Drugs
The three senior CDER officials involved in the controversial approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease are defending their action as consistent with FDA accelerated approval requirements and the need of Alzheimer’s patients for new treatment options. Writing in a JAMA Internal Medicine Viewpoint column,
Drugs
Innoveix Pharmaceuticals has recalled several lots of sterile compounded drug products due to a lack of sterility assurance that was determined by a recent FDA inspection. “Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening,” a
Drugs
Congress has officially weighed in on Biogen’s controversial Alzheimer’s drug approval, requesting documents from the company as part of a broad investigation into whether improper actions occurred during the approval process, whether its marketing and drug pricing are appropriate. A 7/12 joint letter from the House Energy
Drugs
In a briefing document prepared in advance of a 7/15 meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee to discuss the NDA for FibroGen’s roxadustat, the agency raises safety concerns for the committee to consider. The roxadustat proposed indication is to treat anemia due to chronic
Drugs
FDA says hand sanitizer gel produced by Guangzhou, Minghui Cosmetics Co., Guangzhou, China, which recently registered with the agency as a human drug manufacturer, was detained and refused admission at the border. A 7/6 Warning Letter says agency lab testing of a batch of the detained product found that
Drugs
CDER Office of Medical Policy health science policy analyst Heather Stone says the Office of Medical Policy Clinical Methodologies Group (ClinMeth) has made the CURE ID app more effective during the Covid-19 public health emergency. CURE ID allows healthcare providers to report new uses of existing drugs for 325
Drugs
Commenting on an FDA request for information and comments on evaluating the clinical pharmacology of peptides, Merck says its experience is there are few instances in which a one-size-fits-all-type requirement for clinical pharmacology studies would be appropriate. In its response, the company says that due to
Drugs
FDA says its review of Web sites and social media sites maintained by Halodine, Miami, FL, found that the company is marketing non-alcohol-based antiseptic products for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 and other conditions in people. A 7/7
Drugs
FDA and CDC have dismissed the immediate need for Covid-19 booster vaccines in the wake of a Pfizer announcement that the company intends to seek such an authorization in the coming weeks. The company says that initial data from a study demonstrate that a booster dose given six months
Drugs
FDA acting commissioner Janet Woodcock is distancing herself further from the controversial approval of Biogen’s Alzheimer’s therapy Aduhelm (aducanumab-avwa), asking the HHS inspector general to “conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval
Drugs
FDA has placed a clinical hold on a Sigilon Therapeutics Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A following a reported serious adverse event (SAE). To date, three patients have been dosed with SIG-001, according to the company, and the third
Drugs
FDA has approved Bayer’s Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with Type 2 diabetes. Approval was based on data from a 5,700-patient,
Drugs
FDA has granted full approval to Astellas Pharma for Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate for certain adult patients with locally advanced or metastatic urothelial cancer. The therapy was previously granted accelerated approval 12/2019. Approval was based on data from a confirmatory
Drugs
Catalyst Pharmaceuticals is petitioning FDA to require blinded, controlled trials for approval of an NDA or sNDA for any amifampridine drug product intended to treat genetically confirmed cases of congenital myasthenic syndrome (CMS). The 6/14 petition specifically asks that FDA: * instruct review divisions in which a pending NDA for
Drugs
FDA says manufacturers of non-sterile water-based drug products should be aware that Burkholderia cepacia complex (BCC) continues to pose a contamination risk. An agency notice says BCC is a significant pharmaceutical contaminant that has been linked to multiple instances of opportunistic infections. “Inadequate design, control, or maintenance of
Drugs
Faced with mounting criticism concerning Biogen’s controversial approval for its Alzheimer’s therapy Aduhelm (aducanumab), FDA 7/7 approved a narrower product label to limit its indication and usage to disease stages studied in the supporting clinical trials. When the drug was approved last month, critics immediately questioned why
Drugs
FDA has accepted for priority review an AstraZeneca BLA for tezepelumab for treating asthma. The BLA is based on data from the PATHFINDER clinical trial program, including results from the pivotal NAVIGATOR Phase 3 trial in which tezepelumab demonstrated superiority across every primary and key secondary endpoint compared to placebo
Drugs
Novartis has resubmitted to FDA the NDA for its inclisiran, listing its Schaftenau, Austria, facility as the manufacturing site. The company says the resubmission responds to a 12/2020 complete response letter (CRL) from FDA raising unresolved facility inspection-related conditions at a third-party manufacturing facility. The CRL did
Drugs
House government operations subcommittee vice chair Katie Porter (D-CA) says it is apparent from the controversial FDA 6/7 approval of Biogen’s Aduhelm (aducanumab) to slow the effects of Alzheimer’s disease that the drug industry continues to have an undue influence on FDA and HHS. In a
Drugs
Following a meeting with FDA officials to discuss deficiencies in a complete response letter issued for Athenex’ oral paclitaxel plus encequidar to treat metastatic breast cancer, the company says it is evaluating the best way to proceed with a new clinical study it wants to present to the agency in
Drugs
In its mandated report to Congress on drug shortages in the calendar year 2020, FDA identifies two needs that require ongoing work to improve its ability to manage and respond to shortages. The report identifies them as: * need to gain better insight into the supply chain, and * need to increase
Drugs
Attorneys Douglas Farquhar and Sara Koblitz (Hyman, Phelps & McNamara) say that while FDA consistently maintains that a complete response letter (CRL) is not a final agency action and thus cannot be appealed in court, a recent case their firm was involved in may have at least opened a way