Wednesday, August 26, 2026

 

 

What Could A US-Germany Drug Pricing Deal Look Like?

(8/25, Francesca Bruce, Pink Sheet) ...If the pharmaceutical industry were to get its way, the deal would ensure that Germany repeals unpopular cost-cutting measures such as mandatory rebates paid by drug companies to health insurers. The agreement would also include wider reform of the country's AMNOG system, which bases the prices of new drugs on the additional benefits that they offer compared to other treatments... Global Sub. Full

 

The U.S. and Canada Are in a Trade War. China Aims to Win It.

(8/25, Joshua Yang, The Washington Post) ...Canada's decision to walk away from trade talks and impose retaliatory tariffs on U.S. products, becoming the second nation to do so, drew praise from the first. A "Chinese-styled counterattack," state media claimed Sunday. "Canada's response offers the world a glimpse of what China has long stood for."... Full

 

Why a Texas Congressman Believes Chinese Biotechs Are 'Beating Us on Our Ground Game'

(8/25, Will Maddox, Fierce Biotech) ...[F]or Rep. Nathaniel Moran, R-Texas, the debate over the perceived geopolitical threat posed by China's biotech industry misses the point. "The United States has been too focused on measuring the outcomes of strategic scenarios with China and not paid enough attention to the input," Moran told Fierce. "We talk about the growing trials that are happening in China," he continued. "What we forget to focus on is that they are beating us on our ground game. They're doing things at the beginning of the supply chain that lead to the dominance on the output side of who controls the ultimate number of drugs that are important to the United States and our constituents."... Full

 

FTC's Deals on Drug Price Reform Have Critics Questioning Scope

(8/25, Lauren Clason and Katie Arcieri, Bloomberg Law) ...The 10-year pacts would require the companies to overhaul a business model that critics say incentivizes higher drug prices and siphons money from pharmacies and employer health plans. But the unusually broad nature of the deals pose questions about the Trump administration's political motivations and the FTC's role in policymaking... Full

 

CSRxP: Big Pharma Hikes Prices on Nearly 250 Prescription Drugs in Latest Round of Mid-Year Price Hikes

(8/25, CSRxP) ..."Big Pharma routinely hikes prices on blockbuster brand name drugs to boost profits at the expense of American patients and taxpayers," said CSRxP executive director Lauren Aronson. "Big Pharma's egregious pricing practices, including price hikes on older blockbuster products that should face competition in the marketplace, are enabled by exploiting loopholes to game the system and extend monopolies."... Full

 

AHA Worries CMS Proposed Rule Codifies HHS Push For 340B Rebates

(8/25, Lauren Brensel, Inside Health Policy) ..."The AHA is especially concerned that permitting retrospective MFP effectuation could establish the operational foundation for broader manufacturer efforts to move the 340B program away from upfront discounts and toward a rebate-based model," AHA wrote. The lobby group noted it has already communicated to the Health Resources and Services Administration that its proposed 340B rebate pilot would fundamentally alter the program and impose substantial costs and burdens on covered entities... Sub. Req'd

 

FDA Drafts Guidance on Assessing Potency of Immunotherapy Products

(8/25, Joanne S. Eglovitch, Regulatory Focus) ...The guidance addresses how sponsors can develop potency assays for ACTIMPS and selecting bioassays for ACTIMPS. It also addresses assessing potency for specific types of ACTIMPs, including non-personalized peptide- and protein-based ACTIMPs, non-personalized vectored ACTIMPs, and cell-based ACTIMPS... Full

 

Amgen, Medical Centers Diverge on Potential Conflicts in FDA Pilot to Speed Early Drug Trials

(8/25, Zachary Brennan, Endpoints News) ...To better combat China and Australia's dominance in expediting early-phase trials, the FDA and stakeholders are ironing out the details of a pilot program to accelerate first-in-human trials. Amgen, Memorial Sloan Kettering Cancer Center, the Cleveland Clinic and others are weighing in on how the pilot should operate, as it's expected to connect clinical trial sponsors with so-called qualified research institutions (QRIs) to better develop and review protocols for clinical trials... Sub. Req'd

 

HHS Plans New FDA Deputy Commissioner Roles for Technology and Drugs, Sources Say

(8/25, Annika Kim Constantino, CNBC) ...The Department of Health and Human Services is planning to create two new deputy commissioner roles at the Food and Drug Administration, one of which would focus on technology and the intersection of health and artificial intelligence, CNBC has learned. The other new position is for a deputy commissioner for drugs, according to two sources familiar with the plan. The agency already has several deputy commissioners, including an acting deputy commissioner for food, though it is unclear who will step into that role permanently... Full

 

With Drug Prices on the Rise, Georgia Lawmakers Examine Role of Industry Players

(8/26, Ariel Hart, Georgia Recorder) ...Georgia has led the nation in some small steps to prevent potential harms, and the state House of Representatives' study committee is taking the issue on again during the legislative off season. Its next meeting is planned for Wednesday at the Mercer School of Medicine in Macon. The group is called the House Study Committee on Pharmacy Benefits Managers and Consumers' Access to Prescription Medications... Full

 

Maryland Proposes Payment Caps For Ozempic, Jardiance

(8/25, John Collins, The BayNet.com) ...Under regulations proposed by the Maryland Prescription Drug Affordability Board, government purchasers would pay no more than $274 for a 30-day supply of Ozempic and $204 for a 30-day supply of Jardiance, or $6.80 per pill for Jardiance. If adopted, the limits would take effect Jan. 1, 2027. They would apply to eligible government purchasers, including state and local employee health plans and certain publicly operated hospitals, correctional facilities and clinics... Full

 

 

Bristol Myers Ends Blood Cancer Drug Deal with Cell Therapy Maker Cellares

(8/25, Reuters) ...Bristol Myers Squibb has ended its partnership with cell therapy startup Cellares to expand the manufacturing of its personalized blood cancer therapy, a company spokesperson told Reuters on Tuesday. Bristol Myers determined that Cellares' cell therapy manufacturing platform, Cell Shuttle, could not meet the requirements to make its CAR-T therapy, Breyanzi, at commercial scale, the spokesperson said. Cellares did not immediately respond to a Reuters request for comment... Full

 

Johnson & Johnson Scores 1st FDA Label Expansion for Imaavy

(8/25, Kevin Dunleavy, Fierce Pharma) ...Just 16 months after Johnson & Johnson scored its initial FDA approval for Imaavy, the pharma giant has tacked on a label expansion for the monoclonal antibody and potential blockbuster. The FDA has signed off on Imaavy to treat warm autoimmune hemolytic anemia (wAIHA), a rare, life-threatening disorder in which pathogenic immunoglobulin G (IgG) autoantibodies destroy red blood cells... Full

 

 

Norwich Revives Bid to Strip Teva's Exclusivity for Xifaxan Copy

(8/25, Christopher Yasiejko, Bloomberg Law) ...The US Food and Drug Administration "applied an incorrect causation standard" when evaluating whether Teva had forfeited its right to exclusively market its copies of the drug for 180 days, the US Court of Appeals for the DC Circuit ruled Tuesday... Full

 

CivicaScript® Launches 3 Low-Cost Generics to Expand Its Market Impact

(8/25, CivicaScript) ...CivicaScript, a nonprofit company dedicated to bringing low-cost generic and biosimilar medicines to U.S. patients, today announced the addition of three products to its expanding portfolio...Yulithira™ (everolimus) tablets, 2.5 mg, 5 mg, 7.5 mg and 10 mg...Fingolimod capsules, 0.5 mg...Imatinib mesylate tablets, film coated, 100 mg and 400 mg... Full

 

Alvotech Takes First Direct US Commercialization Step In $150M Lotus Deal

(8/25, Dean Rudge, Generics Bulletin) ...Alvotech has taken its first step toward directly commercializing its own biosimilars in the US, retaining rights to market two pipeline candidates alongside Lotus Pharmaceutical under a licensing agreement potentially struck between the two companies worth around $150m. The agreement covers AVT34, Alvotech's proposed biosimilar to Imfinzi (durvalumab), and AVT87, its proposed biosimilar to Hemlibra (emicizumab), in the US and eight Asian markets... Global Sub. Full

 

Biocon Bags Marketing Approval for Pegfilgrastim Biosimilar in Japan

(8/26, ETPharma.com) ...Bengaluru-based Biocon announced to have received marketing approval for its pegfilgrastim biosimilar from Japan's Ministry of Health, Labour and Welfare. The product, a biosimilar to Amgen's brand Neulasta, will be marketed by Swiss giant Sandoz... Full

 

 

Lundbeck Looks to AI to Help Run its Commercial Operation

(8/25, Anna Bratulic, FirstWord PHARMA) ...Lundbeck wants to embed AI deeper into its US commercial organisation by expanding a partnership with life sciences services firm Eversana to deploy the technology across areas like marketing, medical communications, market access and media operations. Financial details weren't disclosed. "Our ambition is to bring human expertise and artificial intelligence together to strengthen how we think, decide and execute across our business," said Tom Gibbs, president of Lundbeck's US business... Full

 

Dr Reddy's Arm Aurigene Inks Global Drug Manufacturing Deal with Pharma Giant

(8/25, Swati Bharadwaj, The Times of India) ...The agreement covers a diversified portfolio intended for the United States, Europe, Canada and emerging markets. It did not, however, reveal the partner's identity, citing confidentiality obligations... Full

 

GLP-1 Retreat: Employers Abandoning Obesity Coverage Thanks To Direct Access Programs

(8/25, Cathy Kelly, Pink Sheet) ..."The percentage of employers covering GLP-1s for weight management has declined," BGH VP Brenna Shebel said during a briefing on the results. In 2025, 72% were covering the treatments, while the number dropped to 60% in 2026, she said...Going forward, "not a single employer will be adding GLP-1 coverage for weight management in 2027," Shebel said... Global Sub. Full

 

Why Businesses Struggle to Forecast Health Costs

(8/26, Tina Reed, Axios) ...A third of employers expect to have a more transparent or new-generation PBM in place next year, and an additional 47% of those surveyed are considering such changes for 2028 or 2029...They are also steering patients to lower-cost drug options, including greater use of biosimilars... Full

 

 

NBIX vs. TEVA: Which Drugmaker Is the Better Investment?

(8/25, Sundeep Ganoria, Globes) ...Teva also maintains a diversified portfolio of higher-margin branded and innovative medicines, which are transforming its portfolio mix and financial profile. Its newer products — Austedo, Ajovy (preventive treatment of migraine) and Uzedy (schizophrenia) — are gaining market share and delivering strong top-line growth... Full

 

Turkey to Probe Alleged Teva Antitrust Violations

(8/26, Dean Shmuel Elmas, Globes) ...The investigation is examining whether Teva manipulated the patent applications for production methods and drug dosages by makling applications after the expiration of the patent protection period, as well as the derivative cancellation methods, which could restrict rival companies. For now, the investigation does not result in sanctions being imposed on the pharmaceutical company operating in the country... Full

 

Israel Has No Shortage of Biomedical Startups, but Where Are the Global Companies?

(8/26, David Adler, Jewish Journal) ...Teva deserves enormous credit. It built an extraordinary global pharmaceutical business, historically rooted in generics, while increasingly developing innovative medicines. Its evolution is an important Israeli success story. But it remains a strikingly limited list... Full

 

 

Redefining Mexico's Generics Market Through Innovation and Access

(8/25, Mexico Business) ...As part of our growth strategy, we are monitoring additional molecules that will lose patent protection in the coming years, with the aim of introducing new therapeutic alternatives in a timely manner in areas such as diabetes, cardiovascular health, central nervous system, gastroenterology, and pain management. By combining innovation, operational agility, and a firm commitment to accessible, high-quality medicines, Avivia Pharma is well positioned to continue strengthening Mexico's private pharmaceutical market... Full

 

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

 

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.