Drugs
In its Biosimilar User Fee Act (BsUFA) 3 goal letter for FY 2023-2027, FDA commits to responding to 90% of original biosimilar product application submissions within 10 months of the 60-day filing date and 90% of resubmitted original biosimilar product applications within six months of the receipt date.
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FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) for treating adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. Approval was based on
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FDA has approved an Incyte supplemental NDA for Jakafi (ruxolitinib) for treating chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Approval is based on data from the Phase 3 REACH3 study of Jakafi
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Attorneys Charles Raver and James Valentine (Hyman, Phelps & McNamara) say they were excited by many of the items included in the FDA PDUFA 7 goals letter for 2023-2027 while recognizing that the real success will come from how the agency implements its goals. “From new initiatives to facilitate
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Researchers from FDA and Stanford University say the agency has no mechanism to find or tradition to cite similar cases when weighing evidence for drug approvals, resulting in “standalone, bespoke decisions.” Writing in the Annals of Internal Medicines, the researchers say that as a result, FDA’s decisions show highly
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FDA and Health Canada have announced a 10/8 regional public consultation on recent International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) activities and future topics. Such consultation meetings are held prior to each bi-annual ICH meeting to seek input on current and future
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FDA is telling NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synchron Research Services, located in Ahmedabad, Gujarat, India, and Panexcell Clinical Lab, Navi Mumbai, India, are not acceptable because of data integrity concerns. An agency notice says the studies must be repeated. The notice says the
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Johnson & Johnson says new data show increased protection against Covid-19 when a booster shot of its vaccine is administered, adding that the vaccine’s safety profile remained consistent after the booster shot. The company says a real-world evidence study for its vaccine demonstrated 79% effectiveness for Covid-
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FDA says Web sites and social media pages maintained by the Fibromyalgia Treatment Group (FTG), Eagle, ID, promote the sale of several products that are unapproved new drugs. A just-released 8/26 Warning Letter gives claims made for the products and says they are not generally recognized as safe
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FDA has approved a Samsung Bioepis and Biogen BLA for BYOOVIZ (ranibizumab-nuna), the first biosimilar version of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor
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FDA has released a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence. The document provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in generic drug controlled correspondence submissions to CDER’s Office of Pharmaceutical Quality (OPQ) regarding chemistry, manufacturing, and
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Medtronic’s Micro Therapeutics unit (dba ev3 Neurovascular) has begun a Class 1 recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to the risk that its delivery system wire and tubes could fracture and break off inside a patient. Attempts to retrieve
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FDA has issued Verrica Pharmaceuticals a complete response letter regarding its NDA for VP-102 for treating molluscum contagiosum. Previously, the agency extended by three months (until 9/23) to allow additional time to review information submitted by the company in response to comments about its human factors study. The
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Pfizer is expanding its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential presence of unacceptable N-nitroso-varenicline levels. “To lessen the impact to patients from a drug shortage due to this ongoing recall, FDA will not object to
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An FDA safety alert warns healthcare professionals and patients not to use compounded products from Prescription Labs, doing business as Greenpark Compounding Pharmacy (Houston, TX), due to lack of sterility assurance. Using non-sterile products may result in serious and potentially life-threatening infections or death, the alert says. FDA
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The U.S. District Court for the Middle District of Florida has entered a consent decree against Premier Pharmacy Labs that prohibits it from producing or distributing any drugs until the company completes corrective actions and comes into FDA compliance. Under the consent decree, Premier Pharmacy may not resume compounding
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FDA has placed a clinical hold against Protagonist Therapeutics and its clinical studies for rusfertide. Affected trials for the injectable hepcidin mimetic include a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2
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Modifications to the risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine approved by FDA 7/20 will take effect 11/15. An agency online FAQ document says the changes are intended to ensure that the drug’s benefits outweigh the risk of severe neutropenia. “The clozapine REMS
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AbbVie has submitted a supplemental BLA for Rinvoq (upadacitinib) (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
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FDA has approved Takeda’s Exkivity (mobocertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The company says Exkivity
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FDA says it has incorporated International Council for Harmonization Q2B Validation of Analytical Procedures: Methodology with the parent document Q2A Text on Validation of Analytical Procedures and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Methodology. The consolidated guidance consists of the previously published FDA guidances,
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FDA has cleared a Biomea Fusion IND to begin a Phase 1 trial of BMF-219, a selective irreversible menin inhibitor, in adults with relapsed or refractory acute leukemia, including those with an MLL/KM2TA gene rearrangement or an NPM1 mutation. The company says BMF-219 is a synthetic compound