DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo.
DUBLIN – European biotechnology firms engaged in the discovery and development of drugs and other therapeutic modalities raised $2.366 billion in equity financing during the third quarter, taking the running total for the year so far to $5.570 billion.
LONDON - The Brexit factor appears to be holding back fundraising across all sectors in the U.K., and life sciences is no exception. After a small pick-up in the second quarter, the third quarter has disappointed, with £214 million (US$263.2 million) raised by U.K. biotechs across the public and private markets.
LONDON – Preparations for a no-deal Brexit are intensifying, with the government repeatedly saying the U.K. will leave on Oct. 31, and little sign that an agreement on an orderly exit will be reached by then. The U.K. Bioindustry Association (BIA) has stepped up its efforts to help members prepare, planning a series of events around the country and switching from monthly to weekly webinars, to provide up-to-date guidance in what is a fluid situation.
LONDON – There is an urgent need for changes to the health technology assessment (HTA) of new antibiotics, to incentivize investment and limit the development of antimicrobial resistance (AMR).
LONDON – The industry has hit out at a proposal by the U.K.'s opposition Labour party to create a state-owned generic drugs company to supply the National Health Service and to force companies to cut the cost of expensive proprietary products.
LONDON – 4BIO Capital announced the first close of its second fund at $50 million, to be exclusively invested in advanced therapies, including cell and gene therapies, RNA drugs that silence or activate genes, oncolytic vaccines and the microbiome.
Shares of San Diego-based Cidara Therapeutics Inc. (NASDAQ:CDTX) enjoyed a skyward ride, closing Tuesday at $2.35, up 67 cents, or 40%, on word of a deal with Mundipharma International Ltd., of Cambridge, U.K., to develop and commercialize rezafungin for invasive fungal infections. "Historically, [antifungal] pricing has been much stronger in the EU, so that is an important opportunity for us and now for Mundipharma as well," Cidara CEO Jeffrey Stein said.