Drugs
Merck and Incyte Corp. have announced plans to advance the clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. The companies say they plan to begin pivotal studies of epacadostat in combination with Keytruda in
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FDA says it has approved Egalet’s Arymo ER (morphine sulfate extended-release tablets), indicated to treat pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. An agency statement says the drug has physiochemical properties expected to make
Drugs
FDA says it is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups, and genders. An agency Consumer Update says that overall, few people sign up for and participate in trials, and those who do participate don’t always represent the U.S.
Drugs
FDA has released a guidance on “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.” The guidance is based on a 2013 drug safety alert that warned about the use of acetaminophen and its association with rare but serious skin reactions. These
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FDA has made available a final guidance entitled “Current Good Manufacturing Practice Requirements for Combination Products.” The document describes and explains GMP requirements for combination products, which published in the Federal Register 1/22/2013. It also includes general considerations for maintaining GMP compliance, as well as analysis of hypothetical
Drugs
Sens. John McCain (R-AZ) and Amy Klobuchar (D-MN) have reintroduced their Safe and Affordable Drugs from Canada Act that they say would allow individuals to safely import prescription drugs from Canada. Under the legislation, prescription drugs would have to be purchased from an approved Canadian pharmacy and dispensed
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Sen. Charles Grassley (R-IA) says the Justice Department “deserves credit for bringing a case over the price fixing of generic drugs. Consumers pay the price for criminal conduct, and the Justice Department is doing its job to protect the public from such conduct.” His statement came in response to
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The owner of a Utah drug distribution company has pled guilty in southern New York federal court to fraudulently distributing more than $100 million worth of prescription drugs obtained on a nationwide black market. Randy Crowell “perverted for profit a health care system designed to get safe and effective medications
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PTC Therapeutics says it plans to file in protest an NDA for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy (DMD) this quarter. The move follows the company’s loss in October of an appeal after receiving a refuse-to-file letter (see story) issued by the Division of
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Data integrity was a top concern for FDA In 2016, according to an analysis by the law firm Mintz Levin. “FDA focused on technical compliance issues that can pose risks to the safety of regulated products, such as data integrity within drug and device manufacturing facilities and unsanitary conditions in
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FDA has accepted for review an Adamas Pharmaceuticals NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules for treating levodopa-induced dyskinesia in patients with Parkinson’s disease. The submission has been given a user fee review target date of 8/24. “Over time, 90% of patients on levodopa therapy
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FDA is seeking information and comments (see FDA notice) about how it plans to administer generic drug program fees beginning in fiscal year 2018 (10/1). Under the user fee program, a fee will be assessed under a three tier system based on application holders: * Large (companies with 20 or
Drugs
FDA has extended by three months the user fee review date for a Roche BLA for Ocrevus (ocrelizumab), indicated for treating patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis. The new target date (3/28) will allow the agency to review a Roche submission on
Drugs
FDA has lifted a full clinical hold on CTI BioPharma’s pacritinib for treating myelofibrosis. The hold was ordered 2/2016 due to excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-1 trial. CTI submitted a complete response submission (see
Drugs
Drug and biologics developers may benefit from a provision in the recently signed 21st Century Cures Act that allows FDA to rely on a “qualified data summary” — a clinical data summary that demonstrates the safety and effectiveness of a drug’s potential qualified indication — to support approval of new uses
Drugs
FDA has canceled a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting to review a Neurocrine Biosciences NDA for Ingrezza (valbenazine) for treating tardive dyskinesia. FDA told Neurocrine that the priority review of the NDA is continuing as planned with a user fee target action date of 4/11, according
Drugs
FDA has accepted for review an Ironwood Pharmaceuticals NDA for Duzallo (fixed-dose combination of lesinurad and allopurinol) for treating hyperuricemia in patients with uncontrolled gout. The user fee target action date is expected in the second half of the year. Lesinurad is a once-daily oral tablet that lowers
Drugs
FDA has cleared a Luminex 510(k) for the Aries Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the agency has cleared for use on the Aries System. The company says that GBS infection is a leading cause of
Drugs
Harvard Medical School professors Aaron Kesselheim and Jerry Avorn say some provisions in the 21st Century Cures law emphasize speed and ease over science and could end up hurting patients and drug development. Writing in a Journal of the American Medical Association Viewpoint column, Kesselheim and Avorn say that while
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Lilly says that the research objectives and study approach for an FDA study of character-space-limited online prescription drug communication generally seem reasonable. The research is to examine two hypotheses, it says in a comment letter. The first is that participants who see substantive risk information in character-space-
Drugs
Acorda Therapeutics is asking FDA to “carefully consider the sufficiency of the applicant’s identification and qualification of potentially genotoxic impurities in reviewing an ANDA referencing its Ampyra (dalfampridine) extended release tablets.” The company petition says that certain potentially genotoxic impurities that may be present in the Ampyra drug substance
Drugs
Public Citizen says that FDA should require changes to the labels for repaglinide-containing medications (Novo Nordisk’s Prandin and Prandimet) and clopidogrel (Bristol-Myers Squibb’s Plavix) to include information on what it says is a serious drug-drug interaction that could result in severe hypoglycemia. The advocacy group’