Drugs
Heron Therapeutics has resubmitted to FDA its NDA for HTX-011, an investigational agent for managing postoperative pain. A company statement says the NDA was resubmitted based on the outcome and final minutes of a September Type A end-of-review meeting with the agency that discussed what was needed
Drugs
Two suits filed by Nexus Pharmaceuticals against two drug compounding firms were dismissed by a California federal court under implied preemption as stated in Buckman v. Plaintinffs Legal Committee. Attorney James Beck (Reed Smith) says in an online post that the court said the suits were preempted because Nexus challenged
Drugs
FDA has granted orphan drug designation for Agios Pharmaceuticals’ first-in-class pyruvate kinase R (PKR) activator mitapivat for treating patients with sickle cell disease. The company says mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes. It previously was
Drugs
The Justice Department says a Virginia federal court sentenced Indivior Solutions to pay $289 million in criminal penalties in connection with a previous guilty plea related to its marketing of Suboxone. The judge entered the sentence under a plea agreement. Altogether, a Justice Department statement says, Indivior Solutions will pay
Drugs
FDA has posted an 11/6 safety labeling change for Genentech’s multiple sclerosis drug Ocrevus (ocrelizumab). The change affects the label’s Warnings and Precautions, Adverse Reactions, Use in Specific Populations, and Patient Counseling/Patient Information/Medication Guide sections.
Drugs
FDA’s recent emergency use authorization (EUA) for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients (see earlier story) contains GMP-related conditions the company must maintain due to concerns raised in two inspections conducted at its manufacturing
Drugs
FDA has awarded a research project to staff at the University of Maryland Smith School of Business to look at the risks to industry and government of returning drug manufacturing to the U.S. A statement from the university says the research will examine advanced manufacturing as a pathway to
Drugs
FDA has cleared a SafKan Health 510(k) for its OtoSet Ear Cleaning System for removing impacted earwax. The device is an alternative to the time-tested ear bladder syringe. The device features a combination “irrigation and microsuction technology built into an automated and wearable device.” The company says it
Drugs
FDA has issued a Manual of Policies and Procedures (MAPP) establishing responsibilities and procedures for the controlled substance staff in the CDER Office of the Center Director to review research protocols sent to the staff from the Drug Enforcement Administration (DEA). The MAPP cites a regulatory requirement that HHS review
Drugs
A Council on Foreign Relations working paper says that a recent FDA rule to encourage drug importation from Canada won’t reduce drug prices or increase the volume of imported drugs. An analysis of the working paper in an online Regulatory Review post from the University of Pennsylvania Law School
Drugs
FDA commissioner Stephen Hahn says the agency has prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with Covid-19. Speaking 11/9 to the GRx+Biosims virtual conference, he also said FDA has worked closely with generic drug applicants whose development work has
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on a drug-drug interaction assessment for therapeutic proteins provides helpful information to sponsors regarding assessing such interactions. “The opportunity for sponsors to consider the specifics of their particular therapeutic proteins in the context of specific indications and concomitant medications
Drugs
Pfizer says the Phase 3 JADE REGIMEN study produced positive results for its atopic dermatitis investigational drug abrocitinib. The study involved patients age 12 and older with moderate to severe atopic dermatitis. A company statement says the study met its primary and key secondary endpoints. Abrocitinib is described as an
Drugs
FDA has approved a Sebela Pharmaceuticals NDA for Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, indicated for colonoscopy preparation. The product was designed to give patients and physicians an alternative to liquid-based colonoscopy preparations. Approval was based on data from two pivotal trials showing that 92% of
Drugs
FDA has granted fast track designation for Surface Oncology’s SRF 388 for treating patients with hepatocellular carcinoma who have been previously treated with standard therapies such as vascular endothelial growth factor targeted agents and programmed death-ligand blockade. The company says SRF 388 is enrolling patients with advanced solid
Drugs
FDA has cleared a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment and machine learning digital platform that monitors and assesses the heart, lungs, and upper vascular system. “Gender-neutral and size adjustable, the SimpleSense platform effectively replaces the digital stethoscope, multi-
Drugs
FDA has issued Eli Lilly an emergency use authorization (EUA) for its investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients. The therapy is authorized for patients 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and
Drugs
A 2/24-2/28 FDA inspection at the Nartex Laboratorios Homeopaticos drug manufacturing facility in Coahuila de Zaragoza, Mexico, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. An 11/4 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and
Drugs
Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive topline results in the Phase 3 NAVIGATOR trial. A statement from the companies says tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. The statement says the drug was very well tolerated
Drugs
With FDA pausing many foreign drug manufacturing facility inspections due to the Covid-19 pandemic, Sens. Elizabeth Warren (D-MA) and Tina Smith (D-MN) are asking the agency for information on the inspections still being held and measures being taken to protect FDA staff who conduct those inspections. In
Drugs
Supernus Pharmaceuticals says it received a complete response letter from FDA for its NDA for SPN-812 (viloxazine HCl) to treat attention-deficit hyperactivity disorder in pediatric patients ages 8-17. A company statement says the primary issue cited in the FDA letter related to the firm’s in-house
Drugs
Beginning next year, CDER Office of Prescription Drug Promotion (OPDP) is revising its core launch review process. “Our goals with these revisions include improving efficiencies, providing timely feedback to firms and maximizing OPDP resources,” acting director Catherine Gray told a Food and Drug Law Institute (FDLI) 10/29 virtual conference.