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31-May-2016 - The proposed $62bn merger with agrochemical firm Monsanto would jeopardise Bayer’s pharmaceutical business, according to a BMI Research analyst.
31-May-2016 - The European Commission (EC) has approved Samsung Bioepis’ Remicade (infliximab) biosimilar.
31-May-2016 - A Granules API plant in Hyderabad which received a Form 483 with three observations has been given the all clear by the US FDA.
31-May-2016 - Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.
30-May-2016 - The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.
27-May-2016 - Celltrion will invest $275m at its biosimilar production site in Korea to ramp up capacity from 140,000L to 310,000L by 2021.
27-May-2016 - TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.
27-May-2016 - Indian drugmaker Biocon has been given the go-ahead to expand a biopharmaceutical manufacturing facility in Bangalore.
26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
26-May-2016 - The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.
25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.
25-May-2016 - The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.
25-May-2016 - Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.
25-May-2016 - The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.
25-May-2016 - An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.
24-May-2016 - Catalent Pharma Solutions has released a new clinical supply labeling tool in response to a "work-around" which could put patients' safety at risk.
24-May-2016 - Combination therapies and collaboration will be key in curing cancer, according to Pfizer which has seen 'astounding progress' in its immuno-oncology partnership with Merck KGaA.
24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.
23-May-2016 - French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.
23-May-2016 - Recombinant albumin supplier Albumedix will help Hebei Changshan Biochem Pharma develop a once-a-week diabetes treatment.
23-May-2016 - Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.
23-May-2016 - Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).
23-May-2016 - APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
19-May-2016 - Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.
19-May-2016 - Researchers have developed an “easy-to-adopt” process for removing excess additives from injectable drugs.
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