Thursday, May 21, 2026

 

 

Pharma's Legal Assault on Medicare Negotiations Hits a SCOTUS wall

(5/20, Lauren Gardner, David Lim, Politico) ...The Supreme Court "was the last frontier for" the industry to challenge the foundation of the authority given to Medicare in the 2022 Inflation Reduction Act, said Andrew Twinamatsiko, director of the Center for Health Policy and the Law at Georgetown Law's O'Neill Institute. "This is a strong signal from the Supreme Court that constitutional arguments are not going to cut it" on the topic, he added...Merck and PhRMA, the lobbying group for brand-name manufacturers, await decisions in lower courts. Pending cases from manufacturers AbbVie and Teva raise novel arguments pertinent to their products' selection for the program, in addition to constitutional claims... Full

 

PBMs Argue HHS OIG Report Proves Consolidation A Non-Issue

(5/20, Gabrielle Wanneh, Inside Health Policy) ..."I think the report absolutely highlights the mass consolidation that's occurred over the years, and it's led to a totally different dynamic in Part D than when the program started 20 years ago," Ronna Hauser, senior vice president of policy and pharmacy affairs at the National Community Pharmacists Association (NCPA), told Inside Health Policy... Sub. Req'd

 

CMS Plans To Train Entire Agency In AI As Part Of Push To Integrate AI In Rulemaking

(5/20, Sigi Ris, Inside Health Policy) ...CMS Administrator Mehmet Oz and CMS Chief of Staff and Deputy Administrator Stephanie Carlton unveiled a new five-year strategic framework for the agency at an event hosted by the Bipartisan Policy Center Wednesday (May 20). The two emphasized internal AI training as part of the framework's "leading payor" pillar... Sub. Req'd

 

FDA Official: 17 Drugs Approved Using Continuous Manufacturing, Growth Seen in Emerging Tech Program

(5/20, Adam Fisher, Regulatory Focus) ...[Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA),] provided an update on FDA's two advanced manufacturing programs, the Emerging Technologies Program (ETP) and its Advanced Manufacturing Technologies (AMT) designation program at the agency's Regulatory Education for Industry (REdI) meeting on 20 May. He also discussed the differences between the ETP and AMT programs... Full

 

FDA Offers New Details On Real-Time Clinical Trial Pilot, But Questions Remain

(5/20, James Jarvis, Inside Health Policy) ...FDA officials also clarified that the agency is not planning to build a centralized platform for sponsors to use in the pilot, similar to ClinicalTrials.gov. Instead, sponsors would likely use their own systems or technology partners to collect and process trial data. Walsh said FDA would have a centralized mechanism for receiving signal data and metadata, but sponsors and trial sites would decide what systems they use to generate those signals... Sub. Req'd

 

US FDA's Real-Time Clinical Trial Pilot Seeks Expansion As Chief Architect Departs

(5/20, Bridget Silverman, Maaisha Osman, Pink Sheet) ...Chief AI Officer Jeremy Walsh's sudden departure days after soliciting industry input on the FDA's real-time clinical trial pilot puts the program's future in question even as the agency plans to expand from two proof-of-concept studies to a 10-15 company pilot... Global Sub. Full

 

Lawmakers, Health Leaders Make Bipartisan Push to Expand Clinical Trials Access

(5/20, Finya Swai, The Hill) ...The Clinical Trial Modernization Act, co-sponsored by Reps. Raul Ruiz (D-Calif.) and Erin Houchin (R-Ind.), is a bipartisan effort aiming to address some of the economic hurdles preventing patients from participating in clinical trials, which rely on community-based research to test the safety and effectiveness of medications, procedures and other health-related interventions...Houchin said a greater emphasis on using artificial intelligence could help streamline the process and improve treatment... Full

 

Will US FDA Staffing Issues Endanger Regulatory Flexibility Despite Steps Forward?

(5/20, Michael McCaughan, Pink Sheet) ...But the bigger message is the acceptance of HS as a surrogate took sustained engagement by FDA officials in CBER and CDER over several years, as well as a strong push by Marks, to move forward. The work may be increasingly challenging for the agency given the loss of experienced staff and leadership during the Trump Administration... Global Sub. Full

 

Dark Times Ahead at The FDA

(5/21, Paul Knoepfler, STAT+) ...Perhaps this administration doesn't want a particularly functional FDA, just one that does what it's told... Sub. Req'd

 

Illinois Lawmakers Consider Board That Could Cap Prescription Drug Prices for Consumers Statewide

(5/20, Jeremy Gorner, Chicago Tribune) ...The board would not be permitted to further cut prices on drugs already negotiated through Medicare but could work to ensure those drugs reach patients who need them... Full

 

Guest Column: Louisiana Deserves to Know What It's Paying for Prescription Drugs

(5/20, Kirk Talbot, Nola.com) ...SB401 does not cap prices. It does not give any board the power to tell a manufacturer what it can charge. It simply asks for facts. Louisiana patients have waited long enough for their state to pay attention. This is how we start... Full

 

 

AstraZeneca, Roche Join Forces to Boost AI-Based Cancer Pathology Across Asia

(5/20, BioSpectrum Asia) ...AstraZeneca and Roche Diagnostics Asia Pacific have announced a three-year Memorandum of Understanding to help advance digital pathology capabilities and elevate cancer care across nine Asia markets, a first in the region. This landmark collaboration aims to accelerate the adoption of AI-powered digital and computational pathology through educational and training initiatives and improve biomarker testing in breast and lung cancer... Full

 

 

Lupin Marks A Return To $1Bn Annual US Sales

(5/20, Urte Fultinaviciute, Generics Bulletin) ...Lupin has also experienced some hiccups with its generic Risperdal Consta. While the product was one of the reasons for achieving high US sales, the firm has not been able to keep up with the demand. [CEO Vinita] Gupta explained that the originator Janssen as well as other generic competitor Teva also had supply issues. "There's a real gap in the marketplace which is a nice problem to have, and we're trying to see how we can best meet the incremental demand," she added... Global Sub. Full

 

Dr Reddy's Labs Launches Oral Semaglutide Biosimilar 'Obeda' Tablets in India

(5/20, Pharmabiz.com) ...Obeda available in 3 mg, 7 mg and 14 mg strengths and recommended for once-daily oral use. It is priced at Rs. 99, Rs. 135, and Rs. 225 per tablet for the 3 mg, 7 mg, and 14 mg doses, respectively... Full

 

Gedeon Richter Wants More On GLP-1s

(5/21, Dean Rudge, Generics Bulletin) ...Head of investor relations Róbert Réthy further confirmed that the firm's co-development arrangement with Malta-based Adalvo - for a rival version of injectable semaglutide - represented only one strand of the firm's GLP-1 strategy..."That was a broader cooperation, a co-development agreement," Réthy said of the deal, before adding: "There are other similar development or co-development agreements we are working on." For now, Richter did not name the additional partners or specify the geographies being targeted... Global Sub. Full

 

New Program Could Bring Low-Cost Generic Drugs to Rural Hospitals

(5/20, Hanna Merzbach, Mountain West News Bureau) ...The Helmsley Charitable Trust is funding the program through Civica Foundation, the philanthropic arm of Civica, a nonprofit generic drug company. Hospitals that opt in will have access to a consistent supply of drugs at wholesale prices, without having to buy in bulk like larger hospitals... Full

 

Meloxicam Could Be Viatris' Late Christmas Present

(5/21, Dean Rudge, Generics Bulletin) ...The NDA acceptance sits among several strategic themes that the company has been emphasizing consistently, including lifecycle optimization of known medicines, higher-margin value-added products, and targeted US launches that go beyond conventional oral solid generics... Global Sub. Full

 

 

Driven by GLP-1s, Pharma's Relationship with Consumers Is Starting to Change

(5/20, Lydia Ramsey Pflanzer, Endpoints News) ..."Pharma has become so much more patient-centric in the last five years, and they're doing things they never did in the past," Eversana CEO Mark Thierer said onstage at the Financial Times' US Pharma and Biotech Summit, in collaboration with Endpoints News... Sub. Req'd

 

Q&A: How Continuous Bioprocessing Is Evolving With Smarter Automation

(5/21, Stuart Tindal, David Chau, Christopher Cole, Zachary Zubulake, PharmTech) ...At INTERPHEX 2026, PharmTech connected with Stuart Tindal, portfolio manager, Intensified Downstream Systems, Sartorius; and David Chau, global technical product specialist, Thermo Fisher-both Bio-Process Systems Alliance committee leaders-discuss automation, single-use technology challenges, and smarter process control in bioprocessing... Full

 

 

Germany And France Join Forces To Counter MFN And Other Threats To European Pharma

(5/20, Francesca Bruce, Pink Sheet) ..."We need to send a clear signal to the pharmaceutical industry that Europe is and will remain an attractive investment location for the long term. We are jointly striving towards this goal," said the declaration, signed by French and German health ministers, Stéphanie Rist and Nina Warken, respectively, at the World Health Assembly, which is taking place in Geneva, Switzerland, on May 18-23... Global Sub. Full

 

Report: EU Makes Progress Toward 2030 Clinical Trial Goals

(5/20, Ferdous Al-Faruque, Regulatory Focus) ...The report was published on May 20 and is based on data from the Clinical Trials Information System (CTIS) between January and the end of March. The report includes numerous details and statistics pertaining to clinical trials in the economic bloc and notes that last quarter, 208 new clinical trial applications were submitted per month in CTIS and the median time from submission to decision was 118 days... Full

 

DoP Invites Pharma Firms to Join Taiwan Collaboration Drive for R&D, Manufacturing & Technology Partnerships

(5/21, Shardul Nautiyal, Pharmabiz.com) ...The Department of Pharmaceuticals (DoP) has invited Indian pharmaceutical companies to express their interest in collaborating with Taiwanese firms under the upcoming 18th India-Taipei Economic Consultation (ITEC). The initiative is aimed at strengthening bilateral cooperation between India and Taiwan in the pharmaceutical sector through research partnerships, joint manufacturing projects and technology-driven innovation... Full

 

What it Will Take for Indian Biosimilars to Win Globally

(5/20, Manoj Panicker, The Financial Express) ...The urgency is evident. As per the Global Biopharma Index 2025, 59 percent of firms report delays in time to market for new therapies, while 51 percent of executives highlight policy and regulatory inconsistency across markets. For India, this means that global alignment must begin at the level of capability creation itself... Full

 

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