Drugs
Charleston Laboratories says it has reacquired all U.S. rights to develop and commercialize its hydrocodone pipeline products from Daiichi Sankyo, ending a three-year collaboration. Charleston says it is centralizing its comprehensive acute pain portfolio and accelerating the process to bring its CL-108 (hydrocodone, acetaminophen, promethazine), an investigational
Drugs
Sunovion Pharmaceuticals has submitted an NDA for dasotraline, an investigational, dual-acting dopamine and norepinephrine reuptake inhibitor for treating children, adolescents and adults with attention deficit hyperactivity disorder (ADHD). The submission is supported by data from the company’s clinical program that included four placebo-controlled safety and efficacy studies,
Drugs
FDA commissioner Scott Gottlieb says CDER and the Office of Regulatory Affairs (ORA) are implementing a “new, historic concept of operations agreement to more fully integrate the drug review programs with the facility evaluations and inspections for human drugs. This new collaboration is a model for how we’ll modernize
Drugs
Pfizer’s Hospira unit is recalling one lot pf vancomycin hydrochloride for injection, 750 mg/vial, following a confirmed customer report of the presence of particulate matter, confirmed as glass, in one vial. A Hospira notice published by FDA says the company has not receive reports of any adverse events
Drugs
FDA has issued SteadyMed Ltd. a Refuse-to-File letter on its NDA for Trevyent (treprostinil) for treating pulmonary arterial hypertension. The agency determined that the application is not sufficiently complete to permit a substantive review, according to the company. “FDA has requested further information on certain device specifications and
Drugs
Lilly and Incyte say they will resubmit their NDA for baricitinib, including new safety and efficacy data, before the end of 1/2018. The decision follows discussions with FDA at the end of August, the companies say. They expect the agency will classify the application as a Class 2 resubmission,
Drugs
FDA has approved a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating tardive dyskinesia in adults. Previously, the product was approved for treating chorea associated with Huntington’s disease. The latest approval was based on data from two Phase 3 randomized, double-blind, placebo-controlled, studies (AIM-TD
Drugs
FDA says it has approved Novartis’ Kymriah (tisagenlecleucel) as the first gene therapy available in the U.S. An agency statement says Kymriah is indicated for treating certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Specifically, it is approved in the U.S. for
Drugs
FDA has accepted an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that the therapies reduced the risk of death by 21% and increased OS by 7.6 months versus Velcade (bortezomib) and dexamethasone
Drugs
A 12/7-12/16/16 FDA inspection at Hetero Labs Ltd., Telangana, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to an 8/15 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has sent Acorda Therapeutics a Refusal to File letter for the NDA for its Inbrija (levodopa inhalation powder), an investigational treatment for symptoms of off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The company reports that FDA found that Acorda’s 6/26 NDA
Drugs
Responding to varying results in the REVEAL study of anacetrapib, Merck’s investigational cholesteryl ester transfer protein inhibitor, the company says it is reviewing the trial results with external experts and considering whether to submit an NDA to FDA. The study of 30,449 patients with atherosclerotic vascular disease receiving
Drugs
Bristol-Myers Squibb and Daiichi Sankyo say they are collaborating on a clinical trial to evaluate the combination of BMS’ immunotherapy Opdivo (nivolumab) and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial cancers. The multicenter Phase 1b open-label study will look
Drugs
An FDA biomarker qualification program online post says that a biomarker context of use (CoU) “is a statement that describes the manner and purpose of use for the biomarker in drug development. The supporting data and analyses submitted with the biomarker qualification submission determine the acceptability of the qualified CoU.
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hetero Labs Limited Hyderabad, India (8/15): FDA inspected the firm’s facility 12/2016 and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to
Drugs
FDA has granted UroGen Pharma a fast track designation for MitoGel and its use in treating patients with low-grade upper tract urothelial carcinoma. The product is currently being evaluated in the ongoing, single-arm, open-label, pivotal Phase 3 OLYMPUS clinical trial. There are currently no drugs approved by
Drugs
FDA has accepted for priority review a La Jolla Pharmaceutical Co. NDA for the investigational drug LJPC-501 (angiotensin II) for treating hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The agency has set a user fee review action target of 2/
Drugs
Federal Register notice: FDA has announced a 12/7 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee
Drugs
On FDA’s behalf, U.S. marshals 8/25 seized five vials of Vaccinia Virus Vaccine (live) belonging to StemImmune Inc. (San Diego, CA), a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military, but administered to patients at the
Drugs
FDA has released more details on a CDER and ORA “concept of operations” agreement to integrate facility evaluations and inspections for human drugs (see earlier story). The agreement outlines responsibilities and the workflow for pre-approval, post-approval, surveillance, and for-cause inspections at domestic and international facilities. It will
Drugs
FDA has approved Kedrion Biopharma and Kmada Ltd.’s KedRab [rabies immune globulin (human)] for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid animal. The human rabies immunoglobulin (HRIG) should be administered concurrently with a full course of rabies vaccine, according to
Drugs
FDA has approved a Teligent ANDA for clobetasol propionate cream USP, 0.05%, emollient, a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Generic annual sales for the product are estimated at $12 million. The approval marks Teligent'