FDA Wants Public To Weigh In On Crafting Regulatory Framework For GenAI Medical Devices
The FDA is seeking public comment on regulating generative AI-enabled medical devices and released a discussion paper on the topic. The agency wants feedback from stakeholders on risk assessment, premarket evaluation, postmarket monitoring and other issues relevant to AI device regulation.
Medtech Insight - August 19, 2026

Regeneron’s Lowy Bets Combinations Will Carry Its Oncology Business Past PD-1
Regeneron built a PD-1 franchise approaching $2bn in annual sales, then bet on antibody combinations, bispecifics and radiopharma. The biology is sound but execution, toxicity and trial design remain challenges.
In Vivo - August 19, 2026

Scale Of UK Herbal Supplement Liver Injury Unknown
The scale of liver injury from botanical supplements in the UK is unknown because adverse reactions to unlicensed products are not systematically collected. The FSA's expert toxicity committee is examining the data gap, with ashwagandha, green tea, and turmeric already under scrutiny.
HBW Insight - August 19, 2026

The $2.2tn Efficiency Gap: Who Got Their Money’s Worth?
The top 15 drugmakers spent $2.2tn over a decade. Only BMS and Takeda destroyed value; Lilly, Novo Nordisk and AstraZeneca converted spending into outsized value.
In Vivo - August 19, 2026

Trump Expected To Nominate White House Advisor Overton As FDA Commissioner
Overton, a physician and Domestic Policy Council deputy, was the summer front-runner among three finalists before Rep. Buddy Carter emerged late. She would take over an agency thinned by the 2025 cuts and the leadership exodus that followed Martin Makary’s resignation.
Medtech Insight - August 19, 2026

How Celltrion Is Making A Splash In Tenders, Formularies And Pharmacies
Celltrion’s newer biosimilars are translating European tender wins and US reimbursement gains into market share, supporting a stronger sales mix and margin expansion heading into the second half.
Generics Bulletin - August 19, 2026

Lundbeck Lays Foundation To Scale Up From 2027
The Danish drugmaker can boast a transformed pipeline and steady revenue rises that should ensure a sustainable healthy future, according to CEO Charl van Zyl.
Scrip - August 19, 2026

Moderna And Merck’s mRNA Cancer Combo Shines In Phase III Melanoma Trial
Moderna shares nearly doubled premarket on the topline, with detailed results due at an upcoming medical meeting and overall survival still maturing.
Scrip - August 19, 2026

Outlook To Expand Ophthalmic Bevacizumab Empire With Pre-Filled Presentation
Outlook Therapeutics is exploring a pre-filled syringe version of its ophthalmic bevacizumab Lytenava, while eyeing Latin America, Asia, and MENA for further deals.
Generics Bulletin - August 19, 2026

Semaglutide Sole-Supplier Status Brings Both Rewards And Challenges For Apotex In Canada
Apotex has found itself left as the only supplier of generic semaglutide in Canada after Dr Reddy’s dropped out and Aspen was unable to launch. But while the Canadian firm is reaping commercial benefits, it is also having to step up supply to meet demand.
Generics Bulletin - August 19, 2026

Why Tenet’s $30m Round Is Really A Bet On India’s Diagnostics Roll-Up
Tenet Diagnostics’ $30m raise from Tata Capital Healthcare Fund and Blue Earth Capital is less a routine growth round and more an early bet on which platform will consolidate India's fragmented, $10bn-plus diagnostics market first.
Medtech Insight - August 19, 2026

Bio-Thera Expands Dupixent Biosimilar Reach With MENA Deal
Bio-Thera has handed Avalon Pharma exclusive MENA rights to its proposed Dupixent biosimilar BAT2406, extending its international commercialization network as competition builds around the $17.8bn biologic.
Generics Bulletin - August 19, 2026

Regeneron’s Uveitis Setback Adds To String Of Recent Pipeline Challenges
Regeneron’s latest pipeline setback puts fresh focus on its remaining ophthalmology bets and the broader slate of clinical catalysts that will shape its growth outlook.
Scrip - August 19, 2026

UK Hopes Quantum Breast Cancer Imaging Can Lower NHS Wait Times
A £1.65m NIHR grant funds Imperial College’s quantum technique for reading infrared tumor signals via visible light — with NHS deployment and NICE engagement in its sights.
Medtech Insight - August 19, 2026

Sandoz’s Generics-Biosimilars Split Reaches US Leadership
Sandoz has appointed separate US heads for generics and biosimilars, extending its global push to give the two businesses more distinct leadership as their commercial dynamics increasingly diverge.
Generics Bulletin - August 19, 2026

HUTCHMED Advances Global Early Trials For First-In-Class Conjugates
HUTCHMED’s Guangxiu Dai talks to Scrip about the firm’s first-in-class antibody-targeted therapy conjugates and strategies for cross-border partnerships.
Scrip - August 19, 2026