Regulatory Filings and Submissions

Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.

EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.

The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.

Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.

GSK has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat.

FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.

The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.

The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.

The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.

FDA has approved Roche’s new cancer drug for treating metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors and neurotrophic tyrosine receptor kinase gene fusion-positive solid tumors.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet.

Orion Corporation announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.