Drugs
FDA reviewers say NDA data support the efficacy of Pfizer’s Paxlovid (nirmatrelvir and ritonavir) for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease. The company’s data also demonstrated that Paxlovid retained antiviral activity against the Omicron variant and
Drugs
As required by the Orange Book Transparency Act of 2020, the Government Accountability Office (GAO) has reviewed FDA Orange Book patent listings for drug/device combination products, including the listings’ implications for generic products. In a report, GAO says it interviewed 15 stakeholders on (1) how Orange Book patent listings
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says a revised FDA draft guidance on the content and format of the Dosage and Administration section of labeling for human prescription drug and biological products provides more detail and direction than its previous 2010 document. PhRMA says the revised guidance “will provide
Biologics
FDA has revised the fact sheets on Janssen’s Covid-19 vaccine to include a warning about reported adverse events that suggest increased risks of myocarditis and pericarditis, particularly within the first seven days after administration. “An additional revision to the fact sheets was made to include that facial paralysis
Devices
FDA has cleared a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the company’s existing artificial intelligence (AI)-powered Tyto Insights smart diagnostic for telehealth use. Wheeze Detection is designed to “aid in the clinical assessment of lung sound data for adults
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
Biologics
Republican leaders of the House Select Committee on the Coronavirus Pandemic are asking FDA for information, communications, and transcribed interviews addressing possible political interference in Covid-19 vaccine and booster approvals. “According to new internal FDA communications,” the lawmakers wrote (contains link to letter) to FDA commissioner Robert Califf, “it
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
Devices
Former Becton Dickinson (BD) medical director Hooman Noorchashm has petitioned FDA to “scrutinize” the company’s 2017 510(k) clearance for the GalaForm 3D due to label misrepresentations and “fraud on FDA.” Noorchashm’s petition alleges that BD “deliberately failed to reveal its true design to market and distribute the
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
Biologics
FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children aged six months through four years at least two months after completing their primary vaccination with three doses of the monovalent vaccine. Previously
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
Biologics
FDA and CDC sent a 3/10 joint letter to Florida surgeon general Joseph Ladapo to correct “misinterpretations and misinformation” about Covid-19-related data from the Vaccine Adverse Event Reporting System (VAERS) cited in an earlier letter from Ladapo to the agencies. The letter took issue with Ladapo’s
FDA Policy/General
“Jim, I think you’ve found a niche,” wrote Pfizer VP for public affairs Joe Pollard in a personal note amid eight subscription checks I found in the mail that chilly April 1985 morning in Morgantown, WV. The week before, I’d sent my first eight-page “test issue” of
Devices
FDA has cleared a PeekMed 510(k) for its Web-based artificial intelligence automated planning solution for use in orthopedic surgery. The product supports live automatic segmentation of CT scans and X-Rays, automatic landmarks detection, and automatic planning within 30 seconds, the company says. The device presents a total
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