Tennessee Governor Signs Bill Enabling Biosimilar Substitution May 14, 2015 Tennessee has joined 11 other states that allow pharmacists to substitute a biosimilar for a branded biological product. Read More
Lithoplasty Clinical Trial Demonstrates Positive Six-Month Results May 13, 2015 Freedom from reintervention was 100 percent at six months, the company claims. Read More
ABPI: Industry Reporting of Trial Results Improving May 13, 2015 Only 10 percent of studies on new treatments approved by the EMA in 2012 were not disclosed within 12 months. Read More
Debiotech Gains iSense Glucose Monitoring Option May 12, 2015 The devicemaker has gained the exclusive rights to iSense’s sensor technology. Read More
EMA Constricts Revolving Door Policy for Expert Advisors May 12, 2015 The EMA is barring individuals who take jobs in industry from serving on any of its advisory committees. Read More
StimGuard Receives FDA IDE Designation for Microsize Bladder Device May 11, 2015 Unlike traditional overactive bladder treatments, the wireless microsize device can be implanted completely through a needle. Read More
FDA Revises Eligibility for BA/BE Study Waivers May 11, 2015 Sponsors of INDs, NDAs, ANDAs and supplemental applications can now request bioequivalence waivers. Read More
The Medicrea Group Launches Spinal Fixation Band in U.S. May 8, 2015 The LigaPASS is for use in scoliosis patients over the age of ten. Read More
FDA Green Lights GSK’s Breo Ellipta for Adults With Asthma May 8, 2015 The drug can’t be given to patients between the ages of 12 and 17. Read More
Sonendo Gets FDA Green Light for Root Canal Cleaning System May 7, 2015 Company plans to launch systems later this year. Read More
Nexium Costliest Drug Prescribed in Medicare Part D, CMS Data Show May 7, 2015 Prescriptions totaled $2.5 billion. Read More
Medtronic Announces FDA Clearance, Launch of Balloon Dilation Catheter May 6, 2015 The catheter is used during a stent implantation to reopen narrowed coronary arteries. Read More