Drugs
FDA and Polynoma have reached agreement under a Special Protocol Assessment on a pivotal Phase 3 clinical trial of the company’s melanoma cancer vaccine seviprotimut-L and its use as an adjuvant treatment for patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection
Drugs
FDA has approved an Idorsia Pharmaceuticals NDA for Quviviq (daridorexant) 25 mg and 50 mg for treating adult patients with insomnia. The drug is described as a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as
Drugs
FDA has removed a clinical hold on Allogene Therapeutics’ AlloCAR T clinical trials. The hold was placed in 10/2021 on five clinical trials involving Allo-501A CAR T cells after a report of a chromosomal abnormality in the company’s ALPHA2 study. The abnormality, which was detected in a
Drugs
FDA has granted 4D Molecular Therapeutics a fast track designation for 4D-125 for treating patients with inherited retinal dystrophies due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene, including X-linked Retinitis Pigmentosa (XLRP). 4D-125 is described by the company as a targeted R100-based product
Drugs
A Texas federal court has ruled against FDA in a Freedom of Information Act (FOIA) lawsuit by Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The group sued FDA in September after the agency denied its request to
Drugs
FDA has amended the emergency use authorization (EUA) for the Moderna Covid-19 vaccine to shorten the time between the completion of primary vaccination with the product and a booster dose to at least five months. The action aligns the recommended interval for a booster shot with that of the
Drugs
AbbVie has submitted a supplemental NDA for Rinvoq (upadacitinib,15 mg once daily) for treating adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs. The submission is based on data from the Phase 3 SELECT-AXIS
Drugs
CDER is embracing industry’s use of physiologically based pharmacokinetic (PBPK) modeling as an alternative bioequivalence (BE) approach after approving a Perrigo Pharma ANDA for generic diclofenac sodium topical gel that does not include a comparative clinical endpoint BE study. In a just-published regulatory research post, FDA researchers say
Drugs
A Pharmaceutical Research and Manufacturers of America (PhRMA)-funded study finds that more than half (50.5%) of every $1 spent on brand medicines went to payers, middlemen, providers, and other stakeholders in 2020. Adding to the debate on what to reform in hopes of reducing drug prices for patients,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should not move forward with a proposed study on text analysis of proprietary name interpretations. The association’s 1/3 comment letter says it is concerned that the “proposed survey will not produce data that will appropriately inform or meaningfully improve
Drugs
FDA has approved an Otsuka America Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in pediatric patients 13 to 17 years of age. Rexulti was originally approved in 2015 for treating schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults. The sNDA
Drugs
CDER approved 50 new drugs either as new molecular entities under NDAs or as new therapeutic biologics under BLAs, according to the Center’s 2021 annual report on drug approvals, “Advancing Health Through Innovation.” The report says the “novel drugs CDER approved in 2021 are collectively notable for their potential
Drugs
The U.S. Federal Circuit Court of Appeals has upheld a lower court decision that found valid a Novartis patent covering a dosing regimen for Gilenya (fingolimod), indicated for treating relapsing forms of multiple sclerosis. The court also affirmed a permanent injunction granted against HEC Pharma until the expiration of
Drugs
n-Lorem Foundation says a recent FDA guidance on the manufacturing processes and stability testing required for antisense oligonucleotides (ASOs) to be administered to nano-rare patients will help the foundation in its efforts to develop ASO treatments. The foundation says the guidance supports the importance of ASO technology as
Drugs
An FDA draft guidance on reporting the amount of listed drugs and biological products under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act would be “exceedingly burdensome,” Pharmaceutical Research and Manufacturers of America tells the agency in a comment letter. It notes that drug company data
Drugs
The Council for Responsible Nutrition (CRN) says an FDA 11/24/21 answer to the council’s 6/1/21 petition asking that the agency revert to its longstanding policy of allowing manufacturers to market dietary supplements containing NAC (N-acetyl-L-cysteine) was nonresponsive in failing to address the
Drugs
FDA has lifted a clinical hold on a Spero Therapeutics Phase 2 trial of SPR720, an investigational oral product being developed for nontuberculous mycobacterial disease. Spero describes SPR720 as a novel class of antibacterial agents that target enzymes essential for bacterial DNA replication. The hold was placed after FDA reviewed
Drugs
FDA has released the FDA-483 issued following a 9/13-11/18/21 inspection at Ideal Pharmacy, a Union, NJ, compounding pharmacy. The seven inspection observations were: * ISO-5 classified areas were not certified under dynamic conditions; * media fills were not performed that closely simulate aseptic compounding operations incorporating,
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) has published a Manual of Policies and Procedures (MAPP) describing the policies and procedures for OPQ product quality assessors to ensure consistent assessment of excess volumes in injectable drug products packaged into vials. The MAPP addresses both liquid and solid drug products that
Drugs
CDER senior policy advisor Brooke Higgins says FDA has seen inspection trends in aseptic technique and behaviors; facility, room, and process design; and the use of media fills. An online report in Healthcare Packaging covers Higgins’ presentation at the 9/2021 Parenteral Drug Association/FDA joint regulatory conference. “We know
Drugs
FDA has accepted for review a Samsung Bioepis/Organon sBLA for their citrate-free, high-concentration formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing AbbVie’s Humira (adalimumab). A Samsung statement says FDA previously approved SB5 as Hadlima, a low-concentration formulation of Humira, in 7/2019. Samsung Bioepis
Drugs
A 9/13-9/14 FDA inspection at a clinical test site maintained by a physician in Kyiv, Ukraine, conducted as part of the agency’s Bioresearch Monitoring Program, found “objectionable conditions.” A 12/21/21 Warning Letter says it appears that the site did not adhere to statutory and