Drugs
FDA has released the form FDA-483 issued following a 7/20-8/1 inspection at Jubilant Generics, a Uttaranchal, India, drug manufacturer. The six inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
FDA has approved AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresectable hepatocellular carcinoma, the most common type of liver cancer. Approval was based on data from the HIMALAYA Phase 3 trial, which showed that patients treated with the combination saw a 22% reduction
Drugs
Janssen Pharmaceutical says new data show that patients given Tremfya (guselkumab) saw a clinical response rate of about 80% in trial subjects with moderately to severely active ulcerative colitis (UC) and who had an inadequate response to previous treatments. The data were from the company’s Phase 2b QUASAR Induction
Drugs
FDA says it does not believe Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) should be withdrawn from the market as requested in a 3/4/21 petition filed by law firm Foley Hoag. The agency denied all elements of the petition except the one asking FDA to explain the basis for allowing the
Drugs
FDA has given accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech), described as the first bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myelomas who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory
Drugs
In advance of a 10/26 meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee meeting to consider GlaxoSmithKline’s anemia drug daprodustat, FDA medical reviewers are raising safety concerns about the drug. The company is seeking an indication to treat anemia due to chronic kidney disease in adult
Drugs
CDER Division of Hematologic Malignancies 2 division director Nicole Gormley has been named acting associate director for oncology endpoint development in FDA’s Oncology Center of Excellence. The agency says Gormley will have a dual role, continuing in her capacity as director of the hematology division. In her new role,
Drugs
For the second time in a year, FDA has inspected contract manufacturer Catalent’s Brussels, Belgium, facility, this time resulting in a nine-item Form FDA-483. The September inspection occurred simultaneously with an inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-
Drugs
FDA says it has determined that there are insufficient data at this time to support a proposed cefazolin susceptible minimum inhibitory concentration (MIC) breakpoint of less than or equal to 16 mg/L as a surrogate for determining breakpoints for oral cephalosporins for treating uncomplicated urinary tract infections (uUTI) due
Drugs
FDA has accepted for a review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT). The therapy is currently approved for treating adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (HCM) to
Drugs
FDA has released three FDA draft guidances that provide general recommendations for physicochemical and structural (Q3) characterization tests, in vitro release test (IVRT) studies, and in vitro permeation test (IVPT) studies for topical generic drug products. The documents are intended to help sponsors who are submitting ANDAs for liquid-based
Drugs
Responding to an upcoming FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to discuss CDER’s Quality Management Maturity (QMM) and Knowledge-Aided Assessment and Structured Application (KASA) programs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it has issues that it would like to be considered by the
Drugs
FDA has published a guidance, Multiple Endpoints in Clinical Trials, presenting the agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how they can be managed in clinical trials for human drugs and biologics. The document says that when more
Drugs
Talaris Therapeutics says it learned on 10/18 of the death of a subject enrolled in its FREEDOM-1 Phase 3 trial of FCR001 in living donor kidney transplant patients. A company statement says the subject was one of three reported in June to have been diagnosed with grade 2
Drugs
FDA has released the form FDA-483 with two observations from a 7/26-8/5 inspection at ImClone Systems, Branchburg, NJ, a drug substance manufacturer. The inspection observations were: * failing to control the disposition and availability of drug substances determined to be within the scope of deviation investigations before
Drugs
A recent inspection at Hikma Injectables USA (Dayton, OH) has led to a three-item Form FDA-483. For example, agency investigators cited the firm’s aseptic processing areas because they did not have adequate monitoring of environmental conditions. The agency also said Hikma’s aseptic processing areas were “deficient
Drugs
FDA says it is launching its Advancing Real-World Evidence (RWE) Program to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications for approved medical products or to satisfy post-approval study requirements. An agency notice says the
Drugs
PTC Therapeutics says enrollment in its Phase 2 PIVOT-HD trial of PTC518 to treat Huntingdon’s disease has been paused in the U.S. due to an FDA request for additional data to allow the study to proceed. A company statement says trial enrollment “is active and ongoing” in
Drugs
FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee10/19 voted 14 to 1 to recommend the market withdrawal of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) because data show the accelerated-approval drug is not effective. It was approved in 2011 for reducing the risk of
Drugs
FDA has released the form FDA-483 issued following a 9/19-9/28 inspection at Torrent Pharmaceuticals, Indrad, Gujarat, India, a finished product and active pharmaceutical ingredient manufacturer. The three inspection observations were: * equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would
Drugs
The latest HDA Research Foundation “Serialization Readiness Survey” says there continues to be uneven readiness as supply chain partners prepare for the 2023 Drug Supply Chain Security Act (DSCSA) implementation milestone. “FDA’s granting of enforcement discretion in 2020 until 2023 for certain wholesale distributor and dispenser requirements, while very
Drugs
Two women who worked for Tellus Clinical Research in Miami, FL, have been sentenced by a Florida federal judge to terms in prison for their part in a conspiracy to falsify clinical trial data. A Justice Department statement says Analay Rico, Fort Lauderdale, a lead study coordinator, was sentenced to