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Vaxcyte’s 24-Valent Pneumococcal Vaccine Shows Best-In-Class Potential

Small Biotech Hopes To Compete In Big Pharma-Dominated Market

 
• By Joseph Haas

The biotech’s share price jumps more than two-thirds as analysts hail top-line Phase I/II data as better than expected. Vaxcyte hopes to hold Phase III planning discussions with the FDA in 2023.

Vaccine syringe
Vaxcyte's proof-of-concept data for its PCV candidate has company, investors excited • Source: Shutterstock

Vaxcyte, Inc. unveiled top-line Phase I/II data for its 24-valent pneumococcal conjugate vaccine (PCV) on 24 October, showing safety comparable to Pfizer Inc.’s Prevnar 20 and demonstrating non-inferiority on opsonophagocytic activity (OPA) across all 20 serotypes covered by Prevnar 20, with higher immune responses seen on 16 serotypes. VAX-24 also addresses four serotypes of invasive pneumococcal disease not covered by Prevnar 20 or any competing product and met standard superiority criteria for each in the data readout, the company said.

Various companies have been competing on what has long been the standard of care vaccine for the prevention of pneumococcal...

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Bayer Bags First Global Okay For Hot Flashes Therapy

 
• By Kevin Grogan

Lynkuet will compete with Astellas's Veozah/Veoza

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 
• By Dexter Jie Yan

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

Ultragenyx and Mereo Still Confident Despite Setrusumab Slip Up

 
• By Kevin Grogan

The osteogenesis imperfecta drug stumbled in a second interim analysis.

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Investors Back Nuclidium’s Next-Gen Copper-Based Radiopharmaceuticals

 
• By Andrew McConaghie

The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.

Lupin’s Cimzia Biosimilar Candidate Reflects Strategy To Separate Wheat From Chaff

 
• By Vibha Ravi

Lupin's choice of a Cimzia biosimilar candidate and partnering with Zentiva reflect a strategy to sort the wheat from the chaff. Of 118 biologics to lose patent protection between 2025 and 2034 as per IQVIA, it’s going for a biosimilar with a single competitor though there could be other spoilers

Taiho’s Oral, Mutation-Agnostic DMD Candidate Misses Phase III Endpoint

 
• By Lisa Takagi

The oral, twice-daily candidate was expected to control decline in motor function in DMD patients regardless of their gene mutations.