Drugs
Responding to an FDA objection to a new dietary ingredient notification submitted by Charlotte’s Web to demonstrate that its full-spectrum hemp extract is reasonably expected to be safe, Council for Responsible Nutrition CEO Steve Mister says Congress must step in and regulate the CBD (cannabidiol) marketplace. Mister appeared
Drugs
ICU Medical has recalled one lot (2,112 units) of Aminosyn II, 15% (amino acid injection) sulfite-free intravenous solution due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. The company says it became aware of the issue while inspecting
Drugs
Moderna says that “robust antibody responses” have been observed in a Phase 2 study of a third dose/booster of its mRNA-1273 Covid vaccine. In a portfolio update, the company also says it completed the rolling submission process for a BLA for the Covid vaccine. In development, it says,
Drugs
FDA has accepted for review a Myovant Sciences and Pfizer supplemental NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. The agency set a user fee review action target date of 5/6/2022. The
Drugs
Apellis Pharmaceuticals says it plans to file an NDA in the first half of 2022 after reporting top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy secondary to age-related macular degeneration. Geographic
Drugs
Wilmington, MA-based Azurity Pharmaceuticals has recalled one lot of Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL kit because some products in the affected lot have been found to incorrectly contain an omeprazole diluent instead of the Firvanq diluent. The vancomycin may not be completely solubilized if the
Drugs
CDER researchers say their review of patient-reported outcomes (PROs) in multiple myeloma (MM) registrational trials shows the need for further research to determine the most appropriate approaches for statistical and analytical methodologies for PRO data in MM trials. Writing in Blood Cancer Journal, the researchers say they found substantial
Drugs
CDER director Patrizia Cavazzoni is scheduled to deliver a keynote address at the 13th Annual Sentinel Initiative Virtual Public Workshop 11/8-9. Co-hosted by the agency and the Duke-Margolis Center for Health Policy, the workshop will hear from the Sentinel community and leading experts about recent developments
Drugs
FDA has revised a guidance, Development of Abbreviated New Drug Applications During the Covid-19 Pandemic—Questions and Answers, which collects questions the agency has received from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during the Covid-19 public health emergency. The 4/
Drugs
FDA says it is reconsidering the need for mandatory opioid prescriber education through the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). A 10/13-10/14 public workshop will be held in collaboration with the Duke-Margolis Center for Health Policy to allow stakeholders to provide input on aspects
Drugs
FDA says its review of Web sites and social media pages maintained by Genesis Nutrition Ultra Slim, doing business as Genesis Ultra Slim, Doral, FL, indicates that the firm markets its Genesis Ultra Slim Gold product intended for weight loss. A just-released 8/6 Warning Letter says the agency
Drugs
FDA has approved Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. A company announcement says Trudhesa uses the firm’s proprietary precision olfactory delivery technology to deliver the active ingredient quickly to the
Drugs
CDER has started its voluntary Novel Excipient Review Pilot Program to allow excipient manufacturers to obtain agency reviews of certain novel excipients before their use in drug formulations. An online statement says the program will initially be available for excipients that (1) have not been previously used in FDA-approved
Drugs
A 2/24-3/3 FDA inspection at Kaleido Bioscience, Lexington, MA, found “objectionable conditions” in the firm’s role as sponsor of clinical investigations for the investigational drug KB109. An 8/26 Warning Letter says the inspection was part of the FDA Bioresearch Monitoring Program and found that Kaleido
Drugs
FDA has placed a clinical hold on the BioMarin BMN 307 Phearless Phase 1/2 study evaluating an investigational AAV5-phenylalanine hydroxylase gene therapy in adults with phenylketonuria. A company statement says the clinical hold was based on interim safety findings from a pre-clinical, non-GLP (good laboratory practice)
Drugs
FDA has accepted for priority review a Global Blood Therapeutics supplemental NDA for Oxbryta (voxelotor) for treating sickle cell disease (SCD) in children ages four to 11 years. A separate NDA was also accepted that is seeking approval for a new age-appropriate dispersible tablet dosage form suitable for pediatric
Drugs
Attorney Sara Koblitz (Hyman, Phelps & McNamara) says the generic carve-out “skinny label” may be effectively dead for any risk-averse generic drug sponsors thanks to a recent Federal Circuit Court of Appeals decision. Writing in her firm’s FDA Law Blog, Koblitz says the generic drug industry is
Drugs
FDA has released the FDA-483 issued following a 2/15-2/25 inspection at Toyobo Co., Otsu, Shiga, Japan. The 10 inspection observations on the document are: * failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * aseptic processing areas are deficient regarding
Drugs
FDA has accepted for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit hyperactivity disorder (ADHD) in adult patients. The agency has set a user fee review action target date of 4/29/2022. Qelbree was originally approved in April for treating ADHD
Drugs
FDA says CDER is proposing to refuse 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 adjunct to diet and exercise to improve glycemic control in adults with
Drugs
House Energy and Commerce Committee chair Frank Pallone (D-NJ) and Oversight and Reform Committee chair Carolyn Maloney (D-NY) have written to FDA acting commissioner Janet Woodcock seeking answers to 15 detailed questions on the agency’s review process and accelerated approval of Biogen’s Alzheimer’s drug Aduhelm
Drugs
Takeda Pharmaceutical is reporting disappointing data from its Phase 3 PANTHER (Pevonedistat-3001) study, which did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). The trial evaluated whether the combination of pevonedistat plus azacitidine as first-line treatment for patients with higher-risk