FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma
Genentech, a member of the Roche Group , announced that the U.S. FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted...
Aurobindo Pharma receives FDA approval for Dolutegravir, Lamivudine & Tenofovir Disoproxil tablets
Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the U.S. FDA under the U.S. President’s Emergency Plan...
Strategic Collaboration Agreement to Co-Develop Multiple Novel Biologic Therapies signed by Samsung Bioepis And Takeda
Samsung Bioepis Co., Ltd. announced that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited to jointly fund and co-develop...
Astellas Pharma begins phase 3 MORPHO trial of gilteritinib as maintenance therapy with FLT3 mutation-positive AML
Astellas Pharma Inc. announced that the first patient was dosed in the registrational Phase 3 MORPHO trial of gilteritinib, the fourth Phase 3 trial...
Ritter Pharmaceuticals Announces Phase 3 Plans after its End of Phase 2 Meeting with FDA on RP-G28 for Lactose Intolerance
Ritter Pharmaceuticals, a developer of novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced its Phase 3 plans...
Aurobindo Pharma receives USFDA Approval for Sevela mer Carbonate tablets
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture...
Bristol-Myers Squibb reports positive results from CheckMate -214 phase 3 study of Opdivo
Bristol-Myers Squibb Company announced topline results from the CheckMate -214 trial investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and...
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The Future of Digital Health
The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....
Five Best Practices to Deliver Exceptional Multichannel Experiences
A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...
The Impact and Use of Social Media in Pharmacovigilance
Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...