Provention Maps Possible Regulatory Path For Troubled Teplizumab
Biotech Aims To Get Type A Meeting With FDA In Q4
Executive Summary
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.
You may also be interested in...
Provention Plans Two-Phase Launch Of Tzield, Pricing Drug Higher Than Expected
At nearly $194,000, the wholesale acquisition cost for Tzield came in above analysts’ $100,000-$115,000 estimates, but payer pushback is not expected as the drug faces no competition.
Sanofi Alliance Is Big Boost For Company Behind Type 1 Diabetes Prevention Drug
Sanofi has deprioritized its presence in type 1 diabetes in recent years but could help turn teplizumab into a game-changer blockbuster product.
Finance Watch: Recent Upswing Turns Down, But Two Small IPOs Launch
Shuttle Pharmaceuticals and PaxMedica launch two small initial public offerings in the US as the market awaits a significant IPO. Also, Assertio closed a $70m follow-on offering, Codiak restructures and cuts jobs, and Vilya emerges with $50m in series A venture capital.