Drugs
FDA has accepted for priority review a Jazz Pharmaceuticals supplemental NDA seeking revised labeling for Xyrem (sodium oxybate) oral solution, to include an indication to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients. The user fee review action target date is 10/27. Xyrem is currently indicated for
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As a result of prescription drug user fees and company consulting and other payments to doctors who testify before FDA advisory committees, the agency has become more industry partner than regulator, speeding drugs to market faster than any other regulatory agency, according to a lengthy report from ProPublica. “FDA is
Drugs
FDA commissioner Scott Gottlieb says the agency will publish on its Web site in the coming weeks a list of surrogate endpoints that were the primary basis of approval or licensure of a drug or biological for both accelerated and traditional approvals. In a 6/25 speech to the National
Drugs
FDA has approved an Achaogen NDA for Zemdri (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. However, the agency issued a complete response letter that refused to approve the drug for treating bloodstream
Drugs
A 12/11-12/14/17 FDA inspection at two Henan Lihua Pharmaceutical facilities in Henan, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients. A 6/12 Warning Letter says specific deviations were: * failure of the firm’s quality unit to review and approve all
Drugs
FDA has accepted for priority review a Genentech NDA for baloxavir marboxil, a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The agency set a user fee review action target of 12/24. “Baloxavir marboxil has been shown in clinical trials to decrease the
Drugs
FDA has accepted for review a Merck supplemental BLA for Keytruda, an anti-PD-1 infusion treatment for use as adjuvant therapy for patients with resected, high-risk stage melanoma. The submission is based on data from the Phase 3 EORTC1325/ KEYNOTE-054 trial that showed a significant benefit in
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FDA has just released the FDA-483 containing six observations from a 9/5-9/14/16 inspection at Mylan’s finished drug manufacturing facility in Maharashtra, India. The specific observations were: * failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; * failing to thoroughly review
Drugs
FDA released its latest updated list of medication guides with three new guides and 22 updated documents. New medication guides were issued for buprenorphine and naloxone subligual film, Nocdurna, Ferring’s Nocdurna (desmopressin), and Novartis’ Zortress (everolimus). Updated medication guides were issued for Cerecor’s Aciphex Sprinkles (raberprazole sodium) and
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FDA accepts an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia, a rare and incurable blood cancer.
Drugs
CBER has created a new dialog avenue for biologic product developers to ask agency experts for advice on advancing a potential product. The just-launched INTERACT meeting program may “help streamline development by, for example, helping sponsors to avoid unnecessary preclinical studies,” the agency says. “At the same time, the
Drugs
FDA has approved a GW Research NDA for Epidiolex (cannabidiol) oral solution for treating seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA approval of a drug based on a
Drugs
FDA has accepted for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for treating first-line advanced non-small cell lung cancer in patients with tumor mutational burden greater than or equal to 10 mutations per megabase. The user fee review action target
Drugs
FDA has approved an Impel NeuroPharma IND for a Phase 3 clincial trial of INP104, a novel, dihydroergotamine (DHE) intranasal product for treating acute migraine. The drug is dosed via Impel’s proprietary Precision Olfactory Delivery. INP104 delivers DHE to the “richly vascularized upper nasal cavity, offering rapid bioavailability without
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the goals of the 2017 Food and Drug Reauthorization Act to advance research and development of medicines for children with cancer. The association’s letter submitted in advance of the 6/20 meeting of the Pediatric Oncology Subcommittee of
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FDA has withdrawn a 9/2017 draft guidance, Statistical Approaches to Evaluate Analytical Similarity, that was intended to provide advice for sponsors developing biosimilar products about the evaluation of analytical similarity between a proposed biosimilar product and a reference product. “After considering public comments that the agency received about the
Drugs
CDER has denied two petitions asking it to deny approval for a Ferring NDA for Nocdurna (desmopressin) sublingual tablets to treat nocturia due to nocturnal polyuria, and has approved the Nocdurna NDA. The denial letter says the petitions were submitted by Serenity Pharmaceuticals and Avadel Specialty Pharmaceuticals. The letter notes
Drugs
In a disclosure reminiscent of others over decades involving pharmaceutical marketing abuses of FDA-approved drugs with devastating side effects and lax FDA labeling enforcement, CBS Evening News 6/21 reported a former Purdue Pharma sales person’s allegation of scientifically unsubstantiated “pseudoaddiction” claims about the company’s blockbuster opioid
Drugs
FDA has issued Staar Surgical a close-out letter that lifts a Warning Letter dated 5/21/2014, a signal that the company has corrected all issues to the agency’s satisfaction. The company says that the action is the “result of a comprehensive remediation program that not only addressed
Drugs
FDA says it is issuing a draft guidance, Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, with recommendations to applicants planning to request a waiver or reduction in user fees. A Federal Register 6/21 notice says the draft revises a 9/2011 guidance.
Drugs
The DC federal court has granted summary judgment to Eagle Pharmaceuticals in its case challenging FDA’s denial of orphan drug exclusivity for the company’s Bendeka (bendamustine), which has been designated as an orphan drug and approved to treat two rare forms of cancer. FDA had argued that it
Drugs
FDA has designated Acurx Pharmaceuticals’ lead antibiotic product candidate, ACX-362E, as a qualified infectious disease product. The designation was granted for the drug’s use in treating patients with Clostridium difficile infection. ACX-362E is being developed as a targeted, narrow spectrum oral antibiotic, and a Phase 1 clinical