24-May-2016 - Catalent Pharma Solutions has released a new clinical supply labeling tool in response to a "work-around" which could put patients' safety at risk.
24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.
23-May-2016 - French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.
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17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”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.
12-May-2016 - VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.
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).
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 - Specialty medicine innovation is driving growth, yet advances are being offset by price concessions from manufacturers, according to IMS Health.
27-Apr-2016 - Britain’s minister for life sciences has called on the country’s £60bn pharma sector to rally together in support of remaining in the European Union.
26-Apr-2016 - The manufacture of controlled substances has faced increased scrutiny over the years, and as such, fewer CMOs are in the market.
26-Apr-2016 - Almac Group has expanded its serialization capabilities to include its US commercial packaging facility in Audubon, PA.
26-Apr-2016 - [View the story "Live from #Biotrinity2016" on Storify]
25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.
22-Apr-2016 - Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).
21-Apr-2016 - Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.
21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.
20-Apr-2016 - Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.
18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.
14-Apr-2016 - Trade secret laws adopted by the European Parliament mean employees who raise concerns about drug safety and efficacy face legal uncertainty says HAI.