Drugs
FDA has granted Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic candidate, CMTX-101, and its use in treating chronic bacterial pulmonary infections in people with cystic fibrosis (CF). The designations follow “encouraging interim results” from Clarametyx’s ongoing Phase 1b/2a clinical
Devices
A 2/24-2/27 FDA inspection at the Mectronic Medicale S.R.L. facility in Bergamo, Italy, identified Quality System, Medical Device Reporting, and other violations in the firm’s illegal manufacturing of adulterated and misbranded laser medical devices. A just-released 6/27 Warning Letter says the firm
Drugs
FDA’s Oncology Center of Excellence will host a two-day (8/27-28) virtual public workshop to advance the development of patient registries in oncology, with a focus on the rare childhood brain tumor known as diffuse midline glioma, also referred to as diffuse intrinsic pontine glioma. The workshop
Drugs
A 1/16-1/27 FDA inspection at the Oasis Medical drug manufacturing facility in Glendora, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/15 Warning Letter says the specific violations were: * failure to establish adequate written procedures for production
FDA Policy/General
Right-wing activist and commentator Laura Loomer is now publicly criticizing FDA commissioner Marty Makary over recent comments surrounding the departure of CBER director Vinay Prasad, accusing Makary of undermining the authority of president Donald Trump and his top advisors. Her criticism of Makary in an 8/5 X post
FDA Policy/General
Former FDA chief of staff Elizabeth Jungman has joined law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washington, D.C. office. As chief of staff under Biden Administration commissioner Robert Califf, Jungman oversaw the day-to-day management of the agency and provided
Drugs
Vertex Pharmaceuticals says its investigational selective NaV1.8 pain signal inhibitor VX-993 did not meet the primary endpoint in a Phase 2 study evaluating its safety and effectiveness in treating acute pain after bunionectomy surgery. As a result, a company statement says, VX-993 will not be moved into
Drugs
FDA has granted Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystrophy (DMD) that is amenable to exon 51 skipping. The designation is based on data from the ongoing DELIVER clinical trial. “As we’ve previously disclosed, DYNE-251 has demonstrated sustained functional
FDA Policy/General
FDA has granted TransMedics Group conditional approval to begin its next-generation Organ Care System (OCS) ENHANCE heart trial. The trial is designed in two parts, according to the company, and will assess the capabilities of TransMedics’ proprietary heart technology. TransMedics says it's OCS platform is designed to
Devices
Philips Respironics is recalling (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure involving the “Ventilator Inoperative” alarm, which can cause therapy interruption or loss. A recall notice says the devices may reboot intermittently, which could stop therapy,
Drugs
Anixa Biosciences says it is assuming full sponsorship of an IND for its experimental breast cancer vaccine as it heads towards a Phase 2 clinical trial. The IND, which had been held by the Cleveland Clinic during a recently completed Phase 1 study, is now being transferred to Anixa. The
Biologics
A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur overriding CBER reviewers and management in the surprise rejection last month of Replimune’s priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec). RP1 is a herpes
FDA Policy/General
HHS acting general counsel Sean Keveney has been appointed FDA’s new chief counsel. Most recently at HHS, Keveney led the Department’s work for the Trump Administration on “discrimination crackdowns” involving Harvard, Columbia, Brown and Duke and their alleged violations of Title VI of the Civil Rights Act of
Drugs
FDA has approved Novo Nordisk’s Alhemo (concizumab-mtci) as a once-daily preventive treatment for bleeding episodes in patients 12 years and older with hemophilia A or B without inhibitors. The action expands on the drug’s initial FDA approval in December 2024 for patients with inhibitors. The approval
Biologics
FDA has issued Regeneron a second complete response letter (CRL) on its BLA for odronextamab, a bispecific antibody targeting CD20 and CD3 in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. In a financial update, the company says the submission was rejected over inspection concerns at
Drugs
Allogene Therapeutics has announced a major change to its ALPHA3 clinical trial for large B-cell lymphoma (LBCL), choosing to use standard chemotherapy for lymphodepletion following the death of a patient attributed to its investigational ALLO-647, an anti-CD52 monoclonal antibody. Lymphodepletion is described as the process by which
Drugs
FDA has approved LENZ Therapeutics’ Vizz (aceclidine ophthalmic solution) 1.44% for treating presbyopia, a common age-related condition that causes blurry near vision. The eye drops work by selectively constricting the iris sphincter muscle to create a “pinhole effect,” which improves near vision by increasing depth of focus without
Devices
Illumina has agreed to pay $9.8 million to settle allegations that it violated the False Claims Act by selling genomic sequencing systems with known cybersecurity vulnerabilities to U.S. government agencies. According to the Department of Justice (DoJ), between 2016 and 2023 Illumina allegedly sold sequencing systems to federal
Devices
Draeger has recalled (Class 1) its SafeStar 90 Plus bidirectional breathing system filter after receiving reports of slow increase of CO2-curve when a gas sample is taken from the filter’s sampling port, according to a recall notice. The filters are designed for infection prophylaxis during mechanical ventilation, particularly
Devices
Hamilton Medical has recalled (Class 1) its coaxial (1.8 m) breathing circuit set with flow sensor and expiratory valve that are used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. The breathing circuit may have a crack in its blue tubing, which is used to deliver fresh gas
Drugs
Eli Lilly is reporting favorable data from the SURPASS-CVOT trial that showed its diabetes drug Mounjaro (tirzepatide) matched the cardiovascular benefits of its older drug Trulicity (dulaglutide). The head-to-head 13,000-patient clinical trial found that Mounjaro was non-inferior to Trulicity in preventing major cardiovascular events
Devices
FDA has approved SetPoint Medical’s SetPoint System, a first-of-its-kind neuroimmune modulation device to treat adults with moderate to severe rheumatoid arthritis who are not adequately managed by, or can’t tolerate, existing advanced therapies such as biological and targeted synthetic disease-modifying anti-rheumatic drugs. A