For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in particular, flowing to the sector, while dealmaking reached historic proportions. Meanwhile, scientific breakthroughs led the way as cell and gene therapies gained ground, the first signs of success emerged with new technologies like CRISPR and the long-awaited promise of genomics found its way to the front lines of health care.
LONDON – While large-scale biobanks that link genomics to longitudinal health records of diagnosis, treatment and outcomes promise to revolutionize understanding of the genetics of complex disease, the detailed statistical analysis of those high-dimensional data is still very much in its infancy.
DUBLIN – Truffle Capital closed off its fifth Biomedtech fund with a €250 million (US$279 million) raise, which it will deploy in about a dozen companies located mainly in France. The fund took a little longer to close than originally planned but it is significantly larger than it had originally intended. “Our initial objective was €200 million,” Truffle Capital CEO and co-founder Philippe Pouletty told BioWorld.
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.