Drugs
The Department of Justice (DoJ) says a Miami, FL, federal grand jury has indicted Jessica Palacio, Miami, on charges of conspiring to falsify clinical trial data for an asthma medication. A DoJ statement says Palacio worked as a study coordinator for Unlimited Medical Research, a Miami clinical trial firm. The
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The 2nd Circuit Court of Appeals has upheld a New York federal court’s determination that a suit accusing Pfizer of failing to adequately warn that its cholesterol drug Lipitor could cause diabetes was preempted by federal law. The appeals court summary order says the decision was based on “substantially
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FDA has published a guidance, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Annexes, providing a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes more predictably and efficiently. The document, approved by the International Council for Harmonization, discusses how to identify the elements in
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FDA has published an International Council for Harmonization guidance, M9 Biopharmaceutics Classification System-Based Biowaivers, describing the biopharmaceutics classification system (BCS)-based biowaivers approach intended to reduce the need for in vivo bioequivalence studies. The document says in vivo bioequivalence studies may be exempted if an assumption of equivalence in
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Rocket Pharmaceuticals says it is pausing its RP-A501 Danon Disease program for additional risk mitigation requested by FDA. The company says the agency asked it to pause patient dosing and modify the protocol and other supporting documents with revised guidelines for patient selection and management. Rocket says it expects
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Novo Nordisk has recalled 1,468 product samples for Levemir (insulin detemir), Tresiba (insulin degludec), Fiasp (insulin aspart), Novolog (insulin aspart) and Xultophy (insulin degludec and liraglutide injection) because they were stored at temperatures below storage requirements. “If product samples are exposed to temperatures below 32°F, it could cause
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FDA has released for public comment changes proposed to Appendix 2 of the International Council for Harmonization Q3D(R2) Guideline for Elemental Impurities. The document says there are four extracts from the guideline appendices with proposed revisions.
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After winning an appeal at FDA last month to remove clinical trial requirements that led to a clinical hold on a study designed to assess the psychological effects of MDMA-assisted psychotherapy, the Multidisciplinary Association for Psychedelic Studies (MAPS) has formally requested that the agency remove the hold. MDMA is
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Bayer is reporting positive data from a second Phase 3 study (FIGARO-DKD) that evaluated the safety and efficacy of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and Type 2 diabetes. FIGARO-DKD met its primary endpoint, demonstrating that finerenone significantly
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Liquidia has resubmitted its NDA for LIQ861 for treating pulmonary arterial hypertension. In 11/2020, FDA issued a complete response letter indicating that the application was incomplete and not ready for approval in its present form. At the time, the company said FDA indicated a need for additional information and
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FDA has released two 2019 Form FDA-483s after inspecting two Hennepin County Medical Center (Minneapolis, MN) clinical investigators who were cited for study violations. The first FDA-483 went to sponsor investigator Lauren Klein, who was cited for failing to submit an IND to FDA for conducting a clinical
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An FDA advisory committee has voted 9 to 9 on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan, indicated for treating adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Panel members were mixed on the adequacy of a single Phase 3 trial submitted to
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FDA has accepted and will give priority review to two applications from Merck and Eisai for the combination of Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) for the first-line treatment of patients with advanced renal cell carcinoma and for the treatment of patients with advanced endometrial carcinoma
Drugs
The Supreme Court should hear the appeal of a Janssen case in which the Philadelphia Court of Common Pleas held the company liable for not adding warnings about specific risks of off-label uses associated with one of its drugs. That’s the view of American Tort Reform Association president
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Some 20 House members, led by Reps. Mikie Sherrill (D-NJ) and Adam Kinzinger (R-IL) have sent a letter to the House Appropriation Committee and its Subcommittee on Agriculture, Rural Development, and FDA, asking that the committee not include any language in the FY 2022 appropriations bill that would
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FDA has just released the FDA-483 issued following a 12/9-12/17/20 inspection at the Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations on the form were: * failing to fully follow the responsibilities and procedures applicable to the quality control unit; * failing to
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Incyte has agreed to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks. The Justice Department says the settlement resolves allegations that from 2011 through 2014 the company “purportedly used an independent foundation as a conduit to pay the copays of certain
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An internal Eli Lilly complaint says that a factory executive changed technical documents required by government regulators to downplay serious quality control problems at the facility that makes the company’s Covid-19 therapy. Reuters reports in an exclusive story that the complaint involves Lydia Wible, an executive at the
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FDA has extended for three years its research collaboration with CN Bio, which will now focus on exploring CN Bio’s “lung-on-a-chip” using the PhysioMimix platform to appraise the system’s use for the evaluation of inhaled drug products and assessing additional applications for CN Bio’s
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FDA has just released the establishment inspection report issued following a 10/7-10/16/20 agency inspection at Juno Therapeutics, Bothell, WA. The report says no previous inspections had been conducted. The six inspection observations in the FDA-483 portion of the report were: * failing to thoroughly review any
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FDA reviewers are questioning the adequacy of a single Phase 3 trial submitted to support a ChemoCentryx NDA for avacopan, an oral small molecule C5a receptor inhibitor indicated for treating adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV). In a briefing document for a 5/6 advisory
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Former CDER Division of Cardiovascular and Renal Products deputy director Stephen Grant has joined NDA Partners as an expert consultant. During his more than 20-year career at the agency, Grant served on CDER Office of Compliance’s Medical and Scientific Affairs staff, Office of Therapeutics Research and Review as