Thursday, December 18, 2025

Teva Price Target Raised to $35 from $31 at Goldman Sachs

(12/18, The Fly) ...Goldman Sachs raised the firm's price target on Teva to $35 from $31 and keeps a Buy rating on the shares... Sub. Req’d

Novartis, Roche Near US Drug Price Deal in Easing of Swiss Trade Tensions

(12/17, Rachel Cohrs and Fabienne Kinzelmann, Bloomberg) ...The White House is set to announce drug pricing deals with pharmaceutical heavyweights Novartis AG and Roche Holding AG as soon as Friday, according to people familiar with the situation, further easing trade tensions with Switzerland after a standoff over tariffs. Other drugmakers could also be included in the announcement, and the details remain in flux, the people said... Sub. Req’d

US Confirms Tariff Elements of Trade Deal With Switzerland

(12/17, Reuters) ...The U.S. Trade Representative on Wednesday announced the implementation of tariff-related elements in a trade agreement framework reached with Switzerland and Liechtenstein in November. The tariff rates announced on November 14 will be retroactive to that date, according to a post in the Federal Register... Sub. Req’d

Watch: Trump Vows to ‘Dramatically Reduce' Drug Prices, Announces New TrumpRX Website

(12/17, Joshua Barajas, PBS News) ...President Donald Trump said in a prime-time address Wednesday that he negotiated with drug companies and foreign countries to reduce the prices on drugs and pharmaceuticals by 400 to 600%..."I'm doing what no politician of either party has ever done — standing up to the special interests to dramatically reduce the price of prescription drugs," he said. The first wave of these promised reductions will be available in the new year through a new website: TrumpRX.gov, Trump said. The site currently says, "Coming soon. January 2026."... Full

Senators Budd, Hassan Introduce Bipartisan Bill to Lower Prescription Drug Prices for American Families

(12/17, U.S Senator Ted Budd) ...U.S. Senators Ted Budd (R-N.C.) and Maggie Hassan (D-N.H.) introduced the bipartisan Biosimilar Inspection Modernization Act, legislation that would make prescription drugs more accessible and affordable by updating and improving the Food and Drug Administration's (FDA) inspection processes for facilities manufacturing biosimilar medicines. Addressing these regulatory barriers would ultimately speed up the number of biosimilars brought to market, in turn increasing competition and lowering costs for patients... Full

US Senator Warns Foreign-Made Generics May Put Families at Risk

(12/18, IANS Live) ...The country's growing reliance on overseas manufacturing of generic drugs and their key ingredients poses serious public health and national security concerns, particularly for seniors and vulnerable populations, said Senate Special Committee on Ageing Chairman Rick Scott on Wednesday..."Every American relying on foreign-manufactured generic drugs deserves to know the risks in their medicine cabinet," Scott said, announcing a renewed push by the committee to highlight what he described as systemic weaknesses in the US pharmaceutical supply chain... Full

Weakened Biosecure Act Poised to Become Law After Senate Passage

(12/17, Jared Whitlock, Endpoints News) ...It's a development that once would have sent panic through drugmaker boardrooms. But the legislation has since been weakened. Biosecure would restrict federal contracts with biopharma suppliers deemed foreign adversaries, though unlike earlier drafts, it stops short of naming the ubiquitous contractors WuXi AppTec and WuXi Biologics... Sub. Req’d

340B Transparency Requirements Will Begin Restraining Spending Growth in 2026

(12/17, Cathy Kelly, Pink Sheet) ...HRSA's 340B rebate model pilot and CMS policies aimed at increasing program transparency and avoiding duplication with Medicare price inflation rebates will help lower the number of drugs subject to 340B discounts, Drug Channels' Adam Fein said... Sub. Req’d

A Breakthrough for Life-Saving Biologic Drugs?

(12/17, Noah Austin, U.S. PIRG) ...More interchangeable biosimilars will allow a greater number of patients the chance to opt for less expensive alternatives. These recent FDA guidelines are a step in the right direction, and now we need Congress to codify and strengthen this initiative by passing the Biosimilar Red Tape Elimination Act... Full

CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

(12/17, Christopher Cole, Mike Hollan, Andy Studna, and Nicholas Saraceno, PharmTech.com) ...Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program... Full

VA Lawmakers Revising PDAB Bill To Address Rare Disease, Pharmacist Concerns

(12/17, Luke Zarzecki, Inside Health Policy) ...Virginia Governor-elect Abigail Spanberger told Inside Health Policy on Tuesday (Dec. 16) she will be introducing a slew of bills on Thursday (Dec. 18) addressing her affordability agenda. But that list will not include the PDAB bill, according to a source close to the legislation. When asked whether she would sign a PDAB bill, Spanberger dodged the question... Sub. Req’d

Takeda's AI-Developed Psoriasis Pill Succeeds in Clinical Trials

(12/18, Kanoko Matsuyama, Bloomberg) ...Algorithms significantly accelerated the identification of zasocitinib from a vast pool of molecules for testing, according to Jeb Keiper, chief executive officer at Nimbus Therapeutics LLC, which discovered the medicine... Sub. Req’d

Eli Lilly & Co. Cuts Price of Popular Diabetes and Weight-Loss Drugs in Canada

(12/17, Chris Hannay, The Globe and Mail) ...In a note to pharmacies Wednesday night, Eli Lilly said the Canadian list price of a four-week supply of Mounjaro or Zepbound would be lowered to $300 for 2.5 milligram and 5 milligram dosages; to $420 for dosages of 7.5 and 10 milligrams; and to $540 for 12.5 and 15 milligram dosages. The new prices take effect on Dec. 29... Sub. Req’d

Alnylam Lays Out $250m to Equip Flagship Facility with Cutting-Edge siRNA Production Tech

(12/17, Fraiser Kansteiner, Fierce Pharma) ...Alnylam plans to spend $250 million in a bid to elevate its 200,000-square-foot facility in Norton, Massachusetts, as the biopharma industry's first fully dedicated small interfering RNA (siRNA) enzymatic-ligation production plant, the Cambridge-based company said Dec. 17. The project is expected to bolster capacity and reduce operating costs at the facility, which officially opened its doors for siRNA oligonucleotide bulk drug substance active pharmaceutical ingredient manufacturing back in 2021, according to Alnylam's website. Online, Alnylam refers to the Norton site as its global production HQ... Full

AstraZeneca Leads Big Pharma's AI Clinical Trials Revolution with Real-World Patient Impact

(12/18, Dashveenjit Kaur, AI News) ...While competitors optimise internal R&D pipelines, AstraZeneca's AI is already embedded in national healthcare systems, screening hundreds of thousands of patients and demonstrating what happens when AI moves from pharmaceutical labs into actual patient care... Full

One Generic Cancer Drug Costs $35. Or $134. Or $13,000.

(12/17, John Tozzi, Tanaz Meghjani and Mathieu Benhamou, Bloomberg) ...Health spending in the US now tops $5 trillion a year with families and companies facing their steepest insurance premium hikes in years. Politicians often blame pharmaceutical companies, insurers, wasteful procedures and a bloated system too tangled to tame. But beneath those familiar explanations lies a lesser known phenomenon. In the opaque world of hospital pricing, medical systems across the country are able to turn routine, decades-old cancer drugs into money-makers, marking up cheap chemotherapy drugs as if they're pricey new treatments... Sub. Req’d

Sun Pharma Declines After US FDA Classifies Baska Facility Inspection As OAI

(12/18, Business Standard) ...The American drug regulator had inspected the [company’s] facility from 8 September 2025 to 19 September 2025. The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI)... Full

Chime Biologics Partners With Libang Pharmaceuticals On A Biosimilar To Amgen's Blincyto

(12/18, Urte Fultinaviciute, Generics Bulletin) ...Under the agreement, Wuhan-based CDMO Chime Biologics will provide end-to-end development and manufacturing services, spanning from CMC development to overseas licensing and financing support, as well as global commercial manufacturing. Financial details of the deal were not disclosed, nor were the exact responsibilities of Beijing Libang Pharmaceutical... Global Sub. Full

Alvotech Quietly Flags Aflibercept CRL Alongside $100M-Plus Financing

(12/17, Dean Rudge, Generics Bulletin) ...Alvotech revealed an FDA complete response letter denying approval for its AVT06 biosimilar to Eylea. This regulatory setback follows a similar rejection of another proposed biosimilar, AVT05, previously attributed to manufacturing deficiencies at its Reykjavik facility... Global Sub. Full

Soaring off the Patent Cliff: Preparing for the Next Wave of Oncology Biosimilars

(12/17, Rachel K. Anderson, PharmD, CSP, Pharmacy Times) ...The projected timing of biosimilar approvals and launches highlights the need for proactive planning. These dates remain subject to change due to litigation outcomes, patent settlements, and regulatory review timelines. Nevertheless, the broad outline is clear: The second half of this decade will be characterized by the steady introduction of biosimilars for some of the most expensive therapies in oncology... Full

Celltrion Secures Autoinjector Approval for Stelara Biosimilars in Europe

(12/18, Yeom Hyun-a, The Chosun Daily) ...According to the company, the CHMP's recommendation for approval is considered a de facto final approval. As a result, Celltrion has secured autoinjector (AI) formulations of 45 mg and 90 mg for both STEQEYMA and QOYVOLMA... Full

Employers Drop Coverage for Weight Loss Drugs as Pharma's Direct-to-Consumer Programs Grow

(12/18, Elaine Chen, STAT+) ...When HCA Healthcare, one of the largest hospital systems in the U.S., recently told employees it would stop covering blockbuster obesity drugs Zepbound and Wegovy next year...In a notice viewed by STAT, HCA said use of the GLP-1 weight loss drugs surged 90% this year, "significantly" raising costs. It instead suggested employees enroll in discount programs introduced by the drugs' manufacturers, Eli Lilly and Novo Nordisk, which allow patients to buy the medicines without using insurance at cash prices that are lower than the list prices... Sub. Req’d

California Telehealth Firm, Florida Medical Practice Indicted in Alleged Illegal Adderall Distribution Scheme

(12/17, Carlos E. Castañeda, CBS News) ...The U.S. Department of Justice said in a press release that San Francisco-based Done Global is charged with one count of conspiracy to illegally distribute Adderall, four counts of illegal distribution of Adderall, conspiracy to commit health care fraud, and conspiracy to obstruct justice. The DOJ has described the case as the department's first criminal drug distribution case involving a digital health platform built around online Adderall subscriptions... Full

Faster Clinical Trials Ahead As EU Launches Biotech Act, IP Debate Looms

(12/17, Vibha Sharma, Pink Sheet) ...The European Commission has published the first part of its long-awaited Biotech Act with proposals to significantly shorten approval times for multinational clinical trials, although its plan to support pharmaceutical innovation by granting an extra 12 months of supplementary protection for certain drugs is likely to provoke debate... Global Sub. Full

Germany Risks Repeating Its Generics Misstep With Biosimilars

(12/18, Borsen-Zeitung) ...From the perspective of AG Pro Biosimilars, the consequences are predictable. If only the cheapest supplier wins insurers' tenders, other companies will eventually withdraw from production. „With these plans, policymakers are heading towards the same vicious circle they fell into with generics", says Walter Röhrer, head of Pro Biosimilars. „That is neither economically sound nor comprehensible."... Full

Regulatory Recap: UK-US Trade Deal Must Not Overlook Off-Patent Medicines

(12/18, Urte Fultinaviciute, Generics Bulletin) ...While the new trade deal between the US and the UK brings clarity, the new agreement should not overlook off-patent medicines, argued Medicines UK's CEO Mark Samuels...He urged the government not to delay and enact the Life Sciences Sector Plan, which was published in July... Sub. Req’d

China Is Increasing Its Share of Global Drug Development

(12/18, Goldman Sachs) ...About a quarter of innovative drug candidates now under active development originate from China. What's more, 46% of new drug molecules that entered into human trials in the first half of this year are from Chinese companies, an increase from about 17% a decade ago. There has been a surge in licensing, with China accounting for about half of all global licensing deals, measured by dollar value, or 26% if measured by deal volume... Full

India Is Trusted Global Supplier of Quality, Affordable Medicines: Commerce Secy

(12/17, PTI) ...Addressing a Chintan Shivir on issues related to pharma exports in Chandigarh, the secretary, in a video message, said that India is the third largest pharmaceutical producer by volume and fourteenth by value, with medicines reaching over 200 markets, including a strong presence in stringent regulatory destinations... Full

India: Generic Medicine Production Rises 26% to Rs 4.06 Lakh Cr in Three Years, Parliament Informed

(12/18, Susmita Roy, Medical Dialogues) ...During a recent Lok Sabha session, Anup Sanjay Dhotre sought details on the growth in generic medicine production over the past three years and asked whether the Government was aware of reports alleging that some manufacturers were supplying empty or half-filled wrappers to bulk buyers. He also questioned whether complaints had been received regarding the quality of generic medicines, whether any studies had been conducted to assess their quality, and what steps were being taken to maintain public confidence in generics... Full

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