Industry News

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

Projects led by collaborating researchers from both Sanofi and Stanford Medicine will focus on autoimmune diseases and inflammatory conditions.

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.

In addition to the traditional FOYA category awards, ISPE recognized two facilities for operational agility during the COVID-19 pandemic.

DCAT’s annual bio/pharmaceutical development and manufacturing business event, DCAT Week, will take place virtually from July 12–16, 2021, with the in-person even postponed to March 20–24, 2022 in New York City.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.

The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

Acting FDA commissioner announces permanent appointment of Patrizia Cavazzoni as CDER director, following year-long acting-director role.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

Scrutiny of the vulnerability in the biopharmaceutical supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.

BIA and Clarivate have released data showing that UK biotech companies are set to experience another strong year for fundraising in 2021.

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices.