FDA Unveils Plausible Mechanism Pathway for Custom Therapies
The US Food and Drug Administration (FDA) has unveiled a new regulatory framework designed to accelerate the approval of personalised therapies by easing traditional...
Henlius, Organon Secure FDA Approval for PERJETA Biosimilar
Shanghai Henlius Biotech and Organon Announced that the US Food and Drug Administration (FDA) has granted approval to the Biologics License Application for POHERDY®...
FDA Announces Removal of Black Box Warnings on HRT Products
The U.S. Department of Health and Human Services (HHS) announced a major policy shift today aimed at re-establishing what it described as gold-standard scientific...
Merck Announces Acquisition of Cidara Therapeutics at $9.2 B
Merck announced that it will acquire Cidara Therapeutics, Inc., after both companies confirmed they have signed a definitive agreement. The deal, executed through a...
Novartis Opens Radioligand Therapy Manufacturing Plant in US
Novartis, a leader in innovative medicines, has launched a 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California. The site marks an important step...
Amgen Announces Phase 3 VESALIUS-CV Clinical Trial Results
Amgen announced new detailed findings from its Phase 3 VESALIUS-CV clinical trial, revealing that Repatha (evolocumab) achieved statistically significant and clinically meaningful reductions in...
FDA Grants Approval for CAPLYTA for MDD Treatment in Adults
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted approval for CAPLYTA (lumateperone) to be used as an adjunctive...
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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...