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9 companies will play a huge role in shaping the FDA’s new approach to digital health fiercehealthcare
August 09, 2017
As the FDA initiate a big reexamine of its plan to regulating health technology, some software companies are ready to have a huge impact on the agency’s methodology moving forward.
Research highlights lack of confidence in serialization preparations pharmaasia
August 09, 2017
More than one third (40 per cent) of pharmaceutical industry professionals are not confident that they will meet serialization deadlines in the US and Europe, according to new industry research.
FDA rejects second Vernalis cough/cold treatment pharmatimes
August 08, 2017
The US Food and Drug Administration has rejected Vernalis’ cough cold treatment CCP-08, which is being developed by US partner Tris Pharma.
Rebiotix Announces First Patient Enrolled in RBX2660 Phase 3 Clinical Trial americanpharmaceuticalreview
August 08, 2017
Rebiotix has enrolled the first patient in a Phase 3 clinical trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection.RBX2660 is the first drug product in clinical study from the Microbiota Restoration Therapy (MRT) plat
Kite begins EU trial of CAR–T therapy pharmatimes
August 08, 2017
Kite Pharma has begun treating the first EU patients with its investigational CAR–T candidate, axicabtagene ciloleucel (axi-cel), in the safety expansion cohort of the ZUMA-1 trial.
Federal judge enters consent decree against outsourcing facility europeanpharmaceuticalreview
August 08, 2017
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction between the United States and Isomeric Pharmacy Solutions…
Wockhardt bags US FDA approval for antibiotic injection expressbpd
August 08, 2017
Oxacillin, a penicillinase-resistant beta-lactam antibiotic, will be launched in the US soon
FDA grants Genentech’s Alecensa Priority Review cphi-online
August 07, 2017
Designation given for initial treatment of people with ALK-positive lung cancer.
FDA approves AbbVie’s Mavyret for hepatitis C europeanpharmaceuticalreview
August 07, 2017
The FDA has approved Mavyret to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis…
FDA advisers reject J&J rheumatoid arthritis drug pharmaphorum
August 04, 2017
The chances of Johnson & Johnson’s rheumatoid arthritis drug sirukumab getting approved in the US look slim, after the FDA’s expert advisers raised concerns about its safety.

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