Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: a look at the global IPF pipeline; US approval for Takeda's narcolepsy drug; Arrowhead talks differentiation in severe hypertriglyceridemia; SMID Q2 developments; and Attruby positioning in transthyretin-mediated amyloidosis with cardiomyopathy.
Scrip - August 17, 2026

France’s Sonomind Aims For Broad Access To Deep Brain Mental Health Ultrasound
Fresh from winning a clutch of innovation awards in France, mental health ultrasound start-up Sonomind is preparing for clinical trials and regulatory work on the back of a €20m series A funding. CEO Jérémy Bercoff explains the company’s commercialization plans.
Medtech Insight - August 14, 2026

FDA Proposes Class I Status For Seven Device Accessories
An FDA notice due in the Aug. 17 Federal Register proposes independent Class I status for seven device accessories, which would exempt them from premarket review. Comments are open for 60 days.
Medtech Insight - August 14, 2026

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

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

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

Reese Consumer Health’s Transition To Developing, Marketing OTC Brands Has Australian Dream
Reese, which also markets PinWorm oral OTC and ColoTest blood test, acquires Australian Dream brand, for an undisclosed price, from Nature’s Health Connection in Campton, KY.
HBW Insight - August 17, 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

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

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

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