Drugs
Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage have filed suit in DC federal court to block HHS and FDA from implementing a program to permit the importation of some drugs from Canada. The suit asks the court to hold
Drugs
A 1/13-2/12 FDA inspection at two AuroLife Pharma drug manufacturing facilities in Dayton, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/16 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
FDA has released a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff. The document’s development was mandated in the 21st Century Cures Act under Section 507, Qualification of Drug Development Tools (DDTs). Once finalized, FDA says the document will represent the agency’
Drugs
FDA has approved an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), a rare genetic disorder. Primary hyperoxalurias (PHs) are caused by excess production of oxalate, a substance consumed in food and also produced by the body, an FDA release says. “PH1
Drugs
FDA has published a guidance, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA, describing an enhanced pathway for discussions between the agency and applicants for ANDAs for a complex product, as defined in the guidance. The document specifically provides information on requesting and conducting product development
Drugs
FDA says the expiration date for 42 lots of Octapharma Produktionsges’ Cutaquig immune globulin, subcutaneous (human)-hipp 16.5% solution can be extended from 24 to 36 months when stored at a cooler temperature under conditions specified in the agency notice. FDA says the 42 lots covered by the new
Drugs
HHS is sidestepping FDA to terminate the agency’s unapproved drug initiative (UDI) as part of the Trump administration’s efforts to reduce prescription drug costs. UDI is an FDA program launched through guidance documents issued in 2006 and 2011. The program aimed to legalize marketed drugs that lack FDA
Drugs
AstraZeneca says it is preparing an emergency use authorization request for its investigational vaccine AZD1222 after an interim analysis showed that the vaccine was highly effective in preventing Covid-19 and no hospitalizations or severe disease cases were reported in participants receiving the vaccine. There were a total of 131
Drugs
FDA has launched its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communication with the agency and to simplify orphan drug designation submissions. “This important initiative is part of broader technology modernization efforts at the FDA to develop a more connected information technology system,
Drugs
FDA has given expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu. Xofluza was approved in 2018 in a tablet formulation for treating uncomplicated flu in patients
Drugs
Mallinckrodt has agreed to acquire U.S.-based Ocera Therapeutics, a clinical-stage biopharmaceutical company in a deal valued at about $117 million. The transaction gives Mallinckrodt Ocera’s developmental product OCR-002, an ammonia scavenger currently being studied to treat hepatic encephalopathy, a neuropsychiatric syndrome that is associated with
Drugs
Federal Register notice: FDA has made available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. The document is intended to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009.
Drugs
Johnson & Johnson (J&J) subsidiary Medical Device Business Services has agreed to pay $10 million to settle allegations under the False Claims Act that former J&J subsidiary Therakos promoted Uvar XTS and Cellex extracorporeal photopheresis systems for unapproved uses in pediatric patients between 2006 and 2012.
Drugs
FDA has issued a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs). It discusses when drug developers should conduct
Drugs
Fresenius Kabi has recalled a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vial due to a trace amount of lidocaine present in the lot. To date, no adverse drug experience reports have been received for the
Drugs
FDA has published a draft guidance, Cross Labeling Oncology Drugs in Combination Regimens, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important consideration for cross labeling of the drugs. The document says it does
Drugs
The Stericycle Recall Insights report for the third quarter of 2020 shows that drug recalls increased markedly in the quarter while medical device recalls fell to their lowest level in several quarters. The report says that drug recall activity increased by 49.5% in the third quarter, with affected units
Drugs
FDA has published a draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, with answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The document says the question-and-
Drugs
FDA has accepted for review an Alvotech USA BLA for its AVT02, a proposed biosimilar to the reference product AbbVie’s Humira (adalimumab) with high concentration dosage forms. A company statement says AVT02 is one of five product candidates from Alvotech that will be commercialized in the U.S. by
Drugs
FDA has approved a Lantheus Holdings and Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid microsphere) injectable suspension, an ultrasound enhancing agent intended for use to enhance suboptimal echocardiograms. Its modified formulation allows both storage and shipment at room temperature (Definity’s previously approved formulation requires refrigerated storage)
Drugs
FDA has informed Bristol-Myers Squibb that it will not complete its review of the company’s BLA for lisocabtagene maraleucel (liso-cel) by the 11/16 PDUFA action date. The drug is indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior
Drugs
FDA has granted Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can be performed entirely at home. The Covid-19 All-In-One Test Kit can produce a positive or negative result at home within 30 minutes. The authorization was based