Any worries by Promedior Inc. investors after Bristol-Myers Squibb Co. (BMS) backed away last year from its option to acquire the firm were resolved in a big way by last week's news that Roche Holding AG is taking over the company in a transaction valued as high as $1.39 billion. Privately held, Lexington, Mass.-based Promedior's lead asset is PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that won breakthrough designation from the FDA earlier this year for idiopathic pulmonary fibrosis (IPF). Read More
BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Read More
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020. Read More
About two months ahead of the priority review action date, Novartis AG scored FDA clearance for Adakveo (crizanlizumab), previously known as SEG-101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 and older with sickle cell disease (SCD). Read More
DUBLIN – Friday marked an important milestone for the EMA as its settles into its new home in Amsterdam. The Dutch authorities formally handed over to the agency the keys to its new building, which is located in the Zuidas district of the city. Read More
HONG KONG – U.S.-based biotech firm Egenesis Inc., headquartered in Cambridge, Mass., has received $100 million through a series B funding round for the development of safe and effective human-compatible organs through gene editing. Read More
Restorbio Inc.'s PROTECTOR 1 phase III study failed to meet its primary endpoint and the company shares tracked deeply downward Friday. The trial was designed to evaluate RTB-101 in preventing clinically symptomatic respiratory illness (CSRI) in adults ages 65 and older. Read More
SHANGHAI – As Chinese biotech companies talk more about innovation, one question is whether they are ready to move into first-in-class drugs from me-too and fast follow-up drugs. Biotech executives said China still lacks the comprehensive ecosystem to support such time-consuming and high-risk R&D, but it is time to do so and they must go ahead. Read More
The discovery that thalidomide and its analogues work by inducing the degradation of transcription factors demonstrated both that protein degradation is a viable mechanism of action for therapeutic small molecules, and that it could be used to target transcription factors, which are undruggable by both biologics and traditional inhibitors. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
