Drugs
FDA inspections of dietary supplement makers in 2016 saw an uptick in GMP violations, according to a report by ConsumerLab.com. Last year, the agency inspected 583 dietary supplement manufacturing facilities, with 362 (62%) receiving a Form 483 indicating GMP noncompliance. In comparison, 2015 saw a GMP violation rate of
Drugs
Array BioPharma has withdrawn its recent NDA for binimetinib monotherapy for treating NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer. The company says the withdrawal was based on a discussion with FDA 3/17 that concluded the clinical benefit demonstrated in the Phase 3 NEMO clinical trial
Drugs
Four former FDA commissioners have penned an open letter to Congress urging the lawmakers to not allow the importation of drugs not approved by the agency as a means to make lower-cost therapies available to U.S. citizens. Signed by Robert M. Califf, Margaret B. Hamburg, Mark B. McClellan,
Drugs
An FDA safety alert has advised health care providers that Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) has seen an increased rate of major adverse cardiac events compared to the company’s metallic Xience drug-eluting stent. BVS, which is implanted during an angioplasty procedure, is used to
Drugs
Esperion Therapeutics says it is planning to file in mid-2019 an NDA for bempedoic acid based on FDA confirmation that the product’s development program is adequate to support approval of an LDL-C lowering indication. The submission would follow successful completion of the firm’s global pivotal Phase
Drugs
FDA has issued AstraZeneca a second complete response letter (CRL) on its NDA for ZS-9 (sodium zirconium cyclosilicate), indicated for treating hyperkalemia (high potassium level in the blood serum). A CRL was issued 5/2016 that identified observations during a pre-approval manufacturing inspection. The agency did not request
Drugs
CEL-SCI Corp. has received the official FDA minutes from a 2/8 meeting that discussed a partial clinical hold placed 9/2016 on a Phase 3 head and neck cancer study with the company’s investigational drug Multikine (leukocyte interleukin, injection). “Pursuant to this partial clinical hold, patients currently
Drugs
Novartis says that a recent draft guidance on “Multiple Endpoints in Clinical Trials” needs to make the distinction between secondary and exploratory endpoints more clear. In just-posted comments, the company says the guidance provides a definition of primary, secondary and exploratory endpoints, where all secondary endpoints require multiplicity adjustments,
Drugs
Attorney Alan Minsk (Arnall Golden Gregory) says that so far in 2017 the CDER Office of Manufacturing Quality has released 14 Warning Letters, all involving manufacturing facilities outside the U.S. “While it is too early in the year to assess whether this reflects an increased FDA focus on foreign
Drugs
Sen. Richard Durbin (D-IL) has introduced two bills to provide steady increases for biomedical and scientific research at a number of federal research agencies. In a statement, Durbin says the bills “will allow America’s best scientists and researchers to spend less time worrying about their budgets and more
Drugs
Alkermes says it has started a new Phase 3 trial of its ALKS 8700, a novel, oral monomethyl fumarate prodrug candidate in development for treating relapsing forms of multiple sclerosis. The five-week head-to-head study is to evaluate the gastrointestinal tolerability of ALKS 8700 compared to Tecfidera (dimethyl
Drugs
FDA has accepted an Asana BioSciences IND for ASN002, a novel dual SYK-JAK inhibitor, for treating atopic dermatitis. In the submission, the company proposes a Phase I randomized, double-blind, placebo-controlled, multiple dose escalation study to evaluate the therapy’s safety and tolerability as well as preliminary efficacy
FDA Policy/General
The Government Accountability Office (GAO) says that since its 2011 report, FDA and the Agriculture Department have made progress in overseeing use of medically important drugs in food animals, but still more needs to be done. The agency’s report says that since 2011, FDA has increased veterinary oversight of
Drugs
Citing rising abuse concerns, FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees have voted 18 to 8 that that the benefits of reformulated Opana ER (oxymorphone hydrochloride extended release) no longer outweigh its risks. Several panel members recommended that the drug stay on
Drugs
Four Republican leaders of the House Energy and Commerce Committee have asked FDA for documents relating to two closed Office of Criminal Investigation (OCI) investigations into the 2007-2008 heparin contamination crisis. In a 3/15 letter to FDA acting commissioner Stephen Ostroff, the four say the committee is continuing
Drugs
Amgen’s Supreme Court opening and response brief in Sandoz v. Amgen cautions that there will be “chaos” in the biosimilar world if the court rules against Amgen’s positions on the Biologics Price Competition and Innovation Act’s (BPCIA) 180-day notice of biosimilar marketing and patent dance provisions.
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for treating adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. The accelerated approval was based on tumor response rate and durability of response, according to the company. Data from
Drugs
An FDA drug safety alert warned 3/15 that Allergan’s Viberzi (eluxadoline), a therapy used to treat irritable bowel syndrome with diarrhea, should not be used in patients who do not have a gallbladder. An agency review concluded these patients have an increased risk of developing serious pancreatitis that
Drugs
The Health Subcommittee of the House Energy and Commerce Committee will hold a 3/22 hearing on “Examining FDA’s Prescription Drug User Fee Program.” Subcommittee chairman Michael Burgess (R-TX) says the hearing “will examine how this important user fee program has been implemented since it was reauthorized in
Drugs
Federal Register notice: FDA has announced a 3/29 Oncologic Drugs Advisory Committee meeting that will review a Genentech BLA for rituximab/hyaluronidase injection for subcutaneous use. The proposed indications are for: (1) Treating patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma
Drugs
A Colordao federal judge has granted a permanent injunction against EonNutra, CDSM, and HABW, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring the businesses to immediately cease operations until they comply with federal law. An FDA news release says Floren marketed products on
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Badrivishal Chemicals & Pharmaceuticals Maharashtra, India (3/2): FDA inspected the firm 8/2016 and cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators