Despite some skepticism heading toward the July 21 PDUFA date, Puma Biotechnology Inc.'s breast cancer drug, Nerlynx (neratinib), won FDA approval a few days early, marking the first treatment designated as an extended adjuvant therapy in patients with early stage, HER2-positive disease.
Cymabay Therapeutics Inc., of Newark, Calif., said it intends to offer and sell 10 million shares of its common stock, subject to market and other conditions, in an underwritten public offering.
In a big news day for Duchenne muscular dystrophy (DMD) companies, Capricor Therapeutics Inc. CEO Linda Marbán told BioWorld that investors will "see news coming in the next week or two with a clearly delineated path to registration" for CAP-1002. "We have a trial design; we have a plan on what has to be done."
Ushering in what could be a new era of treatment for hard-to-fight cancers, members of the FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously Wednesday in support of Novartis AG's CTL-019 (tisagenlecleucel), the first bespoke chimeric antigen receptor T-cell (CAR T) immunotherapy to be considered by the panel.
LONDON - The U.K. government has given the industry formal notice that it aims to keep the Medicines and Healthcare products Regulatory Agency (MHRA) involved in and aligned with the EMA when the U.K. leaves the EU.
Targovax ASA, of Oslo, Norway, said it had allocated 323,268 shares (Oslo:TRVK) to subscribers in its subsequent offering, which expired July 14. Øystein Soug, the company's CEO and primary insider, and his close associate Abakus Invest AS have received their full allocations of subscribed shares and will now hold 109,598 shares, representing about 0.2 percent of the votes and shares in the company following the completion of the offering.
HONG KONG – After more than a decade of development, Maryland-based Tissuegene Inc. and its Asia licensee, Kolon Life Science Inc., received a bittersweet go-ahead from the South Korean authorities to market gene therapy drug Invossa-K.
LONDON – The U.K. government announced an £86 million (US$112.3 million) funding package to promote the uptake of digital health and other novel technologies, as the first step in taking forward the Accelerated Access Review (AAR), an independent report that made 18 recommendations to promote a step change in the speed at which the National Health Service (NHS) adopts innovation.
Although numerous generic drug companies have filed ANDAs referencing Millennium Pharmaceuticals Inc.'s Velcade (bortezomib), it could be a while before a generic version hits the market.
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