Thursday, September 18, 2025

Trump Tariffs On EU Medical Devices Will Drive Up US Patient Bills, Industry Claims

(9/18, Peter Foster in London; Jude Webber in Dublin, Financial Times) ...Jochen Schmitz, chief financial officer of Siemens Healthineers, said tariff impacts could rise to €400mn-€500mn next year for his business, but would be offset over time through higher prices on future contracts and some supply chain shifts. "What people should really understand, when building barriers in the healthcare system like this, is that ultimately it will be to the detriment of patients and their healthcare system," he told the Financial Times. "There is an ethical dimension to this." Med tech analysts said that European businesses have started to shift manufacturing and supply chains in response to the EU tariffs and those imposed on other European countries, like Switzerland which is facing a 39 per cent levy... Sub. Req’d

Trump's Ongoing Battle with the Pharma Industry Shows No Signs of Easing

(9/18, Catherine Arnst, Quartz) ...When a newly reconstituted federal vaccine committee meets this Thursday and Friday, it is widely expected to consider a controversial report prepared by federal health officials that purports to link coronavirus vaccines to the deaths of 25 children, despite little evidence. That report is the latest salvo in a battle being waged by the Trump administration against the drug industry that has created turmoil for pharmaceutical and biotech companies and their investors... Full

Trump Makes a Modi-Xi Alliance More Likely

(9/17, Kathleen Jaeger, The Wall Street Journal) ...A prudent strategy would be to reshore production of essential drugs and collaborate with India on strategic stockpiling, manufacturing, transparent trade and fair reforms to middlemen like pharmacy benefit managers and group purchasing organizations that distort the U.S. generics market...We can't afford to push New Delhi into Beijing's arms. "America first" doesn't mean "America alone." It means working with trusted allies to ensure patients have access to affordable, life-saving treatments. Without generics, we will all pay a steep price... Sub. Req’d

U.S. House Committee Should Advance Q1/Q2 Reforms to Promote Greater Competition and Help Lower Prescription Drug Prices

(9/17, The Campaign for Sustainable Rx Pricing) ...The problem arises in the fact that brand name drug makers can assert "trade secret protection" around many of the products generic drug makers are attempting to copy, meaning generic drug manufacturers have to "essentially play a protracted guessing game with FDA," as Association for Accessible Medicines (AAM) CEO John Murphy III put it in a June 2024 column. Murphy added, this leads to "a lot of spilled ink, wasted resources and unnecessary red tape," and has "delayed generic competition, and in particular competition for critical complex products—a growing category of medicines that have complex active ingredients, formulations, or routes of administration—that are frequently expensive and desperately require generic competition."... Full

More NME Reviews, Reduced Costs Combine To Lower US FDA Voucher Fee

(9/17, Derrick Gingery, Pink Sheet) ...NME reviews increased and cost less in the most recent data available, which pushed the priority review voucher user fee lower for FY 2026. The agency's 76 application reviews in FY 2024, including 42 priority and 34 standard assessments, were substantially higher than the previous year. Review costs also were nearly 5% less in FY 2024 than the previous year, although the total still was among the highest in recent memory... Global Sub. Full

ICER Finds GLP-1s Are Cost-Effective, But Pose Big Budget Concerns

(9/17, Luke Zarzecki, Inside Health Policy) ...Using net prices from SSR Health, the report found with both semaglutide medications priced at $6,830 and tirzepatide at $7,973, all three increased QALYs, evLYs and life-years. All three were cost-effective at the $100,000 per QALY and evLY gained thresholds. But with the potential patient population so high, ICER also found the drugs pose a large potential budget impact... Sub. Req’d

Medicare Should Cover GLP-1 Obesity Drugs

(9/17, Sandi Henderson, The Hill) ...New GLP-1 treatments are a clear, commonsense solution. So why am I, and millions of other Americans, still struggling to access these lifechanging, FDA-approved treatments? Unfortunately, Medicare continues to cling to outdated policies that prohibit coverage of obesity medications under the Medicare Part D prescription drug program. Although the American Medical Association has recognized obesity as a complex disease — a stance now embraced by numerous federal agencies and states that provide comprehensive obesity care coverage — Medicare beneficiaries remain left behind by policies that haven't kept pace with medical progress. As a result, the more than two-thirds of Medicare beneficiaries living with obesity, just like me, cannot access or afford these treatments... Full

PBM Programs Offer Expanded Payments for Independent Pharmacies

(9/17, PCMA) ...A study by Dennis Carlton, Ph.D., professor emeritus at the University of Chicago Booth School of Business and former chief economist at the U.S. Department of Justice Antitrust Division, shows that for all prescription drugs, PBMs are paying independent pharmacies on average higher rates than pharmacies that are affiliated with PBMs. The study also concludes that PBM-affiliated pharmacies are not a driver of high drug costs... Full

Trump Administration Cannot Proceed With Overhaul of US Health Agencies, Court Rules

(9/17, Nate Raymond and Daniel Wiessner, Reuters) ...A federal appeals court on Wednesday refused for now to allow U.S. President Donald Trump's administration to proceed with a planned overhaul of the U.S. Department of Health and Human Services, which would involve reorganizing several agencies and firing thousands of employees... Full

Reshoring Biologics: Geopolitics Meets GMP

(9/18, The Pharma Letter) ...The biologics supply chain has shifted from a technical backwater into a political and regulatory battleground. Vectors, plasmids, and the raw materials that feed them are now viewed as strategic assets. The combination of geopolitical pressure, pandemic scars, and new GMP scrutiny has sparked a wave of capacity building, supplier diversification, and make-versus-buy soul-searching across the USA and Europe... Sub. Req’d

OGD Unofficial Mid-Month Approval Actions for September 2025

(9/17, Bob Pollock, Lachman Consultants) ...It has been a slow go for the first half of September, which is the last month of FY 2025. So far this month, there have been just 17 full-approval actions and 4 tentative-approval actions posted on the FDA daily approval page (here). This is the lowest number of approval actions midway through any month that I can remember in a very long time... Full

Stakeholders Seek Clarity from FDA On Cancer Drug Combo Guidance

(9/17, Ferdous Al-Faruque, Regulatory Focus) ...Drugmakers and research advocacy groups want the US Food and Drug Administration (FDA) to clarify and expand its proposed guidance regarding developing cancer drugs in combination with other novel treatments. Several stakeholders asked the agency to provide more details on how it will assess the contribution of each treatment in the combination therapy and expand on the data sources that can be used to evaluate the drugs... Full

Biocon Adds To A Crowded Field For US Denosumab

(9/18, Dave Wallace, Generics Bulletin) ...Biocon Biologics has received US FDA approval for denosumab biosimilars to Prolia and Xgeva under the names Bosaya and Aukelso. The approvals represent the sixth pair of denosumab biosimilars to be approved in the US, with three suppliers having already launched...And Teva also filed a denosumab candidate with the FDA last year, marking the Israeli firm's first internally-developed biosimilar to be submitted to the FDA, with other biosimilars so far partnered. However, unusually in the biosimilar denosumab field – that has typically seen dual filings for Prolia and Xgeva rivals submitted simultaneously – Teva has specified that it has initially filed only for a Prolia rival, with a biosimilar Xgeva candidate still in trials... Global Sub. Full

French Specialist Horus Takes More European Rights To Formycon's Eylea Biosimilar

(9/18, Dean Rudge, Generics Bulletin) ...French ophthalmology specialist Horus Pharma has picked up the remaining commercialization rights in Europe for Formycon's FYB203 biosimilar Eylea (aflibercept) 2mg product not previously meted out to Teva...At the beginning of this year, Teva – which already sells Formycon's Ranivisio (ranibizumab) biosimilar to Lucentis in Europe – signed a licensing deal for FYB203 providing for rights in "major parts of Europe," excluding Italy, where it is to be sold under the name Ahzantive. "Baiama will be sold as a second brand in addition to Ahzantive, which will be launched by Teva across Europe," commented Nicola Mikulcik, Formycon's chief business officer. "Teva is already successfully marketing our Lucentis biosimilar Ranivisio. With our two-brand-partner strategy we are striving for the best possible therapeutic coverage to fully leverage the high market potential in Europe."... Global Sub. Full

Celltrion Unveils Phase 1 Success for Cosentyx Biosimilar CT-P55 Targeting Korean and Global Psoriasis Market

(9/17, Heo Ji-yoon, Chosun Biz) ...On the first day of the conference, Celltrion unveiled for the first time in a poster the results of a phase 1 clinical trial demonstrating that CT-P55 (ingredient secukinumab), which is being developed as a biosimilar for autoimmune disease treatment, is equivalent in efficacy and safe compared with the original drug...The original drug of CT-P55 is Cosentyx by the Swiss pharmaceutical company Novartis...Celltrion plans to launch Omriclo (ingredient omalizumab), first developed as a biosimilar to the allergy treatment Xolair, in Europe within this year... Full

India Bulk Drug Makers Start Preparing for Ozempic Patent Expiry

(9/17, Satviki Sanjay, Bloomberg) ...From local giants Dr Reddy's Laboratories Ltd. to suppliers like Macleods Pharmaceuticals Ltd., Indian firms are preparing to make bulk drugs for manufacturing generic versions of semaglutide, that Novo sells as Wegovy and Ozempic...Indian API makers will face intense price competition from Chinese companies, which control about 80% of global generic bulk drugs supply chain. Even some API makers in India rely on chemicals from China for making bulk drugs, reflecting a key area of vulnerability... Sub. Req’d

Why Sanofi's R&D Chief Is ‘Pretty Pragmatic' About a ‘Mixed' Year of Clinical Development

(9/17, James Waldron, Fierce Biotech) ...Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, said the data "exemplify our deep understanding of pathway biology and commitment to exploring novel platforms and technologies." "We are encouraged by these results and look forward to continuing to explore brivekimig, and the impact of dual TNF and OX40 ligand inhibition, on the inflammation driving the burdensome symptoms of HS," Johnsen added in a Sept. 17 release. In his interview with Fierce days earlier, Ashrafian also alluded to the "positive study" for brivekimig, suggesting that the "OX40 ligand portfolio is looking pretty good."... Full

Switzerland's Roche Strikes $3.5Bn Deal to Buy US Drugmaker 89bio

(9/18, Hannah Kuchler, Financial Times) ...After Switzerland was hit with the highest tariffs in the developed world, US trade representative Jamieson Greer said "they ship enormous amounts of pharmaceuticals in our country. We want to be making pharmaceuticals in our country." Domestically, some critics have rounded on the country's vast pharmaceutical industry for having sparked the ire of the US president. The two major Swiss drugmakers, Roche and Novartis, have been trying to please the Trump administration by announcing large investments in the US, as the global pharmaceutical industry seeks to avoid tariffs and see off the threat of a policy that would cut US drug prices. The 89bio deal comes as Roche aims to increase in the obesity sector, trying to take a slice of the market from leaders Eli Lilly and Novo Nordisk... Sub. Req’d

Lilly Seeks Mounjaro Approval for Children with Diabetes Following Phase 3 Hit

(9/18, Elizabeth Cairns, Endpoints News) ...Children with type 2 diabetes cannot be treated off-label with GLP-1 drugs, which are approved for adults, such as Mounjaro or Novo Nordisk's Ozempic. If approval is granted, Mounjaro will be the first such drug to reach this younger population, potentially boosting sales...Lilly is also testing its obesity drug Zepbound, which has the same active ingredient as Mounjaro, in adolescent patients with obesity. A study in patients aged 12 to 17 could report in around five years. Novo Nordisk, too, is testing its GLP-1 drug Ozempic in patients aged 10 to 18, with data potentially coming next year. A trial of Wegovy, the same molecule branded for obesity, is also underway in patients as young as 6 years old. Results could emerge next year or in 2027... Sub. Req’d

Novo Nordisk Shares Pop 5% After Wegovy Pill Trial Shows ‘Significant' Weight Reduction

(9/18, Karen Gilchrist, CNBC) ...Trial results showed the "Wegovy pill" led to average weight reduction of 16.6% after 64 weeks, Novo Nordisk said. The company's Chief Science Officer Martin Holst Lange told CNBC that oral treatment offered an important alternative to its existing injection for patients. There are currently no approved oral versions of GLP-1s on the market, however competition from rival Eli Lilly is heating up... Full

Amid Industry Headwinds, Biogen Breaks Ground On New Headquarters

(9/17, Catherine Carlock, The Boston Globe) ...Biogen on Tuesday held a ceremonial groundbreaking of its 16-story headquarters in Kendall Square, ushering in the latest phase of the neighborhood's transformation from "Nowhere Square" to what its backers like to call "the most innovative square mile on the planet."... Sub. Req’d

Global Pharma Giant Expands South Florida Presence

(9/17, Mark Dovich, South Florida Business Journal) ...Lupin Research Inc., a subsidiary of Mumbai's Lupin Limited, purchased the property at 12095 N.W. 39th St. in Coral Springs for $14.6 million. The seller was Nidec Motor Corporation, a motor manufacturer based in Kyoto, Japan. The deed was executed Sept. 9. A Lupin representative declined to tell the Business Journal the company's plans for the site. Nidec did not respond to a request for comment... Sub. Req’d

U.K. Debate Over Investment in Pharma Grows Louder as Trump, An Interested Party, Pays a Visit

(9/17, Andrew Joseph, STAT+) ...The U.K. does not pay as much for drugs as pharma companies believe it should, and those companies have in turn warned they may cut their investments here. Those warnings turned into a rude reality for the country in the past week, as Merck, AstraZeneca, and others all bailed on or paused major projects, with Merck pulling out of a $1.3 billion research center in London that is well under construction. "It's looking like there's a sort of contagion," one member of Parliament said at a hearing this week that was called to discuss the developments in the country's life sciences industry... Sub. Req’d

NHS Patients Do Get Best Drugs, Watchdog Insists in Big Pharma Row

(9/17, Chris Smyth, The Times) ...Lord Vallance of Balham, the science minister, has warned that the NHS will have to spend a larger share of its budget on medicines to maintain Britain's place as a world leader in life sciences, as ministers attempt to persuade the Treasury to pay up. Trump has demanded Britain and other countries pay more for medicines to end "freeloading on US innovation". He may raise the topic with Sir Keir Starmer at Chequers on Thursday after Britain promised in a trade deal to improve conditions for American drugmakers... Full

Europe Struggles with Chronic Drug Shortages, Auditors Warn

(9/17, Christy Santhosh, Reuters) ...The European Commission identified fragile supply chains and heavy reliance on Asian manufacturers, especially for essential drugs such as antibiotics and painkillers, as key causes, the ECA said. In July, European crisis chief Hadja Lahbib said the EU aims to stockpile critical medical equipment and vaccines in case of future health crises and to create a network to improve coordination among member states. But the ECA warned that stockpiling in some countries could worsen medical shortages elsewhere in the bloc... Full

EU Medicine Shortages at Record Levels, Auditors Report

(9/17, Marta Iraola Iribarren, Euronews) ...The report said that absence of a common framework to handle shortages and pan-EU compliance tools is worsening the situation. "Medicine shortages are a persistent issue across the EU, and that's such still a chronic headache for the Union. But they have grown in frequency and severity, reaching record levels in 2023 and 2024," the ECA"s Klaus-Heiner Lehne told reporters while presenting the report. He added that this poses a problem for patients, a challenge for health systems, and a sign of the EU's strategic vulnerability in medicine supply...These shortages included drugs as essential as thrombolytics (used to treat heart attack or stroke patients), amoxicillin, and cyanide poisoning antidotes, among others... Full

ECA Warns EU Lacks Strong System to Tackle Drug Shortages

(9/17, Shajil Kumar, Pharmacy Business) ...All categories of medicines or vaccines are vulnerable to shortage. Shortages peaked in 2023 and 2024, with countries running critically short of 136 medicines between January 2022 and October 2024. Auditors claim EU lacks an adequate legal framework as well as timely and actionable information to deal with shortages... Full

Merck Opens €150M Climate-Neutral Filter Manufacturing Facility in Ireland

(9/18, Dominic Tyer, European Pharmaceutical Review) ...It's the first of the pharma company's manufacturing operations to have been specifically designed to run on a full climate-neutral basis and marks a key milestone in the company's ambition to achieve climate neutrality by 2040...By locating the site in Ireland Merck also hopes to strengthen its "in-region-for-region" supply resilience and reduce cross-border dependencies for its customers... Full

Canada, Britain & Australia Push For Greater International Regulatory Alignment

(9/18, Eliza Slawther, Pink Sheet) ...Health Canada plans to enhance its use of regulatory reliance pathways through new regulations enabled by amendments made last year to its Food and Drugs Act. Meanwhile, the UK and Australia are exploring collaboration opportunities across a range of areas, including clinical trials and regulatory pathways. The UK's MHRA has also held discussions with Australia's TGA on the use of in-silico data in regulatory submissions... Global Sub. Full

Indian Pharma Seeks Exemption from New Wave of US Tariffs

(9/17, The Pharma Letter) ...Indian drugmakers are urging the government to ensure generic drugs are excluded from an ongoing US investigation, warning that tariffs could destabilize global drug supply chains and increase costs for American consumers...A delegation of Indian drugmakers met up with minister Piyush Goyal to appraise him of the matter...Mr Goyal told the delegation that India will firmly push back against any 'unjustified and unreasonable' US tariffs... Sub. Req’d

Indian Pharma Firms Plan 45,000-Cr Capex in FY26, Says ICRA

(9/18, Neetu Chandra Sharma, Business Today) ...Indian pharmaceutical companies are expected to undertake capital expenditure of 42,000–45,000 crore in FY2026, including around 25,000 crore in inorganic investments, according to ratings agency ICRA...The planned capex of 42,000-45,000 crore in FY2026 is higher than recent averages and reflects the industry's intent to expand its specialty and complex drug portfolio, supported by policy measures such as GST exemptions on essential medicines and the government's Production Linked Incentive (PLI) scheme... Full

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