Drugs
Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy demonstrated a significantly significant and clinically meaningful improvement in progression-free survival in the Phase 3 KEYNOTE A-18 trial as a treatment for newly-diagnosed patients with high-risk locally advanced cervical cancer. A company statement says the drug plus concurrent
Drugs
FDA has cleared an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer patients. “We developed Radiant Aura to deliver both electronic brachytherapy and superficial radiation therapy in order to give dermatologists multiple treatment options for their NMSC patients,” a company
Drugs
FDA has granted Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis. Currently, the company is evaluating the drug in a Phase 3 clinical trial (XPORT-MF-034) in combination with ruxolitinib in JAKi-naïve
Drugs
An 11/14-11/21/22 FDA inspection at Centaur Pharmaceuticals Private Ltd. in Mumbai, India, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 6/5 Warning Letter says the specific deviations were: * failure of the quality unit to exercise
Drugs
The CDER Office of Translational Sciences (OTS) says it “works collaboratively to help drive advancements in human health through scientific and regulatory innovation.” The OTS 2022 annual report says its tasks have included: * promoting scientific collaboration and innovation in drug regulatory review across CDER; * assuring the validity of clinical trial
Drugs
Bipartisan leaders of the House Energy and Commerce Committee say they are concerned about the effectiveness of FDA drug inspection efforts in India and China. In a 7/18 letter to FDA commissioner Robert Califf, the lawmakers say the agency’s recent decision to address shortages of critical drugs by
Drugs
Akebia Therapeutics says it has completed an “End of Dispute Type A meeting” with FDA that discussed the company’s upcoming NDA resubmission for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. In May, CDER’s Office of New Drugs (OND)
Drugs
Olympus has recalled (Class 1) about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. The company has issued an “Urgent Medical Device Corrective Action” letter to customers telling them that labeling will be updated to include specificity about
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on scientific considerations for pediatric drug development under the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) “offers valuable direction on various important scientific considerations for pediatric drug development programs, including considerations regarding
Biologics
The Government Accountability Office (GAO) says its study of regenerative medicine led to the development of 11 policy options, several of which involve FDA. GAO says it conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. The report looks at (1) current and emerging regenerative medicine
Drugs
FDA has accepted for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment for unresectable hepatocellular carcinoma (uHCC). The agency has set a user fee review action target date of 5/16/2024. The
Drugs
Eli Lilly has announced full results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease (AD). The data were published 7/17 online in the Journal of the American Medical Association. Lilly filed for
Drugs
BridgeBio Pharma says it plans to file an NDA by the end of the year after reporting “positive results” from ATTRibute-CM, a Phase 3 study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM. “ATTR-CM is an increasingly recognized cause of heart failure,” a company release says. The
Drugs
FDA has issued Catalent a four-page Form FDA-483 after inspecting the firm’s Bloomington, IN manufacturing facility 5/4-12. According to the inspection form, Catalent was cited over written production and process control procedures not being followed or established. Additionally, the agency said the facility’s equipment
Drugs
A 3/6-completed FDA inspection of Fresenius Kabi’s Canton, MA outsourcing facility resulted in a two-item Form FDA-483 that cited the firm over GMP deviations. For example, the facility’s procedures to prevent microbiological contamination of drug products purporting to be sterile are not established, written,
Drugs
FDA has approved a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairment, including those on dialysis. The approval now extends the drug’s use across all stages of renal disease, the company says. Approval was based on data from a
Drugs
FDA has approved a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over-the-counter status. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing
Drugs
FDA has published a draft guidance, Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act, with information for holders of approved applications for human prescription drugs who are required to conduct postmarketing studies or
Drugs
While FDA continues to pursue a new regulatory paradigm for laboratory-developed tests (LDTs), the agency is starting a new pilot program to add more regulatory teeth to LDTs that are used without an approved companion diagnostic for certain oncology drugs. Speaking at a Friends of Cancer Research (FOCR) public
Drugs
An 11/28-12/2/2022 FDA inspection at the NeilMed Pharmaceuticals drug manufacturing facility in Santa Rosa, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other issues in the production of finished drugs. A just-released 5/26 Warning Letter says the specific CGMP violations
Drugs
A 7/10 VeganMed petition asks FDA to revise existing regulations and policies to require drug and dietary supplement manufacturers to clearly label whether ingredients used in their products are animal-derived or contain animal byproducts. “Under the current FDA regulatory framework,” the petition says, “consumers who want to avoid
Biologics
Three Goodwin attorneys analyzed Warning Letters issued following Bioresearch Monitoring (BIMO) program inspections in 2022. Their online post says that BIMO conducted 504 inspections of clinical investigators in FY 2022. Of the 504, nine resulted in a classification of “official action indicated” and 87 resulted in a classification of “voluntary