Cosmo Cuts A Swathe Through Hair Loss Field With Phase III Wins
The company says that clascoterone presents the first potential innovation in over 30 years in male hair loss.
Scrip - December 4, 2025

Reddy’s To Keep Producing Semaglutide In India As Novo Denied Interim Relief
A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.
Generics Bulletin - December 4, 2025

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
Generics Bulletin - December 4, 2025

The Talk Of The Town: Biosimilars Developers React To FDA Streamlining
In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.
Generics Bulletin - December 4, 2025

Lupin Signs A Deal With Valorum For Its First Approved Biosimilar Pegfilgrastim
Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.
Generics Bulletin - December 4, 2025

EPO Appeal Board Strikes Down Biogen’s European Tecfidera Patent
EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.
Generics Bulletin - December 4, 2025

Bayer Aims To Broaden Mirena’s Use With Phase III Endometrial Hyperplasia Study
Bayer has begun a Phase III trial evaluating its intrauterine device for non-atypical endometrial hyperplasia, a condition with no approved medical treatments.
Scrip - December 4, 2025

Scrip 100: Double-Digit Growth Propels Leaderboard Gainers
AstraZeneca, Lilly, Novo Nordisk and Amgen all moved up in the rankings on the Scrip 100 leaderboard powered by impressive double-digit growth.
In Vivo - December 4, 2025

UK MHRA’s Medtech Regulatory Update Must Keep Future EU MDR Changes In Mind
The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.
Medtech Insight - December 4, 2025

Sun’s Ilumya India Price Play Seen Reflecting ‘Global Discipline’
Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?
Scrip - December 4, 2025

CTAD Notebook: Novo’s Semaglutide Data Show No Difference From Placebo In AD
Novo Nordisk presented topline results from its Phase III semaglutide studies at the Clinical Trials on Alzheimer’s Disease meeting, Lilly SVP Ronald DeMattos advocated for anti-amyloid brain shuttles to reduce ARIA and Eisai presented subcutaneous Leqembi data.
Scrip - December 4, 2025

In Latest US FDA Drug Center Change, Lead In OTC Monograph, Switch Program Overhauls Out
FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.
HBW Insight - December 4, 2025