Drugs
FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) tablets for treating patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Approval was based on data from the Phase 3 METEOR trial, which met
Drugs
FDA has granted Bristol-Myers Squibb a breakthrough therapy designation for Opdivo for treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. The designation is based on results from the CheckMate-141 study, a Phase 3, open-label, randomized trial evaluating Opdivo
Drugs
FDA has approved an AbbVie supplemental NDA for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer
Drugs
FDA has released a guidance on “Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products” that provides recommendations to help industry’s development and validation of immune assays for assessing the immunogenicity of therapeutic protein products during clinical trials. It includes input on developing and validating screening, confirmatory,
Drugs
Octapharma USA has recalled one lot (#K551A8441) of Octagam [immune globulin intravenous (human)] 5% liquid preparation due to an increased number of reports of hypersensitivity events. “Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA,
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has voted 7 to 6 that a Sarepta Therapeutics NDA did not provide substantial evidence from adequate and well controlled studies that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit in patients
Drugs
FDA has removed from its import alert NeuroDerm’s third-party manufacturer of infusion pumps used to deliver the investigational drug ND0612 in its current clinical trials. The alert was ordered on Can SpA’s devices 7/2015 after FDA sent it a Warning Letter requesting additional documentation pertaining to
Drugs
Six patients claiming they were harmed by Johnson & Johnson’s Levaquin have amended their federal lawsuit in Washington, DC District Court against the company, former FDA commissioner Margaret Hamburg and her husband Peter Brown, alleging violations of the Racketeering and Corrupt Organizations Act, the Lanham Act, and a variety
Drugs
FDA has accepted for review a Lundbeck NDA resubmission for an intravenous formulation of the anti-epileptic drug carbamazepine. The resubmission was in response to a 2014 complete response letter from the agency that requested additional data associated with product’s chemistry, manufacturing and controls. The proposed U.S. trade
Drugs
FDA says that clinical and bioanalytical studies conducted for drug companies by Semler Research Private Limited, located in Bangalore, India, are not acceptable as a result of data integrity concerns and must be repeated. A notice to drug companies says that Semler is a contract research organization that conducts bioequivalence
Drugs
Vifor Fresenius is asking FDA to grant five-year new active ingredient exclusivity to its Velphoro (sucroferric oxyhydroxide). A 4/15 petition also asks the agency to stay the acceptance, receipt, filing, review, and approval of any ANDA or 505(b)(2) application referencing Velphoro while it continues to consider
Drugs
While it may seem that fewer Phase 2 and 3 studies would be needed for a fixed-dose drug-drug combination product using two drugs that have already been approved, in fact they often require more studies than single component products, according to a Camargo Pharmaceutical Services 505(b)(2)
Drugs
FDA medical reviewers say that clinical data submitted by Sarepta Therapeutics to support its NDA for eteplirsen to treat Duchenne muscular dystrophy (DMD) “overall did not provide statistical evidence to support the efficacy” of the drug. The assessment is part of a briefing document released in advance of a 4/
Drugs
FDA’s Office of Orphan Products Development has granted orphan drug designation to DelMar Pharmaceuticals for its first-in-class small-molecule chemotherapeutic VAL-083 to treat ovarian cancer. According to the company, in over 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute,
Drugs
ProbioTech is asking FDA to change the definition of a dietary supplement under the Dietary Supplement Health and Education Act and to treat probiotic suppositories the same as oral probiotic dietary supplements. A 4/7 petition says that probiotics that are not in the form of a pill, capsule, tablet,
Drugs
An FDA Office of Criminal Investigations probe has led to a Norfolk, VA man pleading guilty to one count of misbranding a drug and selling a drug outside of a legitimate supply chain. Patrick Simanjuntak, who sold insulin on Craigslist to an undercover FDA agent, will be sentenced on 8/
Drugs
FDA Office of International Programs China Office director Leigh Verbois says that China Office staff members spent five days touring the Yangtze River Delta region to meet with counterparts and share information. Writing in an FDA Voice blog post, Verbois says that the region is home to a significant number
Drugs
Nicox SA has submitted through its American subsidiary Nicox Ophthalmics, Inc., an NDA to FDA seeking approval of AC-170, its cetirizine eye drop formulation, for treating ocular itching associated with allergic conjunctivitis. The company says it is also seeking priority review based on clinical pediatric data generated with AC-
Drugs
A just-released FDA-483 issued following a 3/14-3/25 inspection at Catalent Pharma Solutions, St. Petersburg, FL, lists 14 violations, including: failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or
Drugs
An analysis in the Journal of the American Medical Association says that FDA’s Sentinel Initiative has moved from a pilot program to being operational, but still has not reached its full potential. While some observers have heralded developments so far as major achievements, the report notes, only a handful
Drugs
Pharmakon Pharmaceuticals has recalled all lots of its aseptically compounded sterile products due to FDA concerns over a lack of sterility assurance and other quality issues. “Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death,
Drugs
The National Institutes of Health (NIH) says that an evaluation by two consulting firms ordered in response to serious problems identified by FDA in the NIH Clinical Center Pharmaceutical Development Section has led to suspension of production in two facilities. The evaluation looked at all facilities producing sterile or infused