Drugs
Gilead Sciences says it has asked FDA to rescind the orphan drug designation it was recently granted for the investigational antiviral remdesivir for treating Covid-19. A company statement says Gilead is waiving all benefits, such as seven-year exclusivity, that come with an orphan drug designation. The company had
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Alston Bird attorneys say that as a result of FDA’s 3/18 decision to temporarily postpone routine surveillance domestic inspections due to the coronavirus outbreak, regulated industry “must be prepared for FDA’s expanded use of its existing authorities, creative alternatives to ensure the safety of FDA-regulated products
Drugs
Due to coronavirus concerns, Bristol Myers Squibb (BMS) says it will not initiate any new clinical trials globally before 4/13. The freeze could extend longer if the company decides that it is necessary, according to a company notice. For ongoing studies, BMS says new patient enrollment can continue if
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FDA says funds are available for projects to support the agency’s understanding of the potential use of real-world data (RWD) to generate real-world evidence (RWE). An online announcement says FDA is particularly interested in projects that compare the use of RWD and generation of RWE with more
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that a planned FDA study of promotional implications of proprietary prescription drug names “will not produce data that will appropriately inform or meaningfully improve FDA’s regulation of proprietary drug names and, therefore, that it will not provide information
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FDA has accepted for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. The agency has set a 7/21 user fee review action target date. The company says
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A 9/11-9/17/19 FDA inspection at Hangzhou Linkeweier Daily Chemicals Co., Ltd., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing regulations (CGMP) for finished pharmaceuticals. A 3/13 Warning Letter says specific violations were: * failing to conduct for each batch of drug product appropriate laboratory
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A 9/16-9/19/19 FDA inspection at DermaPharm A/S, Farup, Denmark, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory determination of satisfactory
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates that FDA used a new draft guidance on demonstrating substantial evidence of effectiveness for human drug and biological products to complement and expand on an existing 1998 guidance to address new, innovative drug development approaches. In a comment letter, the
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FDA has released a final guidance entitled “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” The guidance was issued in response to a number of queries from entities that are not currently registered drug manufacturers that would
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FDA says patients, caregivers, and healthcare professionals should be aware that EpiPen 3.0mg and EpiPen Jr 0.15mg and their authorized generic versions may potentially have delayed injection or be prevented from properly injecting. The agency notice says problems can be due to (1) device failure from spontaneous activation
Drugs
FDA approved 3/23 orphan drug status for Gilead’s antiviral drug remdesivir, giving the company seven years of exclusivity for the product, which is one of many being tested as a possible Covid-19 treatment. The Intercept reports that experts say the designation could block supplies of the drug
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FDA has given Genentech the green light to begin a randomized, double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the Biomedical Advanced Research and Development Authority to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard of care in hospitalized adult patients with severe coronavirus
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Eli Lilly says it is delaying most new study starts and pausing enrollment in most ongoing studies. For ongoing clinical trials where patients are already enrolled, Lilly says these will continue as planned. “The COVID-19 pandemic has substantially impacted the global healthcare delivery system, including the conduct of clinical
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After touting a drug last week (see story) as already approved for treating coronavirus, president Trump has doubled down in promoting the malaria drug chloroquine for immediate use. During a 3/19 White House press briefing, Trump confusingly said that chloroquine was approved and available for use. “Normally the FDA
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FDA says today (3/23) is the first day that insulin and certain other biologic drugs transition to a different regulatory pathway. “The availability of safe and effective biosimilars and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs
Drugs
FDA has released a guidance entitled “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.” The document addresses the limited number of drugs that are subject to a REMS that requires laboratory testing ( e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging). FDA
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FDA has issued two guidance documents to communicate its policy for temporary manufacturing of certain alcohol-based hand sanitizer products. Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) is immediately in effect and outlines that the agency does not intend
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FDA has issued a guidance entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” The document discusses situations where medical product adverse event reports could be delayed due to pandemic-related high employee absenteeism. The document says that certain required submissions could be delayed provided
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Based on media reports that certain painkillers may worsen coronavirus disease (COVID-19), a new FDA safety update says the agency is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with any worsening symptoms. The news reports came after a 3/11 letter in The Lancet
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FDA has issued Boehringer Ingelheim and Eli Lilly a complete response letter on a supplemental NDA New Drug Application (sNDA) for empagliflozin 2.5 mg and its use as an adjunct to insulin for adults with Type 1 diabetes. The letter states that the agency is unable to approve the
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FDA says it has approved changes to the labeling for Gilead’s Epclusa (sofosbuvir and velpatasvir) to provide for use in pediatric patients with chronic hepatitis C virus (HCV) ages six years and older or weighing at least 37 pounds with any of the six HCV genotypes without cirrhosis or