04-Oct-2016 - A “quality mark” for firms that source from green API suppliers would add patient choice element to fight against antimicrobial resistance according to DSM Sinochem Pharmaceuticals.
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.
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 - 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.
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.
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.
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).
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).
15-Sep-2016 - Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.
15-Sep-2016 - Teva expects to restart drug manufacturing at the Hungarian plant under US import alert in the next few months.
13-Sep-2016 - Takeda will hand regulatory affairs work to PRA Health Sciences under the clinical development services deal announced last night.
12-Sep-2016 - Canada has approved Brenzys, its first biosimilar version of Amgen’s Enbrel (etanercept) made by Korean drugmaker Samsung Bioepis.
06-Sep-2016 - Companies are continuing to invest in the United Kingdom as the country grapples with the post-Brexit industry.
05-Sep-2016 - Elite Pharmaceuticals has received a US FDA warning letter for failing to adequately monitor adverse drug experiences (ADEs).
01-Sep-2016 - India's government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.
01-Sep-2016 - PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.
31-Aug-2016 - An out-of-specification assay result resulted in Teva recalling over 50,000 bottles of the antibiotic amoxicillin made at a facility in Canada.
30-Aug-2016 - Impax Laboratories has issued a voluntary recall for one lot of its Lamotrigine Orally Disintegrating Tablet due to incorrect labeling of its blister packs.
30-Aug-2016 - Congress has asked the US FDA for information on EpiPen generic submissions and processes in light of a series of price hikes by drugmaker Mylan.
29-Aug-2016 - The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.
25-Aug-2016 - Stem cells and biosimilars are driving the Korean pharma market, according to the country’s Biomedicine Industry Association KoBIA.
24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.