News and Trends 14 Jul 2021 EMA Market Approval Rate for Small Biotechs Skyrocketed Last Year The success rate for small biotechs applying for regulatory approval from the EMA has risen by over 100% since 2016, which analysts partly attribute to increased access to sophisticated technology and funding. According to a recent announcement from the EMA, the regulator greenlit a whopping 89% of applications for marketing authorization for new medicines from […] July 14, 2021 - 3 minutesmins - By Victor Kotsev Share WhatsApp Twitter Linkedin Email
News and Trends 17 Jun 2021 FDA Approval of Biogen’s Drug Boosts European Alzheimer’s Space The FDA shocked many life sciences observers by greenlighting Biogen’s treatment candidate for Alzheimer’s last week. Yet, for much of the Alzheimer’s disease community on both sides of the Atlantic, the decision also brings cautious hope. Controversy recently erupted when the FDA conditionally granted accelerated approval to Biogen’s aducanumab, making it the first approved treatment […] June 17, 2021 - 6 minutesmins - By Victor Kotsev Share WhatsApp Twitter Linkedin Email
News and Trends 20 May 2021 EU Approves Edible Insects for Humans but Roadblocks Remain Europe is seeing a surge of interest in edible insect farming after an EU vote earlier this month greenlit the first insect-derived food product for human consumption. But insect protein pioneers still face other obstacles such as restrictions on what insects can be fed. The approval went to dried yellow mealworm developed by French-based biotech […] May 20, 2021 - 6 minutesmins - By Anita Chakraverty Share WhatsApp Twitter Linkedin Email
News and Trends 11 May 2021 ADC Approval Buoys Spirits in Cancer Treatment Space The FDA recently approved an antibody-drug conjugate drug from ADC Therapeutics as a treatment for blood cancer. This has given a major confidence boost to other European companies in the field as the deal mill picks up speed. Last month, ADC Therapeutics in Switzerland broke into the mainstream when its lead candidate Zynlonta received FDA […] May 11, 2021 - 7 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 27 Apr 2021 EMA Approvals for Multiple Sclerosis Highlight Treatment Shortfalls While the EU saw rapid-fire approvals in the multiple sclerosis space last month, the innovations centered mostly on improving existing approaches. Which areas of multiple sclerosis treatment need more options? At the end of March, the EMA made key decisions on three treatments for multiple sclerosis (MS), a chronic neurodegenerative disease affecting 2.5 million people […] April 27, 2021 - 6 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 21 Apr 2021 Vazkepa Gets EMA Nod for Cardiovascular Disease, But Hurdles Remain Last month’s EU approval of Vazkepa — a treatment derived from fish oil and branded as Vascepa in the US — has added much-needed ammunition to the arsenal of doctors battling cardiovascular disease. Yet other similar treatments are returning lukewarm results and the possibility of approvals being withdrawn hangs in the air. Icosapent ethyl, a […] April 21, 2021 - 5 minutesmins - By Victor Kotsev Share WhatsApp Twitter Linkedin Email
News and Trends 18 Feb 2021 Cannabinoids in Focus after GW Pharmaceuticals Snapped up for €6B This month’s €6B acquisition of the UK heavyweight GW Pharmaceuticals by Jazz Pharmaceuticals has been hailed as a major validation of the medical cannabinoid industry. The deal is the largest to date in the medical cannabinoid field. Jazz’s offer valued GW’s shares nearly 50% higher than their previous day’s close. The acquisition is expected to […] February 18, 2021 - 6 minutesmins - By Victor Kotsev Share WhatsApp Twitter Linkedin Email
News and Trends 22 Dec 2020 EMA Greenlights BioNTech and Pfizer mRNA Vaccine for Covid-19 BioNTech and Pfizer’s Covid-19 vaccine, made from messenger RNA, has become the first of its kind to be approved by the EMA. The EMA has granted conditional approval to Comirnaty, a vaccine against Covid-19 developed by BioNTech and Pfizer. The approval comes weeks after the UK became the first country in the world to approve […] December 22, 2020 - 5 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 14 Dec 2020 Will Europe Follow Singapore in Approving Cultured Meat? Singapore is the first country to grant approval to meat grown from animal cells, known as cultured meat. Will European countries follow suit? Eat Just is a San Francisco-based company that sells plant-based alternatives to eggs and other animal products. The firm made headlines last week when it got regulatory approval to market cultured chicken […] December 14, 2020 - 5 minutesmins - By Kostas Vavitsas Share WhatsApp Twitter Linkedin Email
In Depth 4 Nov 2020 The Return of Gene Therapy Gene therapy is a hot area in the biotech industry right now, with many treatments in development and a number of recent approvals. However, the path has not always been a smooth one. Gene therapy has been one of the biggest success stories of the 21st century. Genetic diseases were once seen as incurable, etched […] November 4, 2020 - 8 minutesmins - By Farhan Mitha Share WhatsApp Twitter Linkedin Email
News and Trends 30 Oct 2020 Bayer’s AskBio Acquisition Strong Statement For Gene Therapy in Europe This week, German big pharma Bayer announced a €3.5B takeover of Asklepios BioPharmaceutical, a well known US gene therapy specialist. This is only one of many examples of the funding windfall experienced by the gene therapy field in 2020. Despite the difficulties posed by the Covid-19 pandemic, 2020 has been a good year for gene […] October 30, 2020 - 6 minutesmins - By Helen Albert Share WhatsApp Twitter Linkedin Email
Expert Advice 14 Oct 2020 Everything You Need to Know About Biotech Business Models What’s my business model? Who do I partner with? How do I scale up? These are typical strategic questions a young biotech will regularly face. The business model of a biotech company can determine its long-term trajectory to success. In this article, we’ll focus on a typical ‘platform’ biotech company in the biopharma sector whose […] October 14, 2020 - 6 minutesmins - By External Contributor Share WhatsApp Twitter Linkedin Email