Drugs
The U.S. Supreme Court 6/13 unanimously rejected a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex) by finding that the plaintiffs, a group of anti-abortion doctors, lacked Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.
Drugs
CDER’s Emerging Drug Safety Technology Meeting (EDSTM) program gives applicants with an approved application and/or other relevant parties an opportunity to meet with CDER staff to discuss their research, development, and use of artificial intelligence or other emerging technology in pharmacovigilance (PV). CDER Office of Surveillance and Epidemiology
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FDA says a final report on the Drug Supply Chain Security Act (DSCSA) pilot project program has been issued to mark the conclusion of the pilot. “All supply chain stakeholders can benefit from the information gathered and lessons learned,” an online post (includes a link to the final report) says.
Drugs
FDA has published an International Council for Harmonization guidance, M10 Bioanalytical Method Validation and Study Sample Analysis Questions and Answers, in response to questions posed to the M10 draft guidance. The document says it was created to provide clarity around some of the bioanalytical issues covered in the guidance. “This
Drugs
FDA has granted accelerated approval for Bristol Myers Squibb’s Augtyro (repotrectinib) for adult and pediatric patients aged 12 and older with NTRK (neurotrophic tyrosine receptor kinase) gene fusion-positive solid tumors that are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
Drugs
A New Jersey federal judge has agreed with Amneal Pharmaceuticals and the Federal Trade Commission (FTC) that five Teva ProAir HFA patents should be removed from the FDA Orange Book. Reuters reports the judge agreed with Amneal and FTC that the Teva patents only cover parts of a “metered inhaler
Drugs
Two Morgan Lewis attorneys say a recent FDA draft guidance describing how it intends to implement the Platform Technology Designation Program “marks a continuation and expansion of efforts by Congress and FDA related to advanced manufacturing….” In an online post, the attorneys say the law and guidance define a platform
Drugs
Ultragenyx Pharmaceutical and Mereo BioPharma say there were positive results in the Phase 2 portion of the Phase 2/3 Orbit study of setrusumab in patients with the complex bone and tissue disease osteogenesis imperfecta (OI). A statement from the companies says treatment with setrusumab continued to significantly reduce the
Drugs
FDA has given traditional approval to Lilly’s Retevmo (selpercatinib) for adult and pediatric patients age two and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate). An agency notice says Retevmo received accelerated
Drugs
An FDA review of records submitted by TCT Neutraceuticals SDN. BHD in Puchong, Malaysia, identified significant violations of current good manufacturing practice (CGMP) regulations in the firm’s manufacturing of over-the-counter drugs. A 6/5 Warning Letter says specific violations were: * failure to conduct at least one test
Drugs
A 9/12-9/21/2023 FDA inspection at the Cosmetic Solutions drug manufacturing facility in Boca Raton, FL, identified current good manufacturing practice (CGMP) regulation and unapproved new drug violations in the firm’s manufacturing of finished drugs. A just-released 5/31 Warning Letter says specific CGMP violations
Drugs
The FDA FY 2023 Office of Pharmaceutical Quality (OPQ) annual report says there were 776 drug quality assurance inspections, over 40% more than the 548 in FY 2022. In addition, it says, there were 187 mutual recognition agreement partner inspections, the highest number achieved to date. At the end of
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Biogen praises an FDA draft guidance on developing drugs to treat early Alzheimer’s disease and offers one comment on the diagnostic criteria for early Alzheimer’s and two comments on outcome measures. The company also provides line-by-line specific technical comments. In its response, Public Citizen says that
Drugs
FDA has granted Ipsen accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Approval was based on data showing the therapy’
Drugs
FDA is announcing an Emerging Drug Safety Technology Meeting (EDSTM) program to assist industry in implementing artificial intelligence (AI) capabilities in their pharmacovigilance (PV) activities. The program will provide stakeholders an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technologies
Drugs
FDA’s Peripheral and Central Nervous System Advisory Committee 6/10 unanimously voted (11 to 0) to recommend the approval of Eli Lilly’s donanemab-azbt to treat Alzheimer’s disease. Panel members agreed that the clinical data and biomarker data were convincing on donanemab’s effectiveness. In discussing their
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FDA has approved a Geron NDA for Rytelo (imetelstat) for treating adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks. The company says the therapy is intended for patients who have not responded
Drugs
An inspection last month at Cipla Ltd.’s Maharasthra, India active pharmaceutical ingredient and finished dosage manufacturing facility resulted in a one-item Form FDA-483 that cited its quality system. FDA investigators said the firm’s responsibilities and procedures for the quality control unit are not fully followed -- personnel
Drugs
FDA says that while there were 55 new drug shortages in CY 2023, actions by the agency, manufacturers, and other groups successfully prevented 236 potential shortages. The information is in the agency’s 11th annual report to Congress on drug shortages. It says that of the 55 new shortages, 33
Drugs
Medexus Pharmaceuticals says FDA has accepted for review its Medac licensor’s resubmitted NDA for treosulfan, indicated for combination use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. Medac’s resubmission provided additional information previously requested by FDA relating to the pivotal Phase 3 clinical trial
Drugs
An FDA briefing document released in advance of a 6/10 meeting of the agency’s Peripheral and Central Nervous System Advisory Committee raises some issues about the safety and effectiveness of Lilly’s donanemab-azbt to treat Alzheimer’s disease. The document says the company’s 6/12/2023
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Reps. Donna DeGette (D-CO) and Larry Bucshon (R-IN) are asking stakeholders, interest groups, and healthcare advocates for information on what Congress can do to bring about the next generation of healthcare treatments. “Today we are beginning a new chapter in the legacy of 21st Century Cures,” DeGette and