Monday, March 30, 2026

 

 

In Private Meetings, White House Works to Win Pharma Companies' Support for Drug Pricing Bill

(3/27, Daniel Payne, STAT+) ...The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to people familiar with the meetings. The legislative text, according to a White House official, closely follows the outlines of the voluntary deals the administration made with pharma companies. The draft includes a policy that would allow drugs purchased in cash to count toward a patient's deductible... Sub. Req'd

 

Pharmaceutical Supply Chains Get Tangled in War With Iran

(3/29, Joseph Choi, The Hill) ..."Much larger impact is disruption of airspace and waterway trade routes - tough to quantify but we know a high volume of ingredients from India need to go west to Europe for final manufacturing. Logically that supply chain is vulnerable," the USP noted...[Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists] called this potential pressure on generic drug imports "almost an indirect tariff."... Full

 

GOP Weighs Health Care Moves to Pay for Iran War

(3/30, Peter Sullivan, Axios) ..Scalise deflected when asked last week about including most-favored nation. "Right now, the committee hasn't moved anything," he said, pivoting to say that the House Energy and Commerce Committee is working on a "really important price transparency bill."... Full

 

Top Trump Health Official Describes 'War' With China Over Biotech

(3/27, Max Bayer, Endpoints News) ...John Stanford, who helped organize this week's meeting between investors and the commission as the executive director of Incubate, told Endpoints he believes pricing should be a part of the discussion. "How can policymakers who are championing national security recognize that [most favored nation] or other price control proposals undermine the goals that they're working on with the commission?" Stanford said. "We can't have it both ways."... Sub. Req'd

 

CAP Says TrumpRx May Hike Costs; CMS Official Emphasizes Transparency Over Discounts

(3/27, Maaisha Osman, Inside Health Policy) ...CAP further finds that TrumpRx primarily repackages existing discounts rather than creating new ones, with limited net benefit for patients once existing savings are taken into account. The report says the platform is unlikely to meaningfully improve affordability for most insured Americans, who already access lower negotiated prices through their health plans... Sub. Req'd

 

How to Navigate the Maze of Drug Discounts to Get the Best Price

(3/29, Sydney Lupkin, NPR) ..."The prices vary a lot and they can vary over time. And so it's not clear where you go first," [Ben Rome, an internist and drug policy researcher at Brigham and Women's Hospital in Boston,] says. "Where's the cheapest option for you for this medicine now? TrumpRx is in the mix. Will that be the least expensive option? Maybe in some cases, yes. Maybe in other cases, no."... Full

 

Prescription Drug Pricing Needs to Change, Panelists Say

(3/27, Susan Rupe, Insurance Newsnet) ...The IRA "created an environment where we know what the net prices of drugs are," [Robert Popovian, founder of Conquest Advisors and senior health policy visiting fellow at Pioneer Institute,] said. "It will put pressure on entities that make money on margins. Pharmaceutical companies won't be in bad shape after the IRA - it's all the other entities that make money on margins that will be affected."... Full

 

PCMA Asks DOL To Scrap Pending PBM Rule, But Former FDAer Urges Broader ERISA Reform

(3/27, Gabrielle Wanneh, Inside Health Policy) ...The PBM lobby is pressing the Trump administration to scrap a proposed rule that would for the first time extend some of the new federal restrictions on pharmacy benefit managers to also cover ERISA plans, hinting it might sue if the rule is finalized. But a former top FDA official argues the regulatory proposal only scratches the surface and a more comprehensive approach is needed to adequately rein in PBMs' activities in employer-sponsored plans... Sub. Req'd

 

Washington Is on the Verge of True PBM Reform

(3/30, Neeraj Sood, STAT+) ...Congress and regulators are now converging on a practical, market-based response: the bipartisan PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act and the Department of Labor's proposed PBM compensation disclosure rules. Together they would make drug purchasing work more like a real market - where the buyer can see how the agent gets paid, and the agent has a legal duty to act in the buyer's interest... Sub. Req'd

 

Big Tech's Patent Battering Ram Isn't Lowering Drug Prices

(3/27, James Edwards, Washington Examiner) ...Big Tech's argument goes something like this: PTAB challenges are vital to ending Big Pharma's patents, which prevent generics and biosimilars from entering the market. Therefore, ending unlimited opportunities to challenge drug patents at PTAB will mean higher drug prices. This is the pitch being made in lobbyist meetings on Capitol Hill, in FDA offices, and even in the West Wing... Full

 

US FDA Should Show Its Work on Adcomm Conflict of Interest Decisions, GAO Says

(3/27, Bridget Silverman, Pink Sheet) ...The US [FDA] advisory committee system continues working without published guidance on assessing members' conflicts of interest more than 13 years after legislation required it to be developed, the Government Accountability Office said in a report that called for more transparency in the process... Global Sub. Full

 

 

Blackstone Raises $6.3 Billion for Latest Life-Sciences Fund

(3/30, Preeti Singh, Bloomberg) ...The firm's recent partnerships include those with Merck & Co. for sacituzumab tirumotecan, a protein found on the surface of various cancer cells, and with Teva Pharmaceuticals Industries Ltd. for the clinical development of duvakitug, a human monoclonal antibody that has potential for broad therapeutic applications... Sub. Req’d

 

Investigational Agent ANX005 Shows Safety and Pharmacodynamic Activity in Early Huntington Disease Trial

(3/27, Louie Pasculli, Neurology Live) ...Early-phase data from a multicenter, open-label, phase 1b trial (NCT04514367) suggested that targeted inhibition of the classical complement pathway with ANX005 (Annexon Biosciences) is generally tolerable and engages its intended target in patients with early-manifest Huntington disease (HD). Findings from this study, dubbed ANX005-HD-01, provide initial clinical evidence supporting further exploration of complement blockade as a potential disease-modifying strategy... Full

 

Huntington's Disease Is a Relentless, Neurodegenerative Condition — But Treatment May Soon Be Possible

(3/28, Emilie Le Beau Lucchesi, Discover Magazine) ...A Dutch biopharmaceutical company recently announced the results of a new clinical trial in which patients with Huntington's received AMT-130, a gene therapy that silences the gene responsible for the disease. According to the NIH, the delivery of AMT-130 required only one dose and was administered during a neurosurgical procedure. AMT-130 then reduces the Huntington's protein, slowing the disease's progression and lessening symptoms... Full

 

AstraZeneca Claims Dual Phase III Wins for its IL-33 Biologic in COPD

(3/27, Anna Bratulic, FirstWord PHARMA) ...Across both trials, AstraZeneca said tozorakimab demonstrated "statistically significant and highly clinically meaningful reductions" in the annualised rate of moderate-to-severe COPD exacerbations versus placebo. The benefit was seen in the primary population of ex-smokers, as well as in the broader population that included current smokers, all stages of lung function impairment, and all blood eosinophil counts... Full

 

AstraZeneca's In Vivo CAR-T Posts Myeloma Remissions, but Safety a Concern

(3/27, Ana Bratulic, FirstWord PHARMA) ...An increasingly sought after CAR T-cell therapy approach that eliminates the need for ex vivo manufacturing continues to show early signs of clinical activity in multiple myeloma, according to data from a small Phase I study published in Nature Medicine this week... Full

 

Novartis Adds to Immunology Pipeline with $2b Deal for Excellergy and its Anti-IgE drug

(3/27, Matthew Dennise, FirstWord PHARMA) ...Novartis entered into an agreement to acquire Excellergy, adding Exl-111, a half-life extended, high-affinity anti-IgE antibody to its immunology pipeline. The deal, announced Friday, includes upfront and milestone payments potentially worth up to $2 billion... Full

 

CHMP Recommends Subcutaneous Form of Sanofi's Sarclisa and Four New Drugs

(3/30, Anna Brown, Endpoints News) ...Sanofi on Friday got a positive opinion for a subcutaneous adminstration of Sarclisa across all approved indications, along with a new pharmaceutical form, strength and solution for injection. If approved, Sarclisa would become the first anticancer drug to be administered through an on-body injector, Sanofi said in a Friday release... Sub. Req’d

 

Enanta Pharmaceuticals to Present Data for its STAT6 Inhibitor Program at IMMUNOLOGY2026TM, the Annual Meeting of the American Association of Immunologists (AAI)

(3/30, Enanta Pharmaceuticals) ...Enanta Pharmaceuticals...today announced that preclinical data from the Company's STAT6 inhibitor program will be presented in four posters at IMMUNOLOGY2026™... Full

 

J&J's Darzalex Nets First Self-Administered Cancer Injectable Approval

(3/27, Annabel Kartal Allen, Pharmaceutical Technology) ...Through this Type II label change, approved by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), Darzalex will now become available to European patients for either patient or caregiver administration after the fifth dose, provided the user receives proper training and a healthcare professional determines this appropriate... Full

 

 

'It's Not A Question Of If, It's A Question Of When' - Sandoz's Haruvi On US Biosimilar #1 Ambitions

(3/27, Dave Wallace, Generics Bulletin) ...Sandoz still has an ambition of becoming the number one market leader in biosimilars in the US - and according to the firm's North America head Keren Haruvi, achieving this goal is only a matter of time. Speaking to Generics Bulletin for an exclusive two-part interview - focusing both on Sandoz's North America business, as well as Haruvi's role and achievements as outgoing chair of the US Association for Accessible Medicines - the executive was asked about the firm's previously-expressed goal of taking the top spot in the US biosimilars market... Global Sub. Full

 

Hetero Launches Generic Semaglutide Brands Truglyx, Rolmodl, Moto G Across 75+ Countries

(3/28, Sheeba Farhat, Medical Dialogues) ...Hetero has announced the export launch of its generic semaglutide portfolio, marking a significant step toward expanding access to GLP-1 therapies for the treatment of type 2 diabetes and obesity... Full

 

Henlius-Organon Denosumab Biosimilars To Enter Canada In 2026

(3/27, Urte Fultinaviviute, Generics Bulletin) ...With Health Canada's approval in its pocket, Shanghai Henlius Biotech said its two denosumab biosimilars will be marketed by its commercialization partner Organon "later this year."...Health Canada has approved biosimilars Bildyos and Tuzemty for all indications of the reference products... Global Sub. Full

 

Aurobindo Out-Licenses Two Biosimilars EU Market Rights to STADA

(3/30, ETPharma.com) ...Aurobindo Pharma biosimilars arm, CuraTeQ Biologics has out-licensed its two products European market commercial rights to Germany's STADA Arzneimittel AG. According to a stock exchange disclosure, under the distribution agreement, STADA will market the company's two EMA approved biosimilars under new brand names in select European Union territories, including France and Germany... Full

 

Japan Nod Adds To Growing Momentum For Richter Biosimilars

(3/27, Dean Rudge, Generics Bulletin) ...Mochida Pharmaceutical and Hungary's Gedeon Richter have secured a joint win in Japan, with the Japanese firm obtaining manufacturing and marketing approval for their co-developed tocilizumab biosimilar, marking a further key regulatory milestone for both partners' commercialization ambitions... Global Sub. Full

 

Alembic Pharma Receives US FDA Final Approval for Paroxetine Extended-Release Tablets

(3/30, Pharmabiz.com) ...Alembic Pharmaceuticals Limited (Alembic), a vertically integrated research and development pharmaceutical company, announced that it has received final approval from the US [FDA] for its supplemental Abbreviated New Drug Application (sANDA) paroxetine extended-release tablets USP, 12.5 mg... Full

 

 

Eli Lilly Reaches $2.75 Billion Deal with Insilico to Bring AI-Developed Drugs to the Global Market

(3/29, Evelyn Cheng, CNBC) ...Insilico has developed at least 28 drugs using generative AI tools, with nearly half already at a clinical stage, Alex Zhavoronkov, founder and CEO of Insilico, told CNBC. The company went public in Hong Kong in December. Its shares are up more than 50% year-to-date. "In many ways, Lilly is better than us in some areas of AI," Zhavoronkov said, noting the U.S. pharma giant has "one person" who has brought biology, chemistry and automation under one roof. He added that as part of the deal, Insilico will join Lilly's Gateway Labs community for biotech development... Full

 

Novartis Charts Major Expansion Plan

(3/28, Li Jing, China Daily) ...Novartis will expand its research and development, manufacturing capacity and operations footprint in China with a planned investment of more than 3.3 billion yuan ($460 million), the company said... Full

 

Novartis to Take Earnings Hit From Generic Competition -- Market Talk

(3/30, Dow Jones Newswires) ...Bank of America expects the Swiss pharmaceutical company to report first-quarter core EPS of $2.07, down 10% on year at constant currency and short of consensus estimates of $2.13. The analysts say their forecast for Novartis's quarterly sales of $13.3 billion is in line with consensus estimates, but they anticipate worse generic pressure and the recently closed Avidity deal to dilute margins... Sub. Req’d

 

Biocon's New CEO Tambe Sharpens Focus on Core Therapies, Global Mkts

(3/27, Shilpa Phadnis & Veena Mani, The Times of India) ...As Biocon prepares for a leadership transition on April 1, newly designated CEO and MD Shreehas Tambe has outlined a strategic reset to transform the company into a fully integrated global medicines player...A key pillar of the strategy is a sharper focus on diabetes, oncology and immunology, where the company plans to deepen capabilities and scale rather than pursue broad-based expansion... Full

 

Stryker Restores Most Manufacturing After Cyberattack

(3/27, Ricky Zipp, MedTech Dive) ...[Stryker] is working with its global manufacturing sites as "operations steadily improve towards full capacity," a spokesperson said in a statement emailed to MedTech Dive. Stryker is making "strong progress" on restoring underlying systems that support production and fulfillment...The spokesperson declined to comment on whether Stryker has a timeline for full restoration of its operations, and whether the financial and material impact on the company is yet known... Full

 

Eagle Settles Investors' Drug Revenue Lawsuit for $9.5 Million

(3/27, Martina Barash, Bloomberg Law) ...Eagle Pharmaceuticals Inc. has agreed to pay investors $9.5 million to settle class claims that it "stuffed" its drug distribution channels to boost its reported revenue, according to a court filing. The proposed deal is fair and should receive preliminary approval, the investors leading the suit told the US District Court for the District of New Jersey on Thursday. The settlement amount represents about 9% of the $104.6 million in estimated maximum damages, according to the filing... Sub. Req'd

 

 

Eli Lilly Pushes for NHS Drug Price Increases in Return for Its UK Investment

(3/30, Chris Smyth, Financial Times) ...Britain must agree to regular increases in NHS drug prices and phase out a multibillion-pound rebate scheme if Eli Lilly is to resume investment in the UK, the US pharmaceutical group has said. Patrik Jonsson, president of Lilly's international businesses, told the FT the company was in talks with UK ministers and was feeling "optimistic" about reaching agreement by the summer for Britain to pay more for its medicines... Sub. Req'd

 

UK 'Weeks Away From Medicine Shortages' If Iran War Continues, Experts Warn

(3/28, Bryony Gooch, The Independent) ...Mark Samuels, the chief executive for Medicines UK, representing manufacturers of generic drugs which make up 85 per cent of medications used by the NHS, warned that if the conflict dragged on, drug shortages could emerge in a matter of weeks...Mr Samuels explained that medical distributors typically stock six to eight weeks of stocks to avoid shortfalls, while suppliers to hospitals in England must hold eight weeks' worth... Full

 

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