FDA Vet Bumped Up to Top Spot by Biden Admin on Interim Basis

January 14, 2021

Category: FDA, News, Regulations

Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is set to take over the top spot of the regulatory agency on an interim basis following the […]

European Commission Authorizes COVID-19 Vaccine Moderna in Europe

January 6, 2021

Category: News

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be […]

Novavax announces initiation of PREVENT-19 pivotal Phase 3 efficacy trial of COVID-19 vaccine in the United States and Mexico

December 28, 2020

Category: Industry, Vaccines

Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, […]

Industry, Vaccines

AHA News: What Heart and Stroke Patients Should Know About COVID-19 Vaccines

January 15, 2021


Experts have a simple answer for heart and stroke patients questioning whether they need a COVID-19 vaccination. That answer: yes. “People with all kinds of cardiovascular risk factors and disease should definitely get vaccinated to protect themselves and their families […]

Manufacturing, Research and Development

Cognate BioServices Announces Major Expansion of Manufacturing Facilities in US and Europe

January 14, 2021

Via: BioSpace

Cognate BioServices, Inc.., the premier commercial-ready, global CDMO in the Cell and Gene Therapy industry, announced today its plans to expand cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities, and increase office support at its facilities in the […]

Clinical Trials, Research and Development

Hemogenyx Pharmaceuticals PLC Announces Update on CDX Antibody Development

January 13, 2021

Via: BioSpace

Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”). As a result […]

Cell and Gene Therapy, Industry

Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

January 13, 2021


Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. […]


Clash Over FDA’s Top Lawyer Appointees Causes Further Discord Between Agency and HHS

January 12, 2021

Via: BioSpace

The U.S. Food and Drug Administration (FDA) is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services (HHS), the department that oversees the agency and its operations. As reported in POLITCO, the […]