Drugs
Novartis says it is abandoning its work to gain FDA approval for a generic copy of GlaxoSmithKline’s Advair Diskus (fluticasone propionate/salmeterol). The product is indicated for treating asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in
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A study from Florida Atlantic University’s Schmidt College of Medicine finds that granulocyte colony-stimulating factor (GCSF) or Amgen’s Neupogen, which was approved in 1991 for treating neutropenia (low white blood cells) caused by chemotherapy, may offer a new way to treat strokes. Published in the Journal of
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FDA has issued six final guidances on gene therapy manufacturing and clinical development of products plus a draft guidance on interpreting the sameness of gene therapy products under the orphan drug regulations. In an agency statement (contains links to the guidances), CBER director Peter Marks says “as regulators of these
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FDA has just released the FDA-483 issued following a 12/5-12/13/17 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. Inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions; * aseptic processing areas are
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FDA says it is requiring a new warning and updates on clozapine products and related constipation risks, which can progress to serious bowel complications, hospitalization or death. An updated safety alert says the risk is further increased at higher clozapine doses and when it is co-prescribed with anticholinergics, which
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A 6/24-6/28/19 FDA inspection at Sunstar Guangzhou, Guangdong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/22 Warning Letter says specific violations were: * failing to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance
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Discussions from a 10/2018 joint good clinical practice workshop held by FDA and the UK Medicines and Healthcare Products Regulatory Agency have been published in the journal of the American Society for Clinical Pharmacology and Therapeutics. The article says the workshop “provided the agencies’ perspectives on the importance of
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FDA has approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly’s Trijardy XR (empagliflozin/linagliptin/metformin HCl) to lower blood sugar in adults with Type 2 diabetes, along with diet and exercise. Trijardy XR comprises three Type 2 diabetes medicines in one pill, including Jardiance, Tradjenta and metformin extended release. Approval
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FDA is seeking comments on two proposed studies entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The agency intends to examine four types of endorsers in the studies (celebrity, physician, patient, and social media influencer) and it will examine whether the presence of a disclosure of
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FDA has accepted for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system), for treating Alzheimer’s-type dementia. The agency has set a 7/30 user fee review target action date. The company describes Adlarity as a once-weekly transdermal formulation of Pfizer’s Aricept that
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FDA has approved Merck’s Dificid (fidaxomicin) oral suspension and tablets for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial was previously indicated in adults for treating Clostridium difficile-associated diarrhea. Difficile is a bacterium that causes diarrhea and colitis,
Drugs
FDA has released a final guidance on “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials or to support drug
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FDA is seeking outside groups or individual data scientists for the development of computational algorithms to identify adverse event anomalies in open FDA adverse event data available on its openFDA platform. “Automated adverse event anomaly detection would augment the traditional data mining and case review approach by enabling the unsupervised
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FDA has granted accelerated approval for Epizyme’s Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Approval was based on data from a single-arm cohort (Cohort 5) of a multi-center trial (Study
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A Genentech Phase 3 study (IMvigor010) evaluating Tecentriq (atezolizumab) in people with muscle-invasive bladder (urothelial) cancer did not meet its primary endpoint of disease-free survival. The company says more treatment options are needed after surgery because about half of patients will see disease recurrence within two years after
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FDA has published two guidances dealing with drug-drug interactions. The first guidance, In Vitro Drug Interaction Studies—Cytochrome P450 Enzyme- and Transported-Mediated Drug Interaction, is to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product. The document
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AbbVie says it expects FDA to make a decision before summer on a new indication for its Orilissa (elagolix) to treat uterine fibroids in premenopausal women. The Philadelphia Inquirer reports the agency is considering results from two clinical trials conducted at 77 sites in the U.S. and Canada in
Drugs
FDA has published a guidance, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017, to give stakeholders information on FDA implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA 2), which created changes to the user fee program. The document explains the new fee structure and the
Drugs
FDA says it has determined that Purell Healthcare Advanced Hand Sanitizer products marketed by Gojo Industries, Cuyahoga Falls, OH, are intended for use as consumer and healthcare antiseptics and, as formulated and labeled, are unapproved new drugs. A 1/17 Warning Letter lists some of the company claims for the
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FDA has denied an 8/29/19 Persion Pharmaceuticals petition asking that the agency take two specific actions regarding ANDAs for generic Zohydro ER (hydrocodone bitartrate) extended-release capsules. The petition asked that FDA require: * that any ANDA for generic Zohydro ER contain bioequivalence data from testing in hepatically impaired
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FDA has released a list of potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System that occurred between 9/2019 and 12/2019. The list includes 15 potential signals for a number of different drugs and shows what the potential signal is and
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[Report by David McFarland] How is it that Sarepta is able to again win FDA approval for a Duchenne muscular dystrophy (DMD) drug despite significant resistance from agency superiors? Just-posted approval documents from last month’s green light for Sarepta’s DMD drug Vyondys 53 (golodirsen) shed some light