Drugs
Stakeholders are expressing general support for a PDUFA 6 commitment letter released by FDA for comments. The American Medical Informatics Association (AMIA) says the letter’s references to evidence generation and several recent guidances “signal clear interest by the agency to leverage informatics tools and methodologies to augment regulatory decision-
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FDA has granted Vaccinex an orphan drug designation for its therapeutic monoclonal antibody VX15, which is currently being investigated in a Phase 2 clinical trial (SIGNAL) for treating Huntington’s disease (HD). The company says the SIGNAL trial is based on prior research involving neurodegenerative disease mechanisms, where it was
Drugs
FDA has accepted for priority review a Clovis Oncology NDA seeking accelerated approval for rucaparib and its use in treating advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test) and who have been treated
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Lilly has petitioned FDA asking that the agency refuse to approve any ANDA citing its Forteo (teriparatide [rDNA origin] injection) as the reference-listed drug or reference product, including a specific Teva ANDA. The petition also asks the agency to require that any 505(b)(2) NDA applicant or future
Drugs
FDA has approved in part and denied in part a Cubist Pharmaceuticals 5/7/15 petition asking that it refuse to accept for filing, for substantive review, or for approval any ANDA or 505(b)(2) NDA referencing Cubist’s Dificid (fidaxomicin) 200 mg film-coated tablets that does not
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FDA has approved a Pfizer NDA for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, indicated for treating pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The approval covers the drug’s properties that are
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FDA has extended by three months its review of a Sanofi NDA for iGlarLixi (insulin glargine and lixisenatide) injection, indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Sanofi has submitted updated information on the pen delivery device to address concerns from an advisory committee that reviewed
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FDA has granted Eli Lilly and AstraZeneca a fast track designation for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase 3 clinical trials for treating Alzheimer’s. In addition to the AMARANTH phase 2/3 study, the companies says they will begin a second Phase 3
Drugs
Honeywell has recalled one lot of its 32-ounce Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury, because of product contamination concerns. A recall notice says that while no contamination was detected in its batch testing, the recall is a precautionary measure due to a
Drugs
DEVICES FDA has cleared an Alere 510(k) for its Alere i RSV test for detecting respiratory syncytial virus infection in children and adults. Results for the test are obtained in 13 minutes or less. It works by testing swab samples using Alere’s Molecular In Minutes isothermal nucleic acid
Drugs
FDA says it continues to be concerned about citizen petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. In a just-posted report to Congress on such petitions, FDA complains about its expedited review and responses the statute requires
Drugs
Sagent Pharmaceuticals has recalled one lot of oxacillin for injection 10g (lot OXT512 — expiry 3/2017), which was manufactured by Astral SteriTech, due to a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron
Drugs
FDA has granted Supernus Pharmaceuticals tentative approval for an sNDA requesting a label expansion for Trokendi (topiramate) XR to include preventing migraine headache in adults. The tentative approval is based on an outstanding pediatric exclusivity period which expires 3/28/2017. Additionally, the agency granted final approval to expand the
Drugs
FDA has granted Soligenix an orphan drug designation for dusquetide and its use in treating macrophage activation syndrome (MAS). Dusquetide has previously received an orphan designation for treating acute radiation syndrome. Dusquetide is an innate defense regulator, a new class of short, synthetic peptides that accelerates bacterial clearance and resolution
Drugs
The Environmental Working Group is asking FDA to investigate whether ingredients and other technologies are being used to boost sunnscreen SPF claims by masking the skin reddening that the group says is the body’s warning sign of skin damage. An 8/18 letter says that such products “may encourage
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The National Institutes of Health (NIH) says that a recent survey found that many respondents would be willing to participate in the national Precision Medicine Initiative (PMI) Cohort Program, a longitudinal research program that aims to enroll one million or more U.S. residents to improve the ability to prevent
Drugs
Sage Products has expanded an earlier recall to include one additional lot of its Comfort Shield Barrier Cream Cloths due to contamination (Burkholderia cepacia) concerns. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, an FDA
Drugs
Victor Lamar Coates of Philadelphia has entered a guilty plea to charges of conspiracy to traffic counterfeit Viagra and Cialis and for smuggling, trafficking and introducing the misbranded prescription drugs into interstate commerce. Coates admitted to illegally distributing over 10,000 counterfeit and misbranded tablets, including tablets he illegally imported
Drugs
Arbor Pharmaceuticals has recalled three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal on the blister packs. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process, a recall notice
Drugs
FDA has issued Portola Pharmaceuticals a complete response letter on its BLA for AndexXa (andexanet alfa), indicated for reversing anticoagulant activity of both direct and indirect Factor Xa inhibitors. The letter asks the company provide additional information related to manufacturing, and additional data to support inclusion of edoxaban and enoxaparin
Drugs
Attorney Jennifer Newberger (Hyman, Phelps & McNamara) says that a new pre-RFD (Request for Determination) process announced by the FDA Office of Combination Products (OCP) to provide a more interactive approach to product designation should be “unsettling” to any sponsor who has dealt with OCP. Writing in her firm’
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The Critical Path to TB Drug Regimens says that an FDA draft guidance on infectious disease next generation sequencing laying out a regulatory pathway that better defines the regulatory requirements for next generation sequencing (NGS) will be helpful to those developing diagnostic devices for antimicrobial resistance, and tuberculosis in particular.