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
Biologics
FDA is continuing to closely monitor the various identified variants of the virus that causes Covid-19 and also monitoring for emerging variants, according to a series of 1/25 Tweets by FDA acting commissioner Janet Woodcock. Woodcock says the agency “will continue to factor in newly emerging information in
Drugs
Merck says an FDA draft guidance, Cross Labeling Oncology Drugs in Combination Regimens, is needed, given the increasing importance of oncology combination regimens for optimal patient treatment. “The guidance is informative, but does not include much information on acceptable trial design, except for a brief mention of FDA’s support
Drugs
FDA says its review of records and other information submitted by Yuyao Yijia Daily Chemical Co., Ningbo, China, a registered manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/22 Warning Letter identifies specific violations as: * failing
Drugs
FDA has accepted for priority review a Vertex Pharmaceuticals supplemental NDA to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children ages six through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation
Drugs
Myovant Sciences and Pfizer say that data from the Phase 3 SPIRIT long-term extension study of an investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis showed clinically meaningful reductions in dysmenorrhea (menstrual pain)
Drugs
CDER has issued its 2021 list of new and revised draft guidance documents planned for publication this year. The list covers 105 documents broken into 18 categories. The largest category is Procedural, with 22 guidances, followed by Generics, with 20 documents.
Devices
Faced with ongoing safety concerns about hand sanitizers coming from Mexico, FDA has decided to place all alcohol-based hand sanitizers from the country on import alert to intercept them until the agency is able to review their safety. “Over the course of the ongoing pandemic, the agency has seen
Devices
FDA has released the FDA-483 with eight inspection observations issued following a 3/2-4/6/20 inspection at CareFusion 303, a San Diego, CA, medical device manufacturer. The inspection observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately establish procedures for receiving,