Drugs
A Roche Phase 3 study called COMMODORE 2 that was evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis. The company says that
Drugs
FDA Chief Scientist Namandjé N. Bumpus has proposed an advisory committee review to address a 2021 CDER decision not to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to deliver exenatide, a GLP-1 receptor agonist, as an
Drugs
FDA has accepted for priority review a Biogen and Sage Therapeutics, NDA for zuranolone, a rapid-acting once daily oral drug for major depressive disorder (MDD) and postpartum depression (PPD). The agency has set a user fee review action target date of 8/5. “Most current approved therapies may take
Drugs
Former physician Deepak Raheja (Hudson, Ohio) was sentenced 2/3 to 30 months in prison after pleading guilty to pharmaceutical kickback conspiracy charges involving two Avanir Pharmaceuticals sales representatives. Raheja was ordered to surrender his medical license, pay $2.1 million in restitution, and a $50,000 fine. Between 2/
Drugs
FDA has approved AstraZeneca and Amgen’s Tezspire (tezepelumab) in a self-administration pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Approval was based on data from the PATHFINDER clinical trial program, which showed that the majority (92%) of healthcare providers, patients and
Drugs
FDA has placed a clinical hold on 4D Molecular Therapeutics’ 4D-310 drug being studied for treating Fabry Disease Cardiomyopathy after the company reported three patients experiencing atypical hemolytic uremic syndrome, a condition that affects kidney function and causes blood clots to form. The company says that it stopped enrollment
Drugs
An FDA Office of Criminal Investigations felony case involving a Mays Landing, NJ, man who marketed online a toxic chemical as a weight-loss drug has led to a guilty plea on an obstruction of justice charge after he submitted fictitious medical records and doctor’s letters to the court
Drugs
FDA has approved a Gilead Sciences supplemental BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies
Drugs
Senator Jeanne Shaheen (D-NH) led eight senators in a 2/1 letter to Danco Laboratories, a manufacturer of mifepristone, urging it to submit a supplemental NDA to add miscarriage management to the medication’s label. “Currently, mifepristone’s label includes medication abortion, but it can also be safely and
Drugs
Federal Register notice: FDA is correcting an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple applicants. Before FDA finalized the withdrawals, Sunstar Americas, Sofgen Pharmaceuticals, and Indicus Pharma told the agency that they did not want their ANDAs for chlorhexidine gluconate solution, nimodipine capsules,
Drugs
FDA has approved a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablets that it describes as the first oral treatment for anemia caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. The agency notes that the drug is not approved for patients who are
Drugs
Regulatory consulting firm Greenleaf Health has hired two former FDA officials — former Office of Compliance Don Ashley and former FDA Europe Office deputy director Sandra Kweder. Ashley retired 11/2022 after more than 29 years in federal service, including the 25 years at FDA and the last six as director
Drugs
FDA has issued an import alert and a safety warning on EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. The over-the-counter products are manufactured by Global Pharma Healthcare Private Limited in Tamilnadu, India. “Using contaminated artificial tears increases risk of eye infections
Drugs
A recent New York federal court dismissal of a dietary supplement preemption case can be instructive for drug and medical device manufacturers. Attorney Stephen McConnell (Reed Smith) writes in an online Drug and Device Law post that the case was one of several around the U.S. that involved plaintiffs
Drugs
FDA in a new online post is outlining its current strategy to expand access to overdose reversal products that has culminated in upcoming advisory committee meetings to consider two “priority review” nonprescription naloxone applications. A 2/15 meeting (see story) will discuss Narcan (naloxone hydrochloride) nasal spray submitted by Emergent
Drugs
The FY 2021 Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments shows that as of 9/30/21 there were 373 unique applicants with open postmarketing requirements (PMR)/postmarketing commitments (PMC) and 808 unique open applications. The report also shows that 79% of
Biologics
The Government Accountability Office (GAO) says that as HHS develops a new program to improve domestic infrastructure and expertise to produce medical countermeasures such as drugs and vaccines in response to public health emergencies, it should incorporate an approach to systematically assess and respond to known challenges and risks associated
Drugs
Attorney Amanda Johnston (Gardner Law) says there are five steps leaders of FDA-regulated companies can take to mitigate the risk of Park Doctrine (Responsible Corporate Officer Doctrine) violations. Writing in an online blog post, Johnston says the doctrine “imposes strict, vicarious criminal liability upon responsible corporate officers for misdemeanor
Drugs
FDA has published the International Council for Harmonization (ICH) M13A consensus guideline, Bioequivalence for Immediate-Release Solid Oral Dosage Forms. The document says the guideline is intended to provide recommendations on conducting bioequivalence studies during both the development and post-approval phases for orally administered immediate-release solid oral dosage
Drugs
FDA says individuals can now be prescribed two Covid-19 therapeutics without having a positive test result showing Covid-19 infection. In a 2/1 notice, the agency says the emergency use authorizations for Pfizer’s Paxlovid and Merck’s Lagevrio have been amended to reflect this flexibility. The agency
Drugs
For the fourth time in five years, CDER has again refused to approve sotagliflozin’s use in treating diabetes. In its reply to Lexicon Pharmaceuticals’ response to a proposed order denying the company’s request for a hearing on the Center’s proposal to refuse to approve the company’s
Drugs
CDER has released its 2023 Guidance Agenda showing plans for 98 new and revised guidances in 18 categories. The categories, with the number of guidances proposed in each, are: Administrative/Procedural (17); Animal Rule (1); Biosimilars (1); Clinical/Antimicrobial (1); Clinical/Medical (17); Clinical Pharmacology (3); Compounding (6); Drug Development