Drugs
The Justice Department says four companies and three individuals have agreed to plead guilty to federal criminal charges related to illegally importing and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs falsely marketed as herbal remedies for men. A department news release also says two new cases were
Drugs
An FDA final guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices intends to describe the interactions that are needed to achieve coordinated development of applications submitted to CDER and CDRH, according to CDRH Division of Microbiology Devices branch chief Ribbi Shawar. Speaking at a CDRH
Drugs
An 8/7-8/9/18 FDA inspection at the Hangzhou Sunking Nonwovens drug manufacturing facility in Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 1/29 Warning Letter says the specific violations were: * failing to have, for each
Drugs
A 2/21-2/24/18 FDA inspection at the Vipor Chemicals drug manufacturing facility in Vadodara, Gujarat, India, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients. A just-released 1/29 Warning Letter says the specific deviations were: * failing to transfer all quality or
Drugs
FDA has placed a partial clinical hold on a Xencor a Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies. Patients currently on the therapy may continue treatment on the
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes following complete resection. Approval is based on results from the EORTC1325/KEYNOTE-054 trial, which demonstrated that Keytruda significantly prolonged recurrence-free survival. It was also shown to reduce the
Drugs
An Arizona federal judge has rejected a Goldwater Institute effort to force FDA to publicly describe how dying people can get access to unapproved medicines. The Arizona Daily Star reports that judge Susan Bolton said attorney Jonathan Riches has no legal right to force the agency to disclose how it
Drugs
FDA has accepted a Clearside Biomedical 505(b)(2) NDA for Xipere (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection for treating macular edema associated with uveitis. The agency has set a 10/19 user fee review action target date. The submission is supported by data from the Phase 3 PEACHTREE
Drugs
FDA and Arca Biopharma have reached agreement on a special protocol assessment (SPA) for the PRECISION-AF Phase 3 clinical trial to assess the safety and efficacy of Gencaro (bucindolol HCl) as a genetically-targeted treatment for atrial fibrillation in patients with a specific type of heart failure (those with
Drugs
The Federal Trade Commission (FTC) says it has reached a global settlement with subsidiaries of Teva Pharmaceuticals to prohibit the company from engaging in reverse-payment patent settlement agreements that impede consumer access to generic drugs. The settlement has to be approved by three federal courts in which FTC has
Drugs
FDA has accepted for priority review an AbbVie NDA for upadacitinib and its use in treating adult patients with moderate to severe rheumatoid arthritis. The investigational once-daily oral JAK1-selective inhibitor is being studied for multiple immune-mediated diseases. The company expects a review decision in the third quarter.
Drugs
FDA has released the FDA-483 issued following a 1/30-2/8 inspection at Dr. Reddy’s Laboratories’ drug manufacturing facility in Telangana, India. The form contains 11 inspection observations, several of which are repeated from 2015 and/or 2017 inspections. The observations were: * procedures describing the handling of
Drugs
FDA has released a draft guidance, Competitive Generic Therapies, describing the process that applicants should follow to request designation of a drug as a competitive generic therapy with inadequate generic competition under the FDA Reauthorization Act of 2017. The document includes the criteria for designating a drug as a competitive
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Competitive Generic Therapies” that is intended to help expedite the development and review of certain ANDAs citing reference products that have inadequate generic competition. The document provides a description of the process that applicants should follow to request designation
Drugs
An FDA safety alert is warning consumers about establishments in several states that are offering young-donor plasma infusions to treat various conditions. “The conditions range from normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic
Drugs
FDA Oncology Center of Excellence director Richard Pazdur says although there has been recent progress in risk stratification in hormone receptor-positive breast cancer, there is a need for more sophisticated prognostic-biomarker testing to identify high-risk patients in time to intervene and improve outcomes. Writing in the New
Drugs
FDA has released the FDA-483 containing two observations from a 1/28-2/8 inspection at Lupin Limited, a Goa, India, drug product manufacturer. The observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
Researchers who examined the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products and surveyed providers, pharmacists, and patients say that while there generally was adequate knowledge about using TIRFs, some survey items and claims-based analyses indicated substantial rates of inappropriate use. A Journal of
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda for use in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The submission is based on findings from the Phase 3 KEYNOTE-426 trial, which
Drugs
FDA has issued a final rule that adds six bulk drug substances to its bulk substances listing that can be used by compounders not registered as outsourcing facilities. It also identifies four bulk drug substances that are not allowed to be used. “Developing the bulks lists for these compounders and
Drugs
FDA has accepted a Sarepta Therapeutics NDA seeking accelerated approval for golodirsen (SRP-4053), indicated for treating those individuals with Duchenne muscular dystrophy who have genetic mutations subject to skipping exon 53 of the dystrophin gene. The agency has set an 8/19 user fee review action target date. The
Drugs
A 3/26-4/4/18 FDA inspection at Vitalab Pharmacy, Phoenix, AZ, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk,” according to a just-released 1/10 Warning Letter. The letter acknowledges that on 4/4/18, upon receipt of an