Drugs
FDA has accepted a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy. The agency has set a user fee review action target date in the first quarter
Drugs
FDA says it wants more applicants to participate in its Parallel Scientific Advice (PSA) pilot program for complex generic/hybrid drug products. In an agency podcast, CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says PSA allows applicants to engage in concurrent scientific conversation
Drugs
ADC Therapeutics has paused new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma after reporting seven patient deaths. The action followed a recent review of aggregate data of
Drugs
Genentech says an FDA draft guidance on incorporating clinical outcome assessments into endpoints for regulatory decision-making “marks a critical milestone as the final installment in FDA’s patient-focused drug development (PFDD) methodological guidance series that aims to describe a sustainable path to incorporate patient input as data in
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes the Advanced Manufacturing Technologies Designation Program discussed at an FDA 6/8 workshop on advancing the use and supporting the implementation of innovative manufacturing approaches “has the potential to further the use of advanced manufacturing technologies that can, in turn,
Drugs
FDA has published a draft guidance, Inborn Errors of Metabolism that Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development, with recommendations for optimizing and standardizing dietary management in clinical trials for developing drugs that treat inborn errors of metabolism for which dietary
Drugs
CDER researchers say more study is needed to assess the association between frailty, as measured by the Patient-Reported Frailty Phenotype they developed, and clinical outcomes in multiple myeloma. Further work also is needed to compare this phenotype with other frailty measures, they say in an agency online post “Given
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking the Supreme Court to hear an appeal from the 11th Circuit Court of Appeals that involves the potential for state tort-law liability if drug companies fail to unilaterally change language in the Highlights section of prescription medicine labeling. In its
Drugs
FDA has issued a complete response letter to Sweden’s Xspray Pharma for its NDA for Dasynoc (dasatinib amorphous) to treat chronic myeloid leukemia, its first product to be reviewed by the agency. The company says FDA requested additional information regarding additional information to doctors and users related to the
Drugs
FDA says Cipla US has recalled six batches of albuterol sulfate inhalation aerosol, 90 mcg (200 metered inhalation) due to a container defect that could result in a failure to deliver the recommended dose. An agency statement says the six batches were manufactured in 11/2021. The statement says Cipla
Drugs
FDA has lifted its 4/4/22 partial clinical hold on the Curis TakeAim Leukemia Phase 1/2 study of emavusertib in patients with B-cell malignancies. Under the hold, the agency requested additional safety, efficacy, and other data relating to the drug, including data on rhabdomyolysis and the company’
Drugs
Three Hogan Lovells attorneys say the FDA finalization of a 2018 draft guidance with recommendations on how companies can best present quantitative efficacy and risk information in direct-to-consumer (DTC) promotional materials may signal that the CDER Office of Prescription Drug Promotion (OPDP) “may be preparing to return to
Drugs
Ipsen says it plans to meet with FDA officials and then submit a regulatory application for its elafibranor to treat patients with primary biliary cholangitis. Ipsen and Genfit said elafibranor met its primary endpoint in the Phase 3 ELATIVE trial with a statistically significant higher percentage of patients achieving a
Drugs
FDA has converted from accelerated approval to full approval Eisai’s Alzheimer’s disease drug Leqembi (lecanemab-irmb). The drug received accelerated approval in January. FDA says it was converted to traditional approval following a determination that a confirmatory trial verified clinical benefit, making it the first drug in its
Drugs
A long-awaited new FDA guidance explains how the agency interprets and intends to enforce the prohibition of wholesaling against facilities that compound drugs under Section 503B of the Federal Food, Drug, and Cosmetic Act. Six Reed Smith attorneys write in an online post that the guidance first describes FDA’
Drugs
FDA has issued a complete response letter (CRL) to Regeneron Pharmaceuticals for its BLA for aflibercept 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company says the issuance of the CRL was due solely to an ongoing review of inspection
Drugs
FDA has authorized SystImmune to proceed with a planned study of its BL-B01D1 in an IND for subjects with metastatic or unresectable non-small cell lung cancer. The company says BL-B01D1 is a first-in-class bispecific antibody-drug conjugate developed by SystImmune that targets both EGFR and
Drugs
Harvard Medical School researchers say that for the 409 human drug advisory committee meetings held from 2010-2021, FDA regulatory actions followed the committees’ recommendations 88% of the time. Writing in JAMA Health Forum, the researchers also say the agency called fewer committee meetings as the years progressed (50 meetings
Drugs
FDA has released the form FDA-483 issued following a 6/15-6/23 inspection at an Ipca Laboratories drug manufacturing facility in Dhar, Madhya Pradesh, India. The eight inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Drugs
FDA has issued a complete response letter for an Amneal Pharmaceuticals drug intended to help control Parkinson’s symptoms for a longer duration. The agency letter cited safety concerns, Reuters reports. The company said FDA requested additional data as it was not convinced of the safety of carbidopa, one of
Drugs
CDER has published a Manual of Policies and Procedures, Understanding CDER’s Risk-Based Site Selection Model, outlining how the Office of Pharmaceutical Quality manages the site selection model used by Center staff to prioritize manufacturing sites for routine quality-related (current good manufacturing practice) surveillance inspections. The document says
Drugs
FDA has approved a labeling update for Novartis’ Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. “High LDL-C is one of the most readily modifiable risk factors for heart