‘Animal Testing’ Cut From FDA’s Drug Development Regs, Furthering Embrace Of New Approach Methods
“Animal test” and “animal study” will be replaced with “nonclinical test” and “nonclinical study” in several regulations as part of the FDA’s effort to encourage more NAMs use.
Medtech Insight - September 21, 2026

J&J’s Multibillion-Dollar Caplyta Ambitions Backed By New Data In Bipolar Mania
The company reported results from the first of two Phase III clinical trials in bipolar mania, which could become the antipsychotic’s fifth US indication.
Scrip - September 21, 2026

Beacon Ready To Approach Regulators With Gene Therapy For XLRP
With successful Phase II/III data for laru-zova in X-linked retinitis pigmentosa, Beacon hopes it can bring the first drug therapy to about 20,000 patients in the US, EU and UK with the retinal disease.
Scrip - September 21, 2026

Medtronic Wins FDA Clearance For LigaSure Instrument For Hugo Surgical Robot
Medtronic has secured FDA clearance for its LigaSure RAS Maryland instrument, adding vessel-sealing and cutting capabilities for minimally invasive urologic procedures to its Hugo robotic system. While the clearance expands Hugo’s instrument portfolio, it does not add new surgical indications.
Medtech Insight - September 21, 2026

Cue’s CSU Data Lands In The Pocket, Showing Benefit Over Xolair
The company expects to initiate a Phase IIb/III registration trial testing the anti-IgE IgG1 antibody in CSU and a Phase II study in food allergy, based on the results of a Phase II trial in China.
Scrip - September 21, 2026

Sandoz Receives Canadian Semaglutide Approval Amid Dr Reddy’s Supply Shortages
Canada’s regulator has issued marketing authorizations for Sandoz’s semaglutide, a GLP-1 receptor agonist injection and a generic version of Ozempic.
Generics Bulletin - September 21, 2026

Telix’s $1.65bn ITM Deal Brings Isotope Supply And Therapeutics Under One Roof
By combining its therapeutic and commercial platform with ITM’s isotope manufacturing business, Telix is seeking to build a more vertically integrated radiopharma operation.
Scrip - September 21, 2026

Bayer Legacy Drug Clean-Up Continues With Stivarga Sale
Deal Snapshot: The company is linking up with fellow German firm Grünenthal which will acquire its soon-to-be off-patent cancer blockbuster in a deal worth up to €375m.
Scrip - September 21, 2026

Takeda-Dr Reddy’s Secure First-Mover Window For Qdenga In India, Dengvaxia Out
Takeda has partnered with Dr Reddy’s in India for distribution of its dengue vaccine, which currently has a clear runway in a market where dengue cases have risen elevenfold in two decades.
Scrip - September 21, 2026

Australia Wants To Reverse Switch Higher-Strength Retinol Skincare
Australia has proposed pushing hundreds of non-prescription retinol skincare products into prescription-only Schedule 4, adopting the EU's cosmetic concentration limits but enforcing them through the Poisons Standard.
HBW Insight - September 21, 2026

Regeneron Sees Eylea HD Biosimilars As ‘Very, Very, Very Unlikely’ In 2027
Regeneron sees a 2027 biosimilar challenge to Eylea HD (aflibercept) as highly unlikely, citing development timelines and patent protection, while additional 2mg competitors are expected to intensify pricing pressure.
Generics Bulletin - September 21, 2026

Pipeline Watch: Telix And Pharming Secure FDA Approvals
The FDA approved Telix’s glioma PET imaging agent and expanded Pharming’s Joenja to young APDS patients, while Akeso and BioNTech posted promising Phase III survival data.
Scrip - September 21, 2026

Novo Looks To Direct-To-Consumer And Diversification To Lift Growth
The company wants to build on the Wegovy pill's success but its new forecast of sector-average growth to 2030 has seen its share price decline again.
Scrip - September 21, 2026

The Shift Toward Precision Immunology in Rheumatology Trials
How biomarker-driven strategies are reshaping patient selection, trial design and clinical development in autoimmune disease.
Scrip - September 21, 2026

IGBA Seeks To Emphasize Value With Global Biosimilars Week
This year’s Global Biosimilars Week awareness campaign from the IGBA is less than a month away, with the event running from Oct. 19-24 and focusing on realizing the global value of biosimilars.
Generics Bulletin - September 21, 2026

Generics Line Up Early For Europe’s 2028 JAKi Patent Cliffs
Gedeon Richter and Zentiva have secured CHMP backing for generic rivals to Xeljanz and Jakavi, adding to a growing queue of challengers positioning ahead of key European patent expiries in 2028.
Generics Bulletin - September 21, 2026

Six Chinese Drugs On Course For Blockbuster Status As Five-Year Plan Sets The Bar
China's government is targeting a minimum of five blockbuster drugs by 2030. At least six Chinese-developed molecules are forecast to cross the $1bn mark in that time.
Scrip - September 21, 2026

FDA Consumer Health Advisory: CHPA Working Hard On Rx-To-OTC Switch
What's happening, why it matters and what's next at FDA. This edition explores CHPA's ongoing negotiations with FDA on Rx-to-OTC switch topics, a warning letter for Bausch + Lomb, and the dismissal of Xlcear's health claim complaint.
HBW Insight - September 21, 2026

Inside BioAge: Kristen Fortney on Aging Research Breakthroughs
Kristen Fortney discusses surviving azelaprag's discontinuation, why BGE-102's 86% hsCRP reduction changed BioAge's story and the state of longevity medicine.
In Vivo - September 21, 2026

CDER Director Mike Davis Eyes AI As Solution To Institutional Memory Loss
FDA's drug review chief wants artificial intelligence to do what regulators can no longer do after a wave of retirements: remember every decision the agency has ever made.
HBW Insight - September 21, 2026

BEMT’s US Legacy May Be Framework It Built For Other UV Filters — DSM-Firmenich
Dsm-firmenich spent two decades working to add BEMT to the OTC sunscreen monograph — but the path it cleared for future UV filters and non-animal testing may prove to be the more lasting achievement.
HBW Insight - September 21, 2026