Wednesday, March 11, 2026

 

 

Lutnick Discusses Drug Prices in Meeting With Eli Lilly CEO

(3/10, Reuters) ...U.S. Commerce Secretary Howard Lutnick met with Eli Lilly CEO David Ricks on Tuesday to discuss the Trump administration's "most-favored nation" deals to reduce prescription drug prices, the U.S. Commerce Department said in a statement... Sub. Req’d

 

Lundbeck CEO Talks Drug Pricing, Protecting Biotech and How Europe Needs to 'Step Up'

(3/10, Zachary Brennan, Endpoints News) ...While noting that Lundbeck won't be forging its own MFN deal with the White House, he said the company could end up participating in one of the CMS pilots — GLOBE and GUARD. Unlike current MFN participants, whose interests were "mostly related to alleviating tariffs," [CEO Charl] van Zyl said he has a different motivation: "Ensuring that Europe understands the value of life sciences. We need to see Europe step up... Sub. Req’d

 

Trump's Drug Cost Push Helps Astellas Win Higher Price in Japan

(3/10, Ashleigh Furlong, Kanoko Matsuyama, Bloomberg Law) ...The Tokyo-based drugmaker, in a submission to Japanese officials, argued that domestic drug costs could influence US pricing under Trump's proposed most-favored nation scheme. Following this, Astellas won a reimbursement level for Izervay that was more generous than typical outcomes, Chief Executive Officer Naoki Okamura said in an interview. "We leveraged this most favored nation dialog," Okamura said. He believes Izervay got "relatively reasonable pricing" in Japan... Sub. Req’d

 

Trump Administration Urged to Take on China's ‘Pharma Death Grip'

(3/11, Barnini Chakraborty, Washington Examiner) ...[China specialist Gordon Chang] believes several policy tools could help rebuild domestic capacity and is expected to testify on the options. One would be for the federal government to use its enormous purchasing power to prioritize American-made drugs. Agencies such as the Department of War, the Department of Veterans Affairs, and Medicare could be directed to favor domestically produced medicines whenever possible, and to source from trusted allied nations when the U.S. supply is unavailable... Full

 

Chairman Scott, Ranking Member Gillibrand Set Hearing to Expose China's Control of America's Drug Supply

(3/10, United States Senate Special Committee on Aging) ...On Wednesday, March 11, Chairman Rick Scott and Ranking Member Kirsten Gillibrand will convene a hearing entitled "Foreign Dependence: How China Captured America's Drug Supply." This hearing will expose how China is deliberately pursuing global dominance in pharmaceutical manufacturing through state-directed industrial policy, and how U.S. trade, regulatory, and procurement decisions contribute to the erosion of America's domestic production capacity... Full

 

US Medicare Proposes Buy American Rx Incentives, But What Is A ‘Domestic' Medicine?

(3/10, Michael McCaughan, Pink Sheet) ...In an advance notice of proposed rulemaking released recently, CMS asked for input on the idea of a "Secure American Medical Supplies" designation for hospitals relying on domestic sources. The hospitals would be eligible for enhanced payments reflecting the expected higher cost of US-made products... Global Sub. Full

 

API Innovation Center Highlights Fragility in U.S. Drug Supply Chain in New White Paper

(3/10, API Innovation Center) ...The API Innovation Center (APIIC), a nonprofit dedicated to strengthening national health security through U.S. generic pharmaceutical manufacturing and public-private collaboration, today released its 2026 White Paper, From Fragility to Resilience: Aligning Investment and Purchasing to Secure America's Drug Supply Chain, outlining a policy roadmap to secure the domestic generic drug supply chain... Full

 

Trump Ends Biden's Drug Price Nightmare - Americans Get Real Relief With TrumpRx

(3/11, Nicole Saphier, Fox News) ...These policies represent an important shift toward putting patients, not middlemen, first. It's a strong and necessary start, but sustaining this momentum by increasing competition and expanding access will be critical to finally bringing lasting relief to Americans... Full

 

US Senator Investigates FDA Over Rare-Disease Drug Denials

(3/10, Robert Langreth, Gerry Smith, Rachel Cohrs Zhang, Bloomberg) ...Wisconsin Sen. Ron Johnson said he's seeking the FDA's written denials to drugmakers, known as complete response letters. He plans to write letters to the agency asking why it denied certain drugs. He said he's also considering having top FDA officials, including Commissioner Marty Makary, testify before the Senate's Permanent Subcommittee on Investigations that he chairs... Sub. Req’d

 

AAM and Biosimilars Council Laud FDA Plan to Streamline Biosimilar Medicines Development and Lower Costs for Patients

(3/10, AAM) ...This updated guidance in conjunction with recent FDA actions, such as the October 2025 guidance on limiting the need for comparative efficacy studies, is a clear sign that FDA's thinking continues to evolve in a positive direction. This guidance from the FDA will help biosimilar developers enter the market faster, accelerating access to lower cost treatment options for America's patients... Full

 

The Biosimilars Forum Commends Commissioner Makary and the FDA for Streamlining Development of Lower-Cost Biosimilars

(3/10, Biosimilars Forum) ..."The Biosimilars Forum commends the FDA and Commissioner Makary for taking steps to streamline unnecessary three-way clinical pharmacokinetic (PK) testing when scientifically justified. This change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs, according to the FDA. Commission Makary's leadership will help bring more biosimilars to the market more quickly, ensure those biosimilars can reach patients, and lower everyday healthcare costs for Americans."... Full

 

6-4-2 Blastoff! FDA's New NDC Format Coming...in 2033

(3/11, Kalie E. Richardson, Karla L. Palmer, Dara Katcher Levy, FDA Law Blog) ...Although a change to the NDC format is necessary (given the exhaustion of 5-digit labeler codes), and the move to a consistent 12-digit NDC format should simplify many issues for industry, this transition, as stated above, will require significant preparation by industry and considerable resources... Full

 

PCMA: Governor Sherrill's Budget Address Misses Mark on High Drug Costs

(3/10, PCMA) ..."Contrary to Governor Sherrill's assertion, PBMs are working every day to lower prescription drug costs for New Jersey patients. PBMs save an average of $1,154 per person annually for the 8.3 million New Jerseyans they serve and over the next ten years, that work will save the state more than $37 billion."... Full

 

 

Neurocrine Biosciences to Present at the Stifel 2026 Virtual CNS Forum

(3/11, Neurocrine Biosciences, Inc.) ...Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that members of the management team will participate at the Stifel 2026 Virtual CNS Forum at 4:30 PM EST on March 17, 2026... Full

 

Skyhawk Therapeutics Appoints Aaron Deves as Chief Commercial Officer to Lead Commercialization of SKY-0515 for Huntington's Disease

(3/10, Skyhawk Therapeutics) ...Skyhawk Therapeutics...announces the appointment of Aaron Deves as Chief Commercial Officer. Mr. Deves brings more than 30 years of experience commercializing therapies for neurological disorders, including for chorea associated with Huntington's disease (HD) with AUSTEDO®. SKY-0515 is Skyhawk's lead program and is being developed as a potential disease-modifying therapy for Huntington's disease... Full

 

How Migraine Trials Can Better Capture Patient-Centered Outcomes: Amaal Starling, MD, FAHS, FAAN

(3/10, Amaal J. Starling, MD, NeurologyLive) ...Migraine clinical trials have traditionally relied on standardized endpoints such as reductions in monthly headache days (MHDs) to measure treatment benefit. While these metrics remain central to regulatory evaluation, they may not fully capture the broader burden patients experience, including symptoms like photophobia, nausea, and cognitive dysfunction that affect daily functioning... Full

 

 

Biocon And Cipla Build On Teva's First Generic Saxenda Launch

(3/11, Dean Rudge, Generics Bulletin) ...Biocon and Cipla have moved to expand the small but emerging US market for generic versions of Novo Nordisk's Saxenda (liraglutide), with the firms announcing fresh regulatory and commercial milestones that add to the momentum created by Teva's earlier first-to-market launch. Biocon said it had secured US Food and Drug Administration approval for its liraglutide injection 18mg/3ml (6mg/ml) pre-filled pen referencing Saxenda for chronic weight management... Global Sub. Full

 

FDA Finds Little Evidence That the Generic Drug Leucovorin Can Help People With Autism

(3/10, Matthew Perrone, Associated Press) ...The [FDA] on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration officials that the drug showed great promise for people with autism...[S]enior FDA officials told reporters Monday that their review was narrowed to focus on the strongest evidence, which only supported the drug's use by patients with the rare mutation that impacts folate levels in the brain... Full

 

'The Future Is Bright For Physician Adoption And Patient Access' - Cardinal On US Biosimilar Trends

(3/10, Dave Wallace, Generics Bulletin) ...Talking to Generics Bulletin for an exclusive Q&A as Cardinal Health publishes its latest annual biosimilars report, [Dracey Poore - director of biosimilars at Cardinal Health] also discusses the impact of the latest streamlining guidance on market sustainability, as well as talking about lessons learned from biologic losses of exclusivity so far, and touching on the particular significance of biosimilars in the oncology sphere... Sub. Req'd

 

Shilpa Biologicals To Enter Latin America With SteinCares Biosimilars Pact

(3/10, Dean Rudge, Generics Bulletin) ...Under the terms of the deal, SteinCares will be responsible for registering, marketing and distributing the product throughout Latin America, while Shilpa Biologicals will complete development and handle commercial manufacturing from its facility in Dharwad, India... Global Sub. Full

 

Actelion Settles Tracleer Antitrust Case For $65M Ahead Of Trial

(3/10, Dean Rudge, Generics Bulletin) ...Johnson & Johnson's Actelion Pharmaceuticals has agreed to pay $65m to settle US antitrust claims accusing the companies of blocking generic competition to its pulmonary arterial hypertension treatment Tracleer (bosentan), according to court filings seeking preliminary approval of the agreement... Global Sub. Full

 

Astellas Wins Patent Ruling Blocking Ascent's Myrbetriq Copies

(3/10, Christopher Yasiejko, Bloomberg Law) ...Copies of Astellas Pharma Inc.'s Myrbetriq ER proposed by Ascent Pharmaceuticals Inc. infringe four patents for the overactive-bladder drug, a federal judge ruled, delaying their launch until 2030. Ascent's generic tablets of mirabegron, the drug's active ingredient, infringe US Patent Nos. 10,842,780, 11,707,451, 12,059,409 and 12,097,189, according to Judge Joseph F. Bataillon's opinion docketed Monday in the US District Court for the District of Delaware... Sub. Req'd

 

 

Bright Spots in Tackling AMRs, But Drug-Resistance Outpaces Pharma Industry Efforts: Report

(3/10, PT Jyothi Datta, The Hindu Business Line) ...Drug resistance is outpacing industry-wide efforts, says Netherlands-based Access to Medicine Foundation in its latest Antimicrobial Resistance (AMR) Benchmark report, even as it identified seven innovative late-stage projects that targetted certain drug-resistant pathogens...India's Aurobindo found a mention in the report, along with GSK, Hikma, Sandoz and Teva for their effort in registering child-friendly formulations more widely than peers, though countries in sub-Saharan Africa remain overlooked, it added... Full

 

Novo Nordisk's US Headquarters under Fire in Latest FDA Warning Letter

(3/11, Frasier Kansteiner, Fierce Pharma) ...Amid the company's efforts to resolve issues raised during an FDA inspection early last year, Novo Nordisk's operating base in Plainsboro, New Jersey—already the recipient of a recent Form 483—has been hit with the more severe consequence of a Warning Letter... Full

 

Patients Want Price Transparency, E-Commerce Experience From Pharma DTP Platforms: Survey

(3/10, Andrea Park, Fierce Pharma) ...Among the most popular reasons for the dropoff were that patients either didn't know how much a drug would cost or that they chose not to fill a prescription based on price. Meanwhile, about a third of respondents said they prefer a hybrid or fully online experience to access their medications, and around the same amount said they won't move forward with filling a prescription if they can't access it through their preferred experience... Full

 

 

Public Spending on Prescriptions Rises to $20.1-Billion in 2024 as Use of Ozempic Grows

(3/10, Kelly Grant, The Globe and Mail) ...The CIHI analysis shows that governments in Canada spent $794.1-million on Ozempic, also known as semaglutide, in 2024. That's up from $130.5-million in 2020, when far fewer Canadians took the medication... Sub. Req'd

 

Ottawa Should Prioritize Reviews and Procurement of Canadian-Made Drugs, Manufacturers Say

(3/10, Chris Hannay, The Globe and Mail) ...Canadian-made medication should get priority in government procurement and during Health Canada reviews, according to manufacturers who are urging members of Parliament to boost domestic pharmaceutical sovereignty... Jeff Watson, chief executive officer of generics giant Apotex Inc., said the actions of the Trump administration and other jurisdictions are driving a major shift in how drugs are being made... Sub. Req'd

 

Public Citizen To Push Compulsory Licensing If Pfizer Withholds Drugs From France

(3/10, Gabrielle Wanneh, Inside Health Policy) ...Consumer group Public Citizen says it will encourage compulsory licensing of generic drugs if Pfizer follows through on a threat it made in January to withhold its drugs from France unless the European country pays more for the company's medicines... Sub. Req’d

 

EMA Outlines Methods for Evaluating Supply Chain Vulnerabilities

(3/10, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. The agency said its new framework is intended to prevent potential shortages of drugs considered especially important on the Union List of Critical Medicines (ULCM)... Full

 

Compliance Countdown Begins In EU For Revised Pharmacovigilance Guidance

(3/10, Neena Brizmohun, Pink Sheet) ...The updated guidance, ICH E2D(R1), aims to clarify the management of safety data derived from solicited sources such as social media, market research programs, and patient support programs, according to the European Medicines Agency, which this month published instructions on how to implement the revised guidance... Global Sub. Full

 

Health Ministry Cautious on Timing of Generic Drug Price Cuts, Reaffirms 'No-Exception' Principle

(3/11, Kwak Sung-Sun, Korea Biomedical Review) ...[T]he ministry took a cautious stance on potentially postponing the implementation of the revised plan, leaving the possibility open...[Kim Yeon-sook, director of the Insurance and Pharmaceutical Division at the Ministry of Health and Welfare] explained that more input from the industry, experts, and civil society needs to be gathered before a decision is finalized. She noted that a subcommittee meeting will further discuss the plan and consider input from various stakeholders, including the emergency task force of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)... Full

 

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