TrialScope has acquired Clinical Trial Connect, a platform used by disease foundations and advocacy groups that connects their community members to relevant clinical trials. As part of the acquisition, founder Mike Wenger will share his technological expertise as part of…
Oracle Health Sciences and Phlexglobal Collaborate
Oracle Health Sciences, Clinical technology provider and Phlexglobal, provider of Trial Master File (TMF) technology and services for the global life sciences industry, have announced enhanced integrations designed to speed and accuracy of regulatory compliance and inspection readiness in clinical…
Veeva Survey Finds CROs Undergoing Major Changes
Contract research organizations (CROs) are making significant progress in advancing the industrywide move to improve clinical trial performance, according to the Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report. The findings from Veeva Systems reveal that CROs are eliminating…
Niti Aayog proposes separate regulator for medical devices
People aware of the matter said the Aayog has instead moved a draft Bill proposing that medical devices be governed by a separate regulator. NEW DELHI: Government think tank Niti Aayog has rejected the health ministry’s proposal to bring medical…
Biocon’s biologics portfolio comes into its own
Five years ago, Biocon’s biologics business largely consisted of insulin clones and was worth about ₹400 crore. At the time, Biocon was valued at just under $1 billion. Announcing its second-quarter results on Wednesday, MD and chairperson Kiran Mazumdar-Shaw said…
Warning Letters: FDA Cites Chinese API Maker
Jiangsu NHWA FDA’s warning letter to Jiangsu comes after a five-day inspection of the company’s Jiawang facility last April that uncovered issues with the company’s product testing procedures and investigations into out-of-specification (OOS) test results for active pharmaceutical ingredients…
Zealand takes on Takeda’s IBD drug with tiny buyout
After years developing a peptide to treat short bowel syndrome (SBS), Zealand Pharma is joining the hunt for the white whale of the gastrointestinal track: inflammatory bowel disease. The Danish biotech is buying out Toronto-based Encycle Therapeutics for up to…
South Korea warns of ‘serious risk’ from vaping, considers sales ban
SEOUL (Reuters) – South Korea on Wednesday advised people to stop using liquid e-cigarettes due to growing health concerns and vowed to speed up an investigation into whether to ban sales, a move likely to hit major producers such as…
NeuroRx secures $95M to fund PhIII for NMDA depression drug
After kicking off a Phase III trial testing its NMDA drug in suicidal bipolar depression, NeuroRx has secured access to around $95 million (HKD$750 million) to complete the program and fund the manufacturing activities. New York-based GEM Global Yield has…
Alkermes to lay off 160 in cost-cutting restructure
Dive Brief: Alkermes on Wednesday said it will lay off about 160 employees, curtail future hiring and cut spending as it starts a corporate restructuring designed to stem losses. The Irish biopharma expects to complete most of the job cuts…
