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This author has not written his bio yet.
But we are proud to say that Thomas Gabrielczyk contributed 1996 entries already.
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 on investment.
Celonic AG has pursued an ambitious expansion strategy in mammalian cell line contract manufacturing to establish Phase III and commercial supply by mid-2019. A new GMP facility in Heidelberg was acquired, and capacity is also being expanded at the headquarters in Basel. European Biotechnology spoke with Franzpeter Bracht, COO of Celonic, about Celonics strategy.
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. Instead, development of RAS neoantigen-targeting cancer vaccines will be pushed in colorectal cancer.
Fibra-Cel Disks are an advanced, solid support material for the efficient growth of mammalian and insect cells in bioreactors. They are devised to improve the cultivation of anchorage-dependent as well as suspension cells. Fibra-Cel Disks can be used also for perfusion cell culture with the Eppendorf packed-bed impeller – available for glass, stainless steel, and single-use bioreactors.
British 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 want to offer additional 1,171,875 ADS at the IPO price.
EU 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 said that the new moonshot research section EIC is underfunded. Furthermore, the current funding quote of 11% was too low compared to other international excellence programmes.
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 fumarate (BIIB098).
Austrian 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 vaccines against the human immunodeficiency virus (HIV) and the hepatitis B virus (HBV).
The 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 label.
The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 2018 meeting.