Regulatory Authority Actions

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.

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

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

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

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.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

FDA struggles to track shortages caused by a rise in demand.

Health crises, political tension, and budget concerns were major challenges.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA keeps its user fees but fails to gain important reforms.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.