Friday, May 8, 2026

 

 

Trade Court Rules Trump's 10% Global Tariff Is Illegal

(5/7, Tony Romm, Ana Swanson, The New York Times) ...While the court declared Mr. Trump's tariffs to be illegal, it only explicitly blocked their collection from small businesses and some states that had sued over their legality. It remained unclear how the administration would interpret that order, though it is widely expected to appeal... Sub. Req'd

 

MFN and TrumpRx: What's the Real Impact for the American Consumer?

(5/7, Jonah Comstock, PharmaPhorum) ..."The bottom line is there's a movement afoot, and manufacturers are stepping up to the plate," [Renzo Luzzatti, the president of US Rx Care,] said. "The question is, how does it get integrated into the funded space? And there are a lot of companies that have come into the marketplace to provide various vehicles for that to happen. There are companies putting prepaid Visa cards in the hands of members so they can use it at LillyRx or NovoRx, right? [There's] GoodRx, potentially mail-order pharmacies, like Mark Cuban. And so there's a lot of smart people out there trying to figure out a way how to get these prices under a funded arrangement."... Full

 

Questionable White House Math On Savings From Most Favored Nation Drug Prices

(5/7, Joshua P. Cohen, Forbes) ...In relation to MFN drug pricing, for example, when Trump declares, "now you have the lowest drug prices anywhere in the world," it doesn't stand up to scrutiny. Specifically, research reveals the falsity of the administration's claims when it touts its online platform TrumpRx as offering Americans the world's lowest prices on certain prescription drugs... Full

 

Are The Trump Administration's Efforts to Lower Drug Costs Working?

(5/7, CBS News) ...President Trump has made cutting drug prices a centerpiece of his second term. He's announced deals with major drug companies and launched TrumpRx, where cash-paying patients could find discounted medicines. But a new analysis finds that the reality is more complicated. CBS News medical correspondent Dr. Céline Gounder has more... Full

 

Editorial: America Must Protect Its Drug Supply From China

(5/8, Washington Examiner) ...Sen. Tom Cotton's (R-AR) Securing America's Drug Supply from Communist China Act would "eliminate the national security risk posed by CCP influence over entities that sell pharmaceutical products to the American public."... Full

 

Medicare's GLP-1 Bridge Model Expands Obesity Drug Access

(5/7, Ashley Gallagher, Drug Topics) ...Cristy Gallagher, MPAff, research project director at STOP Obesity Alliance, explains how the Balance Model and a new glucagon-like peptide-1 (GLP-1) bridge program aim to expand access to obesity medications under Medicare and Medicaid, highlighting the critical role of pharmacists in patient care... Full

 

BsUFA IV Talks Begin With Supplement, Fee System Streamlining Proposals

(5/7, Derrick Gingery, Pink Sheet) ...The FDA offered three new categories, Type 1, 2 and 3, with four-, six- or 10-month timelines depending on the resources needed to review the submission, according to minutes of an April 9 meeting where the detailed proposal was discussed. They would replace the existing categories A-F. Agency officials intentionally did not include a category for supplements with comparative efficacy studies because they were not expected to be included in the submissions often... Global Sub. Full

 

Comments on Biosimilar Streamlining Efforts and Context on Commercial Barriers to Competition

(5/7, Ryan Conrad, Brookings) ...Ryan Conrad submitted a comment letter with four key observations about efforts to improve the biosimilar approval pathway by lowering the cost and complexity of biosimilar development, with the aim of spurring competition, lowering prices, and expanding patient access... Full

 

FDA Officials Discuss New AI Tool HALO, Other Applications of AI

(5/7, Joanne S. Eglovitch, Regulatory Focus) ...The system-HALO (Harmonized AI and Lifecycle Operation)-was announced Wednesday, alongside the version 4.0 of the agency's Elsa tool. FDA said that is integrating HALO and Elsa, enabling staff to query data and create workflows without the need to manually upload documents for each chat. This consolidation of HALO is expected to enhance the implementation of AI capabilities within the agency's operations... Full

 

 

AZ/Daiichi's Enhertu Lands Earlier-Line Korean Approvals in HER2 Breast and Gastric Cancers

(5/7, Jim Ji-hye, Korea Biomedical Review) ...The Ministry of Food and Drug Safety (MFDS) approved Enhertu, also known as trastuzumab deruxtecan, with Roche's Perjeta (pertuzumab), as a first-line treatment for unresectable or metastatic HER2-positive breast cancer, Daiichi Sankyo Korea and AstraZeneca Korea said Thursday... Full

 

AstraZeneca Deepens AI Oncology Pact with Immunai

(5/7, Olivia Roger, FirstWord PHARMA) ...Immunai CEO Noam Solomon believes AstraZeneca's decision to deepen the partnership is "a strong signal" the platform is delivering. "We are focused on generating insights that are mechanistically grounded and clinically relevant, and collaborations like this one are how we get there," Solomon said. e Immunai will receive an upfront payment and milestone-based consideration of up to $85 million... Full

 

 

Pfizer Builds Out Separate Biosimilars Division

(5/7, Urte Fultinaviciute, Generics Bulletin) ...Certain off-patent branded and generic sterile injectables, as well as biosimilars, were transitioned from specialty care and oncology product portfolios to a new hospital and biosimilars product portfolio. Pfizer also created a new global hospital and biosimilars division, which will sit with Pfizer US commercial and Pfizer international commercial divisions within the biopharma business... Global Sub. Full

 

Healthy Returns: First Ozempic Generics in Canada Will Be a Test Case for Novo Nordisk

(5/7, Annika Kim Constantino, CNBC) ...Some analysts also don't expect the impact of new Canadian generics to spill over into the U.S. Even so, Ozempic sales here may be pressured by other factors, such as competition with Eli Lilly's Mounjaro... Full

 

Cheaper, Generic Semaglutide Grabs Half of India's Market But Novo Nordisk Holds Its Ground

(5/8, Anonna Dutt, The Indian Express) ...The market for the blockbuster diabetes and anti-obesity medicine semaglutide in India is split evenly between the Novo Nordisk's innovator molecule and the generic versions that were launched just over a month ago, according to pharmaceutical market data... Full

 

GLP-1 Patent Expiry & the Rise of Generics: Transforming the Drug Delivery Device Landscape & Procurement Strategy

(5/8, S. Akila and Rahul R. Patil, PharmExec.com) ...An expected surge in generic GLP-1s is anticipated to reshape not only pharmaceutical pricing and access but also the global MedTech ecosystem supporting drug delivery... Full

 

Strengthening the Generic Drugs Supply Chain

(5/7, Mike Hollan, PharmExec.com) ...Natalie de Graaf, VP and GM of data, AI, and machine learning and solutions for health and national security at the API Innovation Center, spoke with Pharmaceutical Executive about the report's findings. The conversation touched on the following points:... Full

 

 

Gilead Guides for Earnings Loss after M&A Mania, but Bumps up Sales Expectations

(5/8, Elizabeth S. Eaton, FirstWord PHARMA) ...During that call, Gilead Chief Financial Officer Andrew Dickinson assured investors that they "should still expect very strong financial performance, on the bottom line and the top line."..."The business continues to perform really well. You see that in our updated guidance, including the increase in the revenue guidance. You also see the ability to absorb all three of these deals, essentially, and to offset with the revenue outperformance the incremental expenses that we expect this year," he said. "We spent a lot of time planning for this as we were looking at the transaction. So we feel very comfortable about the ability to navigate the incremental expenses."... Full

 

Viatris Beats Quarterly Estimates on China Strength, Branded Drug Sales

(5/7, Kunal Das, Reuters) ...Viatris posted quarterly adjusted profit of 59 cents per share, beating analysts' average estimate of 50 cents, according to LSEG data. Revenue rose 8% to $3.52 billion from a year ago, above estimates of $3.36 billion... Full

 

Lupin's US Business to Stay Above $1 Billion; Biosimilars and Specialty Portfolio to Drive Growth

(5/8, Ekta Batra, CNBC-TV18) ...Ramesh Swaminathan, ED & Global CFO at Lupin, said the company expects margins to remain around 25% for the full year, supported by strong performance from products such as Tolvaptan and Mirabegron... Full

 

Biocon Q4 Profit Drops 57% on Exceptional Item Hit; Biosimilars Business Shines

(5/8, The Hindu Business Line) ...Revenue from operations for the quarter stood at Rs4,517 crore, up 13 per cent year-on-year, including licensing income received during the period. The biosimilars business grew 16 per cent year-on-year to Rs2,756 crore during the quarter. The generics segment, however, declined 17 per cent to Rs847 crore, while the CDMO business grew 3 per cent year-on-year to Rs1,037 crore... Full

 

Claire Mazumdar: The 'Intentional Successor' to Biocon's Kiran Mazumdar-Shaw

(5/7, Himani Kothari, Forbes India) ...Where Mazumdar-Shaw learnt to ferment beer in Melbourne before accidentally falling into biotech, Claire trained at the intersection of science and capital in Boston and the Bay Area, two of the world's leading life sciences clusters... Full

 

From Drug Development to M&A, Big Pharmas Showcase AI's 'Measurable Impact'

(5/7, James Waldron, Fierce Biotech) ...AstraZeneca dedicated a slide in its April 29 earnings presentation to showcasing what it has already achieved-as well as clarifying some bold ambitions. The U.K.-based drugmaker has developed its own open-source generative AI framework, dubbed Reinvent, which has halved the time needed to identify molecular structures that could become potential new medicines... Full

 

Amazon Pharmacy to Offer Home Delivery for Novo Nordisk's Ozempic Pill

(5/7, Paige Minemyer, Fierce Healthcare) ...Per the announcement, Amazon customers will be able to secure the oral GLP-1 medication via same-day delivery or pickup within minutes at its kiosks in short order. The drug, which is approved to manage blood sugar in individuals with type 2 diabetes, was originally sold as Rybelsus but was recently rebranded to Ozempic by Novo... Full

 

 

Challenges Abound To Sustain European Biosimilars 'Advantage'

(5/7, Dean Rudge, Generics Bulletin) ...Chair Christine Berndt argued that the next phase of biosimilar growth will depend on regulatory modernization, procurement reform and policy frameworks that support sustainable competition and long-term investment... Global Sub. Full

 

Germany Wants Cheaper Drugs-And Americans To Pay The Difference

(5/7, Sally Pipes, Forbes) ...The German government is looking to cut healthcare spending by tens of billions of euros. To that end, it is pushing pharmaceutical companies to accept significantly lower prices for new medicines. That may help Germany balance its books. But it comes at a cost to American patients and pharmaceutical innovation. It's also fundamentally unfair to the United States... Full

 

India's Pharmaceutical Sector Consolidates Status as the 'Pharmacy of the World'

(5/8, Peethaambaran Kunnathoor, Pharmabiz.com) ...Looking toward 2030, the industry is projected to reach a valuation of US$ 130 billion. The research suggests that the next phase of growth will be driven by a shift from 'volume to value', with increasing investments in complex generics, biosimilars, and specialty medicines. This transition is expected to further cement India's reputation as a high-tech manufacturing hub rather than just a low-cost provider... Full

 

China Opens New Path For Novel Biomedical Technologies

(5/8, Xu Hu, Pink Sheet) ...Eligible novel technologies will be included in an adjustable list released by the National Health Commission (NHC) and should be highly differentiated or for the treatment of rare diseases, with no other product with the same mechanism of action having received marketing authorization or undergoing confirmatory clinical trials in China... Global Sub. Full

 

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