Federal Judge Rejects Eisai’s Bid to Restore Exclusivity for Two Drugs October 8, 2015 The judge agreed with the FDA’s interpretation that marketing exclusivity begins with the agency’s sign-off on a drug. Read More
Cadence Biomedical Partners with UNO to Research Kickstart Device October 7, 2015 The main objective is to develop affordable and highly effective neurorehabilitation technology. Read More
FDA Clears BMS Melanoma Treatment October 7, 2015 The approval is the first-ever of an immune-oncology combination. Read More
Dako Receives FDA Approval for Lung Cancer Assay October 6, 2015 The diagnostic can reveal if a patient with advanced non-small cell lung cancer is likely to respond to new form of treatment. Read More
Obama Signs Short-Term Funding Deal October 6, 2015 The president and lawmakers now have 10 weeks to avoid a shutdown and work out a longer-term budget deal. Read More
Cardiac Insight Completes Purchase of Cardea Associates October 5, 2015 Cardiac will acquire Cardea’s CardeaScreen handheld device in the purchase. Read More
EMA Guidance Explains How Drugmakers Can Hasten Antibiotics Development October 5, 2015 Pharmacodynamic and Pharmacokinetic data can replace or supplement human dosing studies. Read More
Hoya Acquires Knecht & Müller for Undisclosed Sum October 2, 2015 The acquisition expands Hoya’s footprint in Germany, Austria and Switzerland. Read More
FDA Approves Two Novo Nordisk Diabetes Drugs October 2, 2015 The company expects to launch its once daily insulin Tresiba early next year. Read More
Royal Philips Partners With MIT to Research Less-Invasive ICP Measurement October 1, 2015 Philips will collaborate with neurosurgery experts to test a core estimation algorithm developed by MIT. Read More
FDA Hits Pfizer Subsidiary With Second Form 483 in Five Years October 1, 2015 GMP deficiencies ranged from quality systems, facilities and equipment to materials, production and laboratory systems. Read More
Lima to Acquire Rights to Zimmer’s Knee and Elbow Products September 30, 2015 Lima had previously acquired the rights to these products for European Economic Area and Switzerland. Read More