Wednesday, September 17, 2025

FDA Posts More Than 100 Warning and Untitled Letters in Ad Crackdown

(9/16, Ferdous Al-Faruque, Regulatory Focus) ...In addition to the stack of warning letters published by FDA, the agency also published 40 untitled letters citing companies for advertising practices that go afoul of regulations...For example, AstraZeneca received five letters, Novartis received four letters, UCB received three, Phathom received three, and Boehringer Ingelheim received three. Takeda, Bristol-Myers Squibb, AbbVie, Teva Neuroscience, and Supernus Pharmaceuticals all received two letters each...As an example, FDA sent a warning letter to Teva for its television advertisements for Austedo XR (deutetrabenazine) to treat tardive dyskinesia (TD) in which actors don't show obvious uncontrollable movements after treatment. "These presentations misleadingly suggest that Austedo XR provides a greater magnitude of benefit in the treatment of TD than has been demonstrated," said FDA... Full

FDA Targets Lilly, Novartis, BMS and More in Deluge of Marketing Letters

(9/16, Andrea Park, Fierce Pharma) ...The letters target many of the biggest drugmakers, several of which received multiple letters. At the top of the untitled heap were five for AstraZeneca—plus another for its Alexion rare-disease-focused subsidiary—and three each for Bristol Myers Squibb, Novartis, UCB, Boehringer Ingelheim and Phathom Pharmaceuticals. AbbVie, Takeda, Teva Pharmaceuticals and Supernus Pharmaceuticals each received two letters, while Sanofi and Pfizer were among those who received one apiece. Each of the untitled letters argues that a particular DTC ad is "false or misleading" and so "misbrands" the drug it's advertising. The companies have been given 15 days to formally respond to the allegations... Full

Flood of Warning Letters Follows DTC Ad Clampdown

(9/17, Phil Taylor, Pharmaphorum) ...Meanwhile, the long list of untitled letters – an initial communication from the FDA that identifies violations that don't meet the threshold for a full-blown warning – features multiple entries for AbbVie, AZ, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, Novartis, Phathom Pharma, Supernus Pharma, Takeda, Teva, and UCB. The letters are all dated 9th September – the day the new policy was announced – and are signed by CDER Director George Tidmarsh... Full

Drugmakers Have Pledged to Invest $350 Billion in U.S. After Tariff Threat

(9/16, Peter Loftus, The Wall Street Journal) ..."The vast majority of our products going into the U.S. are manufactured in the U.S.," GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. "This of course adds to it, and it's about the new pipeline that's going through."... Sub. Req’d

PBM Bill Will Pass this Winter: Rep. Buddy Carter

(9/17, Michael McAuliff, Modern Healthcare) ...Our hope is that we're going to have a healthcare package at the end of this year, and we can get it included in that healthcare package. Keep in mind that my bill, the PBM Reform Act of 2025, will save almost $5.5 billion that can be used for other programs. And leadership likes to have the ability to add something into a package that will have savings... Sub. Req’d

Fewer Stelara Biosimilar Makers Are Offering High-WAC Pricing

(9/16, Stanton Mehr, Biosimilars Review & Report) ...Ustekinumab biosimilars are many and largely sold at big discounts relative to the reference product Stelara. The major PBMs are beginning to publish formularies for 2026. For instance, Express Scripts will have two biosimilars on formulary—Biocon Biologic's Yesintek and Alvotech/Teva's Selarsdi (at 90% and 85%, respectively, off the wholesale acquisition cost [WAC] of Stelara) in addition to its unbranded, Quallent version, based on Samsung Bioepis' Pzychiva product, which we assume will be priced at Quallent's familiar 46% off of WAC (as in 2025). Stelara will be excluded from formulary, which is a necessary move for the success of the biosimilars... Full

E&C To Mark Up Pediatric PRV Reauthorization & Generic Drug Transparency Bills

(9/16, Gabrielle Wanneh, Inside Health Policy) ...The House Energy & Commerce Committee Wednesday (Sept. 17) will mark up bills to increase the transparency of generic drug applications and reauthorize FDA's pediatric priority review voucher (PRV) program that expired last year. The latter aims to further incentivize speedier drug development for rare diseases affecting children... Sub. Req’d

The IRA is Evolving – Let's Fix it for Biosimilars

(9/16, Alex Keeton, Biosimilars Council) ...Originally, the Medicare Drug Price Negotiation Program (MDPNP) excluded products with indication(s) approved under a single orphan drug designation. However, the One Big Beautiful Bill Act (OBBBA), which passed in July 2025, reshapes the MDPNP by expanding exemptions for orphan drugs. This shift reveals an important truth: the IRA can, and should, be amended. If it can be modified to keep incentives in place for orphan drug development, it can, and should, evolve further – especially to promote more robust biosimilar competition... Full

Drugmakers Submit Plans to Join 340B Rebate Model Pilot Program

(9/16, Nicole DeFeudis, Endpoints News) ...All eligible drugmakers have applied to participate in the government's pilot program testing a rebate model for certain 340B drug discounts, an HHS spokesperson said. Novartis and Bristol Myers Squibb confirmed to Endpoints News that they submitted their plans for the program to the Health Resources and Services Administration, following a Monday deadline to do so. Johnson & Johnson and AstraZeneca also told Endpoints they intend to participate in the pilot... Sub. Req’d

What Policymakers Need to Know About China's Role in the US Drug Supply Chains and What to Do About It

(9/16, Marta E. Wosinska, Brookings) ...In this paper, I first explain why and how drug shortages happen and how U.S. drug supply chains are most exposed to China. I then discuss the extent to which policymakers can de-risk those supply chains through onshoring... Full

Areteia Posts Phase 3 Asthma Win for Potential Oral Rival to Biologic Blockbusters

(9/16, Nick Paul Taylor, Fierce Biotech) ...The trial compared dexpramipexole to placebo in 600 people with inadequately controlled moderate-to-severe eosinophilic asthma...Both doses significantly reduced average blood absolute eosinophil counts among treated patients between Weeks 20 and 24, the biotech said. Eosinophils are white blood cells that drive symptoms in more than half of people with asthma. People with eosinophilic asthma have multiple treatment options. AstraZeneca's Fasenra, GSK's Nucala and Teva's Cinqair, all of which are anti-IL-5 antibodies, are authorized in the indication. Sanofi and Regeneron's Dupixent, which inhibits the signaling of IL-4 and IL-13, is also approved in the setting. All of the products are injectable biologics... Full

AstraZeneca's Asthma Drug Fails 'Smoker's Lung' Study

(9/17, Pushkala Aripaka, Reuters) ...AstraZeneca said on Wednesday its asthma drug Fasenra failed to control the rate of flare-ups in patients with chronic obstructive pulmonary disease (COPD) in a late-stage study, in a setback to efforts to help tackle a severe lung disease. The drugmaker said Fasenra did not meet the primary endpoint in COPD patients compared with placebo, and added that it would analyze the full study data to better understand the results... Full

‘We Will Become The Number One Biosimilars Provider In The US' – Accord's Kokino Sets Out Ambitions

(9/17, Dave Wallace, Generics Bulletin) ...After launching two biosimilars and acquiring another leading marketed product in a little over a year, Accord Biopharma has made a major push into US biosimilars. Accord US president Chrys Kokino explains to Generics Bulletin how the firm is seeking to become the market leader... Global Sub. Full

Lupin Gets US FDA Nod for Generic Drug Lenalidomide in Multiple Potencies

(9/17, Rahul Goreja, Business Standard) ...Mumbai-based drugmaker Lupin on Wednesday said that it has received approval from the United States Food and Drug Administration (US FDA) for a generic version of Lenalidomide capsules in multiple strengths—2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. The company said that these capsules are used to treat adult patients with multiple myeloma, a blood cancer that develops in plasma cells in the bone marrow... Full

Alteogen Wins EU Approval for Eylea Biosimilar ‘Eyeruxbi'

(9/17, Choi Mun-hee, Business Korea) ...Eyeruxbi is the second biosimilar product approved by Alteogen, following its Herceptin biosimilar. The final marketing authorization was granted about two months after receiving a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in July this year... Full

Horus Pharma Becomes Additional Commercialization Partner for Formycon's Eylea® Biosimilar FYB203 in Selected European Countries Under the Brand Name Baiama®

(9/17, Formycon AG) ...Formycon AG announces that Klinge Biopharma GmbH, the exclusive owner of the global commercialization rights of Formycon's Eylea®1 biosimilar FYB203 (aflibercept), concluded an additional semi-exclusive license agreement with Horus Pharma for the commercialization of FYB203/Baiama®2 in selected European countries. The agreement follows the semi-exclusive partnership signed in January with Teva Pharmaceuticals International GmbH for the commercialization of FYB203/AHZANTIVE®3 covering major parts of Europe and Israel... Full

Saudi Player Jamjoom To Commercialize Bio-Thera's Cosentyx Biosimilar

(9/17, Dean Rudge, Generics Bulletin) ...Bio-Thera Solutions has entered into a licensing agreement with Jamjoom Pharma to commercialize its proposed Cosentyx biosimilar, BAT2306. The deal covers the MENA region, with Jamjoom set to handle regulatory submissions, market access, and commercialization. Bio-Thera will manage product development and manufacturing from China... Global Sub. Full

4 Drugs in Shortage

(9/16, Alexandra Murphy, Becker's Hospital Review) ...Here are four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists... Full

Lilly Unveils 1st of 4 New US Manufacturing Sites with $5B Virginia API Plant

(9/16, Kevin Dunleavy, Fierce Pharma) ...The facility is part of a $27 billion investment plan that the Indianapolis drugmaker laid out nearly seven months ago during a high-profile press event in Washington, D.C., dubbed "Lilly in America." The company expects to break ground this year on each of the new plants, which Lilly calls "mega sites."... Full

GSK Joins US Investment Spree with $30B Planned for Manufacturing, R&D

(9/16, Darren Incorvaia, Fierce Pharma) ...British Big Pharma GSK is welcoming President Donald Trump to the U.K. with a hefty gift: a five-year, $30 billion planned investment in U.S. R&D and manufacturing. The funds are set to be spread across GSK's U.S. supply chain, the company announced in a Sept. 17 release, alongside domestic drug discovery R&D and clinical development operations. During the five-year investment period, the U.S. is expected host more of GSK's clinical trials than anywhere else in the world, the drugmaker added... Full

Lilly Unwraps More Phase 3 Obesity Pill Data, But They Still Lag Behind Novo's Oral Wegovy

(9/16, Elizabeth Cairns, Endpoints News) ...Speaking at a press conference Tuesday ahead of the ATTAIN-1 data presentation, study leader Sean Wharton from McMaster University in Hamilton, Ontario, Canada, said he could not be sure why orforglipron had underperformed compared with oral Wegovy. One of the factors that might have made a difference, however, is the gender of the enrollees in these studies, Wharton said. Around 36% of the ATTAIN-1 subjects were male, which is "a large percentage of men," Wharton said, making the study different from other weight management trials. Only 21% of those in the Novo study were male. And GLP-1s tend to be more effective for obesity in women than in men... Sub. Req’d

Lilly Sees Obesity Drug Leadership Beyond US as It Leans On Consumer-Focused Strategy

(9/17, Maggie Fick and Mrinalika Roy, Reuters) ...Patrik Jonsson said that the drugmaker is applying a consumer-focused commercial strategy similar to its U.S. approach, including partnerships with telehealth and digital platforms to reach patients who are mainly paying for weight-loss drugs out-of-pocket, from Britain to China to the United Arab Emirates. "We learned very rapidly from the U.S. the importance of taking a very strong consumer focus," said Jonsson. Lilly is using that model in markets including Australia and China, where it has partnered with e-commerce giants Alibaba (9988.HK) and JD.com , he said... Full

Novo Nordisk's Alzheimer's Trial a 'Lottery Ticket', Senior Executive Says

(9/17, Stine Jacobsen, Reuters) ...The Danish drugmaker expects data from its pivotal Alzheimer's disease trial by the end of 2025. After blockbuster success in weight loss, Alzheimer's could emerge as the next key frontier for GLP-1 drugs like semaglutide as drugmakers explore new applications beyond obesity and diabetes. "We always presented it as a lottery ticket and it still is because it's very uncertain," Ludovic Helfgott told Reuters in an interview during the European Association for the Study of Diabetes conference in Vienna... Full

Merck Aims to Partner with Pharma Innovators

(9/17, Zhou Wenting, China Daily) ...Germany-headquartered technology giant Merck has set its sights on becoming the "best partner of choice" in the pharmaceutical industry, leveraging its global commercialization capabilities to support Chinese medical innovation on the world stage, a senior executive said. China's pharmaceutical sector has witnessed remarkable innovation over the past decade. The trend of strong growth in overseas licensing deals for Chinese innovative therapies will continue from this year into next, allowing more Chinese innovations to reach global markets, the executive said in an interview in Shanghai... Full

Optum Rx Boosts Reimbursement On Brand Drugs for 2,300 Independent Pharmacies

(9/17, Heather Landi, Fierce Healthcare) ...The rollout of the new reimbursement minimums for brand drugs will benefit more than 2,000 independent pharmacies, or those not affiliated with a pharmacy services administrative organization, chain or other entity. The change, which went into effect Sept. 1, "will support the long-term sustainability of pharmacies, which play a critical role in patient care," Optum Rx said in a press release... Full

Senior UK Official Asks Whether Pause in Pharma Sector Spending Is ‘Co-Ordinated'

(9/16, Anna Gross; Hannah Kuchler; George Parker, Financial Times) ...A senior UK government official has questioned whether pharma companies are running a co-ordinated pressure campaign to drive up state spending on drugs, in a provocative intervention at the start of Donald Trump's state visit to Britain. The official, speaking on condition of anonymity, said a spate of recent announcements about paused or scrapped investments in the UK "look very co-ordinated from the outside"...Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said claims that the companies were colluding were "very serious and unsubstantiated", as well as "categorically untrue"... Sub. Req’d

UK Set On Resolving Standoff with Big Pharma, Science Minister Says

(9/17, Julia Kollewe, The Guardian) ...The UK is determined to resolve its standoff with the pharmaceutical industry and reverse a 10-year decline in NHS spending on medicines, the science minister has told MPs after a string of drugmakers cancelled projects worth nearly £2bn. Patrick Vallance, a former executive at drugmaker GSK, said the country needed to increase spending on medicines and reverse a decade of declining investment...Vallance said the government had not formally restarted talks with the pharmaceutical industry over its medicine pricing mechanism, which collapsed last month without an agreement and has been cited as one of the factors in drugmakers cancelling projects, but ministers were holding "lots of discussions around the commercial environment in the UK" with companies... Full

UK Has Gone from a Leader to a Laggard in Biopharma, Eli Lilly CEO Says

(9/16, Angelica Peebles, CNBC) ...U.S. policymakers should take note as biopharmaceutical companies pull back on investments in the U.K., Eli Lilly Chief Executive Officer Dave Ricks said in an interview with CNBC...Ricks said Lilly had been in talks with U.K. policymakers on changes around intellectual property and regulation, but paused those discussions while it awaits a policy response from the British government. He said it's possible negotiations between the U.S. and U.K. on a trade deal could "shake things loose," but until the situation changes, it's "pretty hard" to consider investing there... Full

Pharma Tells Scotland How to Court Investment Amid UK Life Sciences Turmoil

(9/17, Nick Paul Taylor, Fierce Biotech) ...With drugmakers freezing investment in the U.K., pharma trade group ABPI has set out its vision for how Scotland can buck the trend and become a leader in R&D and cutting-edge medicines. Scotland is part of the U.K. but has devolved powers that provide opportunities to diverge from England, Northern Ireland and Wales. ABPI wants the next Scottish Parliament, which is set to be elected in May 2026, to use those powers to attract pharma investment at a time when companies are rethinking plans to expand in England... Full

Industry Welcomes French And German Calls To Row Back On Water Treatment

(9/17, Dave Wallace, Generics Bulletin) ...A public intervention by the leaders of France and Germany over the Urban Wastewater Treatment Directive has been welcomed by the off-patent industry. French president Emmanuel Macron and German chancellor Friedrich Merz have called for the "examination of targeted simplification regarding the UWWTD," which features an extended producer responsibility scheme that would prove costly for generics suppliers. Praising the intervention, Medicines for Europe and Sandoz CEO Richard Saynor have called for a pause in the scheme to recalibrate expectations... Global Sub. Full

EU's Draft GMP Guideline Signals Major Cultural Shift In Pharma Quality Compliance

(9/16, Vibha Sharma, Pink Sheet) ...Changes the European Commission wants to make to Chapter 1 of the EU good manufacturing practice guideline carry significant implications for how companies approach GMP compliance, Pete Gough, of the consulting, training, standards development and certification organization, NSF, told the Pink Sheet. The revised Chapter 1 promotes a transition from static, documentation-heavy compliance to a dynamic, learning-oriented pharmaceutical quality system, with an emphasis on continual improvement, knowledge management, and risk-based decision-making... Global Sub. Full

Scheme to Boost Innovation in Pharma Sector Soon, Says DoP Secretary

(9/17, Manu Kaushik, Financial Express) ...The government has firmed up plans to launch the Promotion of Research and Innovation in Pharma MedTech (PRIP) scheme this month, Amit Agrawal, secretary at the Department of Pharmaceuticals (DoP), told agencies. The scheme, announced in August 2023, is aimed at fostering innovation in the pharmaceutical and medical devices sectors, with a total financial outlay of Rs 5,000 crore... Full

Japan Expands Essential Drug List For Economic Security

(9/17, Lisa Takagi, Pink Sheet) ...Japan's Ministry of Health, Labour and Welfare (MHLW) has revised its list of pharmaceutical products considered essential for national security, expanding it from the current 450 active ingredients to 759 in total. The supply of all will be subject to regular monitoring by the government, which may order increased production or expanded procurement of related materials if necessary... Global Sub. Full

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