Drugs
The International Council for Harmonization (ICH) Q13 guidance on continuous manufacturing of drug substances and drug products completed step 2 of the ICH process 7/27 and is now available for public review and comment. An ICH online post (contains a link to the guidance) says the document describes scientific
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FDA is telling patients and healthcare professionals that the OCEAN study evaluating Oncopeptides’ Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. An agency drug safety alert says the trial compared Pepaxto with low-dose dexamethasone to pomalidomide (Bristol-Myers Squibb’s
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FDA has accepted for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating recurrent vulvovaginal candidiasis (chronic yeast infection). The agency has set a 1/27/2022 user fee review action date. The submission is based on data from three Phase 3 trials involving more
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Johns Hopkins Center for Drug Safety and Effectiveness professor G. Caleb Alexander, who was on the advisory committee that voted 10-0-1 in 11/2020 not to recommend approval for Biogen’s Alzheimer’s treatment Aduhelm (aducanumab), has gone public with his concerns about the agency’s accelerated approval
Drugs
Regeneron Pharmaceuticals and AstraZeneca have entered into a collaboration to research, develop and commercialize small molecule compounds directed against the GPR75 gene for treating obesity and related co-morbidities. The pact builds on the recent discovery from the Regeneron Genetics Center involving rare genetic mutations in the GPR75 gene associated
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Five King & Spalding attorneys say an FDA draft guidance on safety event analysis and reporting for IND and bioavailability/bioequivalence studies signals the agency’s “current attention on the IND sponsor’s analysis of adverse events that may require expedited reporting to FDA and to all participating investigators.” In
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FDA has accepted for priority review an Aadi Bioscience NDA for its nanoparticle albumin-bound mTOR inhibitor Fyarro (sirolimus albumin-bound nanoparticles for injectable suspension) for treating advanced malignant PEComa, an ultra-rare sarcoma. The agency has set a user fee review action target date of 11/26. The submission
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FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. The company says the approval is based on the Phase 3
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FDA says it will meet with Petros Pharmaceuticals to discuss expansions and modifications to labeling for the company’s Stendra (avanafil) erectile dysfunction medication. The company says the meeting is scheduled for 9/2021. Petros says it is proposing that the time interval between administration of Stendra and nitrates be
Drugs
FDA has approved Sol-Gen Technologies’ Twyneo (tretinoin/benzoyl peroxide) cream 0.1%/3% to treat acne in adults and pediatric patients age 9 and older. The company says Twyneo uses its patented technology to entrap tretinoin and benz oyl peroxide within silica-based microcapsules to stabilize tretinoin from being
Drugs
FDA has issued Iterum Therapeutics a complete response letter on its NDA for sulopenem etzadroxil/probenecid, indicated for treating multi-drug resistant infections, including fast-growing quinolone non-susceptible pathogens. The company says the agency letter “acknowledged that the Phase 3 SURE-1 clinical trial demonstrated statistical significance in difference
Drugs
FDA has revised a Manual of Policies and Procedures (MAPP) entitled “Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act.” The MAPP outlines how FDA will approve an ANDA when the submission coincides with certain changes approved by agency to the labeling
Drugs
Bristol Myers Squibb has voluntarily withdrawn an indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib. The withdrawal is in response to an FDA industry-wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their post-
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FDA has issued Incyte a complete response letter on its BLA for retifanlimab, an intravenous PD-1 inhibitor for treating adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy. The company says FDA
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FDA has approved AstraZeneca’s Bydureon and Bydureon BCise (exenatide extended-release) injection for use in addition to diet and exercise to improve glycemic control in pediatric patients 10 years or older with Type 2 diabetes. Previously, the drug was approved for treating adults with Type 2 diabetes. Approval was
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FDA has approved AbbVie’s Dalvance (dalbavancin) for treating acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. The company says the therapy is the first single-dose option administered as a 30-minute intravenous infusion for treating ABSSSI caused by designated susceptible gram-positive bacteria
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FDA has notified Pfizer that it will not meet the already-extended PDUFA goal dates for the company’s NDA for abrocitinib to treat adults and adolescents with moderate to severe atopic dermatitis and the sNDA for Xeljanz/Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis. The agency
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FDA has granted full approval to the combination of Merck’s Keytruda and Eisai’s Lenvima for treating patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative
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Bipartisan leadership of the House Energy and Commerce Committee is asking FDA acting commissioner Janet Woodcock for information on agency efforts to mitigate the backlog of drug manufacturing facility inspections and human drug applications to ensure patient access to safe and effective medicines. A 7/22 letter says committee members
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FDA has published a guidance, Field Alert Report Submission Questions and Answers, giving the agency’s current thinking on the requirements for submitting field alert reports (FAR) by NDA and ANDA applicants. The document outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. It also
Drugs
FDA has placed a clinical hold on a Magenta Therapeutics Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The company says the agency is “requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/
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The CDER Office of Compliance says a review of the Web site and social media sites maintained by Jordan’s Crossing Herbal Connections, Barnsdall, OK, determined that the company is offering its “Germaphobe’s Delight Spray” to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 7/20