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.
Roche chemo-immunotherapy combo meet NSCLC Phase III endpoint
Latest NewsA 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.
Preparing for the next generation of biologics
BackgroundBiomanufacturing?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.
Expanding scale and reach
BackgroundFlexible 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.
Orphazyme raises €80m in oversubscribed IPO
Latest NewsDanish heat shock protein specialist Orphazyme raised €80m+ through an IPO at Nasdaq Copenhagen adding momentum to the current upswing of European biotech.
Antibiotic Resistance: EU SME alliance calls for specific support to thrive AMR R&D
Latest NewsThe 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.
Bayer inks US$1.55bn cancer deal with Loxo Oncology
Latest NewsGerman 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.
World Nutrition: Insects will be on every table
BackgroundBioeconomy:?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.
Bill Gates invests into Alzheimer’s R&D
Latest NewsBillionaire 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.
The Guide to German Biotech Companies, Volume 19
Sponsored PublicationsThe brand new 19th Guide to German Biotech Companies 2018 provides a wealth of information on companies and organisations offering products and services in the life sciences.
Rapid implemenation of off-line serialisation
BackgroundSerialisation 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.