Regulatory Oversight and Compliance

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

The guidance provides examples of required and recommended information in the Dosage and Administration section.

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.