Drugs
A 10/15-11/8/19 FDA inspection at BHP Holdings, doing business as BioPure Healing Products, Woodinville, WA, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations for dietary supplements. A 6/17 Warning Letter says the company failed to review all product complaints
Drugs
Due to an inspection moratorium, FDA has issued Nabriva Therapeutics a complete response letter (CRL) on its NDA resubmission seeking marketing approval of Contepo (fosfomycin) for injection for treating complicated urinary tract infections, including acute pyelonephritis. In 5/2019, FDA sent the company its first complete response letter, citing issues
FDA Policy/General
FDA commissioner Stephen Hahn says the agency “has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.” Writing in an online post to praise agency staff for their efforts, Hahn says FDA is on
Drugs
Attorneys Allison Fulton and Julia Kadish (SheppardMullin) say a 6/19 FDA guidance advising manufacturers of drugs, biologics, and active pharmaceutical ingredients on manufacturing controls to prevent contamination of drugs with SARS-CoV-2 suggests additional manufacturing controls such as vigilant monitoring and employee exclusion, more frequent cleaning and sanitizing,
Drugs
The FDA Oncology Center of Excellence has launched its Project Patient Voice Web site to create a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. In a statement, FDA says the patient-reported data have historically been analyzed by FDA during the
Drugs
FDA has approved a Karyopharm Therapeutics supplemental NDA for Xpovio (selinexor), a selective inhibitor of nuclear export compound for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It was approved under FDA’s accelerated approval program. The drug first gained accelerated approval 7/2019 in
Drugs
Senators Bob Casey (D-PA) and Susan Collins (R-ME) have introduced the Creating Hope Reauthorization Act (S 4010) that would permanently reauthorize FDA’s rare priority pediatric voucher program. The current voucher program is set to expire 9/30. The program has netted 22 novel therapies for seriously ill
Drugs
Mylan says it is urging FDA to speed up its review of the company’s ANDA for a generic copy of Biogen’s multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) delayed release capsules, following a 6/18 northern West Virginia federal court decision that invalidated a Biogen patent. The current
Drugs
FDA has released a guidance entitled “Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug and Biological Products Manufacturing.” The document provides recommendations to drug and biological product manufacturers about manufacturing controls to prevent contamination of drugs, Covid-19 risk assessments as it relates to
Drugs
FDA has approved an Evoke Pharma NDA for Gimoti (metoclopramide) nasal spray, indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The condition is associated with symptoms such as nausea, abdominal pain, bloating, early satiety, and vomiting which can be severe and debilitating, according to
Drugs
FDA has granted Ovid Therapeutics a rare pediatric disease designation to OV101 (gaboxadol) for treating Angelman syndrome. The company says that OV101 is believed to be the only delta-selective GABA receptor agonist in development and is currently being evaluated in the Phase 3 NEPTUNE trial, with topline results expected
Drugs
FDA says it has published an update to the “List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic.” A statement says the list includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update, and for which FDA has
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on the procedures the Center will use to determine whether a risk evaluation and mitigation strategy (REMS) for a prescription drug product marketed under an NDA or BLA is needed to ensure that the drug’s benefits outweigh its risks.
Drugs
A 6/16 petition submitted to FDA by Dr. Francis E. O’Connell, Jr., asks the agency to adopt language in the Boxed Warning and package insert for opioids that reflects the 9/2019 HHS Guidance for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.
Biologics
Luciana Borio, who was FDA acting chief scientist and served on the National Security Council in the Trump administration, says FDA needs to work to regain public trust after its missteps involving the emergency use authorization for hydroxychloroquine and chloroquine and allowing unapproved serology tests into the country. Interviewed for
Drugs
FDA has approved a label update for Almirall’s Seysara (sarecycline) stating that P. acnes strains displayed a low propensity for developing resistance to sarecycline. This information is included in the Microbiology Section (12.4) of the prescribing information, the company says. Seysara, which was approved 10/2018, is described
Drugs
A $16 million partnership between the Defense Advanced Research Projects Agency and Harvard University is aimed at narrowing down which medication, approved by FDA, is effective for treating Covid-19 patients. The UK’s International Business Times reports the collaboration is working “with the help of cutting-edge computational drug
Drugs
FDA has granted Epizyme accelerated approval for Tazverik (tazemetostat), an EZH2 inhibitor for adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an agency-approved test and who have received at least two prior systemic therapies, and for adult
Drugs
FDA has issued an immediately-in-effect guidance, Statistical Considerations for Clinical Trials During the Covid-19 Public Health Emergency, to address the impact of Covid-19 on meeting trial objectives for clinical trials conducted during the duration of the public health emergency. The document outlines considerations for the statistical
Drugs
The Council for Responsible Nutrition (CRN) is asking FDA to establish a regulatory pathway to legally market dietary supplements containing hemp-derived cannabidiol (CBD). The 6/16 petition says Congress and industry have repeatedly requested that FDA use the authority granted to it by Congress to allow CBD to be
Drugs
The citizen watchdog group Accountable.US says it is concerned about a lack of transparency from the Justice Department (DoJ) in its investigation of alleged price-fixing of generic drugs by Teva. In a 6/16 letter to attorney general William Barr, the group says it is concerned “since the
Drugs
FDA has approved Novartis’ Cosentyx (secukinumab) for treating active non-radiographic axial spondyloarthritis (nr-axSpA). Approval was based on data from the PREVENT trial, which met the primary endpoints “achieving statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40%