Thursday, August 27, 2026

 

 

White House to Announce New Drug Pricing Deals With Biotechs

(8/26, Rachel Cohrs Zhang, Nyah Phengsitthy, Madison Muller, Bloomberg) ...The Trump administration plans to announce a new round of drug-pricing agreements with several midsized biotech companies on Monday, according to people familiar with the matter. The companies will agree to provide discounts on outpatient drugs to state Medicaid programs so that the prices states pay align with what the companies charge in foreign countries, the people said. Participation by state Medicaid programs is optional... Sub. Req'd

 

Trump Administration Preparing New Round of Medicaid Drug-Pricing Deals: Report

(8/26, Nicholas Jacobus, PharmExec.com) ...The exact drugmakers involved in the deals have yet to be named, and the report describing the plan has yet to be independently verified... Full

 

MFN Deal Impact Unclear As White House Ready To Announce Agreements With Mid-Size Pharmas

(8/26, Cathy Kelly and Maaisha Osman, Pink Sheet) ...The impact of the new agreements is unclear because the evidence of the benefit of the initial deals' effect is limited. In addition, the deals will sunset when President Trump leaves office and Congress has not shown much interest in legislation codifying them, despite pressure from the administration. Because the GENEROUS model has not launched, the savings that would be available to Medicaid enrollees through MFN commitments is unclear. Information on how the deals will affect new products, potentially the most impactful aspect of the agreements, also is limited... Global Sub. Full

 

'Still Crickets': Warren Reminds RFK Jr. of Pledge to Publish Secret Trump Deals With Big Pharma

(8/26, Julia Conley, Common Dreams) ...Nearly two weeks after US Sen. Elizabeth Warren wrote to the Trump administration's top health official in her latest attempt to get answers on "secret pricing deals" with Big Pharma, the Massachusetts Democrat said Wednesday that she is still waiting for the White House to make the terms of the agreements public... Full

 

Trump's Tariffs on Generic Drugs Are "Another Wrinkle in an Already Unstable System"

(8/26, The Cancer Letter) ...In the conversation, [Marta Wosinska, a healthcare economist and senior fellow at the Brookings Institution Center on Health Policy,] explains how tariffs will likely not be able to achieve the goals Trump hopes. "This is yet another wrinkle in a really unstable system," Wosinska said. "And whether or not tariffs are playing into this-and tariffs could potentially make things more challenging, you know. Onshoring is not necessarily going to solve our problem, because we have already a lot of domestic manufacturing, and it's really not a domestic versus foreign problem."... Full

 

BIO: CMS Must Drop 'Bona Fide Marketing' Before Finalizing IRA Codification Rule

(8/26, Gabrielle Wanneh, Inside Health Policy) ...The Biotechnology Innovation Organization is calling on CMS to drop its current "bona fide marketing" standard for determining whether existing competition prevents Medicare price negotiation for otherwise eligible drugs when it finalizes its rule to codify the program for future negotiation rounds... Sub. Req'd

 

BIO, PhRMA Ask FDA To Clarify Research Institutions' Role In IND Pilot

(8/26, Lauren Brensel, Inside Health Policy) ...FDA's thinking is that a stronger investigational new drug (IND) application would yield an accelerated path to clinical research, but the groups say the agency's suggested method could impede the review process... Sub. Req'd

 

FAQ: What FDA's New Approach to Biosimilar Interchangeability Means for Developers

(8/26, Emily Schoenthaler, BioPharmInternational.com) ...FDA is proposing a significantly less burdensome path for biosimilar developers, with changes that could reduce several clinical studies historically used to support biosimilar and interchangeable biosimilar applications. The changes could lower development costs and timelines, but because the recommendations remain in draft form, important questions about how the revised framework will work in practice remain... Full

 

Importers Ask Trade Court To Overturn Section 'Predetermined' Section 301 Tariffs

(8/26, David LaRoss, Inside Health Policy) ...The Office of the U.S. Trade Representative illegally "predetermined" the outcome of its forced-labor investigations into 60 foreign economies to pave the way for broad tariffs in violation of both Section 301 of the Trade Act of 1974 and the broader Administrative Procedure Act, importers challenging the duties told a federal court this week... Sub. Req'd

 

State Audit Finds $1.4 Million In Unpaid Fees At Maryland Prescription Drug Affordability Board

(8/27, The BayNet.com) ...Maryland's Prescription Drug Affordability Board failed to adequately collect and account for annual fees used to fund its operations, leaving approximately $1.4 million outstanding as of April 2026, according to a newly released state audit. The Office of Legislative Audits examined the Prescription Drug Affordability Board, known as PDAB, for the period from July 1, 2022, through March 22, 2026. The audit, dated Aug. 19, found weaknesses involving unpaid assessments, returned billing notices, collection procedures and internal financial controls... Full

 

 

Spyre Says Its Anti-TL1A Works in Rheumatoid Arthritis, but Still Falls Short in Phase II

(8/27, Anna Bratulic, FirstWord PHARMA) ...Spyre Therapeutics' stock was down about 14% Wednesday after a topline readout for one of its experimental TL1A antibodies underwhelmed in a Phase II rheumatoid arthritis (RA) study. While SPY072 showed activity, it failed to meet the company's internal efficacy bar for moving it forward as a stand-alone therapy. The candidate is being evaluated in the SKYWAY-RD basket trial across several rheumatic diseases, with separate sub-studies in RA, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA)... Full

 

AbbVie Submits Regulatory Application to EMA for SKYRIZI® (risankizumab) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease

(8/27, AbbVie) ...The application to the EMA is supported by the recently shared positive data from the Phase 3 AFFIRM study1 (NCT06063967), which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, in those with and without prior advanced therapy failure... Full

 

AstraZeneca-Amgen Asthma Drug Succeeds in Late-Stage Oesophagus Disease Trial

(8/27, Reuters) ...The study showed that Tezspire, developed with Amgen, significantly reduced inflammation in the oesophagus and eased difficulty in swallowing compared with a placebo in patients suffering with eosinophilic esophagitis, which affects more than 470,000 people in the United States... Full

 

A Breakthrough Pancreatic Cancer Drug Marks a New Era for Treatment

(8/26, Robert Langreth, Bloomberg) ...Revolution Medicines' pill, which secured US regulatory approval today, is the first in a wave of targeted drugs that could reshape treatment for pancreatic cancer, long one of the hardest types of cancer to treat... Sub. Req'd

 

 

Two Asthma Inhalers to Be Discontinued at the End of November

(8/26, Emily Warner, The Pharmacist) ...Community Pharmacy England (CPE) said that beclometasone dipropionate (Soprobec) 50 micrograms/dose and 250 micrograms/dose inhalers remain available and can support increased demand. Beclometasone dipropionate (Clenil Modulite) 100 micrograms/dose inhalers and the beclometasone dipropionate CFC-free pressurised metered dose inhalers (pMDIs), Qvar and Kelhale, also remain available to support demand where appropriate, it added... Full

 

Biocon And Sandoz Broaden Japanese Biosimilars Alliance With Pegfilgrastim Nod

(8/26, Dave Wallace, Generics Bulletin) ...Biocon has revealed further details of a Japanese biosimilars marketing alliance with Sandoz, as the Indian firm celebrated a local approval for its pegfilgrastim rival to Amgen's Neulasta. Japan's Ministry of Health, Labour and Welfare has issued a marketing authorization for Biocon's pegfilgrastim biosimilar, "with Global Regulatory Partners Japan serving as the marketing authorization holder on behalf of Biocon."... Global Sub. Full

 

Zydus Gets CGT Exclusivity On Scurvy Treatment

(8/26, Dave Wallace, Generics Bulletin) ...Zydus Lifesciences has celebrated its latest approval of a competitive generic therapy in the US, accompanied by 180 days of CGT exclusivity, with the US [FDA's] approval of its generic ascorbic acid for injection...Zydus's version is also available as 2,500mg/5ml and 5,000mg/10ml versions, offering a wider variety of presentations... Global Sub. Full

 

Celltrion's SC Infliximab Franchise Nears Halfway Mark Toward W1Tri. Won Sales Target

(8/27, Korea Biomedical Review) ...Celltrion's subcutaneous infliximab products, Remsima SC and its U.S. brand Zymfentra, posted combined first-half sales of 456.2 billion won ($330.7 million). The strong first-half sales brought the product line closer to the company's annual sales target of 1 trillion won, the company said Thursday... Full

 

 

China Approves J&J's Oral Psoriasis Pill, Says Drugmaker

(8/27, Reuters) ...China's drug regulator has approved Johnson & Johnson's oral pill for psoriasis, the company said on Thursday, intensifying competition in the world's second-largest pharmaceutical market with rivals including Bristol Myers Squibb and AbbVie... Full

 

SK Biopharma Pens $795m Deal to Usher Biohaven's Epilepsy Therapy Towards Hoped-For 2029 Launch

(8/26, James Waldron, Fierce Biotech) ...Biohaven is currently evaluating the daily oral therapy, called opakalim or BHV-7000, in a phase 2/3 study of patients with focal epilepsy. A topline readout is expected later this year... Full

 

The Race to Develop More Medicines Like the New Pancreatic Cancer Drug

(8/27, Rebecca Robbins and Carolyn Y. Johnson, The New York Times) ...Large drugmakers like Eli Lilly, Pfizer, Amgen and AstraZeneca are among the companies racing to develop their own medicines that work like the new drug, daraxonrasib, which is made by Revolution Medicines and will be sold as Rasonque... Sub. Req'd

 

AbbVie's Patient Support Extends to the Classroom with Immunology Scholarship Program

(8/26, Zoey Becker, Fierce Pharma) ...This year, the company is celebrating the ten-year anniversary of its AbbVie Immunology Scholarship, which has helped students with immunology conditions relieve some of the financial burdens of higher education since 2016... Full

 

 

Turkey Probes Israeli Pharmaceutical Company Teva over Claims it Blocked Rivals in Drug Market

(8/27, Dean Shmuel Elmas/GLOBES/TNS, The Jerusalem Post) ...Teva said, "The Turkish Competition Authority's investigation concerns a past antitrust issue related to the drug Copaxone, similar to the process being conducted by the European Commission, which is currently under appeal before the European Court of Justice, and in which Teva rejects any claim of misconduct on its part. This is an investigative process, and we will cooperate with the authorities throughout the process."... Full

 

 

EMA Targets Faster, More Streamlined Data Standards In Draft Framework

(8/26, Eliza Slawther, Pink Sheet) ...The draft framework, which is open for consultation until Sept. 18, covers the processes of creating, updating and implementing data standards by the European medicines regulatory network (EMRN) for both human and veterinary medicines... Global Sub. Full

 

Bio-Based Plastics And Non-PVC Blisters: Sanofi, AZ And Others Float Green Manufacturing Ideas

(8/26, Neena Brizmohun, Pink Sheet) ...Future approaches, as presented by AstraZeneca, include replacing the PVC-containing base of a blister pack with polyethylene, polypropylene, or polyethylene terephthalate. The company's presentation included a discussion of a cross-industry collaborative team of companies that was established to identify the "technical and regulatory challenges, and opportunities for accelerating the transition to alternate blister packaging materials."... Global Sub. Full

 

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