Drugs
Eton Pharmaceuticals has submitted an NDA for topiramate oral solution as a monotherapy for treating partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of
Drugs
A 10/6 New York Southern District ruling in a Freedom of Information Act (FOIA) lawsuit found that FDA appropriately allowed company-directed redactions of commercial confidential information contained in Sarepta’s NDA for Duchenne multiple sclerosis drug Exondys 51 (eteplirsen). The lawsuit by New York University journalism professor Charles
Drugs
In a 9/30 ruling, the 3rd Circuit Court of Appeals rejected the Federal Trade Commission’s (FTC) authority to seek disgorgement under Section 13(b) of the FTC Act. Attorney Karin Moore (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the 3rd Circuit’s
Drugs
Federal Register notice: FDA has announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2021. The vouchers are awarded to sponsors of rare pediatric disease product applications that meet all requirements of the program. The fee rate for FY 2021 is $1,360,
Drugs
A 3/2-3/6 FDA inspection at the LEC Custom Products drug manufacturing facility in Brampton, Ontario, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/24 Warning Letter says specific violations were: * failing to use equipment in the manufacture, processing, packing,
Drugs
Researchers from Pfizer and several universities say that sponsors should consider alternative approaches to statistical analysis that could meet FDA expectations for demonstrating the interchangeability of biosimilars. Writing in the open-access journal BioDrugs, the researchers say it is challenging to conduct clinical studies to support an FDA designation of
Drugs
A 10/8-10/17/19 FDA inspection at Essential Pharmaceutical Corp., Pomona, CA, found the company produces adulterated and misbranded dietary supplements as well as an unapproved new drug. A 9/3 Warning Letter lists specific violations as: * manufacturing an unapproved new drug and marketing it as an over-
FDA Policy/General
Commenting on the FDA Interim Hiring and Retention Assessment conducted by Booz Allen Hamilton, Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency needs to take immediate action if it is to make substantial progress on the PDUFA 6 and Biosimilar User Fee Act (BsUFA) 2 goals on FDA
Drugs
In a rare product approval reversal, FDA has issued a proposal to withdraw from the market Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market because a required postmarket study failed to verify clinical benefit in reducing the risk of preterm birth in women who previously had a spontaneous (unexplained)
Drugs
A new CDER investigation of real-world evidence confirms that patients taking levothyroxine benefit equally from generic and brand-name drugs. The study, the agency says, confirms that real-world equivalence, just like clinical trial data, shows that generic drugs are therapeutically equivalent to brand-name drugs. The review by
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery. An FDA news release says this is the first drug regimen approved for mesothelioma in 16 years. The drug
Drugs
After being confirmed to be infected with Covid-19 late 10/1, President Trump 10/2 was given an investigational drug cocktail from Regeneron that is still undergoing clinical trials. Trump presumably was granted access under an expanded (compassionate use) access protocol. Late in the day, the press pool was
Drugs
FDA has published a guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment, to help sponsors develop drugs to treat opioid use disorder. The document addresses clinical endpoints acceptable for demonstrating the effectiveness of such drugs. It does not address the development of drugs intended only to
Drugs
FDA has published two guidances with recommendations for sponsors on developing drugs and biologics for the adjuvant treatment of renal cell carcinoma and muscle-invasive bladder cancer. Each document has recommendations about eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival,
Drugs
The 3rd Circuit Court of Appeals has remanded to a Pennsylvania federal court a Federal Trade Commission (FTC) case charging that the owners of the AndroGel patent—AbbVie, Abbott, Unimed Pharmaceuticals, and Besins Healthcare—filed sham patent infringement suits against Teva and Perrigo and that AbbVie, Abbott, and Unimed entered
Drugs
Reports published by Democratic members of the House Oversight Committee say that enormous drug company profits are the primary driver of increasing prescription drug prices in the U.S. Kaiser Health News says that the first two reports look at Celgene and Bristol-Myers Squibb’s Revlimid (lenalidomide) cancer treatment
Drugs
The Massachusetts federal court allowed misdemeanor convictions to stand in an off-label promotion case but said “it seems clear that the statutory and regulatory scheme needs to be re-thought.” Attorney Stephen McConnell (Reed Smith) writes online in a Drug and Device Law Blog post that the judge pointed
Drugs
FDA has lifted a clinical hold against Solid Biosciences’ IGNITE DMD Phase 1/2 clinical trial involving SGT-001, a novel adeno-associated viral vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy. The hold was originally placed 11/2019 after the company
Drugs
A review of FDA inspection documents on the agency’s clinical trial oversight during the past 11 years shows enforcement is often light-handed, slow-moving, and secretive, according to the journal Science. The review period of documents obtained under the Freedom of Information Act covered former president Obama’s
Drugs
FDA has published a draft guidance, The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls, with general recommendations for the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by IND sponsors and applicants for NDAs,
Drugs
Catalyst Pharmaceuticals says it will appeal to the 11th Circuit Court of Appeals a ruling by a Florida federal court granting summary judgment to FDA and Jacobus Pharmaceutical and dismissing Catalyst’s case involving orphan drug exclusivity for its Firdapse (amifampridine). In its decision, the district court accepted the report
Drugs
FDA says it has launched its newly redesigned Sentinel Initiative Web site. The agency says the new Web site was designed to increase organization and usability and to assist the Sentinel community with up-to-date information on Sentinel assessments, tools, and news.