Sarepta’s Elevidys Limited To Ambulatory DMD Patients
After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, limiting treatment to ambulatory Duchenne muscular dystrophy patients.
Scrip - November 14, 2025

BMS Sees Another Setback As Milvexian Fails Phase III Test
Two Phase III trials of the Factor XIa inhibitor milvexian are ongoing in atrial fibrillation and secondary stroke prevention, but BMS and partner J&J stopped a third in acute coronary syndrome.
Scrip - November 14, 2025

Merck Offers $9.2bn To Buy Cidara And Phase III Antiviral Flu Preventative
Merck & Co. is looking to bolster its respiratory portfolio with Cidara’s Phase III antiviral conjugate CD388, previously owned by Janssen. Phase III data are expected in 2027.
Scrip - November 14, 2025

Another Bidding War As Lundbeck Swoops In On Alkermes/Avadel Deal
The Danish drugmaker is offering more per share in cash and CVRs than Alkermes did in the deal announced in October.
Scrip - November 14, 2025

Zydus Gears Up For Specialty Acquisitions, Gets gLynparza And Other Approvals
Zydus looks to fill up its coffers ahead of the next round of acquisitions, likely in the specialty drugs space, while US FDA approvals for generics to Lynparza and Vumerity and its first approvals in China and Canada point to a healthy pipeline
Scrip - November 14, 2025

Medicxi Lands €500m For New Fund To Fuel Asset-Focused Biotechs
Medicxi V marks the venture capital firm's biggest fund till date, raising its tally to six funds in the last decade, totaling over €2bn.
Scrip - November 14, 2025

Indegene Exec On R&D Operations In The Age Of GenAI, One Click Submissions
Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.
Scrip - November 14, 2025

Korean Pharma Q3 Roundup: Mixed Earnings, Taxotere Deal, R&D Advances
Scrip brings you its quarterly roundup of earnings and other key developments in the Korean pharma sector including the acquisition of Taxotere by Boryung and the progress of Hanmi’s obesity contender.
Scrip - November 14, 2025

FDA’s New Menstrual Products Guidance Focuses On Product Risks
The US FDA is updating its menstrual products guidance for the first time since 2005, adding new recommendations for menstrual cups as well as additional testing guidelines. The document also reflects a new awareness of the potential risks of contaminants within menstrual products.
Medtech Insight - November 15, 2025

Bayer: Product Launches Alone ‘Not Enough’ To Meet Women’s Health Needs
“It’s not good enough just to provide products anymore, we need to create a service and a holistic approach to products,” argued Bayer Consumer Health's Northern Europe general manager, Mike Knowland, speaking at a recent panel event in the UK Parliament.
HBW Insight - November 14, 2025

Packing Producers: Cali’s EPR, Greenwashing Laws Aren’t Based On Same Definition Of ‘Recyclable’
Single-use packaging producers in California must navigate two different recycling definitions under the state’s EPR law (SB 54) and its greenwash labeling law (SB 343), to meet different compliance standards.
HBW Insight - November 14, 2025

Niagen Bioscience Shines Focus On Consumer Health In Long-COVID Study, Skin Care Launch
Daily Niagen use increased NAD+ levels for subjects in long-COVID study, showing “encouraging within-group improvements” in fatigue, sleep and mood. Tru Niagen Beauty is “cellular-first formula designed to support skin elasticity and the appearance of hair, skin, and nails.”
HBW Insight - November 14, 2025

First Perjeta Biosimilar Is Approved In The US For Henlius And Organon
Shanghai Henlius Biotech and Organon have won FDA approval for the first US biosimilar to Roche’s Perjeta (pertuzumab). Their Poherdy version has also been granted an interchangeability designation. However, launch plans may be on hold for now while the partners fight a lawsuit from the originator.
Generics Bulletin - November 14, 2025

Richter’s ‘Problem Child’ General Medicines Division Suffers 64% EBIT Collapse In Q3
Supply-chain bottlenecks, heavy wholesaler de-stocking, and tighter working-capital controls sent Gedeon Richter’s General Medicines sales down by 17% and slashed adjusted EBIT by nearly two-thirds in Q3.
Generics Bulletin - November 14, 2025

‘Never In Doubt’: Alvotech Dodges UK Injunction To Prepare For EU Aflibercept
UK ruling clears the way for Alvotech to stockpile its aflibercept biosimilar ahead of Eylea’s SPC expiry later this month, positioning the firm for a day-one launch across Europe and the UK.
Generics Bulletin - November 14, 2025

CellProthera Targeting Heart Regeneration Where No Treatment Exists
French biotech CellProthera is advancing to Phase III with its autologous CD34+ stem cell therapy that regenerates tissue after severe heart attacks.
In Vivo - November 12, 2025

Patient-Centric Strategy Drives Memo Therapeutics Forward
Memo Therapeutics is sharpening its focus on its lead antibody Potravitug, for BK polyomavirus (BKPyV) in kidney transplant patients as it prepares for Phase III trials and doubles down on patient engagement.
In Vivo - November 12, 2025

Deals Shaping The Industry, October 2025
An interactive look at pharma, medtech and diagnostics deals made during October 2025. Data courtesy of Biomedtracker.
In Vivo - November 12, 2025