RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Amgen (NASDAQ:AMGN) has submitted a marketing application to the FDA seeking approval of AMG 798, a biosimilar to Roche’s (OTCQX:RHHBY) Rituxan (rituximab).
The company is collaborating with Allergan (NYSE:AGN) on four biosimilars, two of which are approved in the U.S. It has primary responsibility for development, manufacturing and initial commercialization.
Gilead Sciences (NASDAQ:GILD) has submitted a marketing application to the FDA seeking approval of filgotinib for patients with moderate-to-severe rheumatoid arthritis.
It filed the application with a Priority Review Voucher which, if the agency accepts it, shortens the review clock to six months.
The company is co-developing and co-commercializing the JAK1 inhibitor with Galapagos NV (NASDAQ:GLPG) under a 2015 agreement. The filing triggers a $20M milestone payment to GLPG.
The board of Biogen (NASDAQ:BIIB) has authorized the repurchase of up to an additional $5B of its outstanding common stock. All reacquired shares will be retired.
The share buy back program authorized in March is still in effect.
Shares up 1% after hours.
Citing its role to do more to protect the young, Canada Minister of Health Patty Hajdu has proposed new regulations to prohibit the promotion and advertising of vaping products in places that it can be seen or heard by youth, including online.
Hoth Therapeutics (NASDAQ:HOTH) has entered into a research collaboration agreement with Weill Cornell Medicine to examine the ability of retinoic acid metabolism blocking agents (RAMBA) to block acne pathogenic gene expression in human keratinocytes, mouse skin, and carcinogenesis in mice.
The research collaboration will be conducted in three phases for a period of one year.
