Monday, September 29, 2025

Trump Pharma Plan Looks Like Reprieve for Many Drugmakers

(9/27, Frank Connelly, Bloomberg) ..."The actual comment from the president is direct but its impact may be somewhere between nebulous and negligible," Mizuho Securities health-care specialist Jared Holz said in a note. "All major players have some production presence domestically and almost all have announced increased investment directly tied towards local manufacturing."...Still, some drugmakers could be left vulnerable. John Crowley, the President and chief executive officer of the US-based Biotechnology Innovation Organization, decried the tariffs as disproportionately impacting small companies that rely on contractors to do their manufacturing. "The immediacy of punitive, 100% tariffs on innovative medicines for any company without ‘shovels in the ground' would devastate our nation's small and mid-sized biotechnology companies," Crowley said in a written statement... Full

Drug Tariffs Are a Sideshow. Trump's Next Move Could Hit Pharma Harder.

(9/27, David Wainer, The Wall Street Journal) ...Investors are worried about how Trump might use the drug-pricing powers created under the Biden administration. The Inflation Reduction Act allows Medicare to negotiate prices on top-selling medicines. Negotiated prices for the next list of 15 drugs subject to discounts in 2027 are due to be released in November. Analysts fear the Trump administration could apply the law's framework more aggressively than the Biden administration, seeking discounts of 30% to 50% on products such as Novo Nordisk's Ozempic and Teva Pharmaceutical's Austedo, according to JPMorgan's Chris Schott... Sub. Req’d

Donald Trump is Waging War On Sky-High Drug Prices. Can He Win?

(9/28, The Economist) ...Intent on lowering prices, Mr Trump has given leading pharma firms until September 29th to comply with an executive order to peg their prices to the lowest charged in other rich countries—a rule he calls "most favoured nation" (MFN) pricing. If they do not, he thundered, they will face "every tool in our arsenal" against "abusive drug pricing". At the same time, the president wants to encourage homegrown manufacturing. He plans to impose a 100% tariff on branded drugs from October 1st, unless their makers are building factories in America. His administration is also pondering additional duties under a law allowing imports to be restricted on national-security grounds... Sub. Req’d

Trump's Pharma Tariffs Could Raise Drug Prices for Consumers, But Exemptions May Blunt Impact

(9/26, Rob Wile and Steve Kopack, NBC News) ...On the White House website, the administration maintains a "running list of new U.S. investment" from private companies. At least 15 pharmaceutical or drug makers are listed with investments ranging from new manufacturing facilities, tens of billions in expanded U.S. production and increased R&D spending. Many of those announcements would appear to meet the requirements laid out by Trump to avoid the new tariff. Two major European drugmakers, Roche and Novartis, said in statements that they expected little to no impact from the newly announced duties... Full

Latest Trump Tariff Threat May Exempt Many Big Pharma Firms

(9/26, Joseph Haas, Pink Sheet) ...John Crowley, president and CEO of the Biotechnology Innovation Organization (BIO), said in a Sept. 26 statement that the trade group shares the Trump Administration's interest in manufacturing more drugs in the US, but placing 100% tariffs on imported drugs will hurt smaller biopharma companies based in the US. "The immediacy of punitive, 100% tariffs on innovative medicines for any company without ‘shovels in the ground' would devastate our nation's small and mid-sized biotechnology companies," Crowley said. "Most of these companies do not have access to the significant capital needed to immediately establish manufacturing in the US. Due to the complexity and capital-intensive nature of biomanufacturing, the vast majority of these small-to mid-size biotech innovators rely on contract manufacturers to produce their medicines."... Global Sub. Full

How Big Pharma Wants to Lower Drug Prices

(9/29, Steve Ubl, The Washington Post) ...President Donald Trump is right to question why Americans often pay more for medicine than citizens of other countries. The biopharmaceutical industry is responding to Trump's call to put America first by announcing three major actions to lower drug costs for patients, protect medical innovation and strengthen the nation's leadership in life sciences... Sub. Req’d

PhRMA Announces Major Actions as Part of Industry's Commitment to American Patients and Workers

(9/29, PhRMA) ...To put America first, the biopharmaceutical industry is: Delivering $500 billion in new U.S.-based infrastructure investments...Providing 10 million Americans each year with financial assistance to help fill the gaps for patients failed by a broken health insurance system...Announcing AmericasMedicines.com, a new website that will connect patients with manufacturer direct purchase programs...PhRMA will be launching AmericasMedicines.com in January 2026, a new website to help patients more easily access these programs. This new website will allow manufacturers to list a wide range of medicines and connect patients directly to available options prescribed by their doctor. Pharmaceutical manufacturers must make their own decisions to offer direct purchase programs, determine how they will work and if they want to participate in AmericasMedicines.com... Full

The Generics Bulletin Podcast: Talking With AAM President And CEO John Murphy

(9/29, Dave Wallace, Generics Bulletin) ...Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association's latest annual savings report and key topics affecting the US off-patent market... Global Sub. Full

Former Republican Lawmaker Looks to Help US Allies Take Power Away from China

(9/27, Rachel Wolf, FOX News) ...Cathy McMorris Rodgers is continuing her work on Middle East affairs after leaving Capitol Hill. The former congresswoman recently spoke with Fox News Digital about her decision to join the U.S. Israel Education Association (USIEA) as a senior fellow to help cultivate the group's leadership in the pharmaceutical space... Full

Lilly Executives: How the FDA's New PreCheck Program Can Unleash the Future of U.S. Medicine Manufacturing

(9/29,Jeffrey Francer and Victor Cruz, STAT+) ...America's role in advancing science, investing in domestic manufacturing, and protecting public health is at a pivotal moment. Scientific discoveries are creating unprecedented opportunities, and the choices government agencies make today will determine how quickly those innovations reach patients. By modernizing how we develop and manufacture lifesaving therapies here at home, we can bet on ourselves and accelerate delivery to the people who need them most...Yet, despite this commitment, the existing regulatory framework continues to delay turning investments into tangible progress for patients. That's why the Trump administration's Aug. 7 announcement of the Food and Drug Administration's new PreCheck program is so important. The goal is straightforward yet transformative: to accelerate American drug manufacturing by providing earlier, structured feedback and more frequent communication throughout the regulatory process... Sub. Req’d

Wockhardt Says US Tariffs Won't Derail Plans for Antibiotic Zaynich

(9/26, Surabhi Upadhyay, Prashant Nair and Nigel D'Souza, CNBC TV-18) ...Habil F Khorakiwala, Founder and Chairman of Wockhardt Group, clarified that Zaynich is being manufactured in Europe, not India, and therefore will not fall under Indian tariffs. "Our new molecules, like Zaynich, which we would be going to rest as our first drug, the product is entirely manufactured in Europe, and therefore it will not be covered by Indian tariffs, and it would be covered by the European tariffs," he explained... Full

AbbVie Submits NDA for Parkinson's Disease Drug, Tavapadon

(9/26, Logan Lutton, Formulary Watch) ...AbbVie has submitted a New Drug Application (NDA) to the FDA for tavapadon, an investigational, oral, once-daily treatment for Parkinson's disease to be used with or without levodopa, according to a news release published today...Tavapadon is a once-daily oral, novel selective D1/D5 receptor partial agonist that stimulates dopamine receptors partway, which theoretically may cause fewer side effects than other Parkinson's medications that can cause difficulty swallowing, sleep problems and anxiety... Full

Jamp And Kashiv Launch Filgrastim And Pegfilgrastim In Canada

(9/26, Dave Wallace, Generics Bulletin) ...Jamp Pharma has launched its first oncology biosimilars in Canada in the form of its Filra (filgrastim) and Pexegra (pegfilgrastim) rivals to Amgen's Neupogen and Neulasta brands. Supplied through an exclusive partnership with Kashiv Biosciences, the products will compete in markets worth around $57m and $87m respectively. Jamp's Canadian biosimilars portfolio also includes its Alvotech-partnered Jamteki (ustekinumab) and Simlandi (adalimumab) rivals to Stelara and Humira... Global Sub. Full

Hikma And Richter Receive Denosumab Nods In US

(9/29, Dave Wallace, Generics Bulletin) ...Partners Hikma and Gedeon Richter have received FDA approval for their Enoby and Xtrenbo rivals to Prolia and Xgeva – but as the seventh pair of denosumab biosimilars endorsed in the US, they face a fierce competitive landscape...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 specified that it had initially filed only for a Prolia rival, with a biosimilar Xgeva candidate still in trials... Global Sub. Full

Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR

(9/26, Chain Drug Review) ...Amneal Pharmaceuticals has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for a proposed biosimilar to XOLAIR (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR is a registered trademark of Novartis AG... Full

Dr Reddy's And Hetero License Low-Cost Lenacapavir For LMICs

(9/26, Dave Wallace, Generics Bulletin) ...Dr Reddy's and Hetero Labs will be able to sell low-cost generic versions of Gilead's injectable lenacapavir in LMICs under two newly-announced partnerships. The deals were struck through Unitaid, the Clinton Health Access Initiative and Wits RHI, as well as the Gates Foundation. Under the terms of the agreements, the HIV prevention treatment will be available at a cost of just $40 a year in 120 LMICs starting in 2027... Global Sub. Full

Appeals Court Rejects Novartis' Attempt to Block Entresto Generics

(9/26, Zachary Brennan, Endpoints News) ...The US Court of Appeals for the DC Circuit affirmed a district court ruling that denied Novartis' challenge to the approval of MSN Pharmaceuticals' Entresto generic. The appeals court rejected Novartis' claims regarding the structure of the generic from MSN, which launched in the US in late July. "Novartis's objection gives us no reason to question the FDA's expert judgment regarding these scientific issues," Friday's opinion says. Novartis did not immediately respond to a request for comment... Sub. Req’d

Ocrelizumab Shows Benefit in Advanced MS: Phase 3 Data

(9/29, Ted Bosworth, Medscape) ...A new phase 3 trial of ocrelizumab in primary progressive multiple sclerosis (PPMS) showed meaningful benefit in older patients and those with advanced disease — a first for this patient population. "I hope these data change how we think about MS," reported the principal investigator, Gavin Giovannoni, MBBCh, PhD, professor of neurology of the Institute of Neurology at University College London, London, England. The message, he added, is "don't give up on treatment of MS for people in a wheelchair."... Full

Amgen Invests a Further $650 Million in US Manufacturing

(9/26, The Pharma Letter) ...US biotech major Amgen today announced it will invest a further $650 million for the expansion of its US manufacturing network, creating hundreds of new jobs. The planned investment will support increased drug production at the company's biologics manufacturing facility in Juncos, Puerto Roco – a US territory - and integrate innovative advanced technologies throughout the operations process. It is expected to create nearly 750 jobs, including construction roles and new highly skilled manufacturing jobs... Sub. Req’d

Drugmakers Push Trump-Friendly Efforts as Deadline to Lower Prices Nears

(9/26, Elaine Chen and Daniel Payne, STAT+) ..."The tariffs are, I think, becoming less of a headwind just because of ways to navigate around it," said Mizuho analyst Jared Holz, pointing to the announcements that pharma companies have already made to invest in U.S. manufacturing. However, the most-favored nation policy "is a little bit more important as far as investors look at it, because we still don't know mechanistically how it's going to work." The industry appears to be in closer dialogue with the administration about this policy than earlier this year, though. Companies and the Trump administration are discussing plans for a potential event at the White House in the coming weeks announcing lower drug prices, three people familiar with the planning told STAT. Those conversations are ongoing even as no agreements with the administration have been publicly announced... Sub. Req’d

AstraZeneca Plans Direct New York Listing in Another Blow to UK Life Sciences

(9/29, Ayisha Sharma, Endpoints News) ...The new listing will replace the company's Nasdaq-listed American depositary receipts, a type of security that allows US investors to have an interest in foreign businesses, but which are generally harder to trade than directly listed ordinary shares. The change means that AstraZeneca shareholders will be able to trade on the NYSE in addition to the London and Stockholm exchanges, according to a Monday release. AstraZeneca chair Michel Demaré said the company should be able to "reach a broader mix of global investors" as a result of the overhaul... Sub. Req’d

PTT's Lotus Strikes $658M Deal For Alvogen In US

(9/26, Dave Wallace, Generics Bulletin) ...Lotus Pharmaceutical is taking control of Alvogen US in a deal valued at around $658m. The agreement will give Lotus access to the US market, adding Alvogen's salesforce, New York manufacturing facility and R&D pipeline. The transaction builds on a longstanding partnership between the two firms, with Robert Wessman serving as chair of both companies... Global Sub. Full

Lupin Expands In Europe With €190M VISUfarma Acquisition

(9/29, Dave Wallace, Generics Bulletin) ...Lupin has spied an opportunity to expand its commercial infrastructure in Europe while also tapping into the "attractive ophthalmology market," by striking a deal to acquire innovative ophthalmology specialist VISUfarma from GHO Capital Partners. According to Lupin, the acquisition cost comes to €190m ($223m), "subject to customary adjustment on closing." The firm said VISUfarma had annual turnover of €48.1m and a net worth of €134.6m. Lupin said the transaction would be financed "with existing cash on balance sheet" and was expected to close by the end of 2025, subject to certain closing conditions... Global Sub. Full

GSK Switches CEO as Trump Tariffs Test Pharma

(9/29, AFP) ...British pharmaceutical giant GSK on Monday said longtime chief executive Emma Walmsley will be replaced by its chief commercial officer in January, as the company navigates US tariffs on the sector. Luke Miels will take over on January 1 from Walmsley, who will have been at the helm for almost nine years, GSK said in an unexpected announcement... Full

Sanofi Expands $35-Per-Month Pricing to All Insulin Products

(9/26, Kevin Dunleavy, Fierce Pharma) ...In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient's insurance status. The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance... Full

Sun Pharma, Zydus and 3 Others Recall Products in US

(9/29, Ruchika Sharma, Medical Dialogues) ...Sun Pharma, Zydus, Glenmark, Granules India, and Unichem are recalling products in the United States due to various manufacturing concerns, according to the latest Enforcement Report of the US Food and Drug Administration (USFDA). The recalls of affected lots are being made voluntarily by the companies in the American market, the US health regulator said... Full

UK to Offer to Pay More for Drugs to Placate Trump and Pharma Groups

(9/26, George Parker, Anna Gross and Hannah Kuchler, Financial Times) ...After weeks of ministerial wrangling, Sir Keir Starmer's chief business adviser Varun Chandra will travel to Washington next week with a message that Britain is willing to increase its spending on medicines, which has long been a source of contention with the Trump administration. Officials briefed on the discussions said there was an acceptance that the UK will have to give ground. "Our pricing structure is an issue," said one. "We have to be more competitive — the world has changed." "The way in which we value drugs could perhaps be more sophisticated," they said... Sub. Req’d

Trump's 100% Drug Tariff Spares EU, Japan But UK May Face Hit

(9/26, Skylar Woodhouse, Bloomberg) ...Duties on pharmaceuticals from the EU will be capped at 15% per the terms of its framework deal, the official said Friday. Japanese drugs will also be charged the rate spelled out in its pact, the official added. The US-Japan joint statement says American tariff rates on Japanese drugs and semiconductors should not exceed those applied to others, including the EU. The UK, another country that exports pharmaceuticals to the US, would face the 100% tariff, according to a White House official... Sub. Req’d

The Nations and Firms Threatened by Trump's Pharma Tariffs

(9/26, AFP) ...Kathleen Brooks, research director at XTB, said that "most of the big pharma producers already produce their drugs for the American market in the US". However there are many popular exceptions -- such as the blockbuster weight-loss drugs Wegovy and Mounjaro -- as well as some cancer treatments that are all made in Europe, she added...Aiming to protect themselves from Trump's protectionist policies, pharma giants have announced around $300 million in investments in the US in recent months. "Although many pharma companies have pledged to build plants in the US, construction may not have started yet, as these plants are complex to build," Brooks said. However Trump was clear that he defined building as "breaking ground" on construction sites... Full

US Biotechs Think Twice About EU Licensing Deals Amid Trump's Drug Pricing Campaign

(9/26, James Waldron, Fierce Biotech) ...U.S. biotechs are increasingly reluctant to license their drugs to European partners due to the risk of becoming a target of the Trump administration, industry insiders have told Fierce Biotech. Emmanuelle Trombe, a French lawyer with 20 years experience in helping European biopharmas secure the regional licenses to drugs developed by American biotechs, said these negotiations have become "more and more difficult" this year due to a fear of being criticized by the U.S. government... Full

Luring U.S. Drugmakers Back From This Irish Outpost Won't Be Easy

(9/27, Max Colchester, The Wall Street Journal) ...So far this year, more than a dozen of America's biggest drugmakers have pledged to spend over $350 billion collectively by the end of this decade on manufacturing and research in the U.S. Any shift from Ireland is unlikely to take place overnight. It can take about three years to move a manufacturing plant, said Niall Cunneen, a pharma expert at consultants Sia Partners. Investment cycles to develop and produce drugs can stretch over a decade, well past a political term of office in the U.S., and many investment decisions have already been locked in, he added... Sub. Req’d

Ireland Holds its Breath as Pharma Tariff Drama Plays Out

(9/26, Brian Maguire, Eurativ) ...The official's remarks have taken the edge off the immediate uncertainty faced by the Irish pharmaceutical sector. Still, Varg Folkman, Policy Analyst at the European Policy Centre, told Euractiv, "I don't think we can be sure about Trump's intentions regarding tariffs at all. Everything relies on the word of Trump…" He added, "Exemption from the 232 investigations, especially on pharma, was one of the key wins for the EU in the trade deal with the US. Whether the exemption stands or is revisited by the Americans will most likely rely on other issues than trade itself."... Full

'Indian Generics Safe, Tariffs Unwise': Indian Pharma Association Hits Back After US Tariff Concerns

(9/29, Vikas Dandekar, The Economic Times) ...That apart, the IPA sternly warned that undermining its member companies in the US would not just disrupt the "generic supply" broadly, it would create vulnerabilities across the core therapeutic areas of US healthcare. "Worse, it would increase America's reliance on China, which provides state-backed subsidies to drive global health dominance." India, IPA asserted, is already reducing its reliance on China through the production-linked incentive (PLI) programme, which is expanding domestic API and KSM production (active pharmaceutical ingredients and key starting material) and strengthening allied supply chains. The industry body said the Indian generic makers have undergone a profound transformation, backed by the FDA's most recent state of pharmaceutical quality reports that confirmed Indian facilities perform on par with US and global peers in inspection outcomes... Sub. Req’d

US Tariffs Threaten $3.1 Billion of Singapore's Pharma Exports, Trade Talks Ongoing

(9/27, Xinghui Kok, Reuters) ...Pharmaceutical companies in Singapore are seeking clarification on whether they would qualify for an exemption from steep tariffs imposed by the United States on their goods, Singapore's Deputy Prime Minister Gan Kim Yong said on Saturday...This is a concern for Singapore as pharmaceuticals form around 13% of all Singapore exports to the U.S., said Gan. He said that many of the pharmaceutical firms in Singapore have existing plans to expand or build their business footprint in the U.S., which may qualify them for a tariff exemption... Full

China Largely Dodges Trump's Pharma Tariffs

(9/28, Jessica Sier, Financial Review) ...Chinese companies will emerge largely unscathed from US President Donald Trump's 100 per cent tariff on patented drugs, according to analysts, who say the country's pharmaceutical industry is focused on biotechnology partnerships and domestic retail sales..."China's pharma companies are advancing in research rather than manufacturing," Alan Zhang, portfolio manager at Ox Capital, said. "The tariffs will impact some of the traditional pharma but should be limited. However, it is likely to be inflationary to the US."... Sub. Req’d

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