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,
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
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for underrepresented and marginalized populations and applauds FDA for its commitment to trial diversity as seen in a draft guidance on diversity action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
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
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
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
Drugs
Lilly is suing FDA in an Indiana federal court to overturn the agency’s decision that the company’s investigational product retatrutide is a drug and not a biologic. It is one of the first suits to take advantage of the Supreme Court’s decision to scrap the decades-old
Drugs
Responding to an FDA draft guidance on questions and answers about post-approval manufacturing changes to biosimilar and interchangeable biosimilar products, Samsung Bopepis questions the need for an additional guidance since all biologics should be treated the same. “Regulatory consistency and the application of the same regulatory science by regulators
Drugs
The U.S. House of Representatives 9/23 passed the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rare diseases. The bill was introduced by Reps. Michael McCaul (R-TX) and Anna Eshoo (D-CA). According to an Eshoo news release, the measure
Drugs
FDA has just released the form FDA-483 issued following a 10/23-10/27/2023 inspection at the Eisai drug manufacturing facility in Gifu, Japan. The two observations were: * failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and * failure
Drugs
FDA has accepted for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3%, a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor for treating adults and adolescents ages 12 and over with scalp and body psoriasis. The agency has set a user fee review action target date
Drugs
FDA has just released the form FDA-483 issued following a 2/27-3/16/2023 inspection at the Hugel drug substance and product manufacturing facility in Gangwon-do, Republic of Korea. The five specific inspection observations were: * failure to have an established cleaning and disinfection program to prevent the
Drugs
A 2/2-3/2/23 FDA inspection at the Azurity Pharmaceuticals drug manufacturing facility in Wilmington, MA, found that the firm manufactures several prescription drug products referred to as FIRST Unit-of-Use kits that are legally considered to be unapproved new drugs. A 9/20 Warning Letter says