Simplifying Global Compliance
Research and Development
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More
Global drug giant Pfizer said Tuesday that its Phase III Profile 1014 postmarketing commitment study of anaplastic lymphoma kinase-inhibitor Xalkori met its primary objective of prolonging progression-free survival in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) compared with platinum-based chemotherapy. Read More
Novartis estimates that there are about 1.5 million patients in the U.S. with CIU. Read More
Japanese regulators have approved Otsuka Pharmaceutical’s Samsca to treat autosomal dominant polycystic kidney disease, or ADPKD — an expanded indication that the FDA rejected last year. Read More
EU drug regulators Friday recommended Endocyte’s vintafolide for approval as an ovarian cancer treatment, providing the drugmaker with a major milestone in its attempt to market its first product. Read More
Forest Laboratories and Gedeon Richter on Friday touted positive topline results from a mid-stage trial of their investigational antipsychotic cariprazine to treat major depressive disorder (MDD), renewing hope for the candidate recently rejected by the FDA in another indication. Read More
The FDA has granted a breakthrough therapy designation to Pfizer’s investigational bivalent rLP2086 meningococcal B vaccine, the drug giant said Thursday. Read More
Of the approximately 7.7 million new cases of dementia each year, Piramal says, about 60 to 80 percent are Alzheimer’s disease. Read More
Janssen hopes to submit an NDA for the drug later this year.
The FDA has approved Paladin Therapeutics’ oral drug Impavido to treat leishmaniasis, a tropical disease caused by parasites. Read More
The European Medicines Agency (EMA) has launched a new pilot program intended to speed new therapies to patients via a process that authorizes products for use by targeted populations in stages. Read More
Japanese drugmakers Astellas Pharma and Daiichi Sankyo are planning to form the first-ever large-scale compound library, through which they plan to share 400,000 compounds. Read More
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