DUBLIN – The European Medicines Agency’s Committee for Medicinal Products for Human Use closed out its year’s work with positive opinions on two applications, Novartis AG’s Beovu (brolucizumab) in wet age-related macular degeneration and Merck & Co. Inc.’s Recarbrio for treating gram negative infections in adults.
LONDON – Over the next decade pharmacovigilance will move on from a sole focus on adverse drug reactions (ADRs) to encompass monitoring of the in-market efficacy of medicines, according to Guido Rasi, executive director of EMA.
LONDON – Scientists in the U.K. are claiming a world first, after successfully reproducing the electrophysiology of biological neurons in silicon chips. It is said that artificial neurons respond to non-linear physiological feedback in real time, in exactly the same way as their biological counterparts.
LONDON - The number of biotech startups in the U.K. increased by almost 50% between 2014 and 2018, compared to 2012 – 2016, according to the latest data from the consultancy Biocity, which has been tracking the sector since 2005.
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
LONDON – “Innovation only matters if patients benefit.” So said Guido Rasi, executive director of the EMA, as the agency embarks on the next phase of updating its regulatory science, both to tap into a torrent of new technologies and to ensure drug development generates evidence to demonstrate cost effectiveness and speed up access.
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.
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