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But we are proud to say that Thomas Gabrielczyk contributed 2213 entries already.
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 company’s 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 Inc’s 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.
Bioeconomy:?It could be a turning point for the fish meal and fish oil dependent animal feed industry in Europe. Since July, the European Commission has allowed the use of insect-processed animal proteins for aquaculture. According to experts, the use of insect meal as a sustainable alternative opens an US$90bn market.
Billionaire Bill Gates announced he is going to invest US$50m private money into the Dementia Discovery Fund (DDF) to support fresh ideas for developing Alzheimer drugs and diagnostics. The venture capital fund, which kicked off in 2015, includes investors such as GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer and Biogen Idec as well as the UK government.
Serialisation of drugs is confronting pharmaceutical companies all over the world with challenges, especially in relation to data handling and the integration of additional equipment and functions into existing packaging lines. Offline solutions, where secondary packaging is serialized directly by the folding-box manufacturer, combined with sophisticated data flow architectures, are a reliable, flexible, and immediately available alternative to inline serialisation.