DUBLIN – Friday marked an important milestone for the EMA as its settles into its new home in Amsterdam. The Dutch authorities formally handed over to the agency the keys to its new building, which is located in the Zuidas district of the city.
HAMBURG, Germany – Monoclonal antibodies and their various derivatives now represent the biotechnology industry's dominant, incumbent technology. Six of the top 10 best-selling drugs are antibodies. Two more top 10 drugs are biologics based on fusion protein designs. In all, there are around a hundred antibodies on the market. Whether cell and gene therapy (CAGT) will ever attain that level of success was the subject of two lively panel discussions – on deal trends and valuation and on collaboration and integrated development of advanced therapies – which closed the 25th anniversary edition of BIO-Europe Wednesday.
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.
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