Drugs
Novartis 4/15 reported favorable data from a pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study of Fabhalta (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN). According to the company, patients treated with Fabhalta achieved a 38.3%
Drugs
FDA issued Zydus Lifesciences a four-item Form FDA-483 after inspecting the firm’s manufacturing facility (Matoda, Gujarat, India). The form said Zydus’ aseptic processing areas are deficient, specifically its system for monitoring environmental conditions. For example, it said that from 5/23 to 12/2023 the firm manufactured
Drugs
FDA has granted Soligenix an orphan drug designation for the active ingredient in MarVax, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein for post-exposure prophylaxis against MARV infection. Marburg marburgvirus causes Marburg Virus Disease, a related disease to the Ebola virus disease, the company says. “Although
Drugs
CDER is announcing the launch of its Center for Clinical Trial Innovation (C3TI), which the Center says is intended to promote clinical trial innovation activities through enhanced communication and collaboration. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve
Drugs
FDA has classified a 12/4/2023 to 12/15/2023 inspection at Sun Pharmaceutical Industries’ Dadra, India facility as “official action indicated.” The classification is the agency’s most severe and requires corrections and often a follow-up inspection. “We will work with the regulator to achieve fully compliant
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/12 unanimously voted (12 to 0) that the totality of data are adequate to support the use of minimal residual disease (MRD) as an endpoint to support accelerated approval in multiple myeloma (MM) clinical trials. Two applicants — the University of Miami and 12TEAMM
Drugs
FDA has granted PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metastatic head and neck squamous cell carcinomas. LYT-200 is described as an antibody against galectin-9, a potent cancer driver. It is being evaluated in two ongoing clinical
Drugs
As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 4/
Drugs
FDA has approved new safety labeling for Veloxis Pharmaceuticals’ Envarsus XR (tacrolimus), indicated for use with other medicines to help prevent organ rejection in people who have had a kidney transplant. The labeling now reflects an updated contraindication in patients with known hypersensitivity to tacrolimus or to any of the
Drugs
CDER Office of Pharmaceutical Quality acting deputy director of science Susan Rosencrance says the agency has chosen nine applicants for a new Quality Management Maturity (QMM) evaluation program. Speaking at the agency’s Generic Drugs Forum, Rosencrance said the QMM program encourages manufacturers to implement quality management practices that go
Drugs
Oncolytics Biotech is asking for a 2nd quarter Type C meeting with FDA to discuss its planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer. A company statement says its leadership is “optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with
Drugs
FDA has released the form FDA-483 issued following a 3/28-4/4 inspection at the Cipla Limited facility in Raigad, Maharashtra, India, that manufactures human and animal active pharmaceutical ingredients (API) and human drug products. The six inspection observations were: * failure to clean and maintain equipment and utensils
Drugs
FDA has approved an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 11 years with an eosinophilic phenotype. The drug was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in
Drugs
The American Society of Health-System Pharmacists (ASHP) says the current 323 ongoing and active drug shortages are the highest number since the society began tracking shortages in 2001. In an online summary with graphs, ASHP says basic and life-saving products are in short supply including oxytocin, Rho(D)
Drugs
U.S. Representative Ro Khanna (D-CA) took FDA commissioner Robert Califf to task during a House Oversight Committee hearing 4/11 on the agency’s Orange Book and frivolous patents that are listed there to prevent cheaper generics from coming to market. The lawmaker said Americans are frustrated because
Drugs
The Court of Appeals for the Federal Circuit has affirmed the 5/17/2023 decision of the Delaware federal court to deny Norwich Pharmaceutical’s petition to modify the court’s final order preventing FDA from approving Norwich’s ANDA for a generic form of Salix’ Xifaxan (rifaximin) 550 mg
Drugs
FDA has authorized Seattle Children’s to launch the first chimeric antigen receptor (CAR) T-cell clinical trial in the U.S. for children under age 18 with the most common form of lupus. “Despite recent advances in lupus management, many patients have lupus that is resistant to current treatment
Drugs
FDA has granted Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma, a rare cancer that can develop in children, adolescents and young adults. The investigational drug is designed to activate a “novel uptake pathway that allows co-administered or tethered (i.e., covalently bound)
Drugs
Par Pharmaceutical is asking the DC federal court to grant a temporary restraining order to block FDA’s grant of final approval to a BPI Labs NDA supplement for an epinephrine product that cites Par’s Adrenalin (epinephrine) as the reference-listed drug. Par says there is a 30-month
Drugs
The Oncologic Drugs Advisory Committee meets on 4/12 to discuss using minimal residual disease (MRD) as an endpoint in multiple myeloma (MM) clinical trials. An agency briefing document developed in conjunction with two applicants, the University of Miami and 12TEAMM, and distributed in advance of the meeting, says that
Drugs
A new report from the National Academies of Sciences, Engineering, and Medicine calls on FDA, HHS, the National Institutes of Health, and Congress to act to improve the inclusion of pregnant and lactating women in clinical trials. The document says such women are often excluded from clinical trials due to
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the goal of an FDA public meeting to facilitate a discussion of the use of external data sources, Bayesian statistical methods, and modeling and simulation supporting clinical trial complex innovative designs (CIDs), and to explore examples of how CIDs are