Struggling Mereo Biopharma Group plc disclosed six-month data from the open-label arm of its phase IIb dose-ranging study in adults with type I, III or IV osteogenesis imperfecta treated with BPS-804 (setrusumab). Denise Scots-Knight, Mereo's CEO, said results from the Asteroid study were in line with company expectations and she expects 12-month headline data from blinded arms of the study in the second half of this year. Read More
A medicine that may bring people with bipolar depression and acute suicidal ideation a safer, non-hallucinogenic alternative to repeated ketamine use for relapse prevention has succeeded in a small midstage study, supporting pursuit of a pivotal trial by its developer, Neurorx Inc. The Philadelphia-based company said based on its phase II data, the FDA has granted the fixed-dose cycloserine/lurasidone combination, NRX-101, a breakthrough therapy designation and a special protocol assessment for the pivotal study, expected to begin in the second half of this year. Read More
In the ongoing quest for more personalized and effective cancer treatments, Leverkusen, Germany-based Bayer AG is partnering with Roche Holding AG's Foundation Medicine Inc. (FMI) to develop genetic sequencing tests to identify patients who might benefit from various approved and investigational cancer therapies. Read More
The hematology world is a-twitter about the imminent approval of Zynteglo (betibeglogene darolentivec), the lentiglobin cell and gene therapy from Bluebird Bio Inc. that’s expected to become the first gene therapy to address the blood disease beta-thalassemia and the company’s first product to market. Read More
Helix Biopharma Corp., of Richmond Hill, Ontario, said it closed a private placement financing for gross proceeds of CA$507,960 (US$376,163). The company intends to use the net proceeds for working capital and research and development activities. Read More
While some U.S. lawmakers continue to push legislation that would allow the import of drugs from Canada to take advantage of lower prices, another public health agency in Canada is seeking to import an urgently needed tuberculosis (TB) drug from the U.S. that isn't available in Canada. Read More
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, said it signed a co-promotion and sales collaboration agreement with Novartis Pharma KK (NPKK), a unit of Novartis AG, of Basel, Switzerland, covering Equa (vildagliptin), a selective DPP-4 inhibitor, and Equmet (vildagliptin and metformin), a combination selective DPP-4 inhibitor and biguanide agent, to treat type 2 diabetes in Japan. Read More
Adding on to its $14 million series A round in April 2018, TFF Pharmaceuticals Inc. has secured another $8.17 million for the round to support development of its namesake thin film freezing (TFF) technology that was developed to increase the solubility of drugs. Read More
HONG KONG – Many agree that a biotech ecosystem is growing and approaching critical mass in China. But for the industry to leap, biotech scientists point to the need for more clinical talent and a better reimbursement system, while health care investors want to see the ecosystem maturing. Read More
