Drugs
A House Judiciary subcommittee has announced a 7/27 hearing on “Antitrust Concerns and the FDA Approval Process.” The hearing is scheduled for 1:00pm and no witness confirmations have been announced yet. Congress recently has been expressing concern about high prescription drug prices, which some attribute to brand drug
Drugs
FDA has approved a GlaxoSmithKline supplemental BLA for a new subcutaneous formulation of Benlysta (belimumab) for treating adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE) who are receiving standard therapy. SLE is the most common form of lupus, a chronic, incurable autoimmune disease. “After training from their health
Devices
FDA has cleared a Luminex 510(k) for the Aries C. difficile assay, a test designed to detect both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce toxin A, the company says. A 2015 CDC study found that
Drugs
FDA has launched a new tool to help patients seeking expanded access to investigational drugs when there are no alternatives for seriously ill patients. The Expanded Access Navigator is an online tool created under a collaboration including the Reagan-Udall Foundation, pharmaceutical industry, FDA, and others in government. Expanded Access
FDA Policy/General
CVM 7/24 announced it is issuing its own version of FDA’s eSubmitter tool, to be available next month. In a news release, the Center said the software package will be independent from the FDA eSubmitter program, which is an electronic, question-based submission tool for creating and submitting
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The agency has set a user fee review action (XXX DELETE XX)date of 3/5/2018. Opdivo is
Drugs
3 Public Meetings on Drug Distribution Federal Register notice: FDA announces three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.” 07/21/2017 Comments on Unapproved Animal Drugs for Minor Species Listing Federal Register notice: FDA seeks comments on an information collection extension on
FDA Policy/General
Mitsubishi Tanabe Pharma has agreed to acquire NeuroDerm, a clinical stage pharmaceutical company developing drug-device combinations for central nervous system disorders. Mitsubishi will pay $39 per share in cash, which is 79% above currently traded shares. Emergent BioSolutions has agreed to acquire a drug used to treat anthrax from
FDA Policy/General
Former FDA assistant commissioner for compliance policy and recent HHS deputy general counsel David Horowitz has joined Hogan Lovells as a partner in its Washington, DC office. At HHS since 2010, Horowitz oversaw and coordinated legal services supporting FDA, the Centers for Disease Control and Prevention, and the National Institutes
Drugs
FDA has granted Merck tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. The proposed product is being developed by Merck with funding from Samsung Bioepis. “With the tentative approval, Lusduna Nexvue has met all required
FDA Policy/General
Federal Register notice: FDA has announced three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.” The meetings are intended to provide members of the pharmaceutical distribution supply chain and other stakeholders an opportunity to discuss and provide input on strategies and issues related to
Devices
Penumbra has begun a Class 1 recall of its 3D Revascularization device because there is a risk that the delivery wire could break or separate during use. “Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve
Drugs
Oscor Inc. has recalled certain lots of its ATAR Extension Cable due to a risk of them separating from the connectors during use. The extension cable intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker. “Detachment of the extension
Biologics
FDA has accepted an Amgen BLA for Aimovig (erenumab) for preventing migraine in patients experiencing four or more migraine days per month. If approved, Aimovig would be the first monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, the company says. The submission includes data from pivotal studies involving
Devices
Fujifilm has recalled all ED-530XT duodenoscopes after FDA cleared an updated design and labeling request for the device. This action will result in replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and a new operation manual, a recall
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on its “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR part 516.” Section 572 of the Food, Drug & Cosmetic Act provides for a public index listing of legally marketed unapproved new animal
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Animal Drug User Fee Cover Sheet.” The cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether
FDA Policy/General
FDA commissioner Scott Gottlieb has appointed CDRH deputy Center director for policy Lauren Silvis as his chief of staff. She had been serving as acting chief of staff since April. Prior to joining FDA in 2015, she was a partner at Sidley Austin. She previously practiced at Covington & Burling.
Devices
Researchers from Northwestern University and the University of Chicago say that soft tissue fillers (STFs) are safe and are often approved as Class 3 medical devices based on data from randomized clinical trials. However, they write in JAMA Facial Plastic Surgery, “an opportunity remains to strengthen the approval process, particularly
Drugs
FDA has accepted for review a Churchill Pharmaceuticals NDA for Yonsa (abiraterone acetate) ultramicrosize tablets for treating metastatic castration-resistant prostate cancer. The agency has set a 3/19/2018 user fee review action target date. The submission was based on data from the STAAR study, a randomized, open label
Drugs
Med Prep Consulting president Gerald Tighe and pharmacy director Stephen Kalinoski pleaded guilty 7/14 to wire fraud conspiracy regarding distributing cancer drugs contaminated with mold. Their company was a medical drug repackager and compounding pharmacy. The Justice Department and FDA Office of Criminal Investigations say that Med Prep processed
Drugs
FDA released the FDA-483 containing 14 observations from a 4/26-5/10 inspection at Intas Pharmaceutical, a Ahmedabad, Gujarat, India, biosimilar sterile drug manufacturer. The observations were: * laboratory records are deficient in that they do not include a complete record of all data obtained during testing; * appropriate controls