Drugs
FDA has rejected Intercept Pharmaceuticals’ obeticholic acid for treating NASH (nonalcoholic steatohepatitis). Endpoint News reports that FDA postponed two advisory committee meetings that were to consider the company’s NDA and then rejected the drug because agency staff were uncertain if the Phase 3 trial surrogate endpoint (reduction in liver
Drugs
FDA has approved ViiV Healthcare’s Rukobia (fostemsavir), described as a “new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance, or safety considerations.” An agency statement says Rukobia’
Drugs
At the request of FDA, the National Academies of Science, Engineering, and Medicine (NASEM) has conducted an independent assessment and evaluation of the available scientific evidence on the safety and effectiveness of compounded bioidentical hormone therapy (cBHT) products. NASEM concluded that due to a lack of high-quality clinical evidence
Drugs
An FDA safety alert is warning about an increased risk of a false positive result with Becton Dickinson’s BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found 3% of results were false positive for Covid-19, the alert says. The agency
Drugs
The Justice Department says Novartis will pay $678 million to the federal government and several states to settle a whistleblower’s civil fraud suit alleging that the company violated the False Claims Act and anti-kickback laws by providing doctors cash payments, recreational outings, lavish meals, and expensive alcohol to
Drugs
FDA has sent Curativa Bay (Clearwater, FL) a Warning Letter after reviewing the company’s Web site and citing its Advanced Hypochlorous Skin Spray over misleading claims that the product is safe/effective for treating Covid-19. The company claims that applying the skin spray around the face and eyes
Drugs
FDA has approved a Chiasma NDA for Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Acromegaly is a rare chronic disease often caused by a benign pituitary tumor and characterized by excess production of growth hormone
Drugs
A new FDA post discusses research by CDER statisticians who developed innovative and more efficient ways to evaluate transdermal and topical delivery systems (collectively called TDS). Instead of evaluating similarity of adhesion between test and reference scores as the ratio of means (ROM) adhesion scores, CDER statisticians settled for a
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations is helpful and contains a framework drafted in a way that supports the development of innovative gene therapy products. The BIO comment letter says the association appreciates the
Drugs
The Association for Accessible Medicines and Teva have raised identical questions and issues about an FDA draft guidance on technical considerations for demonstrating the reliability of emergency-use injectors submitted under a BLA, NDA, or ANDA. The company and association raise these issues: * FDA needs to come to a reasonable
Drugs
Over the last seven years, FDA has been working to get a handle on its vast data resources to achieve a 360-degree view of the drug development lifecycle. How the agency approached the challenge was recently discussed by CDER Office of Strategic Programs supervisor and computer scientist Shanthi Vigneshwaran
Drugs
FDA has scheduled a 7/21 virtual public meeting to obtain input on the reauthorization of the Generic Drug User Fee Amendments of 2012 for FY 2023-2027 (GDUFA 3). The amendments authorize FDA to collect user fees to support the review of generic human drug applications. A meeting notice
Drugs
An online post explains how FDA is building on its more than a decade of experience in working with the European Commission and its European Medicines Agency (EMA) to collaborate on several scientific and regulatory fronts as part of the Covid-19 response. The paper says that what has helped
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) as monotherapy for treating patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Approval was based on data from the Phase 2 KEYNOTE-629 trial that demonstrated Keytruda’s meaningful efficacy and durability of
Drugs
FDA and the Duke-Margolis Center for Health Policy will hold a 7/13-14 virtual public meeting to explore potential approaches to developing a high-quality real-world data (RWD) ecosystem. The meeting will discuss “technical challenges and cultural barriers to the scalability of data capture processes, as well
Drugs
FDA has published two guidances to address drug development programs for community-acquired bacterial pneumonia and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The documents do not discuss the general issues of statistical analysis or clinical trial design that are addressed in other guidances. The guidances’ contents are
Drugs
A 4/23-4/25/18 FDA inspection at Home Care Pharmacy of Palm Coast, Palm Coast, FL, found deficiencies in the firm’s practices for producing drug products. A just-released 5/4 letter says the deficiencies involved drug compounding regulations and adulterated drug products. The letter says FDA
Drugs
FDA has lifted a partial clinical hold against an Innate Pharma Phase 2 clinical trial (TELLOMAK) that is evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas. FDA’s action is based on a quality assessment of a new GMP-certified batch that
Drugs
CBER has updated its list of guidance documents it plans to issue in 2020. The list totals 28 guidances, including one on “Interacting with the FDA on Complex and Innovative Clinical Trial Designs for Drugs and Biological Products,” and another on “Chemistry, Manufacturing, and Controls Changes to an Approved Application:
Drugs
Public Citizen is petitioning FDA to require a Boxed Warning for all sodium-glucose cotransporter-2 (SGLT-2) inhibitor drugs contraindicating their use in patients with Type 1 diabetes. “There is irrefutable evidence from multiple randomized clinical trials that the SGLT-2 inhibitors canagliflozin (Janssen’s Invokana), dapagliflozin (AstraZeneca’s
Drugs
FDA has accepted for review a Mayne Pharma Group NDA for E4/DRSP (estetrol and drospirenone) for preventing pregnancy. The submission includes data from two Phase 3 clinical studies conducted in more than 3,725 women aged 16 to 50 years. A review action is expected in the first half
Drugs
An 11/13-12/3/19 FDA inspection at Nanobots Healthcare, doing business as Assurance Infusion, Houston, TX, identified serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk. A 6/12 Warning Letter acknowledges that the company ceased sterile compounding 12/19/