Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.
Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.
Drug companies will continue to supply Greece for the time being, but mounting debts make it hard to predict what will happen in the longer term according to industry group EFPIA.
Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.
Research and clinical diagnostic tool provider Bio-Techne has agreed to acquire Cliniqa, which specializes in the manufacturing and commercialization of quality controls and calibrators as well as bulk reagents used in the clinical diagnostic market....
Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.
Intertek will open an immunochemistry lab in Manchester, UK to cater for growing demand for specialised analytical services from biologics and biosimilars developers.
WuXi NextCODE and Fudan University have partnered to bring WuXi’s population human genomics database system and integrated research and clinical tools to the Fudan-led Collaborative Innovation Center of Genetics and Development (CICGD).
European drug industry groups have contrasted 'misguided' cuts to the Horizon 2020 budget with US plans to increase NIH funding for science R&D under the 21st Century Cures Bill.
Replacing animal studies in drug development is impossible according to the European Commission, which has rejected a petition calling for a ban signed by 1.2m people.
The US FDA has issued a warning letter to Czech API manufacturer VUAB Pharma for failing to properly respond to microbiological contamination and data integrity issues.
Tweets warning of Ebola were read by millions before the outbreak was acknowledged say researchers who think the network could be used as an early warning system and guide drug distribution.
The DCGI needs to clarify expiry date labelling rules for topical drugs according to an Indian trade group, which says some members’ products are being deemed to be ‘misbranded.’
The new draft guidance from the US FDA seeks to address the lack of clarity around when new chemistry, manufacturing, and controls (CMC) information must be reported to the agency.
The former general counsel of Bio-Rad Technologies sued the research company in California federal court last week, claiming he was illegally fired in 2013 after he blew the whistle on the company’s bribery in China.
The WHO has yet to decide how to investigate if barriers to competition are preventing vaccine price cuts after World Health Assembly members committed to probe the jabs industry.
Sample and assay technology provider Qiagen has launched a bioinformatics content and software platform for clinical testing labs to interpret and report on genomic variants identified in next-generation sequencing (NGS).
The fourth generation of enhancements to Parexel’s Randomization and Trial Supply Management (RTSM) service aims to simplify patient randomization and clinical supply management to reduce delivery timelines.
Merck Millipore has entered an agreement whereby it will control and manage the Singulex Life Science Research business, which offers a technology that can provide ultra-sensitive protein detection.
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help clients’...
Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences...
EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.
US Senator Bernie Sanders has called on the Secretary of Veteran Affairs to invoke a law which would break Gilead’s patent on Hepatitis C drug Sovaldi and allow cheaper generics.
The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.
Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.
The EMA's assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)
Toronto, Canada-based SB Medical Inc. and Barbados-based TC Medical Group, as well as Hanoch Stein of Baltimore plead guilty last week to a multi-year operation to smuggle and sell misbranded prescription pharmaceuticals and unlicensed wholesaling of...
West Pharmaceutical Services expects annual revenues of up to $5m following the US FDA approval of a client’s product which uses West’s Crystal Zenith delivery system.
Biopharma logistics provider Marken has opened its newest office and warehouse in Philadelphia, which is part of a global drug distribution network comprised of 10 cGMP compliant depots and more than 40 locations around the world.
Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office...
Cloud-based tool provider Medidata has built an open-source connector linking the new Apple ResearchKit with its cloud to enable biopharma companies, CROs and academic institutions to map data generated by ResearchKit apps.
As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier this week that there are “ways to greatly improve clinical trial efficiency,” and cut costs through...
