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With at least two additional ameloyd-β Alzheimer’s drugs in the pipeline, scientists interviewed for a Nature explainer are wondering how FDA will review and decide on the drugs’ fate given the furor over its accelerated approval of Biogen’s Aduhelm (aducanumab). “Some researchers think that the [Aduhelm] approval
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Researchers from Yale and Columbia universities say FDA “can and should harness its enforcement tools to ensure timely submission of trial results information to ClinicalTrials.gov. By doing so, FDA could bring important missing results to light and demonstrate its commitment to protecting patients through clinical trial transparency.” Writing in
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A 10/13-10/29/20 FDA inspection at Advanced Neutriceuticals, doing business as Guyer Institute of Molecular Medicine, Indianapolis, IN, found multiple violations of laws and regulations. An 11/10 Warning Letter says the firm failed to meet conditions for exemption from certain provisions of the Federal Food, Drug,
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Pfizer says it will submit new data as part of its rolling Emergency Use Authorization request for its Covid-19 oral antiviral Paxlovid (ritonavir) that showed the drug significantly reduced hospitalization and death. The data come from an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease
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Reps. Fred Upton (R-MI) and Donna DeGette (D-CO) have introduced the 173-page bipartisan Cures 2.0 legislation to change how the U.S. provides care to patients and to speed the delivery of groundbreaking cures, treatments, and innovations. One of the bill’s key provisions is the
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Pharmaceutical Research and Manufacturers of America (PhRMA) and the Deloitte Center for Health Solutions have issued a report with five strategies for enhancing diversity in clinical trials during the research and development of new medicines. The report, “Enhancing Clinical Trial Diversity: Stakeholder Perspectives on Advancing Research Through Representative Clinical Trials,
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FDA has issued a close-out letter citing resolved GMP issues at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient manufacturer (API) that is the reported maker of the active ingredient in recalled valsartan-containing products over the past several years (see earlier story). An inspection in 2016
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Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating geographic atrophy (GA) secondary to age-related macular degeneration. The announcement follows formal, written feedback from FDA that supports the planned submission, according to the company. The agency reportedly confirmed that
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FDA has less oversight of overseas clinical trials that are used to form the basis of approval for drugs in the U.S. than it does for domestically conducted trials, according to a recent study published in the Journal of Clinical Pharmacology. “My study highlighted loopholes in the agency’s
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FDA has granted PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer. The IgG4 monoclonal antibody is designed to target an immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, according to the
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Topline Phase 2 Lauriet trial results presented by Genentech at the 14th Clinical Trials on Alzheimer’s Disease conference reported that the treatment effect for AC Immune’s semorinemab was confirmed in the 241 trial participants who received one or more doses of the study drug. Data from the population
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Par Sterile Products is asking FDA not to approve an Eagle Pharmaceuticals ANDA citing Vasostrict as the reference-listed drug until Eagle makes changes recommended by Par. Par also asks the agency not to approve any pending or future vasopressin ANDA referencing Vasostrict if it has pH release specifications that
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The Oklahoma Supreme Court has overturned a lower court’s $465 million opioid ruling against Johnson & Johnson, saying the lower court wrongly interpreted the state’s public nuisance law. The Associated Press reports that public nuisance claims are at the heart of about 3,000 suits brought by state
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FDA has granted Elevar Therapeutics an orphan drug designation for rivoceranib and its use for treating hepatocellular carcinoma (HCC). The company says a Phase 3 trial is being conducted in collaboration with Jiangsu Hengrui Medicine Co. in patients with advanced HCC who have not received prior systemic therapy. Rivoceranib is
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FDA has accepted for priority review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction (LVEF). The submission is based on data from
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FDA has cleared a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons to perform navigated computerized tomography (CT)-based total hip replacement surgery. The device is intended to assist surgeons in optimal positioning of the joint implants, automatic 3D segmentation and advanced
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FDA placed an 11/3 clinical hold on Pfizer’s Phase 3 trial evaluating giroctocogene fitelparvovec for hemophilia A that was paused by the company following the observation of factor VIII (FVIII) levels greater than 150% in some study participants. FDA indicated a future communication would contain more information on
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Virginia pharmaceutical manufacturer kaléo has agreed to pay $12.7 million to resolve a whistleblower’s allegations that it caused the submission of false claims for its Evzio, an injectable form of naloxone HCl indicated for use to reverse opioid overdose. A Department of Justice statement says that between 3/
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FDA has cleared a Vektor Medical 510(k) for vMAP, a computational electrocardiogram (ECG) mapping system for use to improve outcomes in ablation procedures. Vector Medical says the device is designed to map potential arrhythmia sources (hot spots) associated with stable or unstable arrhythmias anywhere in the heart in less
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Biogen says it is investigating the death of a 75-year-old patient who had taken the company’s controversial Alzheimer’s drug Aduhelm (aducanumab). An email statement provided to FDA Webview said there is no confirmation the death is related to Aduhlem as it is still under investigation. The
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Research funded by FDA through the Johns Hopkins University School of Medicine under the National Action Plan for Combating Antibiotic-Resistant Bacteria has demonstrated that shorter courses of antibiotics were as effective as longer courses in two specific study populations, reducing the chance for antibiotic resistance. An FDA online paper
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The Consumer Healthcare Products Association (CHPA) says there are several steps FDA should take as it implements the DC Court of Appeals decision in Genus Medical Technologies. The court determined that FDA cannot regulate as a drug any product that meets the definition of a medical device in section 201(