Drugs
CDER drug promotion researchers are evaluating how images can offer misleading perceptions in direct-to-consumer drug ads, in addition to developing validated instruments to measure other perceptions about such ads. In a CDER Office of Prescription Drug Promotion online post, the office discusses a recent study on images in
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk UC, an agency release says. Approval
Drugs
FDA says Pfizer has recalled four additional lots (to a total of 16) of its Chantix (varenicline) due to the presence of N-nitroso-varenicline above the company’s acceptable limit for the impurity. An online notice says the agency reminds consumers taking recalled Chantix to continue taking their current
Drugs
FDA has granted fast track designation for Senhwa Biosciences’ silmitasertib for treating patients with recurrent sonic hedgehog (SHH) driven medulloblastoma. The company says the designation makes it eligible to apply for accelerated approval and priority review when it meets relevant FDA criteria. Senhwa’s clinical partner, the Pediatric Brain Tumor
Drugs
The Sedgwick recall index for the second quarter of 2021 shows drug and medical device recalls continuing to go down. The report says that medical device recalls fell for the fourth consecutive quarter, down 18.4% from the first quarter (212 recalls to 173), for a nine-quarter low. Software
Drugs
The Natural Products Association is petitioning FDA to acknowledge NAC (N-acetyl-L-cysteine) as a legal dietary ingredient. A Nutraingredients.com online post says the molecule, a derivative of the L-cysteine amino acid and a precursor of the cellular antioxidant glutathione, has been on the market for decades
Drugs
CDER has granted Covis Pharma Group’s request for a hearing on the Center’s 10/5/20 proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly). An 8/18 CDER response to the Covis request grants the hearing and addresses other procedural issues related
Drugs
FDA has granted GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or followed prior treatment and who have no satisfactory alternative treatment options. Jemperli’s efficacy
Drugs
Attorney Andrew Tauber (Winston & Strawn) says decisions by both the 1st and 2nd Circuit Courts of Appeal have broadened the definition of what constitutes a major change in a drug that must be approved by FDA before a labeling change, expanding implied preemption of cases brought in state courts.
Drugs
Building on the success of its electrocardiogram (ECG) data warehouse that supports FDA’s cardiac safety review of therapeutic product development programs, the agency has created a first-of-its-kind pediatric ECG data warehouse. The warehoused ECGs will be analyzed in pediatric product development programs to help prevent sudden
Drugs
FDA has approved Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HfrEF). Accounting for about half of heart failure cases, HFrEF occurs when the heart
Drugs
The just-released CDER FY 2020 “State of Pharmaceutical Quality” report shows a slight decrease in the number of drug manufacturing sites from 4,273 in FY 2019 to 4,221 in FY 2020. The count excludes medical gas manufacturers and newly-registered hand sanitizer manufacturers, the report says. Some
Drugs
FDA has told Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for use as an anti-viral barrier product intended to intranasally limit transmission of the viruses to others. The company says FDA indicated that it may pursue an
Biologics
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) has three takeaways from the recent FDA final rule governing how the intended use of a distributed product is to be determined. First, he says in an FDA Law Blog post, the removal of the knowledge provision, which had seemed to problematically suggest
Drugs
Tempus has submitted a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare professionals with data-driven cancer treatment decisions. The submission includes companion diagnostic claims, tumor profiling claims, and microsatellite instability status by using DNA isolated from formalin-fixed
Drugs
FDA has released the FDA-483 issued following a 9/28/20-1/29/21 inspection at the Imprimis NJOF drug compounding outsourcing facility in Lakewood, NJ. The 12 inspection observations, some of which were repeat observations, were: * failing to thoroughly review any unexplained discrepancy, the failure of a batch
Drugs
FDA has approved Eli Lilly’s rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL, indicated for improving glycemic control in adults with Type 1 and Type 2 diabetes, to include administration through continuous subcutaneous insulin infusion with an insulin pump. Lyumjev, a novel formulation of insulin lispro
Drugs
After 24 years at FDA, CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger has decided to retire to spend more time with family. Joining FDA in 1997 as a medical officer at CBER, in 2003, he transitioned to CDER when regulatory authority for therapeutic biologics was transferred
Drugs
Ipsen has withdrawn its NDA for palovarotene, indicated for preventing heterotropic ossification (new bone formation) as a potential treatment for people living with fibrodysplasia ossificans progressiva (FOP). Palovarotene is described as an oral, investigational, selective RARγ agonist. The NDA was accepted for priority review 5/28. The company says that
Drugs
FDA has issued Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer. The agency’s letter requested additional clinical/statistical data and analyses, in addition to citing chemistry, manufacturing and controls issues related to
Drugs
FDA has granted a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Previously, the agency granted a similar designation for toripalimab monotherapy for patients with recurrent or
Drugs
The Cato Institute, a Libertarian think tank, says a case before the U.S. 1st Circuit Court of Appeals is again raising issues involving FDA’s “paradoxical stance” toward off-label use of drugs. A Cato online post says that while it is lawful for physicians to prescribe approved drugs