Drugs
FDA says that Empire Distributors is selling an unapproved new drug, Rhino Black 5K Plus, from its Web site and Amazon.com storefront. A 4/10 Warning Letter says laboratory analysis confirmed that the product contains undeclared active pharmaceutical ingredients sildenafil and tadalafil, used in the branded drugs Viagra and
Drugs
CDER has issued a Manual of Policies and Procedures for its new Biopharmaceutics Council, a multi-disciplinary and cross-organizational panel providing senior management support on development and application of policies, practices, and recommendations related to biopharmaceutics in drug review processes, as well as to other CDER programs, as appropriate.
FDA Policy/General
FDA has issued a draft guidance, Initiation of Voluntary Recalls Under 21 CFR part 7, Subpart C, on the timely initiation of voluntary recalls of FDA-regulated products. The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures;
Drugs
In a report to Congress, FDA says it “remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing other work of the agency.” The report says Section 505(q) of the Federal Food, Drug, and Cosmetic Act applies to
Drugs
The Association for Accessible Medicines says it supports the underlying goals of an FDA draft guidance on competitive generic therapies (CGT), and believes the agency could clarify how CGT designations and exclusivity will be determined and communicated to applicants. The association’s comment letter says (1) FDA should provide greater
Drugs
FDA says it has continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine, urging consumers on the importance of timely immunizations. “It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities,
Drugs
FDA has approved a Merck supplemental NDA for use of its Keytruda (pembrolizumab) plus axitinib (Pfizer’s Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on data from the KEYNOTE‑426 (NCT02853331), an 861-patient trial in those who had not received
Drugs
Alvogen has recalled two lots of fentanyl transdermal system 12 mcg/h transdermal patches due to a labeling error. “A small number of cartons labeled 12 mcg/h fentanyl transdermal system patches contained 50 mcg/h patches,” a recall notice says. “The 50 mcg/h patches that were included in
Drugs
FDA has announced that the National Academies of Science, Engineering, and Medicine (NASEM) is conducting a study to examine the clinical utility of treating patients with compounded “bioidentical hormone therapy” products, such as progesterone and testosterone. NASEM is expected to provide a report evaluating the available scientific evidence relating to
Drugs
FDA has accepted a Molecular Templates IND application for MT-5111, an engineered toxin body (ETB) targeting HER2-positive solid tumors. The company expects to start dosing in a Phase 1 study in relapsed/refractory patients with HER2-positive solid tumors in the third quarter. Molecular Templates describes MT-5111
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for the first generic naloxone hydrochloride nasal spray (Adapt Pharma’s Narcan), indicated for stopping or reversing the effects of an opioid overdose. In announcing the approval, FDA also said it is “planning new steps to prioritize the review of additional generic drug
Drugs
Pfizer and Eli Lilly have reported safety concerns with a Phase 3 study comparing tanezumab 2.5 mg and 5 mg with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. The study, which was designed to evaluate tanezumab’s long-
Drugs
FDA has given approval for MediciNova to proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) patients. If the pivotal trial is successful, data will be used to support a future NDA, according to the company. FDA concurred, it says, on the
Drugs
FDA has approved an Akorn ANDA for a generic copy of Bausch & Lomb’s Lotemax (loteprednol etabonate) ophthalmic suspension, 0.5%, indicated for treating post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of
Drugs
FDA has issued a draft guidance, Bispecific Antibody Development Program, to assist industry and other parties involved in the development of bispecific antibodies. The document covers general considerations and recommendations for bispecific antibody development programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody
Drugs
Friends of Cancer Research chairperson Ellen Sigal says a recent White House memo requiring Office of Management and Budget (OMB) review of all non-binding guidance documents from all federal agencies “potentially threatens the future of many scientific innovations that could save patients’ lives.” Writing in an op-ed in
Drugs
Mustang Bio has reported positive data from a Phase 1/2 clinical trial of a lentiviral gene therapy for treating newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as “bubble boy disease.” Under a licensing agreement with St. Jude Children’
Drugs
FDA researchers have reported for the first time a link between the abnormal chemical environment of sickle cell disease red blood cells and destruction of a highly reactive form of sickle cell hemoglobin by a cellular structure called the proteasome. Writing in JCI Insight, the researchers say they also have
Drugs
FDA has granted Viela Bio a breakthrough therapy designation for the company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, life-threatening autoimmune disease affecting the central nervous system. The designation is based on data from the N-MOmentum study that
Drugs
Corbus Pharmaceuticals says that after a meeting with FDA staff, it will change the primary efficacy endpoint of the ongoing RESOLVE-1 Phase 3 trial of its investigational drug lenabasum for systemic sclerosis in the U.S. The company says the primary endpoint is being changed from change in modified
Drugs
The Supreme Court may decide at a 4/26 conference whether to hear arguments in a case involving adequacy of warnings of adult suicidality for a generic form of GlaxoSmithKline’s Paxil (paroxetine). The Cook County Reporter says the case was brought by the widow of a Chicago attorney who
Drugs
FDA has approved an Akorn ANDA for an over-the-counter version of GlaxoSmithKline’s Flonase (fluticasone propionate) nasal spray USP, 50 mcg per spray, indicated for the temporary relief of hay fever and other upper respiratory allergies in adult and pediatric patients four years of age and older. Akorn