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
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Piqray (alpelisib), indicated in combination with fulvestrant for treating postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by
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
Devices
FDA is warning health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The implants are intended for people age 18 years and over to lengthen a limb, shorten or compress a limb, or transport segments of long bones. An
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
Devices
Alere Inc. and its Alere San Diego subsidiary will pay $38.75 million to resolve federal government allegations that they violated the False Claims Act by billing Medicare for defective rapid point-of-care testing devices. A Department of Justice statement says the government alleges that between 2008 and 2018
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
Devices
FDA says a Quidel 4/26 recall of specified lots of its Lyra SARS-CoV-2 assay due to a significant risk of false-negative results for patients with relatively high amounts of SARS-CoV-2 virus potentially causing the PCR (polymerase chain reaction) amplification to occur before a cycle-
Devices
FDA has cleared an AliveCor 510(k) to use its KardiaMobile 6L device to calculate patients’ QTc interval. The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system, the company says. “QT prolongation can stem from congenital long QT syndrome, many
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Beovu (brolucizumab-dbll), indicated for treating neovascular (wet) age-related macular degeneration. The regulatory review period is 3,064 days, which includes 2,821 days that occurred during the testing phase and 243 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Acacia Pharma’s Barhemsys (amisulpride), indicated in adults for preventing postoperative nausea and vomiting. The regulatory review period for is 2,960 days, which includes 2,085 days that occurred during the testing phase and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The document describes the requirements and recommendations for UDIs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Pulmonx Corp.’s Zephyr Endobronchial Valve Implant, indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. The regulatory
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
Devices
FDA has granted Hyalex Orthopedics a breakthrough device designation for the Hyalex Cartilage System, intended for use in repairing cartilage defects and restoring function for patients with loss of knee articular cartilage and bone requiring surgery. The device’s biomimetic material properties create the potential to replace a damaged joint
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