28-Aug-2015 - The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
27-Aug-2015 - A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation.
27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.
26-Aug-2015 - The UK regulator is launching a calculator to help pharma companies calculate the fees for drug applications.
25-Aug-2015 - The US Patent and Trademark Office (USPTO) has refused to review a challenge to Acorda Therapeutics’ patents from a group trying to block “abusive” IP claims.
24-Aug-2015 - Pfizer has received the final regulatory clearances to acquire Hospira but the US FTC says it must divests four sterile injectable products.
24-Aug-2015 - Drugmakers trying to make blue or green pills for the US market have a new option after the FDA approved a bacteria-derived extract developed by Colorcon for pharma applications.
21-Aug-2015 - The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).
20-Aug-2015 - Merck & Co. has recalled two chemotherapy products because of cracked caps, including one it manufactures for Novartis’ Sandoz.
20-Aug-2015 - Valeant Pharmaceuticals is set to buy Addyi maker Sprout Pharmaceuticals under a $1bn (€895m) deal agreed today.
19-Aug-2015 - Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.
19-Aug-2015 - As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.
18-Aug-2015 - Teva’s UK business has alerted the regulator that packets of the painkiller and anti-seizure medicine Pregabalin are printed with the wrong dosage.
18-Aug-2015 - As part of European efforts to help stem the spread of counterfeit medicines, the European Commission has laid out the details of a key part of its Falsified Medicines Directive (FMD).
13-Aug-2015 - Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.
13-Aug-2015 - Taiwan’s pharmaceutical market is expected to grow to over $8bn by 2020, driven by chronic and non-infectious therapies, but uncertain relations with China, TPP entry, and price cuts will also influence the region.
12-Aug-2015 - GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.
10-Aug-2015 - US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.
03-Aug-2015 - As the US regulator awards iclaprim expedited QIDP status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy.
30-Jul-2015 - A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo.