Foundation Medicine, AZ Partner to Develop Assay for Lynparza June 6, 2016 The assay will be designed to identify patients most likely to benefit from the treatment. Read More
FDA Hits Teva With Complete Response Letter for Huntington’s Disease Candidate June 6, 2016 The agency is asking the company to examine blood levels of certain metabolites. Read More
ArcherDX, Illumina to Develop NGS IVD Tests June 3, 2016 ArcherDX will develop a series of tests using its Anchored Multiplex PCR chemistry. Read More
Congressmen Criticize FDA’s Approach to Off-label Concerns June 3, 2016 The letter took aim at both the FDA and HHS. Read More
Occlutech Gains CE Mark for LAA Occluder June 2, 2016 The implant is designed for the closure of the LAA. Read More
CDSCO Aims to Polish India’s GMP Image June 2, 2016 CDSCO has developed a draft checklist and an evaluation tool to guide inspections. Read More
BioVentrix Secures FDA IDE Approval to Begin Clinical Trial June 1, 2016 The trial involves 120 patients at up to 20 sites nationwide. Read More
BIO Report: Drug Candidates Have 1 in 10 Chance of Gaining FDA Approval June 1, 2016 The overall likelihood of approval for drug candidates in Phase 1 trials is 9.6 percent. Read More
Biocept Launches PD-L1 Liquid Biopsy Test May 31, 2016 The test is designed for use on the company’s Target Selector platform. Read More
AMR Report Aims to Give Drugmakers Cash Inducements May 31, 2016 The report pushes to provide drugmakers with incentives to develop vaccines for drug-resistant infections. Read More
Thermo Fisher Picks Up FEI for $4.2B May 27, 2016 The $4.2 billion transaction is scheduled to be finalized by early 2017. Read More
Novartis’ Entresto Gains Strong Recommendation in Heart Failure Guidelines May 27, 2016 Heart specialists in the U.S. and EU endorsed the drug. Read More