Drugs
FDA has released a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.” The document is intended to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by
Drugs
FDA country director (India) Sarah McMullen says the agency will increase the number of inspections at Indian drug manufacturing facilities in 2024. Speaking with Reuters, McMullen said there were more than 200 inspections in the country in 2023, up from a lull in unannounced inspections during the pandemic. “We are
Drugs
Viking Therapeutics says its Phase 2 clinical trial of VK2735, a dual agonist of glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptor for treating obesity, met its primary endpoint and all secondary endpoints. Patients treated with VK2735 had significant reductions in body weight compared with placebo, the company
Devices
An FDA safety alert is warning patients and healthcare providers about the potential risk of serious complications with Holigic’s BioZorb Marker and BioZorb LP Marker devices, which are implanted in soft tissue (e.g., breast tissue) where the site needs to be marked for future medical procedures, such as
Drugs
An FDA analysis of the first decade of the rare pediatric disease priority review voucher program establishes that a wide range of diseases have seen development, from rare pediatric cancers to rare genetic disorders. “Continued support of product development for children with rare diseases is needed to find treatments for
Biologics
FDA has accepted for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with fluoropyrimidine- and platinum-containing chemotherapy in treating locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The agency has set a December user fee review action target date. The submission is based on data
Drugs
FDA has issued Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schizophrenia, recommending another clinical study to demonstrate the drug’s safety and effectiveness. The company says the agency letter cited the submission’s study (MIN-101C03) as being
FDA Policy/General
Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin has joined Paul Hastings as chair of the firm’s FDA practice. She spent over eight years at the agency before leaving in 2021 to join King & Spaulding as a partner. In her new role, Temkin will
Devices
Vyaire Medical has recalled (Class 1) its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used in manufacturing. An FDA recall notice says the device presents a risk of hypoventilation “caused by duckbill and ring broken/disassembled… Device failure may cause improper ventilation or
Drugs
Milestone Pharmaceuticals says it will resubmit an NDA in the second quarter for etripamil nasal spray, a novel calcium channel blocker for treating paroxysmal supraventricular tachycardia (PSVT). The filing will address issues raised in a 12/2023 FDA refuse-to-file action that found the NDA was not sufficiently complete
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during the fourth quarter of 2023. The regulations are also being amended to improve their accuracy and readability. To view the notice, click here.
Drugs
Boehringer Ingelheim says data from its recent Phase 2 survodutide study showed that up to 83.0% of adults treated with the drug achieved a statistically significant improvement of the chronic liver disease metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%). “The trial met its primary endpoint with survodutide
Biologics
After two complete response letters over inspection concerns, FDA has now granted approval to Alvotech and Teva Pharmaceuticals for Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVie’s Humira. Earlier this year, an FDA reinspection of Alvotech’s Iceland manufacturing facility resulted in a Form FDA-483 with one
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Janssen Biotech’s Rybrevant (amivantamab-vmjw), indicated for treating adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations. The regulatory review period is
Drugs
FDA has created a new CARES Act Amount Information Reporting application for drug establishments (or their authorized agents) to use when submitting annual reports of the amount of listed drugs and biological products produced. If establishments have already submitted their required report for calendar year 2023 using the previous version
Drugs
FDA has denied an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide). This looks to be one of the first tests of the modified authority FDA was granted in 2022 under the Food and Drug
Drugs
New York attorney general Letitia James is urging FDA to take further safety actions to address the “dangers” of Merck’s asthma and allergic rhinitis drug Singilair (montelukast) and generics, particularly for minor children. Despite FDA four years ago approving a new Boxed Warning for Singulair (see story), “the prevalence
Drugs
BrainStorm Cell Therapeutics has submitted a Special Protocol Assessment request for a Phase 3b study of NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS). The submission follows an in-person meeting that BrainStorm held with the FDA in December after the company withdrew its BLA for NurOwn, a move
Drugs
FDA has accepted for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The agency has set a 6/27 user fee review action target date. The companies say the submission
Drugs
FDA has issued Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a beta-lactam/beta-lactamase inhibitor for treating adult patients with complicated urinary tract infections, including acute pyelonephritis caused by susceptible gram-negative microorganisms. The companies say the letter requested additional “chemistry,
Devices
FDA has cleared a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury. The immunoassay is intended for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. “Determination of NGAL is intended to be used in conjunction with
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that research proposed by the CDER Office of Prescription Drug Promotion (OPDP) on implied claims in direct-to-consumer (DTC) drug promotions “lacks practical utility.” The association’s comment letter says it is not clear what the agency intends