Thursday, October 9, 2025

Teva Among Winners As EU Court Voids Biogen's Tecfidera Exclusivity Extension

(10/9, Dean Rudge, Generics Bulletin) ...The decision is a win for generics manufacturers including Teva, Zentiva, and Polpharma, which had challenged the Commission's 2023 move to extend Biogen's exclusivity. It confirms that Tecfidera's market protection expired in February 2024, clearing the way for rival dimethyl fumarate products to return to the European market. It now remains to be seen whether the firms affected will or can apply for damages, given the exclusivity period has already lapsed for the branded treatment for relapsing remitting multiple sclerosis... Global Sub. Full

Trump Excludes Generics From Big Pharma Tariff Plan

(10/8, Gavin Bade, The Wall Street Journal) ..."The administration is not actively discussing imposing Section 232 tariffs against generic pharmaceuticals," White House spokesman Kush Desai said in a statement. A spokesman for the Commerce Department, which is handling the tariff investigation, similarly said that the 232 investigation wouldn't result in tariffs on generics. The move, which isn't final and could change in the coming weeks, comes after months of debate within the administration over how to bring manufacturing of generic drugs back to the U.S. and what role tariffs should play in that effort...The decision not to impose tariffs on generics represents a major scaling-back of the scope of the Commerce Department's tariff investigation into pharmaceuticals... Sub. Req’d

White House Shelves Tariffs On Generic Drugs, Sparing Bitter Pill for American Patients and Indian Pharma Companies

(10/9, Chidanand Rajghatta, The Times Of India) ...As importantly, it has also calmed millions of Americans who were on tenterhooks because they depend on imported generics, mainly from India, to manage health issues ranging from hypertension to depression, ulcers to high cholesterol. Sometimes dubbed a "pharmacy to the world," India is the largest single source of generic prescription drugs for the US market, far exceeding domestic producers (30% share) and other foreign suppliers... Full

Pharma Shares Rally After Report Hints Tariff Relief for Generics

(10/9, Sonu Vivek, India Today) ...The report said that the move to exclude generic medicines from tariffs is not yet final but is being considered seriously. It also added that the decision could change in the coming weeks depending on ongoing internal discussions within the administration..."When we talk about generics, it's a different supply chain from name-brand drugs," said US Trade Representative Jamieson Greer at the Economic Club of New York. "Right now, we're considering the best way to deploy economic tools with respect to generics. A lot of that is coming in tariff-free." The Wall Street Journal report said that the Trump administration is unlikely to move ahead with tariffs on generic drugs and their components after months of internal debate... Full

Tariffs On Generic Drugs Were Always Unlikely, Exemption Makes Sense for All: Pharma Analyst

(10/9, Ekta Batra and Mangalam Maloo, CNBC TV-18) ...Speaking to CNBC-TV18, Vishal Manchanda, Pharma Analyst at Systematix Group, said the decision was in line with expectations and logical from both a policy and business standpoint. "The probability of tariffs being imposed on generic pharmaceuticals was low, and it's panning out along the same lines—generic pharmaceuticals have been exempted," he said. Manchanda added that imposing such tariffs would have hurt both American consumers and Indian manufacturers... Full

The Pharmaceutical Industry isn't Yet in the Clear

(10/9, Caitlin Owens, Axios) ...f anything, the Pfizer deal has been greeted with a sense of relief: If it and future deals satisfy Trump's thirst to go after pharma, they would be a big win compared with steep new tariffs on the sector or adding a most-favored-nation requirement to forthcoming Medicare drug price negotiations. Yes, but: That perspective may be shortsighted. Other observers predict the last few weeks have simply been the warmup act — and that the administration is ready to extract more concessions from the companies... Full

What Pfizer's Deal With Donald Trump Means for Global Drug Pricing

(10/9, Patrick Temple-West and Hannah Kuchler, Financial Times) ...Political worries have hung over the sector for most of the year and share prices have underperformed. But Tim Opler, a healthcare specialist at investment bank Stifel, said the top-30 life sciences companies gained $440bn in value last week, as "it became apparent that Trump's tariff and [pricing] policies were unlikely to impact pharma nearly as badly as feared"... Sub. Req’d

Administration Releases Medicare Drug Price Negotiation Program Final Guidance For 2028

(10/8, Kristi Martin Rachel Sachs, Health Affairs) ...The final guidance for the 2028 cycle of the negotiation program reflects CMS's continued effort to balance statutory requirements with transparency, responsiveness to stakeholder input, and the need to maintain a consistent set of policies for negotiation. While the agency maintained several key policies from prior cycles—such as its qualitative approach to negotiation and its treatment of combination drugs—it also made meaningful changes, particularly in incorporating MA data for Part B and clarifying the treatment of vaccines. As CMS continues its efforts to implement three concurrent negotiation cycles, the 2028 guidance offers important insights into the agency's evolving approach and signals areas for future rulemaking and refinement... Full

Part D Premiums Are Going Up, While Choices Are Going Down

(10/8, Matthew Norawong, PhRMA) ...The Centers for Medicare and Medicaid Services (CMS) recently released their Medicare Advantage and Part D landscape files. These files serve as a comprehensive dataset that lets seniors compare plan options ahead of open enrollment but also show how the Inflation Reduction Act (IRA) continues to disrupt the Part D market. A closer look at the data reveals a disturbing trend: For millions of beneficiaries, premiums are going up, and choices are going down... Full

Senators: Dependence On Foreign Drug Supplies Threatens Security, Health

(10/8, Bridget Erin Craig, UPI) ...The United States has grown dependent on foreign drug supplies, particularly from China and India, causing a national security and public health threat, lawmakers said Wednesday. That was the verdict when senators on the Special Committee on Aging held a hearing titled "Bad Medicine: Closing Loopholes that Kill American Patients" to assess challenges and potential solutions to the country importing 83% of the top-100 generic drugs... Full

Rethinking Manufacturing Quality Oversight for Prescription Drugs

(10/8, Marta E. Wosinska, Brookings) ...In this paper, I propose an alternative but complementary path to enhance U.S. drug quality assurance by requiring every importer to designate a qualified individual—located in the U.S.—who certifies that each batch meets Good Manufacturing Practices (GMP) standards after assessing the firm's compliance, including through additional testing of product. This framework—already established in Europe for drugs and to some extent in the U.S. for certain food imports—raises accountability and increases oversight by adding a second, importer-level layer of verification beyond the manufacturer... Full

Under Trump, Antitrust Regulators May Be More Divestiture Friendly

(10/8, Tim Casey, Pink Sheet) ...Experts at Manatt believe the Trump Administration will continue prioritizing antitrust enforcement in health care, but may be more open to divestiture as a remedy. The FTC and DOJ also likely will continue their hard line stance on collusion in health care. Private equity involvement in health care may be treated differently under the Trump Administration, but "roll-up" strategies likely still will be scrutinized... Global Sub. Full

GSK's Phase III Depemokimab Data to Support FDA Approval

(10/8, The Pharma Letter) ...UK pharma major GSK's clinical data for depemokimab positions the asset for potential Food and Drug Administration approval in asthma and chronic rhinosinusitis, according to reporting by the insights investigative news team at GlobalData...Irena Maragkou, senior healthcare researcher at GlobalData, commented: "Experts say that depemokimab's efficacy is broadly comparable to existing biologics and does not exceed competitors such as Dupixent. However, its ultra-long dosing schedule represents a significant differentiator in a highly competitive market."... Sub. Req’d

Bio-Thera Solutions Announces Expansion of Partnership with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), through Exclusive Commercialization and License Agreement in Canada

(10/9, Bio-Thera) ...Bio-Thera Solutions...today announced an expansion of its partnership with Intas Pharmaceuticals for BAT2506, a proposed golimumab biosimilar, through an exclusive commercialization and license agreement for Canada... Full

Lupin Plans to Build New Pharma Manufacturing Plant in Coral Springs

(10/9, Ruchika Sharma, Medical Dialogues) ...With a projected cumulative investment of $250 million, including research & development, infrastructure and capital expenditures over a five-year period, the new site will have the capacity to accommodate the production of more than 25 critical respiratory medicines, including lifesaving albuterol inhalers for children with asthma and service members at home and overseas... Full

Sanofi Inks Pact With Canadian Tech Company To Bring AI To Preclinical R&D

(10/8, Darren Incorvaia, Fierce Biotech) ...The new deal is part of a broader strategy by Sanofi to adopt AI across its organization, according to the release, including at every stage of R&D. This AI vision also extends to the pharma's investment arm, Sanofi Ventures, which recently announced an investment into AI-powered clinical trial simulation company QuantHealth. That investment came after Sanofi announced it was pumping $625 million more into its venture operation... Full

HealthTap Joins LillyDirect, Bringing Primary Care to Pharma Site

(10/8, Emma Beavins, Fierce Healthcare) ...LillyDirect has been building out its network of independent care providers for a slew of healthcare conditions and specialities, including diabetes, obesity, cancer, dermatology, autoimmune, sleep apnea and migraine. HealthTap will be listed as a provider for treating type 1 and type 2 diabetes on the LillyDirect site. HealthTap CEO Sean Mehra believes Eli Lilly offered them the opportunity to be listed as an independent care provider because of the company's focus on primary care. HealthTap touts its relationship-based primary care focus, saying that 96% of its patients return to the same provider for subsequent visits... Full

Trump Pressure to Hike UK Drug Prices Could Cost NHS Billions, Experts Warn

(10/8, Rebecca Thomas, Independent) ...Health think tank, the Nuffield Trust, urged the government not to give in to the demands of pharmaceutical companies to raise prices, warning that the threshold for spending on new drugs is already too high. It says a new deal will only trigger further increased price demands and make healthcare in the UK more expensive... Full

Olanzapine Prices Continue To Rise In The UK In September

(10/9, Dave Wallace, Generics Bulletin) ...Olanzapine tablets topped our table of the steepest UK generic price rises in September 2025, according to figures provided by WaveData based on UK trade prices to independent pharmacists. Not only did olanzapine 7.5mg tablets in 56-count packs experience the steepest average price increase last month – a 203% jump to £8.96 ($12.03) – but similar rises for multiple strengths of the product meant that it took half of the eight spots in our Biggest Risers table in September, building on multiple treble-digit price rises across several presentations of the antipsychotic that had already been seen in August. And further presentations fell just outside the scope of our table, WaveData revealed... Global Sub. Full

EU Pharma Package: Keep Patients Front & Center In Defining Unmet Medical Need

(10/8, Francesca Bruce, Pink Sheet) ...The patient voice is critical when it comes to defining unmet medical need and producing guidance, according to experts. EU trilogs have begun on the final version of the pharmaceutical package and will determine how unmet medical need is defined. The EMA said it was keen to include patients in its work on unmet medical need... Global Sub. Full

Swiss Drugmakers Face Mixed Fortunes Amid Trump's Tariff Upheaval

(10/8, Aylin Elçi, Swissinfo.ch) ...Pharma giants may escape the worst of the import tariffs threatened by US President Donald Trump as they cut drug prices and commit to invest billions in US manufacturing. But Switzerland's smaller developers face a more uncertain future..."Larger companies have policy teams working on deals, and they do their own negotiations with the US government," an adviser to smaller drug firms told Swissinfo, requesting anonymity to discuss an issue seen as highly sensitive in the industry. "It's still not very clear how small and medium-sized firms will be impacted and the current assumption is that the same rules will apply to all of them."... Full

Irish Pharma Sector Hails €30M Medicines Boost And R&D Tax Credit Increase

(10/9, Brian Maguire, Euractiv) ...Oliver O'Connor, IPHA Chief Executive, said, "Given the current volatile global trading environment, it is imperative that Ireland puts its best foot forward in terms of competitiveness, ensuring we remain an attractive location for FDI and to encourage greater investment in research and development for the future pipeline of innovative medicines." Government ministers hope that the tax credit boost will strengthen Ireland's position as a hub for life sciences investment and a manufacturing base for biopharmaceuticals... Full

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