMorgan

(12/16, StreetInsider.com) ...JPMorgan analyst Chris Schott raised the price target on Teva Pharma to $35.00 (from $28.00) while maintaining a Overweight rating... Sub. Req’d

Q&A: How Complex US Drug Market Impedes MFN Pricing Policy

(12/16, Brian Nowosielski, Drug Topics) ...Ron Lanton III, Esq, discusses previous MFN drug pricing policies and why the free US drug market often yields higher patient costs... Full

'Most Favored Nation' Pricing May Cut Drug Costs. It May Also Cut Off Rural America.

(12/16, N. Adam Brown, MedPage Today) ...Because MFN does not operate in a vacuum, the president's plan is dangerous. Indeed, the MFN plan will sit on top of a landscape where rural hospitals are closing, small pharmacies are fragile, Medicaid is under pressure, NIH budgets are being cut, tariff threats inject uncertainty into global supply chains, and FDA practices have become less predictable for innovators... Full

How Will Plans Cope As Pharma Net Pricing Trend Deflates ‘Gross-To-Net Bubble'?

(12/16, Cathy Kelly, Pink Sheet) ..."The gross-to-net bubble is deflating," Drug Channels Institute President Adam Fein said during a Dec. 12 webinar on drug pricing in the year ahead. "It's not going to deflate entirely but it is starting to deflate meaningfully and … some parts of the industry are starting to adjust to a net pricing drug channel model," he added. "That means changes in the business models for pharmacies, wholesalers, PBMs, manufacturers, patients, everyone. This is going to flow through the channel in a very profound way."... Sub. Req’d

Budzinski Supports Legislation to Crack Down on Predatory Drug Pricing, Rein in Pharmacy Benefit Managers

(12/16, Congresswoman Nikki Budzinski) ..."Prescription drug prices are out of control in America, and predatory PBMs are only making it worse," said Congresswoman Budzinski. "Cracking down on these middlemen, who jack up the cost of lifesaving medications to line their own pockets, is a critical step to bring down prices and protect access to community pharmacies. I'm proud to help introduce this legislation that will provide greater transparency, accountability, and oversight to ensure that PBMs can no longer take advantage of hardworking Illinoisans."... Full

My Prescription Costs What?! Pharmacists Offer Tips That Could Reduce Your Out-of-Pocket Drug Costs

(12/16, Sujith Ramachandran, The Conversation) ...As pharmacy professors who research prescription drug access, we think it's important for Americans to know that it is possible to get prescriptions filled more affordably, as long as you know how before you go to the pharmacy... Full

Generic Drug Lobby, Connecticut Agree on Out-of-State Pricing

(12/16, Ian Lopez, Bloomberg Law) ...Filed Monday with the US District Court for the District of Connecticut, the proposed agreement would cap off the Association for Accessible Medicines' legal challenge against Connecticut over a law meant to prohibit excessive price increases on generic drugs... Sub. Req’d

Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatments for Obesity

(12/16, ICER) ...The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. The final report includes key policy recommendations to help ensure fair access... Full

The Generic's Gauntlet: A Strategic Playbook for ANDA Filing and Market Domination

(12/16, DrugPatentWatch) ...To view the ANDA filing process as a mere administrative checklist is to fundamentally misunderstand its power. This is not simply about creating a "copy" of a brand-name drug; it is about strategically dismantling a monopoly, navigating a complex legal and scientific gauntlet, and ultimately, delivering affordable medicines to millions while capturing significant market share... Full

A Prescription for Success at the FDA

(12/16, Brenda Destro, RealClearHealth) ...Controversy is not new to the FDA. The industry that the agency regulates is valued at $1.6 trillion and consists of a workforce of scientific experts and high-powered entrepreneurs that would be difficult to manage under the best of circumstances. However, in its present state, one expert has described it as "stumbling through a bureaucratic fog in which innovation stalls and risks multiply."... Full

States Consider Payment Limits to Curb Prescription Drug Prices with PDABs

(12/16, Manasi Vaidya, Pharmaceutical Technology) ...State PDABs are still relatively new in the continuum of drug pricing policy. However, as drug wholesalers and some patient organisations push back against certain recommendations, and pharma companies pursue legal challenges, PDABs are approaching a potential inflection point in their efforts to make drugs affordable... Full

Backed by J&J and BMS, Link Cell Debuts with Logic-Gated CAR-T Playbook

(12/17, Anna Bratulic, FirstWord PHARMA) ...The South San Francisco company, founded by Stanford University researchers Robbie Majzner and Crystal Mackall, is betting that a different way of choosing targets may be able to address why CAR-T therapies have struggled to move beyond blood cancers... Full

BMS Strikes $1.1b Multispecific Antibody Pact with Harbour

(12/17, Pavan Kamat, FirstWord PHARMA) ...The partnership will leverage Harbour's platform — which can generate fully-human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format — to build the multispecific assets. The alliance may also utilise Harbour's development capabilities to conduct early clinical trials in China, potentially accelerating timelines... Full

GSK Says US FDA Approved Its Twice-Annual Asthma Drug

(12/17, Ashleigh Furlong, Bloomberg) ...The US Food and Drug Administration approved Exdensur as an add-on maintenance treatment of severe asthma for patients aged 12 years and older, the company said in a statement on Wednesday... Sub. Req’d

MapLight Brightens SandboxAQ with New Deal to Discover New CNS Candidates

(12/16, Darren Incorvaia, Fierce Biotech) ...Under the terms of the deal, MapLight is beaming an undisclosed upfront payment over to SandboxAQ, with the tech outfit also eligible to receive preclinical, development, regulatory and commercial milestone payments worth up to $200 million "in aggregate," the partners announced in a Dec... Full

Lupin Clears Major EU Regulatory Hurdle for Biosimilar Ranibizumab

(12/17, Gareema Bangad, CNBC-TV18) ...In an exchange filing, Lupin said the Committee for Medicinal Products for Human Use (CHMP) has backed the approval of the biosimilar, to be marketed as Ranluspec, in both vial and pre-filled syringe formats... Full

Fresenius Partner Obtains FDA Review for Eylea Biosimilar

(12/16, Sandra Levy, Drug Store News) ..."This submission is a significant milestone in our partnership with SCD and a testament to our shared commitment to improving patient access to affordable treatment options in ophthalmology," said Dr. Sang-Jin Pak, president biopharma, Fresenius Kabi. "It aligns with our #FutureFresenius strategy and reinforces our dedication to expanding our biosimilar portfolio globally."... Full

Sun Pharma Mirrors Dr Reddy's Outcome In Novo Nordisk Semaglutide Litigation

(12/17, Dean Rudge, Generics Bulletin) ...The Delhi High Court has recorded binding assurances from Sun that it will not sell semaglutide in India while the Danish company's local patent IN262,697 remains in force until March 2026. In a six-page order, Novo Nordisk's lawyer told the court that the company agreed to these submissions... Global Sub. Full

New CEO Sonig Leads Rosemont Towards US Ambitions

(12/17, Dave Wallace, Generics Bulletin) ...A refreshed management team will lead Rosemont Pharmaceuticals into its next phase, after generics industry veteran Alok Sonig was named as the UK liquids specialist's new CEO from the start of 2026. Sonig was previously head of North American generics at Dr Reddy's, before joining Lupin where he led the US generics business, at the same time serving as chair of the board at the Association for Accessible Medicines in 2020... Global Sub. Full

Facing Multibillion-Dollar Patent Cliff, Pfizer Plans Slew of Obesity Trials

(12/16, Max Bayer, Endpoints News) ...[CEO Albert] Bourla said the company also sees substantial opportunity in the cash-pay market for anti-obesity drugs, particularly overseas. He compared it to the company's success with erectile dysfunction medication Viagra, which decades ago sealed Pfizer's reputation as a commercial powerhouse. "We are seeing multiples of what we were expecting in a cash market, which clearly also will help us cover and derisk a lot of our projections with Metsera," he said... Sub. Req’d

The EU Biosimilar Industry, Which Is Central to Competitiveness, Needs Ambitious, Coherent, & Competition-Driven Biotech Policies

(12/16, Medicines for Europe) ...The Act's recognition of the economic and industrial importance of the biosimilar medicines industry, in addition to its significant contribution to patient access and to healthcare, confirms their essential role in Europe's strategic autonomy, supply resilience, competitiveness and sustainable access to biological therapies. However, the industry urges policymakers to recalibrate the competitiveness measures, shifting focus away from additional intellectual property extensions which have always promised but never delivered on R&D in Europe... Full

NICE's CEO Hunt Ends With Benger Appointment, Signaling Continuity AS NHS Reforms Loom

(12/16, Anabel Costa-Ferreira, Pink Sheet) ...Deputy chief Jonathan Benger moves up to become NICE's fourth-ever CEO. While the face may be familiar, the challenges are anything but as the HTA body has launched a new joint scientific advice process with the MHRA and will implement new cost-effectiveness thresholds driven by a US trade deal... Global Sub. Full

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