LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
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.
PARIS – A French research consortium bringing together the firm Cap Gemini SE, the Traumabase (traumabase.eu) network, the AP-HP group of 39 teaching hospitals in the Paris region, the École Polytechnique, the National Center for Scientific Research (CNRS) and the Ecole des Hautes Etudes en Sciences Sociales (EHESS), is developing the first AI decision-making tool for managing patients with severe trauma in their first 24 hours.
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).
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.
PARIS – Myriade SAS reported the commercial launch of its Videodrop technology at the second congress of the French Society of Extracellular Vesicles (FSEV) held in October in Nantes. This new nanoscale imaging technique captures all nanoparticles ranging from 30 nm to 10 μm in a droplet of solution (5-10μl volume), without initial data labeling.
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.
RSS
