Drugs
Athenex has decided to abandon its continued development of oral paclitaxel plus encequidar for treating metastatic breast cancer. After the company received an NDA complete response letter earlier this year, which recommended an additional clinical study before considering the submission for approval, the company requested a Type A meeting with
Drugs
Merck has filed an application seeking emergency use authorization (EUA) for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine that new data show significantly reduced the risk of hospitalization or death in Covid-19 patients. Earlier this month, Merck and developmental partner Ridgeback Biotherapeutics announced data from a
Drugs
FDA has approved a ChemoCentryx NDA for Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis in combination with standard therapy. The systemic autoimmune disease is caused by over-activation of the
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 17-0 to recommend approval of Takeda’s maribavir to treat cytomegalovirus (CMV) infection in the post-transplant setting. Panel members agreed with an agency briefing document that while the two trials submitted had significant limitations, there is a considerable unmet need
Drugs
A new FDA pilot program on using novel excipients aims to increase their use, especially if they have potential public health benefits. The pilot was initiated after the agency continually heard that drug developers may fear that introducing novel excipients could cause problems or delays with their drug applications, according
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and older with juvenile psoriatic arthritis (jPsA). The biologic targets cytokines interleukin (IL)-12 and IL-23, both of which have a role in inflammation associated with immune-mediated diseases, according to the
Drugs
FDA has granted Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients. According to the company, the designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque in the ongoing SCarlet RoAD and Marguerite RoAD
Drugs
FDA has granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. An agency announcement says FDA recognized a portion of the database as a source of valid
Drugs
Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have introduced the FDA Modernization Act to end animal testing mandates. Kentucky’s ABC36 TV news says the bill “would end an outdated FDA mandate that experimental drugs must be tested on animals before they are used on humans in
Drugs
FDA has placed a clinical hold on Allogene Therapeutics clinical trials involving Allo-501A CAR T cells after a report of a chromosomal abnormality in the company’s ALPHA2 study. The abnormality, which was detected in a bone marrow biopsy undertaken to assess pancytopenia (low blood counts), was reported to
Drugs
NeuroMetrix has filed a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults. The company received an FDA breakthrough designation for this indication in July. The submission is based on data from a double-blind, randomized, sham-controlled trial (NCT03714425) involving 119 patients
Drugs
FDA has published a draft guidance, Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, describing how the agency will apply certain provisions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA) to human drug products that are compounded by
Drugs
FDA has issued a complete response letter declining to approve in its current form a Polarean Imaging NDA for an investigational drug-device combination product using hyperpolarized xenon-129 gas to enhance MRI imaging in pulmonary medicine. The company says the letter was “unexpected” and contained issues that are “mostly
Drugs
Cassava Sciences says it has started an initial Phase 3 efficacy study of simufilam, its investigational drug for patients with Alzheimer’s disease. A second Phase 3 efficacy study is expected to launch before the end of 2021, the company says. The company announcement says the studies are being conducted
Drugs
Three Faegre Drinker consultants say an FDA September draft guidance on benefit/risk assessments for drugs and biological products “is an important step in increasing transparency of the FDA decision-making process. It gives sponsors, patient advocacy organizations, and other stakeholders a view into how FDA is using the relatively
Drugs
FDA has accepted for review an Acer Therapeutics NDA for Acer-001 (sodium phenylbutyrate) for treating patients with urea cycle disorders (UCDs). Acer says the submission is based on data from two bioequivalence trials in which Acer-001 showed similar relative bioavailability compared to the reference drug, Ucyclyd Pharma’s
Drugs
FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation are sponsoring a two-day virtual public workshop on “Fetal Pharmacology and Therapeutics” on 10/21-10/22. An announcement says the workshop will discuss the current state of fetal pharmacology and therapeutics and how it
Drugs
FDA has published a draft S1B addendum to the International Council for Harmonization (ICH) S1 guidances and documents on the need for carcinogenicity studies for pharmaceuticals. The ICH says the addendum expands the testing scheme for assessing the human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach
Drugs
FDA says its 3/9-3/16/20 inspection at Walter Corp., doing business as The Medicine Shoppe, Port Charlotte, FL, found that drugs the company produces failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, a 9/17 Warning
Drugs
The FDA Antimicrobial Drugs Advisory Committee meets 10/7 to consider Takeda’s maribavir to treat cytomegalovirus (CMV) infection in the post-transplant setting. An agency briefing paper distributed in advance of the meeting says Takeda submitted a Phase 2 and Phase 3 trial evaluating the efficacy of maribavir for
Drugs
An unexpected safety signal has led Takeda Pharmaceutical Co. to halt two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy. Without providing any details of the safety concern, Takeda says that stopping the trials “allows for the timely interpretation of the benefit/risk profile
Drugs
Former FDA human factors team leader Shannon Hoste has been named president of Agilis Consulting, which describes itself as a full-service medical human factors firm. Agilis says Hoste provided oversight to hundreds of human factors submissions to CDRH and CDER, making her a recognized expert in risk management and