Biologics
FDA has granted Merck a breakthrough therapy designation for V116, an investigational 21-valent pneumococcal conjugate vaccine. It is being evaluated for preventing invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20,
Drugs
AbbVie and Genmab say they plan to engage global regulatory authorities based on topline results from the EPCORE Phase 1/2 trial of epcoritamab in patients with relapsed/refractory large B-cell lymphoma. An AbbVie statement says the topline results demonstrated a confirmed overall response rate of 63.1% with
Drugs
FDA has published a new draft guidance, Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials, that expands on an earlier guidance intended to help the industry improve clinical trial diversity. The document says individuals from several named populations are frequently under-
Drugs
The House Committee on Oversight and Reform has released an interim staff report, “The Firm and the FDA: McKinsey & Company’s Conflicts of Interest at the Heart of the Opioid Epidemic.” A committee statement says the report “presents preliminary findings from the committee’s investigation into McKinsey’s consulting
Drugs
FDA has issued a draft guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use, describing how the agency intends to evaluate such waiver requests. The document also makes recommendations on the timing and process for requesting the waiver. “This guidance
FDA Policy/General
Federal Register notice: FDA has announced a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss two bluebird bio BLAs: (1) a BLA for elivaldogene autotemcel for treating patients younger than 18 years of age with early cerebral adrenoleukodystrophy who do not
FDA Policy/General
Federal Register notice: FDA has made available two final device-specific guidance documents for the Safety and Performance Based Pathway. One is on Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway, and the other is on Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway.
FDA Policy/General
Federal Register notice: FDA is permanently debarring Lisett Raventos from providing services in any capacity related to an approved or pending drug product application. FDA bases the debarment on its finding that she was convicted of a felony under federal law for conduct relating to a drug product’s development.
FDA Policy/General
FDA has published a final guidance, Compounding Animal Drugs from Bulk Drug Substances, describing the agency’s enforcement policy for the compounding of animal drugs from bulk substances by or under the direction of veterinarians or pharmacists. The document does not apply to animal drugs compounded for use in investigations
FDA Policy/General
Pro golfer James Hahn has signed on with IBSA Pharma to promote Licart (diclofenac epolamine), the company’s newest topical pain product. A company statement says Licart is the first and only once-a-day topical non-steroidal anti-inflammatory drug indicated to treat acute pain due to minor strains,
Devices
FDA has granted a Safer Technologies Program (STeP) designation to Pear Therapeutics for its Pear-010 product candidate intended to treat acute and chronic pain. The company says the product is intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients age 18 and older with acute
Biologics
Aeglea BioTherapeutics has submitted a BLA for pegzilarginase for treating Arginase 1 Deficiency (ARG1-D). The company says the recombinant human arginase 1 enzyme has been shown in clinical trials to normalize the elevated levels of the amino acid arginine in patients with ARG1-D. It says people living with
Devices
FDA has approved a Boston Scientific PMA for its latest image guided programming software, Vercise Neural Navigator with StimViewXT. The device is intended to provide clinicians in real-time the ability to visualize both lead placement and “stimulation modeling of the brain anatomy of their patients living with Parkinson’s
Drugs
The International Council for Harmonization says three of its guidelines have reached Step 2 in the development process and are now in the public consultation period. The guidelines are: * E11A on pediatric extrapolation; * revision of Q2(R2) on validation of analytical procedures; and * Q14 on analytical procedure development.
Drugs
Some 30 members of the House and Senate have written to the CEOs of seven manufacturers of naloxone, asking them to apply for over-the-counter (OTC) status for the drug. In a statement, the lawmakers say that despite naloxone’s effectiveness in reversing opioid overdoses and FDA’s public
Devices
FDA has announced a 7/12-13 CDRH Patient Engagement Advisory Committee meeting that will discuss and make recommendations on augmented reality (AR) and virtual reality (VR) medical devices. “From diagnostics to clinical decision making, to surgical support, and to directly treating patients, AR/VR devices are used across multiple
Drugs
A 7/6-7/28/21 FDA inspection at Generitech Corp., Fresno, CA, found significant violations of current good manufacturing practice (CGMP) regulations and unapproved new drug and misbranding violations. A just-released 3/1 Warning Letter lists specific CGMP violations as: * failing to thoroughly investigate any unexplained discrepancy or
FDA Policy/General
Federal Register notice: FDA has determined that Clinigen’s Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to safety or effectiveness reasons. The determination means the agency can continue to approve ANDAs that reference the product, which is indicated for treating extravasation resulting from intravenous anthracycline chemotherapy and for
Drugs
FDA says 2021 inspections at three Ultra Seal facilities in Highland and New Paltz, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/14 Warning Letter lists the violations for each facility as: * ULTRAtab Toc Drive o failing to establish and
Drugs
A 9/20-9/24/21 FDA inspection at Yusef Manufacturing Laboratories, Clearfield, UT, found significant repeated violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/8 Warning Letter lists specific violations as: * failing to conduct at least one test to verify the identity
Drugs
Veru Inc. has announced positive efficacy and safety results from an interim analysis of a double-blind, randomized, placebo-controlled Phase 3 Covid-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized patients at high risk for Acute Respiratory Distress Syndrome. The company says the primary
Devices
FDA has issued two guidances with performance criteria for products in support of the 510(k) Safety and Performance Based Pathway. The first guidance, Denture Based Resins — Performance Criteria for Safety and Performance Based Pathway, gives submitters an option to use the performance criteria proposed in the document to support