Thursday, December 11, 2025

Teva Pharmaceuticals Requests Removal of Some Patents From FDA Listing After FTC Warning

(12/11, Katherine Hamilton, Dow Jones) ...Teva Pharmaceutical Industries requested that the Food and Drug Administration remove more than 200 patent listings from its book of approved products. The request came after the Federal Trade Commission in May sent a series of warning letters to Teva and other pharmaceutical companies arguing that some of their patents didn't meet criteria for listing with the FDA... Full

FTC Claims a Win as Teva Moves to Delist Hundreds of Patents from FDA Orange Book, Agency Says

(12/10, Eric Sagonowsky, Fierce Pharma) ...The development marks the latest turn in the FTC's yearslong campaign to confront industry members for alleged patent abuses. Back in September 2023, the agency issued a policy statement warning the industry that the enforcement initiative was about to kick off... Full

Teva Seeks Removal of Over 200 Patents from FDA Orange Book after FTC Challenge

(12/11, Dulan Lokuwithana, Seeking Alpha) ...The FTC challenge followed a ruling from the U.S. Court of Appeals for the Federal Circuit, which, in a legal dispute between Teva and Amneal Pharmaceuticals determined that the Israeli drugmaker's patents were improperly listed in the Orange Book... Full

Teva Files LAI Olanzapine With FDA, Paving Way for $2bn Schizophrenia Franchise

(12/10, Dean Rudge, Generics Bulletin) ...Speaking at the 2025 Jefferies London Healthcare Conference last month, Teva's CEO Richard Francis confirmed that the firm would file a new drug application via the FDA's 505(b)(2) pathway for olanzapine "very shortly," leading to potential market entry as early as October 2026. At the same time, Francis acknowledged the potential use of an FDA priority review voucher to accelerate its timeline, though Teva made no mention of the voucher in its NDA announcement and has not committed to using it for the program. Meanwhile, Teva did not disclose an FDA action date, potential launch timing, or the commercial ambitions it has outlined in recent months... Global Sub. Full

PBM Reform Among Policies Floated For House GOP Health Bill

(12/10, Gabrielle Wanneh, Inside Health Policy) ...House Republicans are signaling they may include pharmacy benefit manager reforms in upcoming legislation to lower health care premiums and expand patient options -- a package they are putting together as a possible alternative to Democrats' call to expand the enhanced Affordable Care Act subsidies that expire this month. A list of nine policy considerations obtained by Punchbowl News also mentions innovation, which potentially could be referring to Republicans' calls to reverse or modify the Inflation Reduction Act's Medicare drug price negotiation measure they assert stifles innovation... Sub. Req'd

Americans Are Facing a Growing Healthcare Crisis - And Your Medicines Are at Risk

(12/10, Jon Toomey, MarketWatch) ...The recent Senate hearing produced several bipartisan proposals, including a recommendation to establish a federal buyer's market for essential medications. That kind of procurement and reimbursement reform could create certainty for investors — and help to launch resilient, domestic pharmaceutical production. The goal of course would be scalable, innovative and advanced manufacturing in the U.S. — something just as critical as the investments in innovation and discovery that once made America a pharmaceutical powerhouse... Full

The Market Is the Expressway to Better American Drug Prices

(12/11, Rev. Ben Johnson, RealClear Health) ...Whether they are driven by the public or the private sectors, pharmaceutical cost reductions matter to the 42 million Americans taking GLP-1 drugs as part of a weight loss regimen. The policies and price updates are complex, but the takeaway is simple: Competition brings down prices. Together, they show what can happen when demand is strong and multiple players - public and private - respond. Free-market economists know that manufacturers do not merely react to market signals without reference to policy statements... Full

Biosimilars Forum Calls for Congress to Pass the Skinny Labels, Big Savings Act to Support Safe, Effective and Lower-Cost Biosimilars

(12/10, Biosimilars Forum) ..."The Biosimilars Forum supports the Skinny Labels, Big Savings Act. This bipartisan legislation will promote free-market competition of biosimilars and improve patient access to lower-cost, FDA-approved medications. This bill will help patients and taxpayers save money on prescription drugs because it will help biosimilar manufacturers bring biosimilars to market more quickly. In fact, 67% of biosimilars had a skinny label at the time of [FDA] approval."... Full

FDA Finalizes Guidance on Promotional Materials for Biologics and Biosimilars

(12/10, Andrea Park, Fierce Pharma) ...Differences from last year's draft version are minimal, including only an addition in the introduction that its recommendations "apply regardless of the medium of the communication (e.g., paper, digital)" and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with "editorial changes for consistency, readability, and clarity," per the FDA... Full

One Year Later, FDA Reorg Drives Faster Warning Letters, Surge In Facility Classifications

(12/10, Sue Sutter, Pink Sheet) ...The October 2024 reorganization that moved compliance functions back into the product centers has resulted in speedier issuance of biologics warning letters and an increase in drug manufacturing facility classifications, FDA compliance officials said... Global Sub. Full

CBER Official Stresses Importance of Preapproval Inspection Readiness

(12/10, Joanne S. Eglovitch, Regulatory Focus) ...Melissa Mendoza, director of the Office of Compliance and Biologics Quality (OCBQ)...emphasized the importance of being prepared for an inspection once the inspection readiness box is checked on the Form 356h, which is the application for marketing a new drug or biologic. "One of the questions on the form is whether the site is ready for an inspection. If the box is checked, we expect the facility to be ready for an inspection," she said... Full

Louisiana Dropped a $4B Medicaid Contract. It's Part of a Broader Fight Over Drug Prices.

(12/11, Alyse Pfeil, Nola.com) ...Louisiana's last-minute decision this month not to renew a $4.2 billion contract with United Healthcare to provide Medicaid benefits for roughly 330,000 people is the latest front in a larger battle some state officials are waging against major health companies over prescription drug prices...The problem does not appear to be with the UnitedHealthcare contract itself - in fact, the Health Department asked lawmakers last month to renew it - Attorney General Liz Murrill has tied it to another issue: a lawsuit over pharmacy benefit managers... Sub. Req'd

Sixth Circuit Appears Likely to Strike Down Tennessee PBM Law

(12/10, Lauren Clason, Bloomberg Law) ...Judges David W. McKeague, Chad A. Readler, and Stephanie Dawkins Davis on the US Court of Appeals for the Sixth Circuit appeared critical and confused by the state's arguments that a district court erred in overturning language governing PBMs' treatment of pharmacies in a case brought by McKee Foods Corp...Tennessee tried to distinguish the pharmacy language from "any willing provider" laws around medical services-which courts have deemed as substantive benefit regulation. But Davis cast doubt on that argument, calling it a "distinction without a difference."... Sub. Req'd

Roche's Columvi Improves Survival in Large B-cell Lymphoma

(12/10, Esme Needham, PMLiVE) ...Roche's Columvi (glofitamab), in combination with GemOx (gemcitabine and oxaliplatin), has demonstrated sustained survival benefit in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT)...The study found that, after a median follow-up period of 35.1 months, overall survival remained twice as long for patients treated with Columvi-GemOx versus patients treated with MabThera/Rituxan-GemOx... Full

Roche Links Oral SERD to 30% Breast Cancer Risk Reduction in Phase 3 Adjuvant Trial

(12/10, Nick Paul Taylor, Fierce Biotech) ...The Swiss drugmaker reported that its phase 3 lidERA trial met its primary endpoint in November. LidERA enrolled 4,100 patients with ER-positive, HER2-negative early-stage breast cancer to receive Roche's oral SERD candidate or standard-of-care endocrine therapy...The analysis of LidERA's primary endpoint showed that 6.7% of patients on giredestrant had developed invasive cancer or died, compared to 9.4% of people in the control arm... Full

Pfizer's Tukysa Delays HER2 Breast Cancer Progression as 1st-line Maintenance Therapy

(12/10, Angus Liu, Fierce Pharma) ...The current standard of care for the disease includes induction chemotherapy in combination with Roche's Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes... Full

Sanofi Faces Scrutiny For Potential Multiple Sclerosis Blockbuster At Critical EMA Meeting

(12/10, Francesca Bruce, Pink Sheet) ...The oral explanation meeting for tolebrutinib, for treating non-relapsing secondary progressive multiple sclerosis in adults, was scheduled for Dec. 10. According to Sanofi, if approved, tolebrutinib "would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity."... Global Sub. Full

Glenmark to Launch Generic Medication in US

(12/11, PTI) ...Glenmark Pharmaceuticals on Thursday said it will launch a generic medication this month in the US market for the treatment of anaemia and to prevent serious side effects caused by large doses of medications that can reduce the impact of folic acid in the body... Full

What's Next in Highmark's Generics, Biosimilars Pipeline as CivicaScript Model Scales

(12/10, Elizabeth Casolo, Becker's Payer Issues) ...Highmark recently shared how it increased generic and biosimilar access to members, focusing on drugs for multiple sclerosis, cancer and autoimmune conditions. The insurer has been working with CivicaScript, a nonprofit generic drug company it helped found, to offer these options. Corey DeLuca, PharmD, Highmark's vice president of clinical and specialty pharmacy services, told Becker's about her expectations for further expansion... Full

Biotech Boss Urges Pharma to Move on From 'Weight-Loss Olympics'

(12/11, Aanu Adeoye, Financial Times) ...Pharma companies need to move beyond the "weight-loss Olympics" and focus on more durable treatments with fewer side effects, according to the chief executive of Zealand Pharma, which this year agreed a $5.3bn obesity partnership with Roche..."We need to get away from the weight-loss Olympics, which is about how fast and rapid and how deep you can go . . . We need to get into durability and quality of the weight loss," Steensberg told the Financial Times... Sub. Req'd

Generic Liraglutide - Overlooked But Not Forgotten

(12/10, Suhas Gondi, M.D., M.B.A., Aaron S. Kesselheim, M.D., J.D., M.P.H., and Benjamin N. Rome, M.D., M.P.H., The New England Journal of Medicine) ...The market entry of generic liraglutide could meaningfully reduce the fiscal burden of GLP-1 drug coverage, but only if patients, clinicians, and insurers choose to leverage this opportunity. Although overall use of liraglutide is low, use of its generic versions is growing, accounting for 76% of all liraglutide prescriptions in the second quarter of 2025... Sub. Req'd

Indian Drugmaker Promises Cheap Alternatives - but There's a Catch

(12/0, Andjela Milivojevic, Paul Eccles, Priyanka Pullu, Reuters) ...R ohit Mukul's Instagram profile contains everything one might expect from a man named on a Forbes 30 Under 30 list this year. Alongside photos of sports cars and snowmobiles are videos in which the Indian businessman explains his family's business model of making high-quality medicines affordable... Sub. Req’d

Will 2026 Be Pharma's M&A Breakout Year?

(12/10, Kelly Bilodeau, PharmaVoice) ...The stars are aligned for forward momentum, "notwithstanding anything disruptive or inexplicable," said EY Americas life sciences leader Arda Ural. Goldman Sachs has gone so far as to predict a record-breaking year for pharma and biotech M&A in 2026, while Ural says he sees a steady recovery and expects deal value to hover around historical levels in the new year... Full

Swiss Government Says New 15% U.S. Tariff Ceiling Retroactive to Mid-November

(12/10, Justin Papp, CNBC) ...The Swiss Economy Ministry said Wednesday that both countries can claim customs refunds dating from Nov. 14. "With the US tariff ceiling set at 15%, trade-weighted US tariffs on Switzerland will fall by around 10% on average, the ministry said in a statement. "This will significantly improve access to the US market for Swiss companies."... Full

Pfizer Signals Leaner Operations in Switzerland

(12/10, Anna Bratulic, FirstWord Pharma) ...Pfizer plans to cut more than 200 jobs in Switzerland as part of a multi-year cost-reduction effort, Bloomberg reported Wednesday, citing people familiar with the matter. The move would reduce its Swiss workforce to roughly 70 employees by the end of this year, down from about 300, according to the report... Full

Win for Pharma, UK Cuts Medicine Rebate Rate Following US Intervention

(12/10, Angus Liu, Fierce Pharma) ...The rebate rate for new medicines under the U.K.'s "voluntary scheme" will be 14.5% of sales to the NHS in 2026, down from 22.9% in 2025, the U.K. government said Wednesday. The scheme, also known as VPAG, is one of two tools—and the vastly more popular one among drugmakers—that the U.K. uses to rein in drug spending... Full

Council And Parliament Reach Deal On EU Pharma Legislation Reform

(12/11, Dave Wallace, Generics Bulletin) ...Aspects relevant to the off-patent industry include updates to data protection and market protection periods, a clarified Bolar provision, and a new transferrable exclusivity voucher granting originators an additional year of market protection, with the latter aimed at incentivizing firms to develop priority antibiotics to help combat antimicrobial resistance. While generics and biosimilars industry association Medicines for Europe said it would have supported more ambitious reforms on access, it believes the "compromise" agreement nevertheless represents "an important step forward" and "progress" for the EU pharma sector... Global Sub. Full

WHO Audit, India Hopes, Will Restore Shine to Its 'Pharmacy of The World' Image

(12/10, Priyanka Sharma, Mint) ...India plans to get its drug regulatory system audited and rated by the World Health Organization (WHO) to detect specific strengths and weaknesses that will help to make it fool proof, according to four officials and a document reviewed by Mint. The move comes after multiple instances of drug safety related incidents in the country as well as export markets raised serious questions on the quality of medicines made in India, often referred to as 'pharmacy of the world'. India faces multiple challenges in drug quality given the sheer scale of the industry, comprising thousands of manufacturers regulated by varying state-level standards... Full

Polpharma Biologics and Libbs Farmacêutica Ink Licensing Agreement for Biosimilar for Autoimmune Diseases in Brazilian Market

(12/11, Pharmabiz.com) ...Polpharma Biologics retains full responsibility for the development and manufacturing of the biosimilar. Libbs Farmacêutica will hold an exclusive license for the commercialization, marketing and distribution of the biosimilar in Brazil. This collaboration opens up exciting new opportunities and demonstrates the shared commitment of both companies to delivering innovative and accessible therapies to patients... Full

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