FDA Approves Antibacterial Orbactiv Under New Incentive Pathway August 13, 2014 The Medicines Company's drug is the third intravenous skin disease treatment cleared under the QIDP designation. Read More
ResMed Launches Air Solutions Platform of Sleep-Disorder Breathing Devices and Software August 12, 2014 The six-component platform covers patients from diagnosis to treatment. Read More
Pfizer Coughs Up $35 Million in Rapamune Marketing Violations Settlement August 12, 2014 The money will be divided among 41 states and the District of Columbia. Read More
EU Regulators Give Alexion’s Soliris Orphan Drug Status August 11, 2014 The designation is for the treatment of myasthenia gravis, which is Soliris’ third indication. Read More
Biosign Flips its Medical Device Line to Global Life Safety Group August 11, 2014 Robert Kaul, who served as CEO to both companies, resigned his post with Biosign. Read More
AstraZeneca Sues Zydus Cadila Over Generic Nexium Bid August 8, 2014 Zydus is seeking to market a generic of the blockbuster acid-reflux drug. Read More
FDA Clears Toshiba’s Ultrasound Blood Flow Visualization Technology August 8, 2014 The technology lets clinicians see microvascular blood flow without contrast agents or invasive measures. Read More
Study: Speedy FDA Approvals Could Jeopardize Safety August 7, 2014 A patient advocate group argues that the FDA doesn’t take enough time to study adverse outcomes. Read More
FDA Approves Medtronic's New Lead and Defibrillators August 7, 2014 The Attain Performa Model 4298 quadripolar lead and the Viva Quad XT and Viva Quad S defibrillators will be available in September. Read More
Cerner Snares Siemens Health Services for $1.3 Billion August 6, 2014 The deal includes plans to align Cerner’s health IT with Siemens’ devices and imaging technology. Read More
Master Clinical Trial Protocols Enable New Antibacterial Drug Development August 6, 2014 Conducting clinical trials with multiple drug candidates from different manufacturers simultaneously will be key. Read More
Flu Vaccine Guidance Issued by EMA August 5, 2014 European flu vaccine developers will have to conduct additional postmarket studies and expand evaluation criteria. Read More