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18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.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.
13-Apr-2016 - Inmunotek has been ordered to recall vaccines made at a facility in Madrid after Spanish regulators identified a number of GMP deficiencies.
12-Apr-2016 - The US ranks first in terms of how its domestic policies contribute to global biopharmaceutical innovation, according to a recent analysis.
11-Apr-2016 - After announcing it won’t acquire Pfizer last week, Allergan has announced a partnership with Heptares to advance medications for neurological disorders.
07-Apr-2016 - Sun Pharmaceuticals has confirmed it will close a Ranbaxy Laboratories facility in Ireland by the end of the year.
06-Apr-2016 - Researchers have established a new mouse model for testing vaccines and therapeutics to fight the Zika virus.
06-Apr-2016 - Pfizer Inc will remain a US firm after calling off a proposed $160bn merger with Ireland’s Allergan Plc.
05-Apr-2016 - For the third year in a row, about 30% of Deloitte poll respondents say their companies experienced supply chain fraud, waste, or abuse in the previous year.
04-Apr-2016 - Quality systems at a plant run by Rusan Pharma still break GMP rules according to a MHRA statement of non-compliance published this week.
30-Mar-2016 - Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.
30-Mar-2016 - A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.
30-Mar-2016 - BioClinica is expanding its eHealth Solutions to support futher growth with the announcement two global executive-level additions.
30-Mar-2016 - There is no evidence PET (polyethylene terephthalate) packaging poses a threat to health but use of phthalate excipients should be minimized according to an Indian Government committee.