In a second first in the same week for China, roxadustat (previously FG-4592), developed by Fibrogen Inc. and partnered in the country with Astrazeneca plc, became the first drug advanced by a global biopharma to receive its initial nod from the National Medical Products Administration (NMPA, formerly the CFDA) before applications were submitted to the FDA and EMA. Read More
After a courtship of more than a year, Tetra Discovery Partners LLC and Shionogi & Co. Ltd. tied the knot to develop and commercialize BPN-14770, Tetra's phosphodiesterase 4D (PDE4D) allosteric inhibitor, for the treatment of fragile X syndrome (FXS), Alzheimer's disease (AD) and other indications marked by cognitive and memory deficits. Read More
Series A financings are continuing their record pace, with five additional companies raising a combined total of $139 million, placing 2018 at the top for most venture capital money ever flowing into early stage companies, and doubling the amount raised one year prior: $5.4 billion vs. $2.6 billion. Read More
Comments on a proposed rule requiring drug companies to disclose pricing information in direct-to-consumer (DTC) TV ads drew both qualified support and strong opposition from predictable quarters in responses posted by the U.S. CMS on Monday. Arguments against the rule from industry and advocates for free commercial speech made clear likely lines of attack while positive feedback suggested in some cases that the rule wouldn't go far enough to clarify true out-of-pocket costs in a complex market. Read More
Stamford, Conn.-based Loxo Oncology Inc. and partner Bayer AG, of Leverkusen, Germany, recently scored their expected win with the accelerated clearance by the FDA for Vitrakvi (larotrectinib) to treat adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without an acquired resistance mutation. Read More
HONG KONG – In a deal involving up to $391.5 million, HKEX-listed Innovent Biologics Inc. (HKG:1801) in-licensed three clinical-stage assets from Incyte Corp. to develop and commercialize them in the Chinese mainland, Hong Kong, Macau and Taiwan. Read More
Transthyretin (TTR) amyloidosis (ATTR), a rare disease caused by the misfolding and aggregation of the TTR protein, has reached an inflection point with two drugs approved to treat the disease this year and multiple drugs in development. Read More
Selexis SA, of Geneva, and Menlo Park, Calif.-based Teneobio Inc. said that they have entered into a second services agreement to expand Teneobio's oncology pipeline of human heavy-chain antibodies (Uniabs), a new class of multi-specific biologics. Read More
