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 - TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.
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 - 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 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.
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 - Clinical Trials Day celebrates the first randomized clinical trial conducted in May 1747 and the clinical research professionals that work in the industry more than 265 years later.
17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”
13-May-2016 - Working together could save regulators millions and increase availability of medicines for patients, delegates say at the EDQM's International Generic Drug Regulators Programme (IGDRP) in Strasbourg.
11-May-2016 - A remediation plan by Medreich Limited is sufficient to bring its Andhra Pradesh antibiotics plant in to compliance with GMP according to French regulator ANSM.
10-May-2016 - Brexit would add extra barriers to licensing medicines in the UK according to the Association of the British Pharmaceutical Industry (ABPI).
10-May-2016 - The former owners of Indian drugmaker Ranbaxy have been ordered to pay Daiichi Sankyo $385m for concealing quality problems across its manufacturing network before selling the business.
09-May-2016 - Drug companies will prioritize the EU over the UK in the event of Brexit according to the ABPI, which says members recognize the benefits of centralised licensing.
09-May-2016 - Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).
09-May-2016 - The manufacturing suspension at a French softgel plant and low demand for modified release tech stunted Catalent’s Q3 2016 results, the firm says.
03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.
02-May-2016 - The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.
02-May-2016 - Full production at Catalent’s Beinheim softgel plant has begun five months after the discovery of out-of-place capsules led to French regulators suspending operations.
It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation work...