Tuesday, March 24, 2026

 

  U.S. Policy & Regulatory News

 

White House Pitches Pharma on Pricing Draft

(3/24, Megan R. Wilson, The Washington Post) ...The Trump administration cut MFN deals, which remain confidential, with 16 massive pharmaceutical manufacturers. Despite striking individual pricing agreements, most drugmakers haven't rallied behind making them permanent. In fact, several people tell me certain companies believed making those deals would mean avoiding legislation altogether, leaving them frustrated by the current push to codify them...Multiple people familiar with the meetings say companies were shown actual legislative text that would implement Trump's MFN drug pricing priorities previously outlined in letters sent to drugmakers last year... Sub. Req’d

 

The Potential Loophole in Trump's Plan to Get Other Countries to Pay More for Drugs

(3/24, John Wilkerson, STAT+) ...The official, Chris Klomp, said last week that the most-favored nation deals aim to increase the prices of new drugs in peer countries, not lower U.S. prices. But by the time companies launch those drugs abroad, the deals might be over and Trump might be out of office. "We told the manufacturers, price wherever you want," Klomp said during STAT's Breakthrough Summit East in New York. "That's fine, just don't undercut us in another wealthy country."... Sub. Req’d

 

Experts: Tariffs Won't Be Enough To Cut Drug Supply Ties With China

(3/23, Inside Health Policy) ..."China is now actively defending its market position by pricing critical antibiotic precursors below the cost at which India, the world's lowest-cost producer of generic drugs, can manufacture them," USAntibiotics President Patrick Cashman said in his written testimony to the committee. "Tariffs alone cannot break this monopoly: a sole supplier facing no competition will raise prices rather than relocate, and the returns on new domestic production facilities are insufficient to attract private capital without government support."... Sub. Req’d

 

Opinion: Japan's Drug Prices Are Creating Problems for Washington and Tokyo Alike

(3/24, John Stanford, BioSpace) ...As they continue their conversation in the weeks and months to come, the president and the prime minister have an opportunity to boost another industry that's critically important for both nations. If they work together to implement drug pricing reforms in Japan, it would help revive the island nation's stagnating life sciences sector, strengthen America's lead in global drug development and deepen an alliance rooted in shared prosperity... Full

 

As TrumpRx Scam Does Virtually Nothing, Big Pharma Jacks Up Prices on Cancer Drugs

(3/23, Brad Reed, Common Dreams) ...The analysis, conducted by Patients for Affordable Drugs, found that pharmaceutical companies increased prices on 64 oncology drugs in the first weeks of 2026, with the vast majority of price hikes coming in above the rate of inflation... Full

 

When Voters Worry About ‘Affordability,' Many Point to Health Care

(3/24, Ruth Igielnik and Kate Zernike, The New York Times) ...Trump has said Republicans can work health care costs to their advantage, by painting insurance and pharmaceutical companies as greedy villains... Sub. Req’d

 

Drugmakers Seek Review of Intervention in HHS Rebate Pilot Suit

(3/23, Nyah Phengsitthy, Bloomberg Law) ...The request from AbbVie Inc., AstraZeneca Plc, Boehringer Ingelheim Pharmaceuticals Inc., Novo Nordisk A/S, and the Pharmaceutical Research and Manufacturers of America asks the US Court of Appeals for the First Circuit to hear why they should have intervened in a case brought by the American Hospital Association against the Department of Health and Human Services' 340B Rebate Model Pilot Program... Sub. Req’d

 

GDUFA IV: Industry Questions Proposed Four-Month pOAI Goal Extension

(3/23, Derrick Gingery, Pink Sheet) ...Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review... Global Sub. Full

 

US FDA Seeks Higher Quality Responses To Form 483 Inspection Findings

(3/23, Sue Sutter, Pink Sheet) ...A drug manufacturer's response to an FDA Form 483 list of inspection observations should include a patient- and product-focused risk assessment of the findings, including possible safety, quality and purity impacts on potentially affected drugs, the US Food and Drug Administration said in a new draft guidance... Global Sub. Full

 

FDA's Biosimilar Achievement

(3/23, Gary Andres, RealClear Health) ...Critics argue that faster approvals could compromise safety. That concern misunderstands what the FDA is doing. The announced recommendations do not weaken scientific standards. They remove unnecessary steps that add time and cost without improving patient protection. Modern analytical testing and clinical data using global products already provide powerful evidence of biosimilarity... Full

 

FDA Posts Photos of Indian Drugmaking Facility Cited in Warning Letter

(3/24, Zachary Brennan, Endpoints News) ...The photographs are the latest sign that FDA Commissioner Marty Makary is taking a tougher stance on foreign drug manufacturers...When asked if the FDA plans to publish more photographs alongside warning letters in the future, HHS spokesman Andrew Nixon told Endpoints News, "We do not discuss our enforcement and compliance strategy."... Sub. Req’d

 

Virginia's Drug Price Caps May Do More Harm Than Good

(3/23, Satya Marar & Archita Aggarwal, RealClear Health) ...Price controls may deliver quick political wins, but they come with hidden costs. By extending federal drug price caps into state policy, SB271 will weaken incentives for medical innovation. This will discourage investment and reduce access to next generation life-saving treatments. Virginia should think carefully before expanding a federal policy that promises short-term gain, but will deliver long-term pain... Full

 

Maryland Panel Likely to Set Upper Payment Limits on Two Drugs Next Month

(3/23, Scott Maucione, WYPR) ...During a meeting next month, the board could put its first limits on Jardiance and Farxiga for state and local government plans, setting a firm boundary with drug companies on how much Maryland will pay for the drugs based on the maximum fair price...The board will look at Trulicity and Ozempic next... Full

 

Illinois Debate On Prescription Drug Discount Program Intensifies

(3/23, Judith Ruiz-Branch, KRCU Public Radio) ...Hospital systems relying on the 340B Drug Pricing Program are calling for reforms and increased funding, while opponents argue it has been exploited for corporate profit. Christina Carney, CEO of Shawnee Health, said restrictions implemented over time by drugmakers are hindering access to some medications. She stressed that funding limitations also prevent organizations like hers from providing critical care to at-risk populations and disproportionately affect rural communities... Full

 

'This Year Is A Pivot To Offense' - AAM's Murphy Steps Up Lobbying Efforts In US

(3/23, Dave Wallace, Generics Bulletin) ...A year ago, the former executive at brand industry associations BIO and PhRMA had promised "a much more aggressive communications approach" from the AAM under his leadership. And speaking to other AAM executives over the course of 2026's conference, multiple individuals credit Murphy for his role in revitalizing the association over the past year and allowing it to gain meaningful traction with policymakers, especially in interactions on Capitol Hill. But for Murphy, this was only the start... Full

 

  Innovative News

 

Sanofi Returns to T-cell Engager Territory with $1.2b Pact for Phase 1-Stage Trispecific

(3/23, James Waldron, Fierce Biotech) ...The California biotech took the TCE, dubbed KT501, into a first-in-human study of patients with rheumatoid arthritis earlier this month, according to the federal trials database. Sanofi is hoping that the candidate, which is designed to bind CD3, CD19 and BCMA, will be of use against a wide range of B-cell-mediated autoimmune diseases... Full

 

Merck Partners with Flagship's 'Somatic Genomics' Startup to Search for Clues to IBD

(3/24, Ryan Cross, Endpoints News) ...The partnership will identify new drug targets for inflammatory bowel disease. It's the third pharma deal Quotient has landed since it was founded by Flagship Pioneering in 2022. It comes with a $20 million upfront payment from Merck and it's eligible to receive milestones worth as much as $2.2 billion... Sub. Req’d

 

BMS Wins Dual Immunotherapy-First Approvals in Classical Hodgkin Lymphoma

(3/23, Catherine Eckford, European Pharmaceutical Review) ...[T]he FDA has authorised the monoclonal antibody alongside doxorubicin, vinblastine and dacarbazine (AVD) in individuals 12 years old and over with previously untreated, Stage III or IV cHL. It represents the first immunotherapy combination approved for patients with this indication... Full

 

  Generics & Biosimilars News

 

Henlius Accelerates Global Push In Checkpoint Biosimilars

(3/23, Dean Rudge, Generics Bulletin) ...Shanghai Henlius Biotech has secured another early-stage regulatory milestone for its checkpoint inhibitor portfolio, with China's regulator approving a Phase I clinical trial for its nivolumab biosimilar HLX18, while the candidate is already advancing in the US... Global Sub. Full

 

  Industry News

 

Report Links ADHD Drug Shortage in US to Global Supply Chain Disruptions

(3/23, Laine Bergeson, CIDRAP) ...The supply chain disruption originated in the European Union, according to the analysis, and supply chain vulnerability likely arose from the degree of concentration among facilities producing amphetamines for the US market. "One study found that 33.7% of generic APIs [active pharmaceutical ingredients] for the US market in 2020 and 2021 were produced by a single facility, and another 30.4% by only 2 or 3 facilities," they write... Full

 

Novartis to Invest $480M in China Following AstraZeneca and Lilly Pledges

(3/23, Anna Brown, Endpoints News) ...The company will pour 1.5 billion yuan ($218 million) into expanding its tablets and capsules site in the Changping district of Beijing, according to a Sunday release in Chinese. Around 1.8 billion yuan ($262 million) will go to launching the "second phase" of the drugmaker's China headquarters and R&D facility in Shanghai. It wasn't clear what that phase entailed, and Novartis didn't immediately comment before publication... Sub. Req’d

 

Gilead Buys Autoimmune Disease Biotech Ouro for $2.2bn

(3/24, Phil Taylor, PharmaPhorum) ...Gilead Sciences has built up its position in the hot area of T-cell engagers (TCEs) for autoimmune diseases with an agreement to buy Ouro Medicines for up to $2.2 billion. The front-loaded deal, which includes an upfront cash payment of nearly $1.7 billion and $500 million in potential achievement-related payments, comes just over a year after Ouro emerged onto the scene with $120 million in first-round funding and a plan to develop bispecific antibody-based TCE therapies for autoimmune diseases... Full

 

Celltrion to Invest 1.2 Tln Won in S. Korea to Meet Rising Demand

(3/24, Kim Boram, Yonhap News) ...Celltrion Inc., a major biopharmaceutical company, said Tuesday it will invest 1.2 trillion won (US$805.6 million) in South Korea to expand production facilities, with additional investment planned overseas, to meet rising global demand...The infrastructure expansion will be carried out in phases through 2030 at its Songdo facilities in Incheon, west of Seoul, as well as at overseas production hubs... Full

 

Egis Pharmaceuticals Begins Major Capacity Expansion in Körmend

(3/23, Hungary Today) ...Work is underway on Egis Pharmaceuticals' capacity expansion project in Körmend (western Hungary), which will create new jobs in the city, Minister of Foreign Affairs and Trade Péter Szijjártó wrote on Facebook on Monday... Full

 

BMS, Insitro Add Two More Targets to AI-Powered ALS Partnership

(3/23, Elizabeth S. Eaton, FirstWord PHARMA) ...insitro has unearthed two more therapeutic targets for amyotrophic lateral sclerosis (ALS) using its AI-enabled platform, Virtual Human. The latest discovery expands the biotech's collaboration with Bristol Myers Squibb as the pair move forward drug development efforts against the newly nominated targets, triggering a $10-million milestone payment... Full

 

Insilico Medicine Launches PandaClaw: Empowering Biologists with Agentic AI for Therapeutic Discovery

(3/23, Insilico Medicine) ...By automating complex real-time analyses, the tool enables researchers to seamlessly discover novel targets, identify new indications, and build disease hypotheses through an intuitive, intelligent natural language interface, thereby accelerating translational medical research... Full

 

The AI Push in Health Care Is Deepening Medicine's Trust Crisis

(3/23, Oni Blackstock, STAT) ...The data show that AI's rapid adoption in health care is worsening the mistrust that Americans already have about our health care system. A February 2025 study that surveyed more than 2,000 Americans found that 66% reported low trust in their health care system to use AI responsibly, and 58% reported that their health care system would ensure an AI tool would not harm them... Full

 

Stryker Continues to Bring Hacked Systems Back Online after Patients Delay Surgeries

(3/23, Conor Hale, Fierce Biotech) ...Stryker continues to dig itself out of the hole left by the global cyberattack it suffered nearly two weeks ago, saying its medical device manufacturing capacity is "ramping quickly as critical lines and plants are brought back online, prioritizing patient needs." The company also said in its update this morning that it is still working to restore its internal electronic ordering and shipping processes... Full

 

  International News

 

India Drug Regulator Tightens Surveillance Against Unauthorised Weight-Loss Drug Sales

(3/24, Reuters) ...The Central Drugs Standard Control Organization (CDSCO) conducted inspections at 49 entities across the country, including drug wholesalers, retailers, and slimming clinics, the statement said. It focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing, the statement said, adding that notices were sent to defaulting entities... Sub. Req’d

 

Mint Explainer: Can India Become a Global Hub for Biologic Drugs? Here's the Plan

(3/24, Priyanka Sharma, Mint) ...With blockbuster drug patents set to expire globally, Mint explains how the country plans to tap a $300 billion biologics opportunity. To handle the work of growing medicines from living cells, India plans to build three new national research institutes and upgrade seven existing ones, including major centres in Mohali, Ahmedabad, Hyderabad, and Kolkata... Sub. Req’d

 

China's Out-Licensing Of Innovative Assets Seen As ‘Rational' Policy-Driven Choice

(3/24, Xu Hu, Pink Sheet) ...The acceleration of commercial health insurance was included in national development plans for 2026 released by the Chinese government in the recent "Two Sessions" policy meetings, and appears key for the next generation of innovative drugs to achieve domestic success... Global Sub. Full

 

Korea's Generic Drug Spending Tops 12 Trillion Won, Up 44% in Three Years

(3/24, Park Ji-soo, Seoul Economic Daily) ...South Korea's spending on generic drugs surged approximately 44% over the past three years, exceeding 12 trillion won ($8.8 billion), according to data released by the National Health Insurance Service (NHIS) on Wednesday. The continued expansion of generics' share is affecting national health insurance finances and overall drug pricing policy, analysts say... Full

 

War Threatens Generic Meds Supply

(3/24, Pharmacy Daily) ...[Infios chief supply chain strategist Steve Blough] predicted the effects will be felt in Australia in four to six weeks, starting with high-volume generic medicines including treatment for diabetes, hypertension and cholesterol, as well as antibiotics. "Certain temperature-sensitive therapies, including some oncology treatments, could also face delays if refrigerated transport capacity becomes constrained," Blough said... Full

 

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