Biologics
Agenus has withdrawn a BLA for balstilimab, its PD-1 inhibitor that was seeking an accelerated approval for second-line treatment of cervical cancer. The decision to withdraw the submission was urged by FDA due to Merck’s recent full approval of Keytruda (pembrolizumab) for treating this patient population (see
Drugs
FDA has approved Biofrontera’s BF-RhodoLED XL, a red-light source for photodynamic therapy (PDT) and its combination use with the company’s Ameluz (aminolevulinic acid hydrochloride) gel for treating mild and moderate actinic keratoses on the face and scalp. The PDT lamp is designed to illuminate large areas
Drugs
FDA has approved Genentech’s Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Susvimo is designed to deliver ranibizumab
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw approval, and the holders of the 216 applications did
FDA Policy/General
Former Obama Administration FDA commissioner and current frontrunner for the nomination Robert Califf seemed on the brink of being announced as President Biden’s choice 2/22 when he visited the White House. According to a Politico report, the White House has spent the last few weeks vetting Califf, who
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Orion Corp.’s Nubeqa (darolutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,576 days, which includes 2,420 days that occurred during the testing phase
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “PHS Guideline on Infectious Disease Issues in Xenotransplantation” (OMB Control Number 0910-0456). The guideline identifies general principles for preventing and controlling infectious diseases associated with xenotransplantation that may pose a risk to public health. It also
Biologics
FDA has denied a 9/27 citizen petition submitted by the Informed Consent Action Network asking it to revoke the emergency use authorizations (EUAs) granted to the Moderna and Johnson & Johnson Covid-19 vaccines. FDA says the petition argued the EUAs should be revoked because Pfizer/BioNTech’s Comirnaty
Drugs
FDA has published a draft guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, with recommendations for sponsors complying with provisions of the Federal Food, Drug, and Cosmetic Act when submitting real-world data (RWD) as study data in applicable drug submissions. The document was issued
Drugs
FDA is expanding its relationship with Aetion to use real-world evidence (RWE) to study Covid-19 interventions and advance regulatory science and innovation. Aetion says the agency and company will use the Aetion evidence platform to develop a framework and system of studies for the rapid assessment of Covid-
Devices
FDA has granted de novo premarket approval to Luminopia for its Luminopia One as a prescription therapy to improve vision in children with amblyopia, also known as lazy eye. The company says Luminopia One is indicated for improving visual acuity in children with amblyopia aged 4-7, associated with anisometropia
Drugs
FDA has placed a clinical hold on an AstraZeneca clinical trial of its investigational blood cancer drug AZD5991. Fierce Biotech reports the company had already put a hold on the trial after heart issues were found in one patient being treated with the drug. AZ told the online newsletter that
Drugs
Merck has recalled one lot of Cubicin (daptomycin for injection) 500mg for intravenous use due to a complaint being received about a piece of glass found in a vial. “Intravenous infusion of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be
Biologics
FDA has approved Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) as an add-on maintenance treatment for patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Approval is based on data from a Phase 3 randomized, double-
Drugs
FDA has approved an Esteve Pharmaceuticals NDA for Seglentis (celecoxib and tramadol hydrochloride) for treating acute pain in adults. The product comprises a co-crystal form of celecoxib (an anti-inflammatory) and tramadol (an analgesic) for pain management, according to the company. “This innovation is the result of applying a
Biologics
CDC’s Advisory Committee for Immunization Practices 10/21 voted to recommend accepting FDA’s 10/20 amended emergency use authorizations (see earlier story) for booster doses of both Moderna and Johnson & Johnson’s Covid-19 vaccines. FDA also authorized the use of any available Covid-19 vaccine as
Devices
FDA has denied a 4/30 Stryker Medical petition seeking a Class 2 510(k) exemption for powered patient transport, all other powered patient transport. The FDA denial letter says the devices are motorized units used to mitigate mobility impairment caused by injury or disease by moving a person from
Drugs
Bryant Ranch Prepack has recalled one lot of methocarbamol 500mg tablets due to a mislabeling error. Bottles in the affected lot have been found to contain methocarbamol 750mg tablets instead of the labeled 500mg, a recall notice says. A patient taking the higher strength methocarbamol could experience excessive central nervous
Biologics
Sens. Susan Collins (R-ME) and Richard Burr (R-NC) are asking FDA and the Centers for Disease Control (CDC) for more efficacy data on Covid-19 vaccines and breakthrough cases. In a 10/20 letter, the two say that while CDC has started to make some additional information available
FDA Policy/General
Updated fiscal year (FY) 2021 FDA enforcement and compliance data show just how badly Covid-19 has decimated the agency’s Warning Letter issuance and inspections conducted, among other compliance actions. Of course, when the agency stopped both domestic and foreign inspections in 2020, it was expected to have a
Devices
FDA says Cook Medical issued a 10/8 recall of its transseptal needle and transseptal needle with catheter. The recall covers all unexpired lots for both products, an agency statement says. The needles were recalled due to complaints of rust on the products. The notice says that the use of
Biologics
FDA 10/20 authorized Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals. Additionally, the agency authorized the use of any available Covid-19 vaccine as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different