Devices
FDA has cleared a Perspectum 510(k) for Hepatica, a precision oncology decision support tool for liver cancer. The device a quantitative multiparametric MRI to provide a liver health assessment based on artificial intelligence (AI)-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat, according to
Drugs
FDA has cleared a Passage Bio IND application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for treating patients with frontotemporal dementia (FTD) with granulin (GRN) mutations. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies,
FDA Policy/General
Some 29 advocacy groups, led by Public Citizen and Physicians for Responsible Opioid Prescribing, are urging the Biden administration not to appoint acting commissioner Janet Woodcock as commissioner of FDA. In a 1/27 letter to incoming HHS officials, the groups say that in her role as CDER director for
Drugs
FDA says Meitheal Pharmaceuticals is recalling one lot of cisatracurium besylate 10mg per 5 mL injection due to mislabeling. A company statement says the recall decision was made after a product complaint found that some cartons in the lot were mislabeled as phenylephrine HCl injection 100mg per mL. The company
Drugs
FDA has cleared an Organicell Regenerative Medicine IND for Zofin and its use in treating patients diagnosed with chronic obstructive pulmonary disease (COPD). The company has planned an upcoming double blinded, placebo-controlled, Phase 1-2 trial assessing the safety and potential efficacy of intravenous infusion of Zofin in COPD
Biologics
Cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation, has contacted the agency and vaccine makers Pfizer and Moderna about the immunological danger he says could be posed by the Covid-19 vaccine to the recently convalescent or asymptomatic carriers of SARS-CoV-2, and especially
Biologics
FDA has resumed conducting “prioritized” inspections by investigator staff in China and they will begin shortly in India too, according to CDER acting director Patrizia Cavazzoni. In a recent Twitter posting, Cavazzoni noted that inspections deemed “mission critical” are still being conducted. “We’re prioritizing inspections so the agency will
Drugs
FDA has accepted for review a Bio-Thera Solutions BLA for BAT1706, a proposed biosimilar to Genentech’s Avastin (bevacizumab). The submission seeks approval for the following indications: (1) treating patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, (2) first-line treatment for patients with non-squamous
Drugs
FDA says it is continuing to investigate the presence of 1-methyl-4-nitrosopiperazine (MNP) in rifampin or 1-cyclopentyl-4-nitrosopiperazine (CPNP) in rifapentine approved for sale in the U.S. An agency statement says both antibacterial drugs are used to treat tuberculosis and rifampin also is used to
Devices
FDA has updated an immediately-in-effect guidance, Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis for the
Biologics
CBER says its review of a Web site and Facebook page indicate that The Body Building, Clovis, CA, is marketing cellular products derived from human umbilical cord or human umbilical cord blood for many diseases and conditions. A 1/25 Notice of Violation says that FDA regulates such products as
Drugs
FDA is permitting KemPharm to proceed under an IND with its planned clinical investigation of KP879 and its use in treating stimulant use disorder (SUD). The company says that SUDs include conditions marked by abuse/misuse of cocaine, methamphetamines, prescription stimulant products that contain methylphenidate or amphetamine, and numerous designer
Drugs
PharmaCyte Biotech says it has started additional studies sought by FDA to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps product for treating pancreatic cancer and the stability of the sequences. The company says it has already demonstrated that the enzyme
Drugs
FDA has granted Veralox Therapeutics an orphan drug designation for VLX-1005 for treating heparin-induced thrombocytopenia (HIT). VLX-1005 is described as a first-in-class and selective small molecule inhibitor 12-Lipoxygenase, a key target within the arachidonic acid pathway. “Preclinical data has demonstrated that VLX-1005 halts
Drugs
Abeona Therapeutics says it has completed a Type B meeting with FDA on co-primary endpoints for its planned pivotal Phase 3 VIITAL study of EB-101 in recessive dystrophic epidermolysis bullosa (RDEB), which is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can
Drugs
CDER says the percentage of pre-approval inspections not conducted and other tools and approaches used instead due to the Covid-19 pandemic rose from 48% in the third quarter of Fiscal Year 2020 to 60% in the fourth quarter, which ended 9/30/20. The Center’s latest update
Drugs
FDA has posted an 11/5/2020 Form FDA-483 response from Bristol-Myers Squibb/Juno Therapeutics that addressed an FDA-483 with six inspection observations issued following a 10/2020 agency inspection at Juno in Bothell, WA. The firm is a CAR-T cell therapy manufacturer and the inspection
Drugs
FDA has denied a 9/30/20 petition submitted by the Outsourcing Facilities Association asking that the agency issue a regulation defining “clinical need” and establish a list of bulk drug substances for which there is a clinical need. The agency denial letter says the petition asked FDA to define
Drugs
Pfizer says its Xeljanz (tofacitinib) failed to meet the co-primary endpoints in the recently completed post-marketing required ORAL Surveillance safety study. The study evaluated Xeljanz safety at two doses versus a TNF inhibitor (TNFi) in subjects with rheumatoid arthritis who were age 50 or older and had at
Drugs
Agios Pharmaceuticals says it will file an NDA in the second quarter for mitapivat for treating adults with pyruvate kinase (PK) deficiency following an announcement of positive Phase 3 data from the ACTIVATE-T trial. The data show that mitapivat in regularly transfused adults with PK deficiency demonstrated a statistically
Drugs
A 10/22-10/29/20 FDA inspection at Professional Compounding Centers of America, Houston, TX, found multiple significant violations, including deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 1/27 Warning Letter says CGMP violations identified at the company’s suppliers caused drugs manufactured
Drugs
FDA has amended its guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency to add content to the question-and-answer appendix about including patients who have received a Covid-19 vaccine or other emergency-use authorization (EUA) products in clinical trials. FDA