Regulatory Filings and Submissions

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to EMA for expanded use of the SC formulation of Darzalex.

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

FDA published guidance for submitting standardized study data in electronic format.

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

Pfizer has announced that FDA has accepted for filing and granted priority review designation for a new drug application and EMA has accepted the MAA for abrocitinib.

Delivery will commence over the course of two months following the EUA and the government will have the ability to purchase up to 650,000 additional vials of the treatment through June 30, 2021 based on product availability and medical need.

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

EC has granted orphan drug designation to Pharming Group for its treatment of activated phosphoinositide 3-kinase delta syndrome, leniolisib.

The Swiss marketing and distribution partner of Diurnal Group, EffRx Pharmaceuticals, has submitted a MAA for Alkindi to Swissmedic.

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.

Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Oxular has been granted rare pediatric disease and orphan drug designations by the US FDA for its proprietary drug, OXU-003.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.