AMR: FDA provides financing model for nove...As first regulatory body in the world, the FDA has presented a market-driven reimbursement mechanism for antibiotics that may incentivise drug development in a niche market with currently low return … more ➔
Targovax refocussing clinical pipeline pos...Despite a 6-month improvement of 2-year-overall survival in pancreatic cancer patients, Norwegian cancer immunotherapy specialist Targovax ASA will terminate development of TG01 in this indication. … more ➔
Autolus Therapeutics aiming for NASDAQ IPOBritish T cell player, Autolus Therapeutics Ltd. wants to go NASDAQ selling 7.8 million American Depositary Shares (ADSs) at at least US-$15, totaling in US$117m. Through a greenshoe option, Autolus … more ➔
EC earmarks €100bn for Horizon EuropeEU Commissioners Jyrki Katainen and Carlos Moedas proposed a budget increase of 25% for the next European Research and Innovation programme Horizon Europe (2021-27) vs Horizon 2020. However MEPs … more ➔
MS: Alkermes bags US$50m milestone from Bi...Alkermes plc (Dublin) received a US$50m milestone payment from Biogen after review of preliminary Phase III gastrointestinal tolerability data of Alkermes’ relapsing-remitting multiple sclerosis candidate diroximel … more ➔
Hookipa and Gilead ink US$400m dealAustrian arenaviral vector technology specialist Hookipa Biotech AG (Vienna, Austria) has licenced its TheraT and Vaxwave technologies exclusively to Gilead Sciences Inc. to develop and globally commercialise … more ➔
Roche set to extend Hemlibra labelThe US FDA has accepted a supplemental BLA to Roche’s existing market approval of the new hemophilia A treatment Hemlibra (emicizumab), which could significantly extend the patient group covered by the … more ➔
EMA recommends nine drugs for approvalThe European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 2018 meeting. more ➔
Denali bags F-Star GammaBrain disease specialist Denali Therapeutics will buy all outstanding shares in British F-Star Gamma Ltd from F-Star instead licencing bispecific antibody candidates that can cross the blood-brain … more ➔
