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Six Pivotal Trial Readouts To Look Out For In Q4

 
• By Ayisha Sharma

With help from Biomedtracker, Scrip takes a look at six drug candidates expecting pivotal data by the end of the year. The assets span a range of therapeutic areas, from ophthalmology to neurology, and are poised to become market firsts, rivals to dominant products or win important label expansions.  

Arrow shooting through complex maze
These Six Drug Candidates Are Approaching The End Of The Pipeline • Source: Shutterstock

Roche Holding AG and partners Chugai Pharmaceutical Co., Ltd. and MorphoSys AG are anticipating data from their IgG1 antibody for Alzheimer’s disease (AD), gantenerumab.

The candidate targets amyloid beta, an approach that saw a recent resurgence of confidence after rival Eisai Co., Ltd....

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IO Biotech Plans Cylembio Filing Despite ‘Narrowly Missed’ Phase III Endpoint

 
• By Mandy Jackson

The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.

Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 
• By Dexter Jie Yan

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

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Novartis’s ‘Pipeline-In-A-Product’ Assets Progressing Well

 
• By Kevin Grogan

CMO Shreeram Aradhye talks to Scrip about the promise shown by ianalumab, remibrutinib and a next-generation CAR-T for immunological disorders.

Vertex’s Pain Drug Failure Adds To Investor Doubts

 
• By Andrew McConaghie

A Phase II trial to develop a second NaV1.8 pain signal inhibitor for acute pain has failed and the US FDA has given a thumbs down on Journavx’s path to broader use in peripheral neuropathic pain.

Cardiff Pushes Towards Colorectal Cancer Phase III As Funding Questions Loom

 
• By Manas Mishra

Cardiff Oncology is open to going it alone, a partnership and even an exit as the San Diego, CA-based firm tries to push its PLK1 inhibitor through late-stage development.