Friday, March 27, 2026

 

 

Navarro: U.S. Still Planning 15 Percent Tariffs, Using Section 232 to Replace IEEPA Regime

(3/26, Inside Health Policy) ...The Trump administration is still planning to raise temporary global tariffs from 10 percent to 15 percent and to use Section 232 of the Trade Expansion Act of 1962 to approximate the "emergency" duties struck down by the Supreme Court last month, White House trade adviser Peter Navarro said on Wednesday...The administration, he added, will continue to expand the list of products subject to Section 232 duties... Sub. Req’d

 

Health-Care Costs Are Forcing Terrible Trade-Offs

(3/27, Lisa Jarvis, Bloomberg) ...Trump's two main efforts - benchmarking US drug prices to those in other wealthy countries and launching the direct-to-consumer portal TrumpRx - haven't done much to reduce what consumers actually pay for medicine. The White House's much-vaunted "most-favored nation" deals with drug companies were billed as correctives to the longstanding imbalance between the high prescription prices paid by Americans and the comparatively cheap cost enjoyed by their peers abroad... Sub. Req'd

 

1 Big Thing: China's Rise Threatens Pharma's Status Quo

(3/27, Caitlin Owens, Axios) ... "China's still some time away from competing on the late-stage development cycles, but we should not assume that will always be the case, and we should assume they will get there sooner rather than later," said USC Schaeffer Institute senior scholar Lowell Schiller, a senior FDA official in the first Trump administration... Full

 

2. More Competition Could Mean Lower Prices

(3/27, Caitlin Owens, Axios) ...The goal is partly to get European countries to pay more for drugs. But countries may simply refuse to buy new drugs at higher prices for their health systems...And if China can soon offer up viable alternatives, those nations may not have to choose between cost and access... Full

 

DOJ Defends Drug Negotiation Program In Latest SCOTUS Brief

(3/26, Jessica Karins, Inside Health Policy) ...The Department of Justice has submitted a brief to the Supreme Court defending the Inflation Reduction Act's drug price negotiation program, continuing the Biden administration's legal defense of the program and setting the stage for a decision soon on whether the justices will hear the case. Bristol Myers Squib and Janssen Pharmaceuticals (Johnson & Johnson) have asked the high court to hear their cases that the Medicare negotiation program is illegal... Sub. Req'd

 

AHIP: With PBM Reform Win, Focus Should Turn To Drug Marketing

(3/26, Dorothy Mills-Gregg, Inside Health Policy) ...Following the passage of pharmacy benefit manager reforms, Congress and the Trump administration should now turn their focus to limiting drug manufacturer's commercials and closing holes in the innovation and affordability policies setup in the Hatch-Waxman Act, the head of the country's leading health insurance lobby said... Sub. Req'd

 

Inside PBM Reform: How PBMs Are Becoming the Most Transparent Actors in the Supply Chain

(3/26, PCMA) ...The Consolidated Appropriations Act (CAA), passed into law this year, is the last mile on the PBM transparency journey. The transparency PBMs provide, and the reporting that is required, is second to none. Soon, data on every claim, every drug, every contract, and every fee will be easily accessible to employers, unions, and the government... Full

 

Biopharma Industry Pushes Back on FDA's 'America First' User Fee Proposals

(3/26, Zachary Brennan, Endpoints News) ...Biopharma industry representatives are taking issue with some of the FDA's more political proposals in the next round of user fee agreements, particularly ones that would limit the small business waiver to only US applicants and reduce user fees for companies that run their Phase 1 trials in the US... Sub. Req’d

 

His Own Words: FDA Commissioner Martin Makary On His First Year Achievements And Challenges

(3/26, Sue Sutter, Pink Sheet) ...The FDA declined to make Makary available for an interview with the Pink Sheet to mark his one-year anniversary in office, saying the timeline was not feasible. However, Makary provided written responses to questions about his first year as commissioner and his priorities for year two... Global Sub. Full

 

US FDA Commissioner Makary's 'Bold' Year 1 Reforms Clouded By Staff Churn, Process Issues

(3/26, Sue Sutter, Pink Sheet) ...Makary has been a steadfast advocate for several of the White House's "America First" priorities, including reducing drug prices and onshoring manufacturing in the US. Association for Accessible Medicines CEO John Murphy praised the FDA's "more aggressive posture … of getting biosimilar drugs on the market."... Global Sub. Full

 

Advocacy Group Calls for Greater Transparency at FDA

(3/26, Jeff Craven, Regulatory Focus) ...Irene Park Ulrich, PharmD, MPH; and Peter Lurie, MD, MPH, of the Center for Science in the Public Interest in Washington, DC, argued that stakeholders in the public health community should use the momentum generated by Commissioner Martin Makary's goal of "radical transparency" at FDA to advocate for greater transparency at the agency... Full

 

Industry Calls for Synchronized Implementation of ICH M4Q(R2)

(3/26, Joanne S. Eglovitch, Regulatory Focus) ...The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant restructuring of the quality section of the Common Technical Document (CTD), bringing major changes for both the industry and regulators. As such, ICH and regulatory authorities should promote global synchronization of the guideline's implementation to reduce the need for maintaining dual dossier structures... Full

 

When Cheap Becomes Fragile: How the Race to the Bottom in Generics Undermines Manufacturing Quality and What to Do About It

(3/24, Marta E. Wosinska, Brookings) ...Introducing a QP system, complemented by mandatory import testing of every batch, provides a stronger safeguard for drug quality. Combining mandatory product testing of imports with batch certification by a qualified U.S.-based person who bears personal sign-off responsibility strengthens both detection and deterrence and underscores that safeguarding drug quality and CGMP compliance is an industry obligation-not a task that can be offloaded to regulators alone... Full

 

HHS Taps Diverse Crew For New Health Reform Advisory Panel

(3/26, Amy Lotven, Christian Robles, Dorothy Mills-Gregg, Inside Health Policy) ...HHS tapped a diverse crew to sit on a new advisory panel charged with finding ways to insert MAHA values like fighting chronic disease into health care delivery and finance reform that includes well-known health guru Tony Robbins, who recently chatted with Administrator Mehmet Oz at CMS' Quality Conference, a venture capitalist, an interoperability vendor, several people with expertise in value-based care, and more... Sub. Req'd

 

Kansas Lawmakers Pass PBM Bill, But Drug Pricing Reform Stalls

(3/26, Matt Resnick, The Topeka Capital-Journal) ...Hope is fading fast for Senate Bill 284 - legislation that would require drug manufacturers to sell outpatient medications to eligible hospitals and clinics at significantly reduced rates. Senate Bill 20, a related measure, places regulations on the middlemen responsible for negotiating drug prices between pharmacies, manufacturers and insurers. Those influential intermediaries, known as Pharmacy Benefit Managers, also set reimbursement rates for prescription medications... Full

 

State PBM Bans Would Devastate Pharmacy Access

(3/26, Eric Maus, Citizens Against Government Waste) ...Legislators are right to be concerned about the cost of healthcare. However, legislation to ban a PBM from owning or operating a pharmacy in any state would have a devastating impact on pharmacy access and prescription drug costs, and these bills should be rejected... Full

 

House Advances Prescription Drug Discount Card Proposal, H.577, With Overwhelming Bipartisan Approval

(3/26, State of Vermont: Office of the State Treasurer) ...Under the bill, Vermont would join ArrayRx-a coalition of states pooling their buying power to negotiate lower drug prices. By leveraging combined resources through the partnership, the ArrayRx discount card would be available to Vermonters free of charge and at no on-going cost to the State. The House's approval is a major milestone toward H.577 becoming law. The bill now heads to the Senate for consideration... Full

 

 

Teva's Strategic Shift Gains Momentum with Key Preclinical Achievement

(327, Ad Hoc News) ...The company has achieved a preclinical milestone for its drug candidate TEV '325, reinforcing its ambitions in the competitive biologics sector. This progress, realized through a collaboration with partner Biolojic Design, highlights the increasing role of artificial intelligence in developing next-generation therapies central to Teva's future growth plans... Full

 

Biolojic Design Earns Preclinical Milestone from Teva for First AI-Designed Multibody in Autoimmune Disease, TEV ‘325 (formerly BD9)

(3/25, Biolojic Design) ...Under the terms of the agreement, Teva is developing TEV ‘325 and has exclusive rights to develop, manufacture and globally commercialize the compound. In exchange, Biolojic is eligible to receive milestone payments based on the achievement of certain pre-clinical, clinical, regulatory, commercial milestones and royalty payments... Full

 

AstraZeneca Drug Reduces COPD Flare Ups in Late-Stage Trials

(3/27, Reuters) ...The treatment met the main goal in the two clinical studies, and reduced the annualised rate of moderate-to-severe COPD flare-ups versus placebo in the primary group of former smokers and in the overall study population, the drugmaker said... Full

 

 

Dr. Reddy's Renames Ozempic Generic After Novo Nordisk Trademark Challenge Over Olymvic

(3/27, Ashmit Kumar, CNBC-TV18) ...The dispute centres around Dr. Reddy's generic version of Ozempic, which was initially branded as Olymvic. Novo Nordisk flagged the name, arguing that its similarity to Ozempic could potentially lead to confusion among patients. Following the objection, Dr. Reddy's has now agreed to change the name of its drug, marking an early win for Novo Nordisk in the branding battle around semaglutide generics... Full

 

Yoshindo Builds In-House Biosimilars Capacity With Cytiva Support

(3/26, Dean Rudge, Generics Bulletin) ...Global bioprocessing supplier Cytiva has agreed a manufacturing deal with Japan's Yoshindo to support domestic biosimilar production, as the partners look to strengthen local supply and accelerate the facility's readiness. Under the agreement, Yoshindo will establish biosimilar drug-substance manufacturing capabilities at its Toyama plant, with supply targeted from 2028. The move is intended to improve access to affordable biologic medicines in Japan while reducing reliance on overseas production... Global Sub. Full

 

Sandoz Springs Into Germany And Switzerland With A New Antihistamine Nasal Spray

(3/26, Urte Fultinaviciute, Generics Bulletin) ...The firm has launched a generic rival to Viatris' Dymista (azelastine/fluticasone) in Germany and Switzerland, offering patients a "high-quality alternative to the reference medicine."... Global Sub. Full

 

Celltrion Wins Japan Approval for Xolair, Eylea Biosimilars, Expanding Into Allergy and Ophthalmology Markets

(3/27, Kim Ji-hye, Korea Biomedical Review) ...Omlyclo is the first Xolair biosimilar approved in Japan with the full range of indications, including bronchial asthma, idiopathic chronic urticaria, and seasonal allergic rhinitis. It is available in both prefilled syringe (PFS) and autoinjector (AI) formulations for enhanced patient convenience... Full

 

Egg-Based Drugmaker Neion Bio Emerges From Stealth to Cook Up Multi-Product Biosimilar Collab

(3/26, Zoey Becker, Fierce Pharma) ...Using its Raptor platform to produce recombinant biologics in eggs, the company is teaming up with an unnamed pharma company to co-develop and supply up to three monoclonal antibodies in a deal that includes upfront and milestone payments, plus profit sharing upon potential commercialization... Full

 

 

Novartis to Buy Allergy-Drug Developer Excellergy for Up to $2 Billion

(3/27, Adrià Calatayud, The Wall Street Journal) ...Novartis sees in Palo Alto, Calif.-based Excellergy a good fit that builds on its long-standing presence in allergic diseases. The company recently launched a new drug called Rhapsido for chronic spontaneous urticaria—or chronic hives with no known trigger—and is evaluating it for another form of hives, food allergy and skin condition hidradenitis suppurativa... Sub. Req’d

 

Biocon Appoints Shreehas Tambe as CEO & MD

(3/27, PTI) ...Biocon Ltd on Friday said it has appointed Shreehas Tambe as CEO & Managing Director, effective April 1, 2026. As the first CEO of the integrated Biocon, he will lead the combined platform spanning biosimilars and generics, strengthening the company's ability to operate at scale and compete effectively in global markets, the company said in a statement. Further, Kedar Upadhye has also been appointed as Chief Financial Officer, Biocon said... Full

 

 

Iran War: Fuel Woes Exacerbate Fragility Of Europe's Medicines Distribution System

(3/26, Francesca Bruce, Pink Sheet) ...Shortages and escalating prices of fuel caused by the war in Iran could jeopardize Europe's medicines distribution system, which is "already close to breaking point" in some markets, said Kasper Ernest, director general of GIRP, the association of European full-line medicines wholesalers. Pharmaceutical companies that distribute their medicines directly to pharmacies and hospitals are making the system less resilient when emergencies occur, he said in an interview with the Pink Sheet... Global Sub. Full

 

South Korea Eases Biosimilar Phase 3 Rules to Speed Development and Exports

(3/27, Hong Da-yeong, Chosun Biz) ...The Ministery of Food and Drug Safety said on the 27th it will begin a prior review to ease phase 3 clinical requirements for biosimilars (biosimilar). The move is expected to shorten biosimilar development timelines and expense and speed up overseas expansion... Full

 

Korea's Reshuffled ‘Innovative Pharma' Criteria Target R&D, Transparency

(3/27, Jung Won Shin, Pink Sheet) ...Under a new initiative aimed at strengthening original R&D, South Korea's government unveils revised criteria for both domestic and foreign pharma firms to be formally certified as "innovative" and eligible for certain policy support... Global Sub. Full

 

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