Monday, December 1, 2025

Teva Bets Big on Israel To Reinvent the Future of Health

(12/1, Maayan Hoffman, The Media Line) ...Teva is launching Teva Rise, a new open-innovation platform meant to bring the company closer to startups and technology disruptors working to improve human health. The goal, Teva said, is to position itself not just as a pharmaceutical manufacturer but as a bridge between the greatest tech talent and global healthcare needs...According to Teva, the initiative is part of the company's broader "Pivot to Growth" strategy, a plan to transform Teva into a more agile, technology-driven healthcare leader... Full

UK and US Poised to Agree Zero-Tariffs Deal on Pharmaceuticals

(12/1, Richard Fletcher and Alex Ralph, The Times) ...Under the agreement, expected to be announced over the coming days, the government is understood to have agreed to lower an industry sales rebate rate on NHS drug prices and to also improve the NHS's cost-effectiveness measure for drugs, according to industry sources... Full

US Medicare Price Cuts Manageable for Most Drugmakers, Analysts Say

(11/28, Bhanvi Satija, Maggie Fick and Patrick Wingrove, Reuters) ...U.S. Medicare price cuts of up to 85% will have a lesser impact on drugmakers than initially feared, with most of the hit already reflected in forecasts, Wall Street analysts said...Bernstein analysts said that five of the 15 targeted medicines will become generic by 2027, limiting their exposure to price cuts. The lower prices could even keep patients on the branded therapies longer, boosting volumes, they said... Sub. Req’d

In Medicare Drug Negotiations, Trump Administration Embraces a Policy The GOP Once Despised

(11/26, Daniel Payne, STAT+) ...Drug pricing experts and patient advocates worry the sometimes-deeper discounts through Trump's dealmaking won't last. "I don't know how sustainable [MFN] is," Sean Sullivan, a professor at the University of Washington who researches health economics, said, noting the IRA is more concrete because it's a law. "If they were serious about MFN, they would put it in law, instead of one-off press releases."... Sub. Req’d

Real Savings: Medicare-Negotiated Discounts On Cancer Drugs Range From 40%-60%

(11/28, Cathy Kelly, Pink Sheet) ...The announcement describes the negotiated discounts as a reduction in list prices, as opposed to actual net prices, consistent with the first cycle release. The approach makes evaluating the price reductions difficult because the impact of additional confidential rebates is unclear... Global Sub. Full

Pharmacies Will Be The Canary in The Coal Mine on The Medicare Drug Price Negotiations

(11/28, Sujith Ramachandran, STAT+) ...Without timely monitoring of Part D claims records, patients may be harmed and the promised Medicare savings will disappear... Sub. Req’d

CMS' MFPs For GLP-1s Raise Questions Over How They Will Coexist With Trump-Novo Deal

(11/26, Maaisha Osman, Inside Health Policy) ...Medicare is prohibited by law from covering weight-loss drugs, and the administration plans to sidestep that restriction through a new pilot program. Lilly CEO David Ricks told reporters that the initiative will begin in 2026 as a voluntary Medicare Part D demonstration offering coverage for the medicines at no cost to participating private plans, before becoming mandatory in 2027. The government has not yet released further details on how the anti-obesity medication (AOM) pilot will operate or be financed... Sub. Req’d

Ozempic, Wegovy Medicare Prices Muddled by Trump's Dueling Deals

(11/26, Nyah Phengsitthy, Bloomberg Law) ...There's also "a lot of missing information" on what this means for the insurers that administer Medicare's prescription drug, or Part D, plans and how this will affect premiums next year, said Kristi Martin, former Medicare chief of staff under the Biden administration, now a health-care director at Camber Collective... Sub. Req’d

Biden's IRA Is Harming Cancer Patients

(12/1, Tomas J. Philipson, The Wall Street Journal) ...Policymakers need to ensure the IRA doesn't kill off the cumulative research that could make cancer easier to endure and more affordable to treat. More broadly, lawmakers must understand that for cancer and other diseases, medical progress doesn't end at FDA approval -- many times that's only where it begins... Sub. Req’d

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market

(11/30, Skylar Jeremias and Giuseppe Randazzo, The Center for Biosimilars) ...In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency... Full

FDA Official Plans to Change Vaccine Approval Process, Claiming that Covid-19 Shots Caused Child Deaths

(12/1, Kaanita Iyer, Adam Cancryn, CNN) ...In an internal memo obtained by CNN, Dr. Vinay Prasad — the FDA's chief medical and scientific officer and the director of the Center for Biologics Evaluation and Research — claimed, "Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death."... Full

FDA's Plan to Boost Biosimilar Drugs Could Stall at the Patent Office

(11/28, Arthur Allen, KFF Health News) ...Under the guidance the FDA proposed, the agency would begin overseeing biosimilars similarly to the way it regulates generics, which are copies of simpler molecules, usually pills. This change in approach could allow companies to save up to $100 million for each drug they develop, enabling them to make more products for underserved patients, said Stefan Glombitza, CEO of Formycon AG, a maker of biosimilars based in Germany... Full

FDA Takes Important Steps Forward for Consumers

(11/26, Sally Greenberg, RealClear Health) ...As a consumer group with a longstanding focus on the safe use of medications, the National Consumers League takes very seriously the FDA's role in ensuring that all approved drugs are safe and effective. The FDA is the gold standard for safety, and we believe the approval of biosimilars in a more streamlined fashion outlined in this new policy directive will not shortchange safety or put patients at risk in any way. These changes are sensible and more efficient, and above all, protect patient safety... Full

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

(11/28, Derrick Gingery, Pink Sheet) ...The FDA said one ANDA was submitted in October when it and other federal agencies were considered "closed" due to a lapse in funding. But the agency told the Pink Sheet that the reason the one ANDA was submitted was "due to an administrative matter on the applicant's part."...When the shutdown ended, the FDA said all original ANDAs and certain prior approval supplements submitted between Oct. 1 and Nov. 13 were assigned a submission date of Nov. 13, which is the day the government reopened... Global Sub. Full

FDA Publishes New PSGs Including For Generic Zepbound Rivals

(11/27, Urte Fultinaviciute, Generics Bulletin) ...The FDA released a new batch of 76 PSGs, of which 32 were new and 44 were revised guidances. Out of these, 64 PSGs were for products with no approved ANDAs, including 27 complex products. Additionally, 29 PSGs will provide development support for complex products, seven of which were new, and 22 were revised guidances... Global Sub. Full

Aeon Secures Funding As FDA Sets New Date For Botox Biosimilar Review

(11/28, Dean Rudge, Generics Bulletin) ...Aeon Biopharma has secured fresh momentum for its ABP-450 (prabotulinumtoxinA) proposed biosimilar version of Botox (onabotulinumtoxinA), completing the first closing of its previously announced PIPE financing while simultaneously locking in a new FDA meeting date to review its analytical development plan... Global Sub. Full

Pennsylvania Loses Hundreds of Pharmacies After a Law Promised Help

(12/1, Spotlight PA) ...State Sen. Lindsey Williams (D., Allegheny) — one of six lawmakers who signed a July letter raising concerns about the enforcement of the bipartisan and much-touted law known as Act 77 — told Spotlight PA she wants pharmacists to feel that PBMs truly are being held accountable. "That's what this legislation is trying to do," she told Spotlight PA. "And I'm hoping that we can push it along to make sure that it fulfills its intent."... Full

Pharmacy Deserts Make Staying Healthy Harder

(11/30, The Boston Globe) ...One way to prevent closures is through payment reform to ensure that insurers compensate pharmacists — regardless of whether they are independent or part of a chain — a fair amount for dispensing drugs... Full

Phase 4 Data Support Effectiveness of Deutetrabenazine in Managing Tardive Dyskinesia, Chorea

(11/26, Louie Pasculli, Neurology Live) ...Teva Pharmaceuticals announced data from the ongoing real-world phase 4 study, coined IMPACT-TD Registry, evaluating the efficacy of deutetrabenazine (Austedo) tablets and its extended-release tablet formulation (Austedo XR) in patients with tardive dyskinesia (TD). Overall, the findings showed that both treatments are associated with reduced severity of involuntary movements and improvements in patient-reported quality of life... Full

AI Boosts Parkinson's Disease Cell Therapy Development

(11/28, Bridget Silverman, Pink Sheet) ...Developers of two of the most advanced clinical candidates, Aspen Neuroscience's autologous ANPD001 and BlueRock Therapeutics' allogeneic bemdaneprocel, described applying AI and machine learning to ensure cell therapy quality during a Nov. 18 National Academies of Sciences meeting on regenerative medicine and AI... Global Sub. Full

Teva Pharma Receives European Marketing Approvals for Ponlimsi, Biosimilar to Prolia and Degevma, Biosimilar to Xgeva

(11/27, Pharmabiz) ...These approvals mark another significant milestone in Teva's industry-leading biosimilars portfolio and its ongoing commitment to improving patient access to essential biologic therapies across Europe. Teva plans to launch both products in key European markets in the coming months...Steffen Nock, SVP head of biosimilars & chief science officer, said: "This approval represents an important step forward in increasing patient access to biosimilar therapies for serious bone conditions, underscoring our commitment to supporting better care for patients."... Full

Lupin Gets USFDA Nod for Biosimilar Drug

(12/1, News 18) ...The US Food and Drug Administration (USFDA) has approved Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta (pegfilgrastim) injection, the Mumbai-based firm said in a statement... Full

Celltrion Biosimilar Added to 2 Preferred Drugs Lists in U.S.

(12/1, Choi Kyong-ae, Yonhap News Agency) ...The agreements will make Stoboclo-Osenvelt the first biosimilar to be included on U.S. PBM preferred drug lists for its reference medicine, Prolia-Xgeva, according to the company...Celltrion plans to launch five new biosimilars -- Steqeyma, Omlyclo, Avtozma, Eydenzelt and Stoboclo-Osenvelt -- in global markets by the end of the year... Full

Zentiva Expands into Biologics with the EU-Wide Launch of Its First Biosimilar

(12/1, Zentiva) ..."Today's launch is a key moment for Zentiva," said Steffen Saltofte, CEO, Zentiva. "We are taking a significant step into the field of biological medicines. Biosimilars are a natural extension of our mission to make high-quality treatments more accessible and affordable for people across Europe. This expansion also positions Zentiva for sustainable growth in one of the most dynamic segments of the pharmaceutical industry."... Full

Celltrion secures Health Canada Go-Ahead for Eylea biosimilar

(11/28, Annabel Kartal Allen, Pharmaceutical Technology) ...The therapy will now be available in both a pre-filled syringe and a vial version. Eydenzelt is designated for use in all approved Eylea indications... Full

Roche Expands Veeva Partnership with Global Rollout of AI-Driven Vault CRM

(12/1, Indian Pharma Post) ...Roche says the move marks a step forward in its digital transformation strategy. "We're excited to expand our partnership with Veeva by implementing Vault CRM across our global Pharma organization," said Wafaa Mamilli, Roche's chief digital and technology officer. "With data and AI at its core. Vault CRM will help us create more personalized interactions, giving our teams the insights to better support healthcare professionals and the patients they serve."... Full

Kroger Ordered to Give DOJ Documents About Opioid Prescriptions

(11/26, Daniel Seiden, Bloomberg) ...Kroger Co. must give the US Department of Justice unredacted documents as part of an investigation into whether the company submitted false claims to Medicare about opioid prescriptions, despite Kroger's patient privacy concerns... Sub. Req’d

GLP-1s Go from Niche to Mainstream

(11/29, Adriel Bettelheim, Axios) ...The bottom line: We may just be watching the beginning of the drugs' rise into the mainstream — but there's still a ways to go before they're cheaper and easy to get... Full

Who's Hired? Alvotech Promotes McClellan To COO

(11/27, Dave Wallace, Generics Bulletin) ...Alvotech has announced the appointment of chief scientific officer Joseph McClellan to become the biosimilars developer's chief operating officer... Global Sub. Full

Indian Pharmaceutical Industry: Transitioning into a Global Innovation and Manufacturing Powerhouse

(11/30, P B Jayakumar, FORTUNE India) ...Over the past decade, the Indian pharmaceutical industry has undergone a structural transformation, evolving from "pharmacy of the world" to an "innovation powerhouse," say experts. Once known primarily for its dominance in generics and vaccines, the sector is rapidly emerging as a global innovation engine—powered by large-scale manufacturing, the rise of sophisticated contract research and manufacturing organisations, and multinational pharmaceutical companies establishing global capability centres in India... Full

India's Pharmaceutical Sector Rapidly Shifting to Innovation-Driven Ecosystem

(11/30, The Statesman) ..."This transition is being accelerated by government and CDSCO reforms such as streamlined approvals, reduced regulatory layers, decriminalisation of non-serious offences, and the recommendation of R&D projects worth Rs 5,000 crore," said Dr. R Chandrashekar, Joint Drugs Controller, The Central Drugs Standard Control Organisation (CDSCO)... Full

Data Exclusivity Will Extend Pharma Monopolies, Delay Access to Affordable Medicines, Activists Say

(11/26, Bindu Shajan Perappadan, The Hindu) ...Members of Indian civil society organisations, patient groups, and concerned individuals working on public health and access to medicines have written to the Union Ministries of Health and Commerce, seeking to keep data exclusivity provisions out of India's drug regulatory framework... Full

India Readies More Regulatory Reform, Globally ‘Aligned' Biosimilars Guidance

(11/27, Anju Ghangurde, Pink Sheet) ...Addressing a recent industry event, Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), said that while a lot of "interventions, streamlining and improvement" has happened in the regulatory domain, "more rationalization" is expected in the near future. "There are multiple channels in different parts of the government which are discussing deregulation or regulatory rationalization or making the regulation ‘lighter.' There are at least four-five channels where I am participating as a regulator," Raghuvanshi said at a workshop organized by the Indian Pharmaceutical Alliance (IPA)... Global Sub. Full

Interview | EFPIA President: Europe Needs Mindset Shift and Decisive Action to Reclaim its Leadership in Global Health Innovation

(11/27, Anca Alexe, Business Review) ...In an exclusive interview with Business Review, Stefan Oelrich, President of the European Federation of Pharmaceutical Industries and Associations (EFPIA), argues that what Europe needs now is not a minor adjustment, but a strategic realignment – a reset that can reinvigorate the virtuous circle of healthcare through the three As: Attract, Accelerate, and Access... Full

European Commission Dismisses Calls For Pause On Waste Water Directive

(11/27, Anabel Costa-Ferreira, Pink Sheet) ...The European Commission has indicated to the Pink Sheet that it will not pause implementation of the controversial extended producer responsibility (EPR) system, which, under the revised Urban Waste Water Treatment Directive (UWWTD), will see the pharmaceutical and cosmetics industries cover the costs of additional wastewater treatment... Global Sub. Full

Who Does What? EU RADIAL Study Exposes Oversight Challenges In Decentralized Trials

(11/28, Vibha Sharma, Pink Sheet) ...Decentralized clinical trials, which are performed in or near a participant's home, are transforming traditional research models, but this shift brings new complexities. Even fundamental steps, such as clearly defining roles and responsibilities and ensuring robust oversight, require meticulous planning to safeguard patient safety and trial integrity... Global Sub. Full

EU HTA Regulation Brings Alignment – But National ‘Recipes' Still Rule Reimbursement

(11/27, Eliza Slawther, Pink Sheet) ...It is important to recognize that the way individual member states use the EU-level joint clinical assessments (JCAs) reports that were introduced by the regulation is not a "one-size-fits-all" approach, and that countries "still have their own recipe, their own approach and preferences for different types of information and analyses," [Ruairi O'Donnell, EU HTA lead at pharmaceutical services provider Cencora, formerly known as AmerisourceBergen.,] told the Pink Sheet in an interview... Global Sub. Full

UK Budget: Little Mention Of Pharma, But Some Support For Innovators

(11/28, Eliza Slawther, Pink Sheet) ...The budget, which is reviewed annually, did include some promising pledges for biotech scale-ups, according to the UK Bioindustry Association. Most notably, the government is increasing company eligibility limits for the Enterprise Management Incentives (EMI) scheme to allow scale-ups to join start-ups in offering tax-advantaged shares to employees. The EMI aims to help small- and medium-sized enterprises to recruit and retain key workers by offering company shares to employees... Global Sub. Full

Legal Challenges Mount Over Germany's Controversial Combination Rebate

(11/27, Francesca Bruce, Pink Sheet) ...There could be some relief ahead for pharmaceutical companies affected by a deeply unpopular 20% rebate on so-called free combination drugs in Germany as legal challenges against the measure continue to mount, said Alexander Natz, secretary general of EUCOPE, which represents small and medium sized innovative pharmaceutical companies in Europe... Global Sub. Full

France To Offer 14-Day Clinical Trial Reviews To Attract Research

(11/26, Francesca Bruce, Pink Sheet) ...The new process would also bring France further into line with increasingly competitive markets like Denmark, which announced a similar 14- day timeline for the assessment of Phase I and I/II trial applications earlier this year... Global Sub. Full

PhRMA Urges Japan To Maintain Drug Prices Amid MFN Concerns

(11/27, Lisa Takagi, Pink Sheet) ...Pharmaceutical Research and Manufacturers of America (PhRMA) chair and Pfizer CEO Albert Bourla urged the Japanese government to maintain its reimbursement prices for patent-protected drugs and limit the range of current price-cutting policies in his latest visit to the country, pointing to the US's most favored nation (MFN) policy... Global Sub. Full

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