Drugs
Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurrent chemoradiotherapy alone in treating newly diagnosed patients with high-risk locally advanced cervical cancer. The data come from the Phase 3 KEYNOTE A-18 trial, which is supporting a
Drugs
FDA has approved Pfizer’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), a pentavalent vaccine that protects against the most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years of age. The company says the vaccine “combines the components from two
Drugs
FDA has approved a BioMarin Pharmaceutical supplemental NDA for Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates). The company says the indication was approved under accelerated approval based on an improvement in annualized growth velocity. Previously, the drug was indicated for children
Drugs
FDA says the Oncology Center of Excellence (OCE) Scientific Collaborative supports agency oncology staff who participate in regulatory science research. OCE says its research looks at applied research questions to address specific challenges arising during the IND and NDA/BLA review process. OCE has identified these nine scientific interest areas
Drugs
FDA says Hygienic Labs in Denver, CO, a manufacturer of over-the-counter (OTC) drug products, has not responded to several agency requests for records and other information. In a just-released 9/19 Warning Letter, the agency says it is unlawful to refuse to permit access to or copying
Drugs
Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The company’s decision to seek approval is based on new data from the
Drugs
Nine staff members in various positions in FDA, CDER, and CBER say the terms real-world data (RWD) and real-world evidence (RWE) are often used interchangeably and inconsistently, including in submissions to the agency involving RWE to evaluate the effectiveness of drugs and biologic products. Writing in an open-
Drugs
A 3/2-3/10 FDA inspection at Nectar Lifesciences in Chandigarh, India, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released Untitled Letter says the specific violations were: * failing to establish appropriate written procedures that are designed to prevent microbiological contamination
Drugs
FDA has published a guidance, Benefit-Risk Assessment for New Drug and Biological Products, to tell drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA premarket and postmarket regulatory decisions on NDAs and BLAs. The document addresses decisions
Drugs
Harvard Medical School professor Jerry Avorn thinks recent court decisions involving “compelled speech” could end up limiting FDA’s ability to ensure that drug makers accurately describe their products’ side effects. Writing in a New England Journal of Medicine Perspective column, Avorn cites the Supreme Court decision in 303 Creative
Drugs
FDA has cleared an Intellia Therapeutics IND for its NTLA-2001 to treat transthyretin amyloidosis with cardiomyopathy. The company says a global Phase 3 study of the drug is expected to start by the end of this year. NTLA-2001 is described as the first CRISPR therapy candidate to be
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for use with platinum-containing chemotherapy as neoadjuvant treatment and continuing as a single-agent post-surgical adjuvant treatment for resectable non-small cell lung cancer (NSCLC). Approval was based on data from the KEYNOTE-671 trial in 797 patients with previously untreated
Drugs
FDA says CDER is soliciting comments on the barriers and facilitators to incorporating successful or promising innovative clinical trial approaches in drug development programs. An online notice lists questions the agency says could be considered in responses. “Comments submitted to this public docket will inform CDER’s future work related
Drugs
Verrica Pharmaceuticals is asking FDA to take specific actions on the compounding of its Ycanth (cantharidin) by pharmacies and outsourcing facilities. Ycanth is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The petition asks the agency to: * remove cantharidin
Drugs
FDA has released the form FDA-483 issued following an 8/21-9/1 inspection at the Samsung Biologics drug manufacturing facility in Incheon, Korea. The six inspection observations are: * the Manufacturing Scientific Analytical Technology laboratory used to support application submission testing has inadequate controls over data integrity; * written production
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the Supreme Court should hear an appeal filed by Danco Laboratories and FDA challenging a 5th Circuit Court of Appeals decision that would restrict how the abortifacient Mifeprex (mifepristone) is distributed to and used by patients. In its petition, Danco asked the
Drugs
FDA has denied without comment a UCB 5/16 petition asking the agency not to approve an Apotex ANDA for fenfluramine oral solution that cites UCB’s Fintepla (fenfluramine) oral solution as the reference-listed drug, unless specified conditions are met. The denial letter says UCB specifically said the Apotex
Drugs
Aldeyra Therapeutics says it is addressing “substantive” late review-cycle concerns raised by FDA on the company’s NDA for reproxalap for treating the signs and symptoms of dry eye disease. During a recent meeting with Aldeyra, FDA stated that “[i]t does not appear that you have data to
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The agency has set a user fee review action target date of
Drugs
Omeros says it is discontinuing its development of narsoplimab for treating immunoglobulin A (IgA) nephropathy based on Phase 3 clinical trial (ARTEMIS-IGAN) data that did not show statistical significance. An interim analysis of the ARTEMIS-IGAN trial failed to show a “statistically significant improvement over placebo,” the company says.
Drugs
AbbVie is reporting “positive results” from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi (risankizumab) 600 mg intravenous [IV] drug compared to Janssen’s Stelara (ustekinumab) 600 mg IV in patients with moderately to severely active Crohn’s disease who have
Drugs
FDA has posted a final guidance entitled “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” The document is intended to alert pharmaceutical makers and state-licensed pharmacies who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol