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FDA Approvals

World Health Organization Authorizes SINOVAC’s CoronaVac for Emergency Use

Drug Development
SINOVAC Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed by SINOVAC Life Sciences...

FDA Grants Fast Track Designation to CERC-002 for Treatment of Hospitalized Patients with COVID-19

FDA Approvals
Cerecor Inc., a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, announced that the...

FDA accepts Airway Therapeutics IND application for Covid-19

FDA Approvals
The US FDA has accepted Airway Therapeutics’ Investigational New Drug (IND) application to develop AT-100 (rhSP-D) for treating Covid-19. A new recombinant human protein rhSP-D,...

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use

FDA Approvals
Johnson & Johnson announced that the U.S. FDA has issued EUA for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson...

PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs

FDA Approvals
The Parenteral Drug Association (PDA) announced it has signed an agreement to collaborate with Deloitte Consulting, LLP and the U.S. FDA’s Compounding Quality Center...

Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA

FDA Approvals
Samsung Biologics announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy,...

Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA

FDA Approvals
Samsung Biologics announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy,...

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The Future of Digital Health

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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

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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

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Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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