Where Next For Biologics In COPD After Roche’s Astegolimab Phase III Missfire?

 

The Phase III failure could dent Roche’s hopes of entering the COPD market with its novel therapy, despite its success in a large Phase IIb trial. It also marks another disappointment for the anti-IL33/ST2 approach.

Abivax Over The Moon As Obefazimod Storms Phase III

 
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Stock shoots up over 460% on positive results in two ulcerative colitis trials of the oral first-in-class candidate.

The Duchenne Gene Therapies Lining Up To Take Elevidys’ Place

 

Regenxbio and Solid Biosciences believe they have a next-generation approach to AAV-based gene therapies – but must distance themselves from Sarepta’s safety and efficacy problems.

Replimune CRL Could Hold Warning For Accelerated Approvals

 

FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.


Sanofi Doubles Down On Respiratory Vaccines With Vicebio Buy

 
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The French major is paying $1.15bn For the UK biotech and its bivalent candidate, VXB-241.

Chinese Biotechs Sweep ADC Plus PD-(L)1/VEGF Bispecific Combos Into Phase II

 

Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.

Pharma Gets A Compatriot At CDER With Tidmarsh Appointment To Top Spot

 

Drug manufacturers may find comfort in the appointment of former biotech CEO and entrepreneur George Tidmarsh to lead the FDA’s Center for Drug Evaluation and Research.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.


Pipeline Watch: Five Approvals And Twelve 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.

Genentech Gets Columvi Complete Response Following ODAC’s No

 
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Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

Insmed’s New R&D Site Focused On ‘Synthetic Rescue’

 

A new small-molecule approach to turning on beneficial genes to counteract disease-causing mutations is being pioneered by Insmed’s UK-based scientists.


AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
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As AI-driven firms including Insilico, big pharmas J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

In Brief: Kezar Plots Lupus Revival For Zetomipzomib As FDA Lifts Hold On Hepatitis Trial

 
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The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.

AstraZeneca’s Amyloidosis Drug Fails In Phase III But Subgroup Hopes Persist

 

Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.


PureTech Ponders Way Forward As CEO Exits

 
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Bharatt Chowrira departs days after firm’s chair stepped down.

Kailera Eyes Global Obesity Market With Hengrui’s Phase III Dual Agonist

 
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With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.

Sellas Targets Tambiciclib To Adverse-Risk Frontline AML Patients After Phase II Success

 

The biotech announced positive Phase II data for the drug combined with AbbVie/Roche’s Venclexta and BMS’s Vidaza in relapsed/refractory acute myeloid leukemia.

China’s Mid-Cap Companies Thriving On Big Pharma Deals

 

Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.