Drugs
FDA commissioner Stephen Hahn says that to date the agency staff has been performing user fee review activities despite also being heavily involved in Covid-19-related activities. In a statement, Hahn says that part of the review activities has involved looking at ways to use technology and established agreements
Drugs
Mayne Pharma has filed an NDA for E4/DRSP (estetrol and drospirenone), a combined oral contraceptive indicated for preventing pregnancy. The company describes the novel, next-generation oral contraceptive as containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring estrogen that is produced by
Drugs
Three healthcare activists whose suit persuaded a federal judge to order companies to add 10 years’ of information to the ClinicalTrials.gov Web site say that site could help inform the public about Covid-19 drug trials if government agencies would require companies to submit all their trial results. Writing
Drugs
Bayer’s donation of three million Resochin (chloroquine phosphate) tablets to the U.S. national stockpile for use in treating Covid-19 patients is raising red flags, according to a Reuters article. The news service says three U.S. government sources familiar with the donation told it there is reason
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The agency has set a user fee review action target date of 10/25. The submission is supported by data from the randomized, controlled PALM clinical trial
Drugs
The International Council for Harmonization (ICH) says its S11 guideline on nonclinical safety testing supporting the development of pediatric medicine reached Step 4 of the ICH process this month. ICH says the guideline provides direction on the nonclinical safety studies important to support a pediatric development program. It reportedly recommends
Drugs
FDA says that a Web site operating at unitedpharmacies.md is offering drug products for sale in the U.S. intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A just-released 3/30 Warning Letter says the firm’s products are considered to be unapproved new
Drugs
FDA has approved a UroGen Pharma NDA for Jelmyto (mitomycin gel), indicated for treating low-grade upper tract urothelial cancer (UTUC). FDA describes Jelmyto as an alkylating drug that “inhibits the transcription of DNA into RNA, stopping protein synthesis and taking away the cancer cell’s ability to multiply.” Approval
Drugs
The United States Pharmacopeia (USP) says it supports efforts to foster access to biosimilars and to pursue initiatives that facilitate increased competition for biological products. Commenting on an FDA/Federal Trade Commission 3/9 workshop on a competitive marketplace for biosimilars, USP says its public quality standards “serve an important
Drugs
FDA has granted RemeGen a fast track designation for RC18, a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein for treating systemic lupus erythematosus. The chronic autoimmune disease attacks healthy tissue and affects upwards of 1.5 million people in the U.S.
Drugs
The New Civil Liberties Alliance (NCLA) says it is concerned that an FDA decision that will prevent the dissemination of information related to the genetic variants on drug response (pharmacogenomics or PGx) will adversely affect public health. The NCLA concern is expressed in its 4/14 comment supporting a 1/
Drugs
An 8/13-8/17/19 FDA inspection at a subsidiary of Option Care Health, HomeChoice Partners, doing business as Bioscrip Infusion Services, Augusta, GA, found “serious deficiencies in this facility’s practices for producing sterile drug products, which put patients at risk.” A 4/9 Warning Letter says specific
Drugs
Two stakeholders are suggesting changes in an FDA draft guidance on bridging for drug-device and biologic-device combinations. AdvaMed’s comment letter commends the agency for implementing the guidance and offers “minor revisions to improve the clarity and impact” of the document. The Biotechnology Innovation Organization says the draft
Drugs
India’s Economic Times reports that FDA has cleared within 10 days four drug manufacturing facilities operated by the country’s leading drug companies at a time when supply chain disruptions caused by the coronavirus pandemic are creating drug shortages worldwide. Cleared were Lupin’s Nagpur manufacturing facility, Dr. Reddy’
Drugs
FDA has accepted for priority review a Fennec Pharmaceuticals NDA for Pedmark (sodium thiosulfate), indicated for preventing ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients one month to 18 years of age with localized, non-metastatic, solid tumors. The agency set a user fee review action target date of
Drugs
Kadmon Holdings says it has received FDA meeting minutes on a planned NDA submission for KD025 for treating patients with chronic graft-versus-host disease (cGVHD). Based on the FDA feedback, the company believes its proposed data package will be sufficient to support the NDA, which will include data from
Drugs
FDA and the Federal Trade Commission say that their review of the Web site and Facebook page maintained by Gaia Arise Farms Apothecary, Waynesville, NC, found offers to sell a product known as True Viral Defense or Viral Defense Tincture intended to mitigate, prevent, treat, diagnose, or cure Covid-19.
Drugs
FDA has sent Herbs of Kedem a Warning Letter after reviewing the company’s Web site (www.kedemnatural.com) and determining that it is offering for sale unapproved new drugs for treating Covid-19 patients. The company is promoting its herbal products as being safe and effective for treating Covid-
Drugs
FDA has extended until 6/5 the deadline to apply for a funding opportunity to examine the use of real-world data (RWD) to generate real-world evidence (RWE) in regulatory decision-making. FDA intends to encourage innovative approaches to further explore RWD use while making sure that scientific evidence
Drugs
A just-published study report in the New England Journal of Medicine on the compassionate use of Gilead’s investigational remdesivir in Covid-19 patients shows improvement in oxygen-support status in 68% of patients, and overall mortality was 13% over a median follow-up of 18 days. The small
Drugs
FDA has sent a Warning Letter to Earthly Wellness over unapproved and misbranded products related to Covid-19. The letter says that FDA and FTC reviewed the company’s Web and social media sites promoting herbal tinctures and herbal remedy products for treating Covid-19 despite the products not being
Drugs
Novartis says it has confirmed a safety signal with Beovu (brolucizumab) involving “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.” Beovu is a human vascular endothelial growth factor inhibitor indicated for treating neovascular (wet) age-related macular