Drugs
FDA has granted an accelerated approval to Novartis for its supplemental NDA for Scemblix (asciminib) for the drug’s expanded use in treating newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Currently, Scemblix is approved for adult patients with Ph+ CML-
FDA Policy/General
Former president Donald Trump appears to be elevating former presidential candidate and now supporter Robert F. Kennedy, Jr’s role in his new administration if Trump wins the upcoming election. In September, Kennedy told former Fox News talk show host Tucker Carlson that he had been asked by Trump to
Drugs
FDA has notified Vivus that it has removed the requirement for a cardiovascular outcome trial for its weight-management medication Qsymia (phentermine and topiramate extended-release capsules). An agency letter said that positive topline data from a postmarketing study evaluating the effect of Qsymia on 24-hour ambulatory blood pressure
Devices
FDA has cleared a Paragonix Technologies 510(k) for its transportable perfusion device KidneyVault and its use in kidney preservation. The company says the device uses “streamlined digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport.” The device is intended to be used for the
Drugs
Republican House Energy and Commerce Committee members are calling for the transparent release of clinical data from taxpayer-funded research in reaction to a New York Times article about an NIH-funded researcher and a study of puberty-blocking drugs that was withheld from publication because of the “charged American
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Antimicrobial Animal Drug Sales and Distribution — 21 CFR 514.87.” The collection helps support the agency’s requirements for new animal drugs containing an antimicrobial active ingredient. Sponsors of animal drugs containing an antimicrobial active ingredient are
Drugs
A bipartisan Congressional effort is being made to broaden FDA interpretations when deciding on priority review vouchers to increase treatments for sickle cell disease (SCD). In a 10/25 letter to FDA commissioner Robert Califf, senator Tim Scott (R-SC) and rep. Danny Davis (D-IL) have raised concerns about
Drugs
Drug compounding outfit FarmaKeio Outsourcing has filed a lawsuit in the Northern Texas District Court against FDA seeking a court order to permit the compounding of sodium thiosulfate, an active ingredient used to treat severe medical conditions including cyanide poisoning and calciphylaxis. The firm’s complaint challenges what it calls
Drugs
FDA has issued PharmaTher a complete response letter (CRL) on its ANDA for Ketarx (ketamine) and its use in anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. “The deficiencies cited in the CRL are classified as minor,” the company says. The agency letter requested new and updated information
Devices
FDA has granted Distalmotion a de novo marketing authorization for the Dexter Surgical Robot for adult inguinal hernia repair. The device is designed to “seamlessly integrate” into existing operating workflows, and compatible with current operating room equipment, according to the company. It offers single-use instruments and permits “direct and
Devices
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Devices
Kinova is recalling (Class 1 device correction) its Jaco assistive robotic arm due to an increased fire hazard if the outer coating of the arm has any damage and makes contact with an electrically powered wheelchair that has electrical leakage caused by modifications, damage, or malfunction. The device is intended
Devices
FDA has issued a safety alert recommending that healthcare providers not use BioZorb Markers and BioZorb LP Markers manufactured by Hologic. The alert is based on a company recall notice due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue. The devices
Drugs
FDA has approved an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Approval was based on data
Drugs
FDA has granted Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease (SCD). The company says the preclinical work supporting AND017's designation will be presented in a future scientific meeting and published in a scientific journal. Hydroxyurea and L-glutamine are
Devices
Smiths Medical is recalling (Class 1) specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. “If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which
Devices
FDA has approved Medtronic’s Affera Mapping and Ablation System with Sphere-9 Catheter, which it describes as a mapping and pulsed-field radiofrequency ablation catheter for treating persistent atrial fibrillation and cavotricuspid isthmus-dependent atrial flutter. The device was designed to address “procedural challenges faced by the electrophysiology community,
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications, abbreviated new animal drug applications, and conditionally approved new animal drug applications made during April, May, and June. They are also being amended to improve their accuracy and readability. To
Drugs
Responding to an FDA request for information on biosimilar product development guidances, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency issuing cross-cutting guidances for a class of biosimilar products rather than product-specific guidances (PSGs). The PhRMA comment letter says the trade group is concerned
FDA Policy/General
Federal Register notice: FDA is announcing a 12/4 Pharmacy Compounding Advisory Committee meeting to discuss various bulk drug substances being considered for inclusion on the agency’s 503A bulk drugs listing. Section 503A of the Federal Food, Drug, and Cosmetic Act describes the conditions that must be satisfied for
Biologics
Intellia Therapeutics says new data from the ongoing Phase 1/2 study of NTLA-2002 in patients with hereditary angioedema (HAE) suggest the CRISPR-based gene editing therapy has the potential to eliminate HAE attacks following a one-time infusion. Results were published online 10/24 in The New England
Drugs
Citing New York Times 10/23 reporting that participants in two Alzheimer’s drug trials were not told if their genetic profiles indicated a higher risk of brain injuries from the drug, Public Citizen is calling on FDA and the HHS Office for Human Research Protection (OHRP) to look into