Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: who’s setting the M&A pace this year; Roche’s pipeline reset; wet AMD market shakeup; Merck & Co. pulls I-DXd filing; and Merck withdraws Recarbio from the market.
Scrip - October 5, 2026

Independent Review Finds FDA Met MDUFA V Commitments, As PCCP Authorizations Triple
An independent Booz Allen Hamilton review found FDA has met its MDUFA V commitments to date. Authorized PCCPs rose to 88 in FY 2025 from 27 a year earlier, but 510(k) time to decision, a goal FDA shares with industry, keeps missing its target.
Medtech Insight - October 2, 2026

US FDA Principal Deputy COO Melissa Shea Departs For NIH
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
Medtech Insight - October 2, 2026

Big Win For Small Patients: FDA Approves First Pediatric Heart Valve That Expands With Growth
The FDA has approved Edwards Lifesciences’ Autus Size-Adjustable Valve, a pediatric pulmonary heart valve designed to expand as a child grows. The novel device, the first agency-cleared valve with polymeric leaflets instead of animal tissue, could reduce repeat open-heart surgeries.
Medtech Insight - October 2, 2026

US FDA Looking At Ophthalmic Manufacturing With Magnifying Glass
CDER executives note focus on GMP compliance by manufacturers and marketers of eye drops and other ophthalmic products at CHPA Regulation, Scientific & Quality conference.
HBW Insight - October 5, 2026

Hyloris Secures A Japanese Deal With Mikasaseiyaku For Maxigesic IV
Hyloris and AFT Pharmaceuticals have licensed Japan commercialization rights for Maxigesic IV (paracetamol/ibuprofen) to Mikasaseiyaku, extending a global partnership network that now covers more than 100 countries.
Generics Bulletin - October 2, 2026

Lendava Plant Opening Boosts Sandoz’s Biosimilars Capacity
A key piece of Sandoz’s ‘Bio100’ strategy has fallen into place with the opening of a major biosimilars manufacturing plant in Lendava, Slovenia.
Generics Bulletin - October 2, 2026

Accord And Bio-Thera Appeal After US Simponi Setback
After J&J’s Janssen succeeded in obtaining a US injunction preventing Accord and Bio-Thera from launching their FDA-approved Simponi biosimilars, the partners have hit back with an immediate appeal. But it is now unclear whether they will be able to launch golimumab as planned by the end of Q4.
Generics Bulletin - October 2, 2026

Proof of Concept - Can AI Outrun the Next Outbreak?
Jared Bauer, co-founder and CEO of Seek Labs, joins Proof of Concept to explain how his company's AI engine maps conserved targets across 145+ pathogens to build programmable CRISPR therapeutics and rapid, lab-free diagnostics.
In Vivo - October 2, 2026

Gilead’s Duty-To-Innovate Win: What The HIV Drug Ruling Means For Pharma Lifecycle Strategy
California's top court refused to hold Gilead liable for delaying a safer HIV drug to protect its franchise – a win for industry. But a parallel Canadian case, and a live split over what it means for lifecycle strategy, leave the duty-to-innovate question unsettled.
In Vivo - October 2, 2026