1. Scrip
  2. >>Business

Provention Maps Possible Regulatory Path For Troubled Teplizumab

Biotech Aims To Get Type A Meeting With FDA In Q4

 
• By Sten Stovall

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.  

Provention Must Address FDA Concerns Cited In Complete Response Letter • Source: Alamy

Provention Bio, Inc. is making some headway in its efforts to unblock the regulatory passage of its potential immunotherapy, teplizumab, following receipt in July of a complete response letter, and plans to request a fourth quarter 2021 Type A meeting with the US Food and Drug Administration to discuss the way forward for the anti-CD3 monoclonal antibody.

The biotech is busy collecting fresh data after receiving the complete response letter regarding its filing for teplizumab as a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

Bristol Appoints AstraZeneca’s Massacesi As Next CMO

 
• By Jessica Merrill

Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

Deal Watch: Novartis Hopes To Ace Inflammatory Disease With Matchpoint Tie-Up

 
• By Joseph Haas, Lisa Takagi, and Manas Mishra

Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.

Viking Rapidly Advancing Oral And Injectable VK2735 For Obesity

 
• By Joseph Haas

In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.

More from Scrip

Deal Watch: Novartis Hopes To Ace Inflammatory Disease With Matchpoint Tie-Up

 
• By Joseph Haas, Lisa Takagi, and Manas Mishra

Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Executives On The Move: Three New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Trogenix and Quetzal Therapeutics, plus Synendos Therapeutics gains a new CMO from Roche.