Another Safety Alert For Impella As Abiomed Warns Of Controller Failure
FDA alert is 14th in three years as Impella faces growing questions about its safety and efficacy.
Medtech Insight - September 25, 2026

BsUFA IV Agreement Includes Push To Reduce Revenue, Cuts Product Development Fees
The changes should lead to lower annual revenue targets and will eliminate fees created in 2012 to help the program’s growth.
Generics Bulletin - September 25, 2026

GLP-1 Giant Eli Lilly Eyes $100m Oura Stake As Smart-Ring Maker Heads For IPO
Oura is asking public markets to value a sleep-tracking ring at $16bn, with Eli Lilly and Dragoneer lined up as early buyers — a filing that arrives on the back of $1.21bn in nine-month revenue and 74% year-on-year growth.
Medtech Insight - September 25, 2026

The Eight Potential Immunological Blockbusters Coming To Market In 2027
Of the 11 novel products in development in the immunology segment due to be launched next year, eight are expected to pull in blockbuster sales as the myasthenia gravis and hereditary angioedema markets get more packed.
Scrip - September 25, 2026

Executives On The Move: Jasper Therapeutics Bolsters Leadership After Kira Merger
Among other executive moves is Bavarian Nordic recruiting a new CEO from Sanofi and Legend Biotech bringing in a new CEO from Novartis.
Scrip - September 25, 2026

‘SNAC’ Bar: Novo Turns Up Heat In India Oral Semaglutide Patent Battle
Novo Nordisk's oral semaglutide patent battle in India turns combative, with the Danish firm crying foul over Torrent's court undertaking on the SNAC concentration and also seeking to “cross-verify and check” Sun’s assertions pertaining to the product.
Scrip - September 25, 2026

FDA Nod For Welireg-Lenvima Extends Merck’s Push Across The RCC Pathway
With another RCC approval in hand, Merck now faces the bigger question of how far it can extend Welireg through earlier treatment, combinations and new disease settings.
Scrip - September 25, 2026

NRx Speeds Up Ketamine Verdict With FDA Revision
NRx Pharmaceuticals has reported positive news on its ANDA for preservative-free IV ketamine, with the FDA moving up the product’s GDUFA goal date to Nov. 10 after reclassifying an ANDA amendment from major to minor.
Generics Bulletin - September 25, 2026

MPP Targets Pandemic Preparedness With Xofluza Generic Licenses
The Medicines Patent Pool has granted 11 sub-licensees the right to develop, manufacture and supply generic versions of Roche’s Xofluza (baloxavir marboxil) in 129 low- and middle-income countries.
Generics Bulletin - September 25, 2026

Should Pharma Use Its PR Clout Against Climate Damage?
Campaigners are calling on pharma companies and health organizations to refuse to work with PR agencies that also work for fossil fuel companies.
Scrip - September 25, 2026

Do API Exporters Really Need To Brace For The Sept. 29 Deadline Of US Tariffs?
Sept. 29 marks the deadline for round two of US tariffs to hit. Scrip examined US Pharmacopeia data to consider what proportion of active pharmaceutical ingredients (API) makers need to brace for the impact of a 100% tariff.
Scrip - September 25, 2026

The Trust Test: Why Health Leaders Should Rethink Who Speaks For Them
Jemilah Mahmood, exec director of Sunway Centre for Planetary Health, argues pharma companies should screen PR agencies for fossil fuel client ties, calling it "basic due diligence of credible climate and health leadership."
In Vivo - September 25, 2026

Should Pharma Care Who Else Its PR Agencies Work For?
A growing coalition of health organizations is calling on the pharmaceutical industry to stop working with PR companies that also serve fossil fuel clients, but an investigation found the question has not yet registered within pharma’s procurement practice.
In Vivo - September 25, 2026

Norstella Launches Capsul, A Daily Intelligence Brief For Pharma and Biotech
The free-to-read intelligence brief is written and curated by the journalists behind Pink Sheet, Scrip and In Vivo.
Scrip - September 25, 2026

CHPA RSQ Conference: From AI To UV Filters, NAMs To Supply Chain Security
Presentations at Sept. 28-30 conference include leaders from FDA’s drug and medical device centers and supplement program outlining priorities and projects and workshop on new approach methods for drug studies.
HBW Insight - September 25, 2026

Lipo Flavonoid Fails To Support Earwax Removal Efficacy, Safety And Market Claims In NAD Review
NAD says Lipo fails to support express claims for Earwax Cleansing Kit & Aid Drops including “5 times faster than traditional cleansers” and “clinically tested formula” challenged by eosera.
HBW Insight - September 25, 2026