CDRH Sets September Meeting To Address AI, Digital Health Regulatory Science Gaps
The FDA’s device center will hold a public meeting in September on how regulatory science must evolve to keep pace with advances in medical technology. Discussions will focus on AI and digital health, emerging technologies, and new approaches to evidence generation and testing.
Medtech Insight - August 14, 2026

BMS Targets Community Setting With Zenbexus, Its First Approved CELMoD
Zenbexus (iberdomide) got FDA accelerated approval for multiple myeloma as the first in the new class of oral targeted protein degraders that BMS is developing to supplant the older IMiD class.
Scrip - August 14, 2026

Hemophilia Gene Therapy’s Commercial Reckoning
Two of three approved gene therapies for hemophilia have left the market and a fourth candidate went to a bankruptcy auction recently and found no buyer. The science worked but the business did not. What went wrong? And what does it mean for every gene therapy program that follows?
In Vivo - August 14, 2026

Newly Public Yarrow Brings A First-In-Class Approach To Graves And TED
CEO Rebecca Frey talked to Scrip about the company’s plan to develop a potential first-in-class anti-TSHR antibody after completing a reverse merger to go public.
Scrip - August 14, 2026

Beiersdorf CEO Teases Novel Microbiome Approach To Acne
Beiersdorf is moving decades of microbiome research toward a consumer skin-care application, using probiotic strains to target acne through a different biological approach.
HBW Insight - August 14, 2026

First FDA-Approved OTC ED Treatment: Why Haleon Walked And What Comes Next
Haleon will no longer market Eroxon in the US after repeat sales of the first FDA-approved OTC ED treatment disappointed. Consumer efficacy doubts appear central to its struggles. Developer Futura presses on with a new distributor, a commission-based model, and an FDA filing for a line extension.
HBW Insight - August 14, 2026

NSAI Will Make ‘Orderly Exit’ From MDR Notified Body Business
Company cites increasing regulatory complexity as it seeks buyer for notified body within 1-3 years.
Medtech Insight - August 14, 2026

Zealand CEO Talks Up Petrelintide’s Weight Loss Prospects
Adam Steensberg tells analysts that KOLs like the value proposition that has been built for Roche-partnered petrelintide, "a benign, highly tolerable therapy delivering double-digit weight loss."
Scrip - August 14, 2026

Respiratory Feats Put Glenmark’s US Recovery On Firmer Footing
Glenmark’s US recovery accelerated in Q1 FY27 as respiratory launches drove nearly 20% underlying growth, with further approvals expected in the second half and management forecasting sustained momentum.
Generics Bulletin - August 14, 2026

GSK India Portfolio Pivot Gathers Pace, Blenrep Poised As Oncology ‘Arrowhead’
GSK India sharpens its specialty thrust with a string of oncology and vaccine launches lined up as the company aligns with the group’s wider global strategy while also holding ground on its general medicines base.
Scrip - August 14, 2026

EU PPWR Labeling For Medtech: New Symbols, Old Space Problem
The PPWR bolts new packaging-labeling duties onto device packs already governed by the MDR and IVDR. Manufacturer identification kicks in from Aug. 12; harmonized material and sorting pictograms follow from 2028. Experts told Medtech Insight the hardest part is finding room for it all.
Medtech Insight - August 14, 2026

Alfasigma Continues Expansion With Nordic Deal
Following a share purchase agreement between Italian firm Alfasigma and Nordic Group B.V, Alfasigma is set to acquire 100% of shares in the Nordic group and its subsidiaries, widening its specialty portfolio.
Generics Bulletin - August 14, 2026

Spending More To Produce Less? How Industry Productivity Is Really Faring
Norstella’s new Pipeline-to-Patient Productivity Index promises to give the most comprehensive assessment of pharma productivity yet – its inaugural findings capture the many moving parts in getting novel drugs to patients and the scale of the challenges facing the industry.
Scrip - August 14, 2026

Europe May Follow France’s Biosimilar Lead, Germany Reforms Cut Both Ways: Lupin CEO
France’s model of incentivizing biosimilars substitution to aid innovator drug purchases could be worthy of emulation while Germany’s recently announced changes cut both ways, says Lupin’s CEO Vinita Gupta as she also talks of South Africa semaglutide launch plans.
Generics Bulletin - August 14, 2026

G&W Must Face Jury Over Alleged Generics Price-Fixing Conspiracy
G&W Laboratories has failed to escape the states’ wider generics price-fixing case, leaving allegations over an overarching conspiracy and key product-specific claims for a jury to consider in February 2027.
Generics Bulletin - August 14, 2026

Novartis Keeps UK Entresto Generics At Bay Until 2028
Accord has failed to clear the way for its planned UK generic Entresto launch after the High Court upheld Novartis’ patent and SPC, although one of the generics firm’s validity attacks came close to succeeding.
Generics Bulletin - August 14, 2026

Novartis Keeps UK Entresto Generics At Bay Until 2028
Accord has failed to clear the way for its planned UK generic Entresto launch after the UK High Court upheld Novartis’ patent and SPC, although one of the generics firm’s validity attacks came close to succeeding.
Generics Bulletin - August 14, 2026

Sumitomo Rebuts Gotham’s Accounting ‘Black Hole’ Allegations
Sumitomo Pharma has had to address allegations relating to its accounting practices from US investment company Gotham City Research, which charges the Japanese firm inflated earnings.
Scrip - August 14, 2026