03-Sep-2015 - Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan’s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order.
03-Sep-2015 - Sandoz has launched Zarxio, the first biosimilar in the US, despite a last ditch effort to block the copycat version of Neupogen by Amgen.
02-Sep-2015 - Amgen has retracted a study showing how grizzly bears could hold the key to understanding diabetes after one of the authors was found to have manipulated data.
02-Sep-2015 - Pfizer has confirmed it is in discussion with labour unions in Korea as part of an evaluation of its business in the country.
31-Aug-2015 - New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.
31-Aug-2015 - The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
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 Japanese Government says consolidation of the country’s generics sector is needed to secure supplies.
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 - Valeant Pharmaceuticals is set to buy Addyi maker Sprout Pharmaceuticals under a $1bn (€895m) deal agreed today.
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 - The GSK site tainted with Legionella bacteria will likely reopen in a few days, the company says.
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.
11-Aug-2015 - The annual announcement of FDA user fees has brought scrutiny on the price tag for generic drug applications, as the approval backlog is almost a year longer than in 2012.