Calcium

Arising out of Calcium’s DEI initiatives, the agency has launched the “I DON’T HAVE A BOX” campaign to drive awareness of the “race box” used in health data collection and its shortcomings in capturing true racial and ethnic diversity.

Kimberly Cash, Two Labs

For emerging manufacturers, listing through all the steps of a launch plan can be intimidating, so hearing that medical affairs and communications needs to be integrated from the beginning can feel like one more thing is being added to the overflowing to-do list of an understaffed team.

The biopharma world – and markets – spent Thursday evening reacting as the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s AMX0035. 

Intercept Pharmaceuticals

Intercept Pharmaceuticals Inc. said on Friday its treatment for patients with advanced liver scarring due to non-alcoholic steatohepatitis (NASH) failed to meet the main goal of a late-stage study, sending its shares down as much as 21%.

Moderna

As it gears up to launch several new products in the coming months, Moderna has created a new leadership role and onboarded an industry veteran, the company announced Thursday.

handshake

Two struggling Boston-based gene therapy companies – Solid Biosciences and AavantiBio – announced Friday they are merging to develop a portfolio of neuromuscular and cardiac programs, initially focusing on a lead candidate to treat Duchenne muscular dystrophy.