Drugs
FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX101 (minocycline foam, 4%) for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older. The agency has set a user fee review action target of 10/20. The submission is supported
Drugs
The Medical Device Information Consortium (MDIC) has released a landscape analysis report created from work conducted by its somatic reference sample (SRS) initiative. The report says the subgroup was charged with conducting a thorough analysis of projects related to NGS (next-generation sequencing) reference samples to (1) avoid duplicative efforts;
Drugs
Attorney Eric Alexander (Reed Smith) says that until the Supreme Court decides the Fosamax decision from a New Jersey federal court that were overturned by the 3rd Circuit Court of Appeals, other jurisdictions will continue to look at the same types of questions. In an online blog post, Alexander says
Drugs
FDA has released the FDA-483 with eight observations from a 12/10-12/21/18 inspection at Brookfield Medical/Surgical Supply, a Brookfield, CT, outsourcing facility. The inspection observations were: * · failing to have written procedures for production and process controls designed to assure that the drug products have the
Drugs
FDA has accepted two Allergan supplemental BLAs to expand its Botox (onabotulinumtoxin A) label for treating pediatric patients (two years of age and older) with upper and lower limb spasticity. The pediatric upper limb spasticity indication submission has been designated a six-month priority review with a user fee action
Drugs
Allergan says topline results from three pivotal studies of its rapastinel as an adjunctive treatment of major depressive disorder failed to differentiate from placebo on primary and key secondary endpoints. A company statement says that in all three studies, the drug was well tolerated without any signal of psychotomimetic side
Drugs
FDA has accepted for review a Genentech supplemental NDA for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. FDA approved the therapy 10/2018 for treating acute, uncomplicated influenza in people 12 years of age or older. The agency
Drugs
University researchers who analyzed 20 new molecular entities (NMEs) approved by FDA between 1/2011 and 9/2017 exclusively on non-inferiority pivotal trials say that both drug sponsors and FDA can do a better job of communicating non-efficacy benefits. In a JAMA Internal Medicine Research Letter, the authors
Drugs
FDA has approved a Janssen Pharmaceuticals NDA for Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for treating depression in adults who have not responded to other antidepressant medicines (treatment-resistant depression). “Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato
Drugs
Local governments in the U.S. that use CanaRx to supply prescription drugs for covered employees are raising questions about a recent FDA Warning Letter that says the online pharmacy has delivered unapproved and misbranded drugs to its U.S. consumers. A Kaiser Health News article posted by National Public
Drugs
Alnylam Pharmaceuticals says it will complete its NDA rolling submission for givosiran, indicated for treating acute hepatic porphyria (AHP) after reporting that the ENVISION Phase 3 study met its primary efficacy endpoint and the majority of secondary endpoints. Specifically, givosiran met the primary endpoint of reduction in the annualized rate
Drugs
In a legal filing to the Massachusetts Superior Court, Purdue Pharma cites statements from state officials to make the case that it is not solely responsible for causing the state’s opioid crisis. “To be sure, there is an opioid crisis in the Commonwealth,” the document says, “but the responsibility
Drugs
FDA has released the FDA-483 issued following a 12/3-12/14/18 inspection at Michigan Medicine, an Ann Arbor, MI, drug compounder producing sterile and non-sterile drug products. The four inspection observations were: * failing to disinfect materials or supplies before they enter the aseptic processing areas; * personnel
Drugs
A 7/9-7/19/18 FDA inspection at Actavis Laboratories FL, Davie, FL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/1 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and process control designed
Drugs
The Tufts Center for the Study of Drug Development says contract research services have become an integral component of drug development, representing the single largest category of research and development spending by pharmaceutical and biotechnology companies worldwide. The Center’s latest Impact Report (subscription or purchase required) estimates 2018 expenditures
Drugs
Apotex has recalled four lots of drospirenone and ethinyl estradiol tablets because the contraceptive may contain defective blisters with incorrect tablet arrangements or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. According to a recall notice, the packaging error could cause a patient to
Drugs
A 7/10-7/18 FDA inspection at Andapharm, Ft. Lauderdale, FL, found repeat violations of current good manufacturing practice regulations for finished pharmaceuticals. A 2/28 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures for cleaning and maintaining equipment; * failing to establish and
Drugs
National and international ultrasound societies have petitioned FDA to remove a “black box” warning from ultrasound contrast agent (UCA) labels. The petition, filed by the International Contrast Ultrasound Society, cites an extensive body of favorable safety data that were not available in 2007 when the boxed warnings were first mandated
Drugs
Pharmaceutical Research and Manufacturers of American (PhRMA) says FDA should consider publicly disclosing supporting documentation and information for surrogate endpoints used for approvals of NDAs and BLAs with all necessary protections for trade secrets and confidential information, as is the practice with qualified biomarkers, and should use the List of
Drugs
A bipartisan group of four senators say recent FDA guidances aimed at facilitating development of lower-cost biosimilars may have the opposite effect for development of generic insulin. In a 3/1 letter to FDA commissioner Scott Gottlieb, Sens. Richard Durbin (D-IL), Tina Smith (D-MN), Kevin Cramer (R-
Drugs
FDA has sent Evoke Pharma a multi-disciplinary review letter on its 505(b)(2) NDA for Gimoti (metoclopramide), a nasal spray indicated for treating gastroparesis. The letter, according to Evoke, identifies three NDA sections with deficiencies and concerns. These incude: Chemistry (combination product quality control and reproducibility specific to
Drugs
Intellipharmaceutics International has resubmitted an NDA for its oxycodone ER product candidate, indicated for treating pain. In 2018, FDA issued Intellipharmaceutics a complete response letter on the NDA that provided certain recommendations and requests for information, including that it complete the relevant Category 2 and Category 3 studies to assess