HAMBURG, Germany Despite the biotech industry's recent record-breaking run in terms of fundraising and new drug approvals, the ongoing drug pricing controversy is acting as a drag on biotechnology investment. Since the debate started to heat up about four years ago, the Nasdaq Biotechnology Index is down 14%, while the S&P 500 Index is up by 46% during the same period, David Thomas, vice president, industry research at the Biotechnology Innovation Organization (BIO), told delegates attending the opening plenary session at BIO-Europe. "Something is clearly holding back investors in our space," he said.
LONDON The EU's next large-scale public-private research partnership in health is taking shape and due for launch at the start of 2021, succeeding the current €3.6 billion (US$4 billion) Innovative Medicines Initiative 2 (IMI2). The new program, the Innovative Health Initiative (IHI), will see the scope of joint research among the industry, academics and SMEs expand beyond pharmaceuticals, to include medical technology, biotech, digital health and vaccines.
LONDON The Swiss headquarter operations of Arvelle Therapeutics GmbH are taking shape as the company awaits the outcome later this month of the FDA's deliberations on its in-licensed asset, cenobamate, and prepares to apply for EMA approval for the novel epilepsy treatment in the first half of 2020.
LONDON The U.K. government told the industry to maintain its readiness for a no-deal Brexit Tuesday, as it was forced to ask the EU for another extension after failing to get a revised withdrawal bill through Parliament.
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.