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29-Sep-2016 - The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
29-Sep-2016 - The US FDA has placed a Phase III trial for Cel-Sci’s head and neck cancer candidate on clinical hold.
29-Sep-2016 - AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.
28-Sep-2016 - Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
28-Sep-2016 - Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.
28-Sep-2016 - Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.
27-Sep-2016 - Abec has completed work on Regeneron’s biologics facility in Ireland just 28 months after it was hired to kit out the repurposed computer plant.
27-Sep-2016 - Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.
27-Sep-2016 - BASF is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.
27-Sep-2016 - Becton Dickinson says it is upgrading equipment and technology at its Holdrege manufacturing facility to better serve the global diabetes market.
26-Sep-2016 - Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
26-Sep-2016 - Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.
26-Sep-2016 - Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.
26-Sep-2016 - Analytik Jena and the Fresenius University of Applied Sciences are to create a joint application center for customers for teaching and research.
22-Sep-2016 - The US FDA has warned people not to use a $30 DIY epinephrine delivery device developed after Mylan increased the price of the Epipen.
22-Sep-2016 - Colorcon and Dow have expanded a nine year controlled release alliance to include further solubility, coating and ion exchange platforms.
22-Sep-2016 - Sartorius Stedim Biotech claims it has a platform that can help biopharma companies carve months off the development time for new products.
22-Sep-2016 - Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.
21-Sep-2016 - Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.
21-Sep-2016 - Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
21-Sep-2016 - Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.
20-Sep-2016 - The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.
20-Sep-2016 - Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
20-Sep-2016 - Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.
19-Sep-2016 - The EMA has recommended a European ban of all non-critical drugs made by US CMO Pharmaceutics International Inc (Pii).
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