Drugs
Republican leaders of the House Energy and Commerce Committee say it’s time for FDA to stop delaying and “pursue thoughtful, Constitutionally-sound solutions that will provide certainty for the future” in terms of appropriate off-label communication. In an online blog post, the leaders note that FDA announced in
Drugs
Vanda Pharmaceuticals is asking FDA not to approve an ANDA referencing its Fanapt (iloperidone) until expiration of the three-year exclusivity covering changes made to the Fanapt labeling for which the company says that a clinical study relating to maintenance treatment was essential. Fanapt is approved for treating schizophrenia in
Drugs
The Biosimilar Working Group of the International Pharmaceutical Regulators Forum (IPRF) has published for comment a “reflection paper” proposing principles on the extrapolation of indications in the authorization of biosimilar products. (FDA is a member of the IPRF.) The paper suggests that the extrapolation of indications of a biosimilar product
Drugs
Tonix Pharmaceuticals says that preliminary topline results from its Phase 3 AFFIRM study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg in patients with fibromyalgia failed to achieve statistical significance in its primary efficacy endpoint of the proportion of patients who reported a 30% or greater reduction
Drugs
Evoke Pharma says it is preparing a 505(b)(2) NDA for Gimoti (metoclopramide), indicated for relieving symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The product is based on the company’s patented nasal delivery formulation technology. Evoke says it recently met with FDA under a
Drugs
GlaxoSmithKline and Innoviva have released positive data from the pivotal Phase 3 FULFIL study with investigational closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) in patients with chronic obstructive pulmonary disease (COPD). The study was designed to evaluate the effects of once
Drugs
The Clinical Decision Support Coalition is asking FDA for guidance that answers specified questions arising out of three case studies developed by the coalition on issues around a risk-based and clearly defined regulatory system for clinical decision support software that appropriately balances the need for regulatory oversight with the
Drugs
Aerie Pharmaceuticals has filed an NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, a novel once-daily eye drop designed to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The filing includes data from two Phase 3 registration named Rocket 1 and Rocket 2. The company says
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The agency has set a user fee review target date of 12/24.
Drugs
FDA has granted Taxis Pharmaceuticals a qualified infectious disease product designation for TXA709, which targets acute bacterial skin and skin structure infections caused by Staphylococcus aureus, including methicillin-resistant strains. TXA709 is a prodrug that produces a derivative of benzoic acid that disrupts the form and function of the bacterial
Drugs
FDA has just released the FDA-483 that was issued at the conclusion of a 2/8-2/25 inspection at Bausch & Lomb’s facility in Tampa, FL. Specific violations noted on the form included: * failing to include conclusions and follow-up in written records of investigations into unexplained
Drugs
An 8/10/15-8/13/15 FDA inspection at Zhejiang Hisoar Pharmaceutical Co., Taizhou City, China, found current good manufacturing practice and data integrity violations in the firm’s manufacturing of active pharmaceutical ingredients, according to an 8/11 Warning Letter. Specific violations included: * failing to maintain complete data
Drugs
A Louisiana federal court says that three state liability claims against Janssen over its diabetes drug Invokana may proceed toward trial. The judge ruled in a case brought by a woman who claims the drug caused her kidneys to fail. Her initial suit was dismissed for lack of specificity, but
Drugs
FDA has extended by three months the review of a Novo Nordisk NDA for IDegLira, a fixed-dose combination of Victoza (liraglutide), a glucagon-like peptide-1 receptor agonist, and Tresiba (insulin degludec), a long-acting insulin analog. The company submitted the NDA 9/2015, and with the review extension
Drugs
AstraZeneca says recent Phase 3 data demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, which is detected by the presence of eosinophils in the blood. The SIROCCO and CALIMA trials evaluated
Drugs
FDA has granted Sage Therapeutics a breakthrough therapy designation for SAGE-547 for treating postpartum depression (PPD). The company recently reported top-line results from a placebo-controlled Phase 2 trial in women with severe PPD in which SAGE-547 showed a reduction in depression scores compared with placebo. “There
Drugs
A 11/30-12/3/15 FDA inspection at Pan Drugs, Vadodara, India, found significant violations of current good manufacturing practice regulations and data integrity concerns in the firm’s manufacturing of finished pharmaceuticals, according to an 8/25 Warning Letter. Specific violations included: * failing to establish an adequate quality
Drugs
FDA has granted Catalyst Pharmaceuticals an orphan drug designation for Firdapse (amifampridine phosphate) for treating myasthenia gravis. The rare disease is caused by antibodies to the muscle-specific kinase (MuSK-MG) and is “characterized by a predominance in females, prominent bulbar involvement, more severe clinical condition and resistance to treatment,
Drugs
Pressure from Capitol Hill is continuing against Mylan and its pricing on Epipen. Senate Finance Committee Ranking Member Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) have now sent a letter to HHS secretary Sylvia Mathews Burwell requesting additional information regarding EpiPen’
Drugs
FDA has issued a final rule that bans 19 active ingredients — including most commonly triclosan and triclocarban — from use in over-the-counter (OTC) antiseptic wash products. “Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both
Drugs
FDA has granted Biogen fast track status for aducanumab, an investigational treatment for early Alzheimer’s disease. The therapy is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability
Drugs
Ariad Pharmaceuticals has completed a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, for its use treating patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib. The company is seeking accelerated approval and has requested a priority review.