Tuesday, February 10, 2026
U.S. Policy & Regulatory News
With Scant Data, RFK Jr. Credits Trump Tariffs for Higher Drug Prices in Europe
(2/9, Zachary Brennan, Endpoints News) ...HHS Secretary Robert F. Kennedy, Jr. repeated claims Monday that the threat of tariffs and President Donald Trump's "personal intervention" have pushed European countries to raise drug prices. While that's not backed up by any current European-wide data, pharma execs are expecting prices to rise there... Sub. Req’d
Op-Ed: Health Insurance CEOs Told Congress They Want to Lower Costs. Providers Have Heard This Before—and Congress Has, Too
(2/6, Brandon Edwards, Fierce Healthcare) ...If insurers want to be credible partners in lowering costs, the next step is measurable reduction in administrative burden, fewer delays in care delivery and clearer alignment between cost controls and the real decisions patients are being forced to make... Full
Trump's Drug Pricing Plan Gets Lukewarm Reception
(2/9, Lia DeGroot, Roll Call) ...Sen. Bill Cassidy, R-La., a Senate Finance Committee member who chairs the Health, Education, Labor and Pensions Committee, said he had spoken with White House staff about the proposal. "It has to be codified, right?" Cassidy said. "But there's a lot of details to work out if you even think it's a good idea."... Full
Tuberville Joins CLEAR LABELS Act to Protect American Patients Through Drug Origin Transparency
(2/9, U.S. Senator Tommy Tuberville) ...U.S. Senator Tommy Tuberville (R-AL) joined U.S. Sen. Rick Scott (R-FL) in introducing the Consumers Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act to add country of origin labeling requirements to the United States' prescription drug supply chain... Full
Securing a Healthier Future Through Generic Drugs
(2/10, Sen. Rick Scott, RealClearMarkets) ...The truth is, most of our generic drug supply comes from overseas, produced in underregulated markets and in factories with far less oversight than those in the United States, and the danger of our overreliance on foreign-made medicines and Active Pharmaceutical Ingredients (APIs) from India and Communist China cannot be overstated. Most people don't understand how vulnerable our country's pharmaceutical supply chain is, even though they've experienced it themselves... Full
Import Alert: India Drug Maker Recalls Cholesterol Meds Due To Manufacturing Defects
(2/9, Kenneth Rapoza, Coalition for a Prosperous America) ...One way to protect and expand domestic investment would be implementing a Tariff Rate Quota (TRQ) on generics. This would protect U.S. labs by limiting their import competition, helping to build out a more reliable domestic supply chain, providing the financing and growth math add up for corporate investors and lenders... Full
Faster FDA Reviews Cut Red Tape, But Critics Wonder at What Cost
(2/9, Charles Gorrivan, Bloomberg) ...Even just from a business-planning perspective, critics say the fast-tracked drug-approval pilot program makes it harder for pharma companies and their investors to model and prepare, because there's little clarity in advance if your drug will get expedited... Sub. Req’d
IRA Price Reductions to Have Little Impact on Future Innovation, Analysis Finds
(2/9, Denise Myshko, Managed Healthcare Executive) ...Researchers found that revenues from these negotiated drugs account for just 10% of the companies' total revenue and that these firms remain highly profitable despite price reductions for Medicare patients and are unlikely to impact future investment in innovation. The study was published in January 2026 in Drug Discovery Today... Full
'Bat-Sh*t Crazy': Biopharma Leaders Unload on Regulatory Chaos
(2/10, Tom Randall, Endpoints News) ...Regulatory uncertainty continues to cast a shadow over the industry. An overwhelming 69% of survey respondents said the regulatory environment had deteriorated compared to a year ago — only 7% said it had improved. There was little optimism things would get better in 2026... Sub. Req’d
Generics & Biosimilars News
Sandoz And Former Parent Novartis Hit With Fresh US Generic Price-Fixing Suit
(2/9, Dean Rudge, Generics Bulletin) ...These arrangements, the states contend, allowed manufacturers to maintain higher prices than would have prevailed in a competitive market. "Apparently unsatisfied with the status quo of ‘fair share' and the mere avoidance of price erosion, [conspirator] Teva and its co-conspirators embarked on one of the most egregious and damaging price-fixing conspiracies in the history of the US," plaintiffs allege... Global Sub. Full
India's Lupin Settles US Patent Dispute with Astellas Pharma for $90 Million
(2/10, Reuters) ...Under the agreement, Lupin and its U.S. unit will pay Astellas a $75 million upfront payment and per-unit licensing fees on Mirabegron sales through September 2027, the company said in an exchange filing. In a separate statement, the Japanese drugmaker said the settlement concludes its litigation with Lupin and added that it is reviewing the potential financial impact for the fiscal year ending March 31, 2026... Sub. Req’d
Organon And Henlius Settle US Perjeta Litigation
(2/10, Dave Wallace, Generics Bulletin) ...Under a global license agreement penned in 2022, which saw Henlius receive $73m upfront, US-based Organon holds exclusive commercialization rights for Poherdy – also known by the codename HLX11 – in most markets outside of China, including the US... Global Sub. Full
Drugmakers Fail to Shed Collusion Claims From Walgreens, Kroger
(2/9, Katie Arcieri, Bloomberg Law) ...Judge Jacqueline Scott Corley of the US District Court for the Northern District of California on Feb. 6 denied the pharmaceutical companies' motion to dismiss a "reverse payment" claim from the plaintiffs—Walgreens Boots Alliance Inc., Kroger Co., and Albertsons Cos.—alleging Takeda paid TWi $9.5 million to refrain from launching the generic version of Takeda's Dexilant product until January 2022... Sub. Req’d
Bio-Thera Partners With Avalon Pharma For Keytruda Biosimilar In Middle East
(2/9, Urte Fultinaviciute, Generics Bulletin) ...Under the agreement, Bio-Thera will be responsible for the development, manufacturing, and supply of the biosimilar, codenamed BAT3306...Financial details of the agreement and projected market sales in the region were not disclosed by the pair... Global Sub. Full
Fresenius Kabi, Phlow Ink US Onshoring Alliance to Boost Epinephrine Injection Supply
(2/9, Zoey Becker, Fierce Pharma) ...The collaboration is billed as the "first-ever" end-to-end manufacturing pact of its kind and will see Phlow producing the active pharmaceutical ingredient (API) for the drug, while Fresenius Kabi will be responsible for performing the formulation and production of finished doses for hospitals and clinics... Full
Industry News
Lilly Joins in Vivo CAR-T Sprint with $2.4B Orna Acquisition
(2/9, Kyle LaHucik, Lei Lei Wu, Endpoints News) ...Lilly is snapping up one of the main circular RNA startups, which had launched in 2021 to much fanfare as mRNA therapeutics gained much attention following the advent of the Covid vaccines. Lilly said Orna's circular RNA platform could lead to longer-lasting expression of therapeutic proteins, but the company has yet to prove out its approach in clinical trials... Sub. Req’d
Lilly, Innovent Pen $8.8b Oncology, Immunology Collab That 'Moves Beyond Traditional Licensing'
(2/9, James Waldron, Fierce Biotech) ...The companies didn't disclose the specific targets they have in mind nor how many drugs they expect to eventually be produced under their latest agreement, but, along with the upfront money, Suzhou, China-based Innovent is also in line for heavily backloaded development, regulatory and commercial milestone payments that could reach a combined total of $8.5 billion. Should these drugs make it to market, Innovent will be in line for royalties on sales outside of China... Full
AstraZeneca Forecasts Steady Growth in 2026 on Strong Cancer Drug Demand, Shares Rise
(2/10, Reuters) ..."The momentum across our company is continuing in 2026 and we are looking forward to the results of more than 20 Phase 3 trial readouts this year," Soriot said in a statement. Shares were up 1% in morning trading after earlier rising as much as 2.2% after what Barclays analysts said was a "reassuring" update overall... Full
CVS Tops Quarterly Estimates, Reaffirms Profit Outlook as Turnaround Plan Takes Effect
(2/10, Annika Kim Constantino, CNBC) ..."'24 was a tough year for the company. So '25 righted the ship," CVS CFO Brian Newman said in an interview. CVS, which operates one of the largest pharmacy chains in the U.S., sees full-year profit coming in between $7 to $7.20 per share. That's in line with the $7.17 per share that analysts were expecting, according to LSEG. Newman also said the company is maintaining its 2026 revenue guidance of at least $400 billion... Full
Breckenridge Expands Injectables Portfolio Through Medichem Collaboration
(2/9, Dean Rudge, Generics Bulletin) ...Under the agreement, the partners will focus on providing high-quality, cost-effective treatments for hospital settings, with both firms highlighting a shared emphasis on quality, reliability, and addressing critical patient needs... Global Sub. Full
BMS to Deploy Evinova's AI for Trial Optimisation
(2/9, Gabrielle Mostello, FirstWord PHARMA) ...Evinova's Study Designer is an AI-based platform that supports trial design and optimisation, protocol authoring and downstream system integration through a Unified Study Definitions Model (USDM) data architecture. The company said its Cost Optimizer module delivers cost estimates with more than 97% accuracy, supporting forecasting at multiple stages of development — from early high-level projections to detailed estimates used for investment decisions — while allowing scenario modeling with an in-depth breakdown of key cost drivers... Full
Takeda Taps Iambic's AI Platform in $1.7b-Plus Drug Discovery Deal
(2/9, Elizabeth S. Eaton, FirstWord PHARMA) ...Takeda's tie-up with Iambic will lean on the AI firm's AI drug discovery models to move forward a set of "high-priority" small molecules, details on which remain under wraps. "Iambic's small molecule platform…offers the potential to de-risk candidate selection, improve probability of success, and more quickly advance select programmes from early project start to IND," said Chris Arendt, Takeda's chief scientist and head of research... Full
Zydus Lifesciences Net Profit Rises 2% as Labour-Code Provision, Taxes Weigh on Earnings
(2/9, Viswanath Pilla, Moneycontrol.com) ...Revenue from operations surged 30 percent YoY to Rs.6864.5 crore, driven by strong US generics performance, double-digit growth in India formulations, a sharp jump in consumer wellness revenue due to the consolidation of Comfort Click, and a scale-up in international markets... Full
AstraZeneca Reiterates $80 Billion Revenue Goal for 2030
(2/10, Billy Gray, The Wall Street Journal) ...Chief Executive Officer Pascal Soriot said in a call with reporters on Tuesday that the group's confidence in reaching $80 billion in revenue in 2030 was growing. Some analysts were skeptical of that goal when it was announced two years ago, and meeting it would depend in large part on sustained pipeline success... Sub. Req’d
AstraZeneca CEO Teases Weight-Loss Drug Candidate as Profit Meets Target
(2/10, Steve Goldstein, MarketWatch) ...The company said it's starting a Phase III program on the oral drug elecoglipron after it said obese or overweight participants with at least one comorbidity met the primary endpoint in a Phase IIb trial. "The only thing I would say is that we have a very competitive profile," said CEO Pascal Soriot in a press conference with reporters. AstraZeneca plans to release trial results at the American Diabetes Association conference in June. "We will not unleash all of those investments if we didn't believe in the product, so I can only say we have a product, a whole agent, with a competitive profile."... Full
Novo Nordisk Escalates Fight Against Hims & Hers
(2/9, Peter Loftus, The Wall Street Journal) ...In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hers of violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines... Sub. Req’d
The Weight-Loss Price Wars Are Breaking Big Pharma's Business Model
(2/7, David Wainer, The Wall Street Journal) ...Typically, drug prices climb or plateau until generics arrive years later. That trend should be even stickier in a duopoly. Yet the obesity market has turned traditional pharma economics upside down. As Leerink analyst David Risinger notes, there isn't a comparable precedent for this level of price erosion in the industry's history... Sub. Req’d
Pharma Eyes AI Deals to Stem Lost Revenues From Patent Expirations
(2/9, Frankie Fattorini, Pharmaceutical Technology) ...According to a GlobalData Strategic Intelligence report, the patent cliff between 2024 and 2030 will see the global share of drugs protected under patents fall from 6% to 4%; between 2025 and 2030, an estimated $236bn will be lost in US revenues alone as a result... Full
International News
EU AI Act Could 'Set Back' Benefits Of AI In Drug Development If Applied To R&D
(2/9, Eliza Slawther, Pink Sheet) ...The EU's Artificial Intelligence (AI) Act was formally adopted last year, with many of its provisions expected to apply this year or next. For pharmaceutical and biotech companies, however, ambiguities in the legislative text may raise concerns around how extensively the Act will apply to drug R&D activities... Global Sub. Full
EMA Proposes GMP Update to Eudralex to Address Nitrosamine Impurities
(2/9, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) has proposed expanding Annex 15 of the EU EudraLex to make it mandatory for all chemical and biological active substance (AS) manufacturers in a concept paper. The update is intended to address nitrosamine impurities found during the manufacturing of sartan medications... Full
Made in India, But What's Next? Pharma Stalwarts Debate The Future
(2/10, Jessica Jani, T. Surendar, Mint) ...The panel was unanimous in its view that biopharmaceuticals represent both the biggest opportunity and the biggest risk. Unlike small-molecule generics, biologics demand longer timelines, higher capital, and a tolerance for failure that Indian companies have historically avoided. Not every large firm, Shanghvi cautioned, will-or should-make that leap... Full
Indian Pharma Must Move Beyond Generics to Credible Innovation, Say Industry Leaders
(2/9, Bhupendra Paintola, CNBC-TV18) ...At a panel discussion on the sidelines of the book launch Made In India: The Story of Desh Bandhu Gupta, Lupin and Indian Pharma by Manish Sabharwal, some of the industry's most influential voices reflected on why innovation continues to be Indian pharma's toughest frontier and what must change over the next decade... Full
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