Drugs
An investigational Parkinson’s drug under development by Prothena is being called into question because of falsified research publication allegations centered around one of NIH’s top officials. An investigation by the journal Science raises issues with research conducted and published over the past two decades by NIH neuroscientist Eliezer
Drugs
FDA has granted Eli Lilly full approval for Retevmo (selpercatinib) for adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy. The drug received accelerated approval for the indication for patients 12 years of
Drugs
AbbVie has submitted a BLA seeking accelerated approval for Teliso-V (telisotuzumab vedotin) and its use in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. “The c-Met protein is
Drugs
AbbVie says a pivotal Phase 3 (TEMPO-1) trial for tavapadon as a monotherapy in early Parkinson’s disease met its primary endpoint. The investigational D1/D5 dopamine receptor partial agonist is being evaluated as a once-daily treatment for Parkinson’s. Patients treated with tavapadon in both dose groups,
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitative HBV antibody assays, and quantitative HBV nucleic acid-based assays from Class 3 to Class 2 (general and special controls), subject to premarket notification. The agency is also proposing three new device
Drugs
Four Ropes & Gray attorneys say one final and two draft guidances recently published by FDA “reflect continued efforts … to modernize clinical trial policies, including by promoting flexibility in clinical trial design and capitalizing on the technological advances and efficiencies of the modern healthcare landscape.” In an online post, the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for SpringWorks Therapeutics’ Ogsiveo (nirogacestat hydrobromide), indicated for adult patients with progressing desmoid tumors who require systemic treatment. The regulatory review period is 5,425 days, of which 5,089 days occurred during the testing phase
Drugs
Pfizer is withdrawing all lots of its sickle cell disease treatment Oxbryta (voxelotor) from all markets where it is approved and is discontinuing all active Oxbryta clinical trials and expanded access programs worldwide. A company statement says the decision “is based on the totality of clinical data that now indicates
Drugs
The Society for Women’s Health Research says it recognizes the critical role of increasing diversity across the research enterprise by reducing barriers to clinical trial participation for underrepresented and marginalized populations and applauds FDA for its commitment to trial diversity as seen in a draft guidance on diversity action
Drugs
FDA has lifted a clinical hold on Biomea Fusion’s Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in Type 2 and Type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. The agency previously cited deficiencies based on the level of possible drug-induced hepatotoxicity
Drugs
Writing in BMJ, two U.S.-based investigative journalists are raising issues of conflict of interest on the FDA advisory committee that recommended approval of Lilly’s Kisunla (donanemab) Alzheimer’s drug. FDA approved the drug 7/2. A 1/2023 FDA letter to Lilly denying approval of Kisunla cited
Drugs
Bayer has submitted a supplemental NDA for oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide), seeking approval for its use in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is currently approved for treating mHSPC in combination with ADT and docetaxel. The
Drugs
The FDA Oncology Drugs Advisory Committee voted 2-10-1 against recommending the use of immune checkpoint inhibitors (ICIs) in first-line advanced gastric cancer with PD-L1 (programmed death ligand 1) protein expression less than 1. The committee discussed the question through data supporting the current approvals of Bristol
FDA Policy/General
Federal Register notice: FDA, CDC, and NIH are announcing an 11/25 public workshop entitled “Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants.” The workshop is intended to exchange information with the medical and scientific community about the regulatory and scientific issues associated with use
Drugs
The Association for Accessible Medicines and its Biosimilars Council say they support FDA’s approach to applying the same principles to postapproval manufacturing changes for all 351(k) biological products, regardless of whether they are licensed as biosimilar or interchangeable. “Importantly, and consistent with FDA regulations and guidance, these same
Drugs
FDA has approved AstraZeneca’s Tagrisso (osimertinib) for adults with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations as detected by an
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Recall Authority.” FDA regulations give it the authority to issue an order requiring manufacturers, importers, distributors, and retailers of a device to immediately cease its distribution if there is reasonable probability that it would cause
Drugs
Merck says the Phase 3 KEYFORM-007 trial of investigational favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint (overall survival (OS)) in patients with previously treated PD-L1 positive microsatellite stable metastatic colorectal cancer. A final pre-specified analysis found that the favezelimab and pembrolizumab fixed-dose combination
Drugs
FDA has posted the form FDA-483 issued following a 9/4-9/15/2023 inspection at Samsung Bioepis in Incheon, Republic of Korea, and following a 3/23-3/30/2023 inspection at Terumo Yamaguchi in Yamaguchi, Japan. The Samsung Bioepis form lists two inspection observations: * failure to ensure
Devices
Two U.S. House of Representatives Democrat lawmakers are calling for an HHS Office of Inspector General (OIG) investigation into potential conflict-of-interest appearances (see story) raised in last month’s New York Times investigative article on retiring CDRH director Jeff Shuren’s regulatory role and the legal work
Drugs
Media in Cincinnati, OH, are reporting that FDA and Customs and Border Protection (CBP) seized $270,000 worth of shipments of counterfeit versions of Ozempic, Wegovy, and Trulicity, weight loss drugs manufactured by Novo Nordisk and Lilly. A CBP spokesperson told the local media that 63 shipments were seized containing
Devices
FDA has cleared a Piur Imaging 510(k) for the Piur tUS Infinity, which the company says is an advanced ultrasound technology that changes existing 2D ultrasound devices into 3D systems for thyroid imaging. “This cutting-edge technology provides clinicians with highly detailed volumetric datasets of thyroid lobes and nodules