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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.
GARDP:?Six European states, together with the British Wellcome Trust and South Africa, have pledged €56.5m to help develop new antibiotics that break resistance. The ambitious goal of the Global Antibiotic Research and Development Partnership (GARDP) is to develop and deliver up to four new treatments that enter clinical development within the next six years.
The EU is investing another €6.3m into the blood diagnosis of primary breast cancer and rectal cancer. In the 4-year LIMA project, Royal Philips will lead a SME consortium that combines liquid biospy of circulating tumour cells (CTCs) with Magnetic Resonance Imaging (MRI).
Antibody-drug-conjugate (ADC) specialist Heidelberg Pharma AG has raised €34.4m through the issuance of 7,484,190 new shares at €2.60 and 14,968,380 convertible bonds with a nominal value of €1 each. Baader Bank AG acted as global coordinator and sole bookrunner.
Amsterdam has beaten Milan and Copenhagen in the race to become the European Medicines Agency’s new home. Pharma and biotech stakeholders applauded the vote as Amsterdam achieved the hightest rate of acceptance of the EMA staff for relocatation, according to a survey.
A Phase III study (IMpower150) sponsored by Roche has shown that a combo of the companys PD-L1 blocker atezolizumab (Tecentriq) and VEGF blocking antibody bevacizumab (Avastin) plus paclitaxel + carboplatin vs Avastim plus chemotherapy significantly reduced the risk of disease progression or death in patients with advanced lung cancer.
Biomanufacturing?While the FDA and EMA have for the first time okayed the switch from batch to continuous manufacture of a pill – Janssen Cilag’s HIV protease inhibitor darunavir (Prezista) – the
industry is still waiting for such a signal in the biologics field. The FDA wants to boost adoption, and biopharma majors, such as Novartis, Amgen and Biogen, launched a pilot project to lay the groundwork for the next generation of production: continous USP and DSP, and alternatives to CHO cells.
Flexible and reliable contract manufacturing and development have become the key success factor in the development of biopharmaceuticals. Due to the long process time and high investment needed to build up production capacities, outsourcing of biologics manufacturing provides both access to advanced technologies and necessary capacity along with flexibility in timing and output.
Danish heat shock protein specialist Orphazyme raised €80m+ through an IPO at Nasdaq Copenhagen adding momentum to the current upswing of European biotech.
The BEAM Alliance has called out worldwide stakeholders to support SME-driven innovation to revive the product pipeline fighting antimicrobial resistance (AMR). In a position paper the alliance representing roughly a fifth of the global 250 antibiotics developers describes what SMEs need to make their 100 pipeline drugs a success in fighting AMR.
German Bayer AG has acquired ex-US commercialisation rights to Loxo Oncology Incs Phase II lead larotrectinib (LOXO-101), which targets TRK (tropomyosin receptor kinase) fusions in 17 cancer types, and LOXO-195, a Phase I/II compound designed to prevent acquired resistance against larotrectinib.