FDA and Infant Bacterial Therapeutics agree on the design of Phase III study
For an extended time, IBT has consulted with the US FDA on how the company’s planned Phase III study should be designed.
IBT announced the...
Impulse Dynamics announces successful implantation of first patient since FDA approval of Optimizer Smart System
Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM therapy, announced that the first patient to receive the Optimizer Smart System...
B. Braun launches the First FDA-Approved Heparin Sodium Prefilled Syringe with attached safety needle
B. Braun Medical Inc. announced the launch of its Heparin Sodium Injection, USP - the first Heparin 5,000 USP Unit / 0.5 mL prefilled...
U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA
Pfizer Inc. announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA„¢ (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab),1 for the treatment...
Halozyme Announces FDA Approval Of Herceptin Hylecta
Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, announced that Genentech, a member of the Roche Group, has received approval...
U.S. FDA Approves DARZALEX Split-Dosing Regimen
The U.S. FDA gave Janssen Biotech, a Johnson & Johnson company, and their research partner, Copenhagen, Denmark-based Genmab A/S, an approval for their Darzalex...
EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma
Takeda Pharmaceutical Company Limited announced that the EC extended the current marketing authorization of ADCETRIS (brentuximab vedotin) to include treatment of adult patients with...
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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...