Proteostasis Therapeutics Inc. CEO Meenu Chhabra pointed to a “new reality in cystic fibrosis [CF] research” faced by her firm and others: the challenge of enrolling the best patients. Read More
While the market gave Adamas Pharmaceuticals Inc. shares a thrashing Tuesday, newly installed CEO Neil McFarlane wouldn’t call it quits on the data generated from the phase III of ADS-5102, the Inroads study for treating multiple sclerosis patients with walking impairment. Read More
The warning bells about the global threat of the rise of antimicrobial-resistant (AMR) infections and dearth of new antibiotics seem to have been ringing for several years now. However, the prospects of companies developing new antibiotics, buoyed by regulatory incentives and grant funding, should on the face of it be an attractive proposition for investors. Read More
The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but generic drug makers and device makers saw other benefits. The two bills not only repealed the medical device tax, but also would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, a move intended to tamp down on the cost of small-molecule pharmaceuticals and biotech therapies. Read More
HONG KONG –Nkmax America Inc., of Santa Ana, Calif., a natural killer (NK) cell-based therapy developer, has secured $11 million in a seed funding round. It is the company’s first funding round in the U.S. capital market. The company is owned by South Korean biotech firm Nkmax Co. Ltd. based in Seongnam. Read More
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 to address depressive symptoms in multiple sclerosis (MS). Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
