Drugs
Akebia Therapeutics has submitted an NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia due to chronic kidney disease in adult patients on or not on dialysis. The submission was prepared in collaboration with Otsuka Pharmaceutical. It includes data from over 8,000 patients
Drugs
FDA has granted Biom Therapeutics an orphan drug designation for BIO017 and its use in treating Angelman syndrome. The company plans to begin a clinical trial involving BIO017 in the fourth quarter. The company says Angelman syndrome is a subset of epilepsy. Preclinical results, according to Biom, showed the drug’
Drugs
CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth (PTB) risk is not persuasive and will not change its course to withdraw Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market. Late last year, FDA proposed a rare product approval reversal for Makena because
Drugs
FDA has accepted for priority review a Mirum Pharmaceuticals NDA for maralixibat, an oral apical sodium dependent bile acid transporter inhibitor for treating cholestatic pruritus in patients with Alagille syndrome, a rare liver disease for which there are currently no approved therapies. The company says the drug works by inhibiting
Drugs
FDA has approved an Astellas Pharma NDA for Myrbetriq (mirabegron extended-release tablets) for treating neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules (mirabegron for extended-release oral suspension) for treating NDO in pediatric patients aged three
Drugs
A wave of negative drug approval news has left industry and financial analysts wondering if FDA has raised the bar on drug approvals, but FDA dismisses the concern, claiming it is business as usual. Over the past few months, some high-profile drug reviews have hit snags and FDA watchers
Drugs
FDA says it is asking all manufacturers of over-the-counter Benzedrex (propylhexedrine) decongestant inhalers to consider product design changes that support safe use. The request is included in an agency drug safety communication that warns that abuse and misuse of the inhaler can lead to serious harm such as
Drugs
Alembic Pharmaceuticals has recalled one lot of telmisartan tablets, USP, 20 mg, packaged in 30-count bottles (Lot # 1905005661) due to a mislabeling concern. The company says it received a complaint that one bottle labeled as 30-count telmisartan tablets 20mg incorrectly contained 30 tablets of telmisartan tablets 40mg. Patients
Drugs
The Critical Path Institute (C-Path) is joining the CDER Office of Translational Science and the Division of Cardiology and Nephrology in an Acute Kidney Injury (AKI) Project to develop a suite of prognostic tools to improve the prediction and detection of drug-induced kidney injury (DIKI). A C-Path
Drugs
FDA is republishing fee rates for the over-the-counter (OTC) monograph drug user fee program. A Federal Register notice says the rates were authorized under the 3/2020 Coronavirus Aid, Relief, and Economic Security Act to support the modernization of the OTC monograph program. After the fees were initially
Drugs
EMD Serono says there are several things FDA should consider as it continues planning a workshop on “Best Practices for Development and Application of Disease Progression Models.” In a 3/22 comment letter, the company asks the agency to consider: * best practices for machine learning and artificial intelligence in the
Drugs
A suit filed by Arbor Pharmaceuticals in a Georgia federal court challenging an FDA determination concerning the withdrawal of its original Nymalize (nimodipine) “raises interesting questions of statutory interpretation and the scope of FDA’s powers,” according to attorney Sarah Cork (Proskauer Rose). Writing in an online post, Cork says
Drugs
A 3/25 FDA advisory committee voted 19 to 1 that a Pfizer-proposed Risk Evaluation and Mitigation Strategy (REMS) in its BLA for osteoarthritis drug tanezumab subcutaneous injection does not ensure that the drug’s benefits outweigh its risks. FDA reviewers told panel members that the REMS was not
Drugs
Exela Pharma Sciences is asking FDA to refund FY 2021 PDUFA user fees assessed against the company’s nicardipine HCl injection and stop assessing user fees in the future. A 3/18 citizen petition says that to help facilitate the prompt refund of the user fees that were “improperly assessed,
Drugs
FDA has issued a refusal to file letter for Novo Nordisk’s 1/20 label expansion application for once-weekly semaglutide 2.0 mg to treat Type 2 diabetes. The company says the agency requested additional information including data relating to a proposed new manufacturing site. “While additional information needs
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FDA has denied an 8/3/06 petition from the governors of Kansas, Minnesota, Vermont, and Wisconsin asking that the agency issue product-specific guidance for the development of insulin and human growth hormone (HGH) that are therapeutically equivalent to branded products approved by FDA. The petition also asked that
Drugs
At the 1/13 meeting of the PDUFA 7 reauthorization FDA and Industry Manufacturing Subgroup, the two sides continued discussions around a CMC readiness pilot for certain products. A meeting summary shows that both the agency and industry representatives saw potential benefit in a pilot and discussed the duration of
Drugs
FDA has granted Reneo Pharmaceuticals a Fast Track designation for REN001 and its use in treating patients with primary mitochondrial myopathies (PMM). The company describes REN001 as an oral selective peroxisome proliferator-activated receptor delta agonist currently in clinical development for genetic mitochondrial diseases that typically present with myopathy and
Drugs
FDA has approved a Pacira BioSciences supplemental NDA to expand Exparel’s (bupivacaine liposome injectable suspension) label to include use in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia. The company says the approval provides an alternative to opioids, the current standard
Drugs
Oramed Pharmaceuticals says it has screened the first patients for the second of two concurrent Phase 3 studies of its ORMD-0801 oral insulin capsule for treating Type 2 diabetes. The company says the studies are being conducted under an FDA-approved protocol to treat Type 2 diabetes patients who
Drugs
Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage are jointly asking FDA not to authorize the New Mexico Health Department’s Section 804 drug importation program application and to disclose the identities of the foreign seller, importer, and FDA-registered
Drugs
A 3/19 petition filed by Loeb & Loeb on behalf of an unnamed client asks FDA to take specific actions about the adequacy of safety labeling for Incyte’s Jakafi (ruxolitinib) tablets, one of the JAK inhibitor drug products. The petition asks that: * FDA open a public docket to