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.
02-May-2016 - Specialty medicine innovation is driving growth, yet advances are being offset by price concessions from manufacturers, according to IMS Health.
28-Apr-2016 - Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.
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 - [View the story "Live from #Biotrinity2016" on Storify]
26-Apr-2016 - Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.
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.
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.
21-Apr-2016 - The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.
21-Apr-2016 - Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.
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.
20-Apr-2016 - Single-use is the future but stainless steel bioreactors will always play a role in drug production says an expert, who thinks firms could do worse than consult a CMO before deciding in which technology to invest.
20-Apr-2016 - The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.
19-Apr-2016 - Janssen says the new US FDA-approved production method for its HIV drug Prezista is more efficient and will help it better control inventory.
19-Apr-2016 - The US FDA has hit an Indian formulation facility run by Alembic Pharmaceuticals with a Form 483 with four observations.
18-Apr-2016 - Researchers as The Scripps Research Institute (TSRI) are working to create a public database where researchers can easily access biomedical knowledge.
It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation work...