Given improvements that Basel, Switzerland-based Novartis AG made to its patient access program for Kisqali (ribociclib), the U.K.'s National Institute for Health and Care Excellence (NICE) is recommending the drug, used with fulvestrant chemotherapy, as an option for people with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy.
Neuralstem Inc., of Germantown, Md., completed a reverse stock split of its shares of common stock at a ratio of 1-for-20. The reverse stock split becomes effective Wednesday. The split enables Neuralstem to regain compliance with the $1 minimum bid price condition of Nasdaq.
Eyenovia Inc., of New York, said it closed its underwritten public offering of 4.38 million shares of common stock at $2.78 each for net proceeds of approximately $11.2 million.
Flex Pharma Inc., of Boston, said its stockholders approved all proposals relating to its planned merger with Houston-based Salarius Pharmaceuticals LLC at its special meeting. The merger is expected to be completed within the next two weeks.
Two decades in the making, a mutual recognition agreement between the FDA and EMA is now fully implemented. Slovakia was the last EU member state to get the FDA's seal of approval for its conduct of drug manufacturing inspections.
Valeo Pharma Inc., of Montreal, said it filed its final short form prospectus in each of the provinces and territories of Canada in connection with its sale of a minimum of 4 million units and a maximum of 16 million units at CA50 cents each for gross proceeds of between CA$2 million (US$1.53 million) and CA$8 million (US$6.13 million).