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.

Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, named Lars Peter Brunse executive vice president and chief production officer.

DUBLIN – To no one's great surprise, UCB SA and Amgen Inc. confirmed Monday that they had received a complete response letter from the FDA for their BLA for Evenity (romosozumab), which is in development for osteoporosis in postmenopausal women.

Clarus Ventures, which has been shifting iteratively from traditional venture investing to structured financings, completed its transformation with the close of Clarus IV LP, which topped its $750 million goal by attracting $910 million in assets. The size of the fund pushed the firm, which has offices in Cambridge, Mass., and South San Francisco, beyond $2.6 billion in assets invested across 50 private and public life sciences companies.

Cancer Prevention Pharmaceuticals Inc., of Tucson, Ariz., said it launched a phase II trial at Vanderbilt University Medical Center to test CPP-1X in patients with precancerous gastric lesions who are at high risk for gastric cancer.