Drugs
An 8/3-8/9/22 FDA inspection at the Profounda, Inc., drug manufacturing facility in Orlando, FL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/1 Warning Letter says the specific violations were: * failing to establish written procedures for production
Drugs
The Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) have supplemented their comments to the U.S. Patent and Trademark Office (USPTO) about that agency’s collaboration with FDA. PhRMA’s letter was submitted to “address certain aspects of comments presented by (1) Fresenius Kabi regarding
Drugs
Staff from CDER and the Oncology Center of Excellence say there are challenges and specific areas for improvement, including assay validation, standardization of collection methods to optimize performance, and considerations in trial design and statistical methodology, in using minimal residual disease (MRD) data as a prognostic biomarker, a measure of
Drugs
Servier says its Phase 3 INDIGO clinical trial assessing vorasidenib in monotherapy for patients with residual or recurrent IDH mutant low-grade glioma met its primary endpoint of progression free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). Patients enrolled in the study had residual
Drugs
FDA has announced a 5/2 Webcast entitled “Navigating the First ICH Generic Drug Draft Guideline — M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms.” The Webinar will take an in-depth look into the draft guidance and explain the ICH’s current scientific thinking, and provide clarification on FDA’
Drugs
An 8/30-9/9/22 FDA inspection at the Formology Lab drug manufacturing facility in Chatsworth, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/1 Warning Letter says the specific violations were: * failing to conduct at least one test to verify
Drugs
A 7/19-8/5/21 FDA inspection under the Bioresearch Monitoring Program at the clinical site operated by Dr. Maggie Jeffries/Avanti Anesthesiology in Houston, TX, found that the site did not adhere to the applicable statutory requirements and regulations governing the conduct of clinical investigations and the protection
Drugs
FDA has placed a clinical hold on Mersana Therapeutics’ Phase 1 trial of XMT-2056 after the company suspended it due to a recent Grade 5 (fatal) serious adverse event (SAE) that was deemed to be related to the study drug. The company says the SAE and its cause remain
Drugs
FDA has released a final guidance entitled “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” Acid reducing agents (ARA) can increase gastric pH which may affect the solubility and dissolution characteristics of some orally administered drugs, the agency says. “As
Drugs
FDA has approved an Acadia Pharmaceuticals NDA for Daybue (trofinetide) oral solution for treating Rett syndrome, a rare, genetic neurological and developmental (XXX INSERT XXX)disorder, in adults and children two years of age and older. The disorder affects brain development, according to an FDA release, adding that patients typically
Drugs
The main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays, according to CDER Drug Shortage Staff team leader Emily Thakur. In an online post, Thakur talks about recent drug supply challenges, shares new FDA guidance, and offers solutions to resolve drug shortages. “It is
Drugs
A new Government Accountability Office (GAO) report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt advanced manufacturing. The report was mandated by the CARES Act to report on the federal pandemic response, particularly FDA’s efforts to support advanced manufacturing as a
Drugs
FDA has published a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health emergency (PHE), which will officially end 5/11. Because many of the guidance documents issued during the PHE to address Covid-19 were tied to
Drugs
FDA has split into two its guidance entitled “Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).” The two new guidances have no changes to the agency’s enforcement policy, and the action is intended
Drugs
FDA has approved a Pfizer NDA for Zavzpret (zavegepant), the first calcitonin gene-related peptide receptor antagonist nasal spray for treating adults with acute migraine headache with or without aura. Approval was based on data from a Phase 3 study that showed Zavzpret was statistically superior to placebo on the
Drugs
Four FDA and European Medicines Agency staffers who work in the joint parallel scientific advice (PSA) program say their evaluation of program activity from 2017 through 2021 demonstrated its value to product sponsors and the two agencies. Writing in Therapeutic Innovation and Regulatory Science, the four say the program “provides
Drugs
Lilly says it is ending clinical development of solanezumab for preclinical Alzheimer’s disease due to disappointing results from the Phase 3 A4 study that was launched in 2013. The company reports that the drug failed to meet its primary or secondary endpoints in that it did not slow cognitive
Biologics
FDA commissioner Robert Califf says truth is “losing the [misinformation] battle right now” and FDA and many other stakeholders can and must do more to try to protect people from medical misinformation. In an interview with the online newsletter Stat News, Califf said the agency may need to update its
Drugs
FDA’s just-released budget request for FY 2024 has the agency seeking a $372 million (10%) boost and a $150 million increase in user fees. The total funding being proposed for FDA, including $3.5 billion in total user fees, is $7.2 billion. “This funding will allow the
Drugs
AstraZeneca says data from its ADAURA Phase 3 trial showed that its lung cancer drug Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung
Drugs
FDA has approved an Amphastar NDA for naloxone hydrochloride nasal spray 4mg, which is delivered using the company’s proprietary nasal delivery device. A company statement says the naloxone spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous
Drugs
The Natural Products Association and the Alliance for Natural Health have petitioned FDA to determine that nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement. A statement from the two associations (contains a link to the citizen petition) says the groups also want the agency to: