The Medicines Company Announces FDA Approval of KENGREAL (cangrelor) as an Adjunct to Percutaneous Coronary Intervention (PCI) for Reducing Thrombotic Events Novel intravenous antiplatelet agent adds to MDCO commercial offerings in the cardiac cath lab Field force in place and product ready for supply in July PARSIPPANY, N.J.–(BUSINESS WIRE)– The Medicines Company (MDCO) today announced […]

The U.S. Food and Drug Administration on Monday approved Medicines Co’s blood clot preventer Cangrelor, which has faced multiple setbacks since it first entered late-stage studies close to a decade back. Cangrelor, also known as Kengreal, is an intravenous therapy aimed at preventing blood clots in patients who need percutaneous coronary intervention (PCI) or angioplasty, […]

An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) met all primary and secondary endpoints in a Phase III study determining safety and efficacy, the companies jointly announced this morning. The Phase III ANNEXA-A study showed andexanet alfa, an investigational drug that received a breakthrough […]

Germany-based Boehringer Ingelheim announced today positive results from a Phase III RE-VERSE AD clinical trial. The study shows that 5 grams of idarucizumab almost immediately reversed the anticoagulant effect of dabigatran (Pradaxa) in patients who needed it under emergency situations. Study results were also simultaneously published in The New England Journal of Medicine under the […]

The newest HPV vaccine safely and effectively prevents at least four different kinds of cancer in the population recommended to receive it, according to a study in Pediatrics today. Gardasil 9, manufactured by Merck, protects against nine strains of the human papillomavirus, an infection transmitted through direct or indirect contact with the genitals of an […]

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission has approved Opdivo, a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. Today’s approval allows for the marketing of Opdivo in all 28 Member States of the EU. It follows an accelerated […]

Amgen Inc said its drug met the main goal of improving overall survival in metastatic colorectal cancer patients who have not responded to chemotherapy. The late-stage study was testing the drug, Vectibix, in combination with best supportive care (BSC), compared with BSC alone. Patients who received 6 mg/kg of the drug every 14 days and […]

Amgen (AMGN), headquartered in Thousand Oaks, Calif., announced yesterday that its Phase III study of Vectibix (panitumumab) had met its primary endpoint in the treatment of chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC). The study was designed to determine the survival benefit of Vectibix and best supportive care (BSC) in comparison to BSC […]

The U.S. Food and Drug Administration said on Thursday it had sent warning letters and seized potentially dangerous, unapproved medicines and medical devices from more than 1,050 websites globally. Inspectors from the FDA and other federal agencies screened and seized illegal drugs and medical devices received through international mail facilities in Chicago, Miami and New […]

R&D efforts on the part of major biopharmaceutical companies for novel drugs to treat depression and other CNS diseases have eroded over the past decade. In fact, a study published by the Rand Corporation referred to these as “neglected diseases”, a jarring comment when one considers how widespread these diseases are and that current treatments, […]