Drugs
A 10/12-10/20/2023 FDA inspection at the Kilitch Healthcare India drug manufacturing facility in Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/28 Warning Letter says the firm’s drugs were adulterated because they were prepared, packed, or
Drugs
FDA’s review of records submitted by Jiangsu Meifan Biotechnology Co. Ltd., a manufacturer of over-the-counter drug products in Jiangsu, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/3 Warning Letter says specific violations were: * failure to have, for each
Drugs
FDA has granted Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor. PT217 was previously granted orphan drug status for treating SCLC in 2022.
Drugs
Harvard Medical School researchers say most cancer drugs granted FDA accelerated approval did not demonstrate benefit in overall survival or quality of life within five years of the accelerated approval. Writing in JAMA, the researchers conclude that “patients should be clearly informed about the cancer drugs that use the accelerated
Drugs
BrainStorm Cell Therapeutics says it has received an FDA written agreement under a Special Protocol Assessment on the design of its planned Phase 3b trial of NurOwn in amyotrophic lateral sclerosis (ALS). The SPA agreement “validates the clinical trial protocol and statistical analysis” of the planned trial, “demonstrating their adequacy
Drugs
An 11/13-11/17/2023 FDA inspection at the Antaria Pty. Ltd. drug manufacturing facility in Queensland, Australia, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 3/22 Warning Letter says specific deviations were: * failure to adequately investigate and document out-
Drugs
The Congressional Research Service (CRS) says a recent Court of Federal Claims ruling in a case brought by Vanda Pharmaceuticals against FDA raises issues of interest to Congress that could result in new legislation. In a Legal Sidebar, CRS describes the case in which Vanda claimed that FDA violated its
Drugs
FDA has issued Alkem Laboratories a 10-observation Form FDA-483 after inspecting the firm’s Baddi, Himachal Pradesh, India manufacturing facility last month. The agency inspection cited Alkem for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
Drugs
FDA has cleared a Spirair 510(k) for its SeptAlign system for treating nasal septal deviation (NSD), a “minimally invasive treatment that can be safely and conveniently performed under local anesthesia,” according to the company. “The bioabsorbable SeptAlign implant is inserted in the cartilage near the front of the nose
Drugs
FDA has approved a supplemental BLA submitted by Janssen for Carvykti (ciltacabtagene autoleucel) to treat adults with relapsed or refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide (Celgene’s Revlimid). Carvykti is the
Drugs
FDA has issued Supernus Pharmaceuticals a second complete response letter (CRL) on its NDA resubmission for the company’s apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (“off”episodes) in Parkinson’s disease. The letter said the submission is not ready for approval in its present
Drugs
FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents 12 years of age and older with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed. Approval is based on data from the DANCE study
Drugs
FDA has accepted for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome. The submission is based on data from the SPIBA-001 Phase 3 Natural History Control Study and additional supporting efficacy and safety data from the TAZPOWER Part 2 baseline-controlled trial, according to the company.
Drugs
FDA has approved a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal
Drugs
FDA has granted Daiichi Sankyo an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Approval was based on data from 192 adult patients with
Drugs
FDA has issued Jubilant Generics a four-observation Form FDA-483 after inspecting the firm’s Roorkee, Uttarakhand, India facility in February. The inspection cited the firm for not making written records for all investigations into unexplained discrepancies. FDA also took issue with the quality control unit and its responsibilities
Drugs
AbbVie has petitioned FDA urging it to crack down on newly introduced unlicensed desiccated thyroid extract (DTE) products. The company acknowledges that it makes Armour Thyroid (thyroid tablets, USP), an unlicensed DTE product that has been used in the U.S. since the early 1900s for treating hypothyroidism and other
Drugs
Liquidia says it has submitted to FDA a 3/28 decision by the Delaware federal court setting aside an injunction that it issued in 8/2022 in a suit filed by United Therapeutics to prevent the agency from granting final approval to Liquidia’s Yutrepia (treprostinil) inhalation powder. A Liquidia
Drugs
Novartis says it will seek FDA approval in the second half of this year for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — to slow disease progression in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibition
Biologics
Four Hogan Lovells attorneys say a discussion paper published by CBER, CDER, CDRH, and the Office of Combination Products on artificial intelligence (AI) and medical products aims to provide greater transparency on how the agency’s Centers are collaborating to safeguard public health while fostering responsible and ethical innovation. The
Drugs
After reporting disappointing data last month from the Phase 3 PHOENIX clinical trial of Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate and taurursodiol), the company says it is voluntarily removing the drug from U.S. and Canadian markets. At the time the data came out, Amylyx said
Drugs
Smiths Medical is recalling its PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the device may intermittently provide continuous positive gas flow instead of the intended cycling like human breathing when it is switched to the “ventilate” operating mode. “This non-cycling and continuous positive gas