Drugs
FDA has released four cancer clinical trial eligibility criteria guidances. A guide on “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections” provides recommendations on the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)
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FDA has approved an Allergan supplemental BLA for an expanded use for Botox (onabotulinumtoxinA) — treating spasticity in pediatric patients two years of age and older, including those with lower limb spasticity caused by cerebral palsy. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles
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Washington Legal Foundation has submitted a comment to FDA supporting the citizen petition of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information. The letter says FDA is running a suppression campaign that not only threatens the public health but also runs afoul of the Constitution. “By prohibiting clinical labs
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates the work FDA has done on advancing the inclusion of diverse populations, including racial and ethnic minorities, in clinical trials. Commenting to the agency docket on strategic priorities for the FDA Office of Minority Health and Health Equity, PhRMA says
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FDA has accepted for review Leo Pharma’s BLA for tralokinumab for treating adults with moderate to severe atopic dermatitis. A company statement says FDA has set a PDUFA target action date in the second quarter of 2021. Leo describes tralokinumab as a fully human monoclonal antibody that specifically neutralizes
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Brilinta (ticagrelor) for reducing subsequent strokes in patients who experienced an acute ischemic stroke or transient ischemic attack. The user fee review action is expected in the fourth quarter. The submission is based on results from the Phase 3
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The Delaware federal court has denied a defendant’s motion to dismiss a generic drug patent case, rejecting the argument that conversion of a Paragraph IV certification to a Paragraph III certification deprives the court of subject matter jurisdiction. Attorneys Charles Chevalier and Christine Gaddis (Gibbons) write in their firm’
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A 6/18-7/2/19 FDA inspection at Washington Homeopathic Products, Berkeley Springs, WV, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A just-released 6/19 Warning Letter says the specific CGMP violations were: * failing to establish an adequate quality
Drugs
Biogen and Eisai say that Biogen has completed the submission of a BLA to FDA for approval of aducanumab, an investigational treatment for Alzheimer’s disease. A company statement says the completed submission followed ongoing collaboration with the agency and includes data from the Phase 3 EMERGE and ENGAGE studies
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FDA says its review of a Web site operated by Ionogen, Knoxville, TN, found that the company is marketing its Ionopure Skin & Hands for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 7/7 Warning Letter says the agency considers
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Mylan has recalled one lot of daptomycin for injection, 500 mg/vial, due to particulate matter found in one single-dose vial. To date, Mylan has not received any adverse event reports related to the recall, according to a recall notice. The antibacterial is indicated for treating complicated skin and
Drugs
FDA has issued Merck and Eisai a complete response letter on their request for accelerated approval of an NDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The agency told the companies that another combination therapy (presumably Roche’s Avastin
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The Microbiome Therapeutics Innovation Group is asking FDA to finalize a 2016 draft guidance that updated a 2013 guidance outlining an enforcement discretion policy on the IND requirements for using fecal microbiota transplantation (FMT) to treat C. difficile infection not responding to standard therapies while the agency further considered the
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Drug companies have made more than 800 price increases this year and adjusted the cost of 42 medicines up by an average of 3.3% so far this month, according to GoodRx as reported online by Politico. “While the size of that increase is not out of line with past
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FDA is asking public stakeholders such as patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts to notify the agency if they intend to participate in periodic consultation meetings on PDUFA reauthorization. A Federal Register notice says PDUFA authorization expires 9/2022 and new legislation will be
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FDA has approved Astex Pharmaceuticals’ Inqovi (decitabine and cedazuridine) tablets to treat adults with myelodysplastic syndromes and chronic myelomonocytic leukemia. An agency statement says the approval “represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a healthcare facility
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An 11/25-11/28/19 FDA inspection at Vega Life Sciences, Sangreddy District, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 6/17 Warning Letter says the specific deviations were: * failing to control and monitor solvent recovery procedures to ensure
Drugs
Public Citizen has written to HHS secretary Alex Azar, FDA commissioner Stephen Hahn, National Institutes of Health director Francis Collins, and National Institute of Allergy and Infectious Disease director Anthony Fauci asking HHS to announce that FDA will not permit and NIH will not support any clinical trial in which
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FDA has published a list of REMS updates for five drug products. The list shows changes for Akcea’s Tegsedi (inotersen), Celgene’s Pomalyst (pomalidomide), Takeda’s Natpara (parathyroid hormone), Indivior’s Sublocade (buprenorphine extended-release), and Zogenix’ Fintepla (fenfluramine).
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FDA has approved Genentech’s Phesgo (pertuzumab, trastuzumab, and hyaluronidase ZZXF) for injection under the skin to treat adult patients with metastatic HER2-positive breast cancer, and for treating adult patients with early HER2-positive breast cancer. An agency announcement says patients should be selected based on an FDA-approved
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FDA has approved Merck’s Keytruda (pembrolizumab) for intravenous injection for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The agency says it is the first immunotherapy approved for this patient population as a first-line treatment that is administered
Drugs
FDA has published a draft guidance, Development of Anti-Infective Drug Products for the Pediatric Population, with general recommendations on developing anti-infective drug products for the pediatric population. The document does not address the full scope of considerations for pediatric anti-infective drug development. Additional information is available through