Pharvaris’s Phase III HAE Data Position Deucrictibant For 2026 NDA Filing
Pharvaris’s oral bradykinin B2 antagonist hit all endpoints in a Phase III study in hereditary angioedema attacks, meaning the drug could be competing soon with Kalvista’s Ekterly.
Scrip - December 3, 2025

Bristol To Add Patients To Cobenfy Trial To Make Up For Site Irregularities
The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.
Scrip - December 3, 2025

Deal Watch: Akebia Gets Phase II Alopecia Areata Candidate From Cost-Conscious Q32
AstraZeneca quietly acquires Six Peaks, plus deals involving Bayer/Dare, Tempest/Factor, XenoTherapeutics/Repare, DayOne/Mersana and more.
Scrip - December 3, 2025

Phase III Data Positions Capricor To Refile Deramiocel In Duchenne Cardiomyopathy
The pivotal Phase III trial met the primary and secondary endpoints, showing skeletal and cardiac benefits and supporting deramiocel as a treatment for Duchenne cardiomyopathy.
Scrip - December 3, 2025

Analysts Unfazed By Janux’s Weaker Prostate Cancer Results
Janux wowed last year with first data from its ‘masked’ T-cell engager, JANX007, but investors have been spooked by newly updated results for the product. Analysts, however, still think it can compete with rivals from Amgen and J&J.
Scrip - December 3, 2025

Vertanical Closes In On Goal To Replace Opioids For Pain
If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.
Scrip - December 3, 2025

CTAD Notebook: Novo Explains Semaglutide Alzheimer’s Rationale, Roche’s Trontinemab Update
At the Clinical Trials On Alzheimer’s Disease meeting, Novo explained why it tested semaglutide in AD a day before the company’s Phase III EVOKE/EVOKE+ presentation, Roche updated Phase Ib/IIa results for its anti-amyloid trontinemab and UCB’s bepranemab remains in limbo.
Scrip - December 3, 2025

HighTide’s First-In-Class Diabetes Contender Numerically Superior To Farxiga Glycemic Control
In the head-to-head Phase III HARMONY trial in metformin-failed type 2 diabetes, HighTide's HTD1801 yielded a mean 1.12% reduction in HbA1c from baseline at 24 weeks, versus 0.93% for AstraZeneca’s Farxiga.
Scrip - December 3, 2025

Truvian Secures FDA Clearance For Benchtop Blood-Testing System, Eyes Full Launch H2 2026
Truvian reached a major milestone with the FDA clearance of its blood-testing benchtop but is awaiting further FDA clearances of blood panels before a full launch in the second half of 2026.
Medtech Insight - December 3, 2025

US CGM, Pumps Reimbursement Change Raises Access And Pricing Concerns
New rule in effect Jan. 1 follows OIG call for CMS to use competitive bidding to adjust payments for continuous glucose monitors after finding that Medicare was paying above supplier costs and retail prices.
Medtech Insight - December 3, 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

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
Generics Bulletin - December 3, 2025

Pricing Peak Propels Propranolol To Pole Position In November
Propranolol prices that were almost five times higher in November meant that the beta-blocker topped our table of UK price rises this month, as ciprofloxacin prices also continued to climb.
Generics Bulletin - December 3, 2025

FDA Approval Sets Stage For Accord’s 2026 Denosumab Biosimilars Rollout
FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.
Generics Bulletin - December 3, 2025

Amneal Scores Dual FDA Wins In High-Value Complex Generics
Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.
Generics Bulletin - December 3, 2025

Astellas Joint Venture Aims To Automate Cell Therapy Manufacturing
Cellafa Bioscience, an Astellas-Yaskawa joint venture, uses Maholo robotic automation and AI to standardize cell therapy manufacturing, targeting GMP compliance within two years and global expansion.
In Vivo - December 3, 2025

Separations, Value Creation And Innovation – Healthtech’s Script In 2026
Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.
In Vivo - December 3, 2025

2026’s Sales Growth Winners And Losers
The pharmaceutical industry continues to experience significant shifts in sales performance, with some companies achieving remarkable growth while others face stagnation or decline.
In Vivo - December 3, 2025