Launching a broad new front in its long-running battle against dementia and other neurological diseases, Biogen Inc. has moved to license multiple Sangamo Therapeutics Inc. programs for $350 million up front plus up to $2.37 billion in development, regulatory and commercial milestone payments. Read More
With the FDA’s blessing, Biohaven Pharmaceutical Holding Co. Ltd.’s Nurtec ODT (rimegepant) enters a massive market for treating migraine in adults. In the U.S. alone, more than 25 million people have been diagnosed and seek treatment. Read More
DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches. Read More
Aptevo Therapeutics Inc.’s chief scientific officer, Jane Gross, told BioWorld that the sale of the firm’s marketed recombinant hemophilia B therapeutic, Ixinity, to Medexus Pharmaceuticals Inc. allowed for a “cleaner message” to Wall Street. “It was a little difficult to explain having a commercial asset and an R&D pipeline,” she said. Read More
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company. Read More
HONG KONG – Singapore-based Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy (RMAT) designation by the U.S. FDA based on data from two independent phase I/II trials in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma. Read More
The U.S. FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition (CPC) says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting (CPAM). It added that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process. Read More
BioWorld looks at translational medicine, including: Finding the next pandemic threat early on; Microglial fresh start helps heal brain trauma; Finding the silent majority; Anatomy study reveals schizophrenia subtypes; Increasing immune activity improves autoimmunity; How cancer cells hibernate…; …And who makes their bed; Blocking trash trashes MSI-hi tumors; New splicing factor implicated in muscular dystrophy. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antibe, Biodelivery, Galera, Huya, Ironwood Sorrento. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agex, Altimmune, Generex, Graybug, Merck, Sonoma, Therapix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Biohaven, Boehringer Ingelheim, Debiopharm, Lilly, Fennec, Innocoll, Mereo, Shionogi, Takeda. Read More
