Drugs
Applied Therapeutics plans to request a pre-NDA meeting with FDA on its govorestat (AT-007), a central nervous system penetrant aldose reductase inhibitor for treating patients with galactosemia, after reporting data from a recent Phase 3 study. Govorestat demonstrated “consistent long-term clinical outcomes benefit across a range of
FDA Policy/General
Federal Register notice: FDA is announcing that an emergency use authorization was granted 3/24 to BioSynchronicity Corp. for its molecular diagnostic and antigen test for detecting Covid-19, C-Sync Covid-19 Antigen Test. To view the notice, click here.
Drugs
FDA has granted Lantheus Holdings and Point Biopharma Global a fast track designation for 177Lu-PNT2002 for treating metastatic castration resistant prostate cancer (mCRPC). The companies say the radiopharmaceutical therapy combines a prostate specific membrane antigen (PSMA)-targeted ligand, PSMA-I&T, with a beta-emitting radioisotope. The therapy
Drugs
After a delay caused by an FDA 2021 inspection and Warning Letter, the agency has approved Medtronic’s MiniMed 780G System that includes modifications to the device’s SmartGuard (SG) Technology and expanding the indications for use to include the Guardian 4 Sensor. The device is intended for “continuous delivery
Biologics
bluebird bio has submitted for priority review a BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for patients with sickle cell disease ages 12 years and older who have a history of vaso-occlusive events. The submission is based on data from 36 patients in the HGB-206 Group
Drugs
Generic drug lobbying arm Association for Accessible Medicines (AAM) says FDA’s draft guidance entitled “Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA” does not implement user fee-negotiated commitments regarding teleconferences and meetings as intended, which may deter their use. In just-posted comments to
Drugs
FDA has placed a partial clinical hold on a Foghorn Therapeutics clinical study of FHD-609 in synovial sarcoma and SMARCB1-deleted tumors after the company paused enrollment due to a Grade 4 QTc prolongation event in a synovial sarcoma patient who received the second highest dose. The partial hold
Devices
FDA has cleared a Maxtec 510(k) for the MaxO2 ME+p, an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. The company says the device is also designed for use in
Devices
Avanos Medical has recalled its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold (labeled 72-hour-use) after receiving complaints about cracked manifolds during use. “A cracked manifold can cause leaks in the respiratory circuit, which may lead to the patient receiving inadequate ventilation,” a recall
Drugs
FDA has extended by three months its review of a Daiichi Sankyo NDA resubmisson for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy for treating adult patients with newly diagnosed (FTL3-ITP positive) acute myeloid leukemia (AML). The revised user fee action target date
Drugs
CDER has denied a 2021 citizen petition from Bausch Health that urged FDA not to approve any ANDA that cites Duobrii as the reference-listed drug unless the application meets all the specifications sought by the company. DuobriI (halobetasol propionate and tazarotene) lotion is a topical drug to treat adults
Drugs
FDA has approved Novartis’ Radioligand Therapy (RLT) manufacturing facility in Millburn, NJ to manufacture prostate cancer therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan), which has been on the agency’s drug shortage list. “Production will begin in the coming weeks and ramp up gradually,” Novartis says. “The site is expected
Drugs
New research on drug direct-to-consumer (DTC) television advertising has (XXX INSERT XXX)found that viewers misinterpreted oncology clinical trial endpoint-related claims that referred to overall survival (OS), overall response rate (ORR), and progression-free survival (PFS). “Although participants differentiated between OS, ORR, and PFS, we found evidence
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Pharming Technologies that was related to its rare pediatric disease drug Joenja (leniolisib), which was approved 3/24. Joenja is indicated for treating activated phosphoinositide 3-kinase delta syndrome, a rare genetic disorder that leads to
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Pharming Technologies that was related to its rare pediatric disease drug Joenja (leniolisib), which was approved 3/24. Joenja is indicated for treating activated phosphoinositide 3-kinase delta syndrome, a rare genetic disorder that leads to
Devices
FDA is providing further clarification about a safety alert issued earlier this month that recommended against the use of certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by the company. Laboratorytests show these masks “do
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” The document provides recommendations to assist sponsors in developing drugs to prevent or treat acute radiation syndrome caused by exposure to ionizing radiation from accidental or deliberate events. To view
Drugs
FDA has released the form FDA-483 issued following a 3/21-3/29 inspection at Lupin Limited, a drug manufacturer in Pithampur, India. The 10 inspection observations on the form are: * investigations of a failure of a batch or any of its components to meet any of its specifications
Drugs
Sarepta Therapeutics has submitted comments on an FDA draft product-specific guidance (PSG) for golodirsen intravenous solution, a treatment approved under the accelerated approval pathway for treating Duchenne muscular dystrophy in patients who have a confirmed genetic mutation in the dystrophin gene that is amenable to exon 53 skipping. The
FDA Policy/General
FDA has cleared a GE HealthCare 510(k) for its Carescape Canvas patient monitoring platform. The company says the Carescape Canvas and its Carescape ONE are part of an adaptable system that can easily scale up and scale down monitoring capabilities based on the acuity of each individual patient. “As
Drugs
An FDA online post describes the work done by agency researchers in the Division of Applied Regulatory Science to develop a new quantitative structure-activity relationship (QSAR) model to predict blood-brain barrier permeability. The post says two statistical-based QSAR models were developed to predict drug permeability across the
Drugs
“Had FDA been enforcing the regulations … up to this point, the U.S. government could have imposed at least $45 billion in fines,” say three Johns Hopkins University students who are members of the Clinical Trials Transparency Committee of the Hopkins chapter of Universities Allied for Essential Medicines (UAEM). “However,