Drugs
FDA says it has approved BeiGene’s Brukinsa (zanubrutinib) capsules for treating adult patients with mantle cell lymphoma who have received at least one prior therapy. Brukinsa was approved on the basis of a clinical trial of 86 patients with mantle cell lymphoma who had received at least one prior
Drugs
FDA has released the FDA-483 issued following a 9/1-9/18 agency inspection at Isorx Corp., a Richmond, CA, producer of sterile and non-sterile drugs. The four inspection observations were: * failing to disinfect materials or supplies before entering the aseptic processing areas; * disinfecting agents and cleaning wipes
Devices
FDA has cleared a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden (TMB) in cancer tissue. The company describes the assay as the first “custom-targeted whole exome sequencing platform to report both overall tumor mutation burden
Drugs
FDA has granted X4 Pharmaceuticals a breakthrough therapy designation for mavorixafor for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company described mavorixafor as a potential first-in-class,
Drugs
FDA has placed a clinical hold on a Marker Therapeutics planned Phase 2 study of its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant and active disease setting. The company says the agency “reviewed our submission and requested
Drugs
Researchers from Harvard Medical School and other institutions say FDA should update and revise existing guidances for anti-infective drug approvals to recommend appropriate clinical outcomes consistent with general scientific and regulatory parameters. Writing online in JAMA Internal Medicine, the researchers say that 21 of 27 guidances reviewed recommended surrogate
Drugs
HHS secretary Alex Azar says the administration is changing a key element in its plan to lower drug prices because President Donald Trump wants the plan to go further than originally announced. The Hill reports that Azar spoke at an Axios event and said that under the original proposal some
Drugs
FDA has been making less use of human drug advisory committees, scheduling only 23 meetings this year, according to an analysis by Eye on FDA. There are 31 total advisory committees, with 18 of them relating to human drugs. The report says that 19 of the 23 meetings were related
Drugs
The Stericycle Expert Solutions First Quarter recall index says drug recalls decreased 6.5% to 72, the second-lowest number in the past 12 quarters. However, recalled units stayed high at just over 22 million. “The average number of recalls per quarter so far in 2019 is trending to be
Drugs
Braeburn says that in light of the FDA decision to grant its April petition requesting revocation of Indivior’s orphan designation for Sublocade (buprenorphine extended-release) injection, Braeburn’s Brixadi (buprenorphine) weekly and monthly extended-release injection to treat opioid use disorder can be marketed as of 12/1/20.
Devices
FDA has issued a guidance, Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices, to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a medical device. The document describes the information CDRH and CBER, in collaboration
FDA Policy/General
In a Securities and Exchange Commission (SEC) case that could affect FDA and several other government agencies that routinely seek disgorgement, the Supreme Court has agreed to consider the question of whether the SEC has the legal authority to seek disgorgement. The case follows a unanimous high court 6/2017
Drugs
GlaxoSmithKline says next year it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome (HES) based on just-announced positive results from a pivotal study. The Phase 3 study met its primary endpoint — demonstrating a statistically significant result with 50% fewer patients experiencing a HES flare
FDA Policy/General
Federal Register notice: FDA is announcing a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision making. The workshop’s discussions will be used in developing patient-focused drug development guidance as required by the 21st Century Cures Act and as part of commitments agreed
Devices
FDA has launched Web pages on devices used to treat temporomandibular disorders (TMD), including temporomandibular joint (TMJ) implants. The pages (1) provide information on FDA-approved devices that are used for TMD, including TMJ implants; (2) share information for patients considering TMJ implants; and (3) present postmarket surveillance study information,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3” (OMB Control Number 0910-0523). Agency regulations permit it to determine the organizational component within FDA assigned to have primary jurisdiction for
Drugs
A 5/27-6/5 FDA inspection at Mylan Laboratories’ Unit 8, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). An 11/5 Warning Letter says specific violations were: * failing to have adequate written procedures for the receipt, identification, and
Drugs
A 4/22-5/3 FDA inspection at Cadila Healthcare, Ahmedabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 10/29 Warning Letter lists the specific violations as: * failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or
Devices
Becton Dickinson (BD) has submitted a PMA supplement for an expanded version of its BD Onclarity HPV Assay. The device detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath Collection Vial. The submission includes data collected during a three-
Devices
FDA has approved a Hologic PMA for its 3DQuorum Imaging Technology for use with the company’s Clarity HD high resolution imaging technology to reduce tomosynthesis image volume for radiologists. The 3DQuorum technology uses Hologic’s Genius Artificial Intelligence-powered analytics to reconstruct high-resolution 3D data to produce 6
Devices
Worried about device shortages that could occur from recent closures due to environmental concerns at facilities that use ethylene oxide (EtO) to sterilize medical devices, FDA convened an advisory committee last week to discuss options and alternative sterilization methods. Members of FDA’s General Hospital and Personal Use Devices Panel
Devices
The International Medical Device Regulators Forum (IMDRF) has published three clinical final documents. The first, “Clinical Evidence—Key Definitions and Concepts,” is intended to (1) introduce the concepts of clinical evaluation and clinical evidence; (2) examine the relationship between clinical investigation, clinical data, clinical evaluation, and clinical evidence; and (3)