Drugs
Some researchers are complaining the meta-analyses, which combine the results of many clinical studies in an effort to make it easier for doctors to keep up with research, are affected by conflicts of interest in those who do the analyses. A National Public Radio report quotes Stanford University professor
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FDA has granted Chromocell and Astellas Pharma a fast track designation for drug candidate CC8464/ASP1807 for managing neuropathic pain associated with idiopathic small fiber neuropathy. In 2015, the companies entered into a license and collaboration agreement for developing the product. Chromocell submitted an IND for CC8464/ASP1807 in July,
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Sen. Ed Markey (D-MA) says FDA “must not become complicit in the growing prescription fentanyl problem this country is combating.” In a letter to FDA commissioner Robert Califf, Markey particularly referenced Insys Therapeutics’ Subsys, which was approved by FDA in 2012 only for intense and persistent cancer pain. Markey
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In response to increasing data integrity citations in Warning Letters and inspections, FDA has signed an agreement with CluePoints to develop a data driven software tool to detect data anomalies indicative of fraud, misconduct or sloppiness. Earlier this year, the agency released a draft guidance, Data Integrity and Compliance with
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FDA has granted MediciNova an orphan drug designation for MN-166 (ibudilast) for treating amyotrophic lateral sclerosis (ALS). Currently, the company has two ongoing clinical trials that are evaluating MN-166 in ALS in collaboration with researchers at Carolinas HealthCare System’s (CHS) Neuromuscular/ALS-MDA Center and Massachusetts General
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AstraZeneca says it has stopped a Phase 2a trial for asthma therapy AZD9412 (inhaled interferon beta) based on an interim analysis that found an “overall very low number of reported severe exacerbations” that could make primary endpoint conclusions difficult. “The interim analysis confirmed the positive safety and tolerability profile seen
Drugs
FDA says it has identified more than 10 lots of oral liquid docusate sodium manufactured by PharmaTechm, Davie, FL, as the source of a multistate outbreak of Burkholder cepacia. An agency safety update says its investigation also detected B. cepacia in the water system used to manufacture the product. The
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A 1/18-1/22 FDA inspection at China’s Yangzhou Hengyuan Daily Chemical Plastic Co. found significant violations of current good manufacturing practice regulations, according to a 9/26 Warning Letter. Specific violations included: * failing to provide adequate written production and control procedures that are designed to assure that
Drugs
A 6/20-6/23 FDA inspection at Laboratoire Sintyl, Geneva, Switzerland, found numerous violations of current good manufacturing practice for finished pharmaceuticals, according to a 9/29 Warning Letter. Specific violations included: * failing to establish written policies and procedures applicable to the quality control unit, including the review of
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The Third Circuit Court of Appeals has sided with a Pennsylvania federal court’s ruling that the Sheller law firm lacks standing to bring suit to compel FDA to approve its petition over the use of Janssen’s Risperdal (risperidone) and generic forms of the drug in children. Sheller represents
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The Massachusetts federal court has dismissed an indictment charging two former New England Compounding Center employees with felony counts of dispensing drugs into interstate commerce without a valid prescription. Attorney Andrew Hull (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the controversial aspect of the
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Rep. Ron DeSantis (R-FL) has introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act of 2016 (H.R. 6241), to provide for reciprocal marketing approval of certain drugs, biological products, and medical devices that are authorized to be lawfully marketed abroad but not in the U.S.
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Mylan has agreed to the terms of a $465 million settlement with the U.S. Department of Justice and other government agencies to resolve questions that have been raised about the classification of EpiPen Auto-Injector and EpiPen Jr. Auto-Injector under the Medicaid Drug Rebate Program. “The terms of
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FDA has sent Nicox a complete response letter (CRL) on its NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching associated with allergic conjunctivitis. The letter cited a GMP inspection at a third party facility producing the active pharmaceutical ingredient as the reason for not approving
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FDA has released a guidance on “Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process” for panels convened to determine whether a sunscreen active ingredient or combination of sunscreen active ingredients is generally recognized as safe and effective and should be added to the over-the-counter( OTC) sunscreen drug
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FDA has approved Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for an oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received an orphan drug designation for this indication and will be the first available intravenous formulation of
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Flamel Technologies has reached agreement with FDA for a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial of FT218, a once nightly formulation of sodium oxybate that uses the company’s proprietary drug delivery platform, Micropump. The Phase 3 trial, entitled “A Double-
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Alnylam Pharmaceuticals has decided to discontinue developing revusiran, an investigational RNA interference therapeutic being developed for treating hereditary amyloid transthyretin amyloidosis with cardiomyopathy. The decision was based on a data monitoring committee (DMC) recommendation involving a Phase 3 study called ENDEAVOUR. The DMC did not find conclusive evidence for a
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FDA has approved an Orexo U.S. supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) 0.7mg/0.18mg for treating patients with opioid dependence. The approval adds a new dosing option to Zubsolv’s existing approved dosing range that includes 11.4mg/2.9mg, 8.6mg/2.1mg, 5.
Drugs
A split vote (15 to 13) by FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has recommended increasing the minimum dose for injectable and intravenous administration of naloxone for treating overdoses outside of a hospital or medical setting. Panel members said
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CDER has appointed a National Institutes of Health (NIH) official as director of its Office of Medical Policy (OMP). Center director Janet Woodcock says that Jacqueline Corrigan-Curay will start on 10/16. In an announcement to Center staff, Woodcock said that Corrigan-Curay “brings to the position a unique
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Researchers from the University of Wisconsin and the University of Pennsylvania report in the New England Journal of Medicine that data monitoring committees (DMCs) need to be prepared for the unexpected in the drug trials they monitor. “DMCs play a critical role in the conduct of clinical trials by assessing