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CBO Says CREATES Act Would Save Over $3 Billion
The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion.
Drugmakers Say FDA’s FAR Guidance Contradicts Existing Regulations
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments.
EMA Broadens Valsartan Contamination Investigation
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan.
Expert Committee Recommends Patient-Focused Dissolution Standards
“I believe it’s something that’s going to have wide support,” said temporary voting member Paul J. Smith, director of the University of Maryland’s statistics program.
FDA Adds Immediate-Release Opioids to REMS to Expand Training, Labeling
FDA Commissioner Scott Gottlieb said the action introduces “a more stringent set of requirements.”

Medical & Scientific Excellence Awards - Have you entered yet?
New from PharmaTimes Media is the Medical & Scientific Excellence Awards.Highlighting this important area of work within the pharmaceutical industry, the awards are designed to recognise the outstanding achievements of medical and scientific professionals.
2018 PM Society Digital Awards winners announced
Bedrock, DDB Remedy and Insypher lead the agency field, Gilead tops the pharma chart
ABPI enters five-year partnership with AHSN
The Association of the British Pharmaceutical Industry (ABPI) is linking arms with the Academic Health Science Network in a five-year partnership that strives to accelerate uptake of transformative biomedical innovations by the NHS
Celgene walks away from Oncomed’s navicixizumab
Celgene has decided not to exercise its option to license OncoMed's bispecific antibody navicixizumab.
Daiichi to test cancer drug combo
Daiichi Sankyo has entered into a clinical trial collaboration agreement with a subsidiary of MSD to evaluate a potential new combination therapy for breast or lung cancers.
CR UK forms £30m partnership with EU cancer charities
Cancer Research UK is partnering with European cancer research charities AIRC (Associazione Italiana per la Ricerca sul Cancro) and FC AECC (Asociación Española Contra el Cáncer) to invest around £30 million in six international collaborations aiming to accelerate progress in translational research.