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.
GSK has confirmed its new UK plant will continue to supply the US with Ellipta inhalers after capacity at its facility in North Carolina comes online this year.
While there are currently several techniques for producing tissue from heart cells, a new method reduces the amount of cells needed, making it easier and cheaper to replicate.
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.
Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.
Rutgers leading continuous manufacturing guidance efforts
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.
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.
API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.
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.
The International Clinical Trial Center Network (ICN) adopts Clinerion's patient recruitment system as an official service to help its members speed trail startup.
Heptares Therapeutics and Kymab Limited have entered into a strategic collaboration to discover, develop, and commercialize novel antibody therapeutics.
Replikins’ genomic understanding of the Zika and Flaviviruses has led to the development of a trivalent vaccine for Zika, Dengue, and Japanese Encephalitis.
Using an experimental Internet of Things system that enables remote monitoring, the companies believe the multi-year project has the potential to change the way clinical trials are conducted.
Several US states have approached Braeburn Pharmaceuticals after the firm said it was reassessing plans to invest $20m in North Carolina following the passing of House Bill 2.
Janssen is already working on continuous manufacturing methods for other drugs says Rutgers University which helped develop the new Prezista production process approved by the US FDA.
Sekisui XenoTech announced that it now offers genotyped hepatocytes for polymorphic enzyme drug metabolism studies as part of its cell- and tissue-based product catalog.
WellSpring Pharma Services has announced a $3 million capital investment in new equipment in addition to a new strategic partnership with IDT Australia to manufacture drugs targeting the US market.
Celgene has exercised its option to develop and commercialize therapeutic antibody candidates that target CD19 - a protein found on cancerous B cells - in a deal with Juno therapeutics.
A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.
Finding the right patients quickly is an ongoing problem in launching clinical trials, so several companies have formed an alliance to advance precision medicine development.
After announcing it won’t acquire Pfizer last week, Allergan has announced a partnership with Heptares to advance medications for neurological disorders.
