Devices
The Center for Science in the Public Interest and 15 other public interest organizations are asking FDA to regulate laboratory-developed tests (LDTs). A 5/30 letter says the agency has the authority to regulate LDTs but has chosen not to use it because early tests were fairly simple and
Biologics
FDA has completed a previously delayed pre-licensing inspection of China-based Shanghai Junshi Biosciences’ toripalimab manufacturing site. The product is being developed by Coherus BioSciences and Junshi for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). Coherus says the inspection concluded with a three-item FDA Form-483. It says
FDA Policy/General
FDA and the European Union have agreed to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals. Under the expanded MRA, FDA can rely on GMP inspections of veterinary product facilities conducted by
Drugs
FDA continues to ramp up its return to face-to-face (FTF) meetings and beginning 6/12 CDER and CBER will expand in-person FTF industry meetings to include requests for Type B End-of-Phase 2 requests. The End-of-Phase 2 requests join the previously announced Type A,
Drugs
FDA is proposing to amend its Medication Guide regulation to require applicants to create a new one-page Patient Medication Information (PMI) for prescription drug products. A Federal Register notice says the PMI would have a standardized format and content that would be submitted to the agency for approval. The
Drugs
A 3/21-4/28/22 FDA inspection at New England Life Care, doing business as Advanced Compounding Solutions in Woburn, MA, found multiple violations of the Federal Food, Drug, and Cosmetic Act. A 5/16 Warning Letter says the investigators found serious deficiencies in the company’s practices for
Drugs
FDA has accepted for priority review a Bristol Myers Squibb NDA for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI) for treating patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The agency has set a review action target date of 11/27. The submission
Drugs
FDA has approved Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent. The company is seeking an indication for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial
Drugs
Hyman, Phelps & McNamara says a client that develops drugs intended to treat neovascular age-related macular degeneration (nAMD) has concerns about an FDA draft guidance on developing drugs to treat nAMD. The firm’s comment letter says the areas of concern are the guidance recommendations for the comparator arm,
Biologics
FDA has accepted for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The company is seeking accelerated approval from FDA, which
Drugs
Janssen has submitted an NDA to FDA for an investigational single-tablet combination of macitentan (Janssen’s Opsumit) 10 mg and tadalafil (Lilly’s Cialis and others) 40 mg for the long-term treatment of pulmonary arterial hypertension in some specified adult patients. A company statement says the NDA is
Devices
FDA has cleared a Think Surgical 510(k) for its TMINI Miniature Robotic System for performing total knee replacement surgeries. The device includes a wireless robotic handpiece to assist surgeons. “Following a CT-based three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for surgeon hand movement to locate
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” The document provides recommendations to assist manufacturers in complying with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation
Drugs
Pfizer says that its investigational hemophilia drug marstacimab met its primary endpoints in the Phase 3 BASIS trial, demonstrating statistically significant and clinically meaningful effects. A company statement says marstacimab is an investigational anti-tissue factor pathway inhibitor being studied to treat hemophilia A or B for people without inhibitors
Drugs
CDER’s Office of New Drugs has denied an Akebia Therapeutics dispute resolution request following its receipt of a 3/22 complete response letter (CRL) for vadadustat, but the company says it was offered a “path forward” to resubmit the NDA, indicated for treating anemia due to chronic kidney disease
Drugs
The National Organization for Rare Disorders says it appreciates FDA efforts in a draft guidance on clinical trial considerations to support accelerated approval of oncology drugs “since the guidance, when finalized, will likely have far-reaching impacts on rare disease drug development well beyond oncology products.” The comment letter recommends:
Devices
iRhythm Technologies says it received a 5/25-dated Warning Letter that cites violations from an 8/22 agency inspection. “The Warning Letter alleges non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.” The document provides recommendations for demonstrating efficacy for drugs that are intended to reduce diabetes-related hyperglycemia (i.e., antihyperglycemic drugs) and to mitigate iatrogenic hypoglycemia
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” The document discusses general recommendations for performing covariate adjustment using linear models, and for performing covariate adjusting using nonlinear models. To view the notice, click here.
Drugs
Bristol Myers Squibb says its Breyanzi (lisocabtagene maraleucel) showed “deep and durable efficacy” in the Phase 1/2 TRANSCEND CLL 004 study of adults with relapsed or refractory lymphocytic leukemia or small lymphocytic lymphoma. A company statement says Breyanzi delivered statistically significant complete response rates, the primary endpoint, in 18.
Drugs
AstraZeneca says the Phase 3 DUO-E trial showed statistically significant and clinically meaningful improvement in progression-free survival of advanced endometrial cancer when its Imfinzi (durvalumab) was used in combination with platinum-based chemotherapy and followed by Imfinzi plus Lynparza (olaparib) or Imfinzi alone as maintenance therapy. A company
Drugs
FDA has released the form FDA-483 issued following a 4/17-4/21 inspection at the UCB Pharma drug manufacturing facility in Braine-l’Alleud, Belgium. The three inspection observations were: * failure of the quality unit to establish adequate document control of the forms used for good manufacturing practice