Devices
Researchers from the Medical Device Innovation Consortium (MDIC), including an FDA representative, have produced a paper and framework to give clinical trial researchers and teams an opportunity to incorporate lessons learned from case studies on the use of patient preference information (PPI) into their clinical development programs. “As the body
Drugs
FDA commissioner Robert Califf says the agency has launched the FDA Overdose Prevention Framework, its vision for undertaking “impactful, creative actions to prevent drug overdoses and reduce deaths.” In an FDA Voices post, Califf says agency activities within four overarching priorities are dynamic to allow it to recalibrate its approach
Drugs
FDA has lifted a partial clinical hold on Curis’ TakeAim Leukemia study that is intended to evaluate emavusertib in a monotherapy phase of the trial. The partial hold remains in place for the combination therapy phase (Phase 1b) and the expansion phase (Phase 2a) of the study until Phase 1a
Devices
Hamilton Medical has recalled its Hamilton-C6 Intensive Care Ventilator after customer complaints were received about a hardware issue with the ventilator’s status indicator board. “The status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board,” a recall
Drugs
Outlook Therapeutics says it has resubmitted to FDA a BLA for its ONS-5010 (Lytenava) (bevacizumab-vikg) to treat wet age-related macular degeneration. Company officials say they have worked for the past three months to provide the additional information FDA required that was not in the 3/2022 BLA
Biologics
Erytech Pharma says it is no longer seeking approval for Graspa (L-asparaginase encapsulated in red blood cells) in hypersensitive acute lymphoblastic leukemia (ALL) following FDA feedback that requested additional clinical data. “In multiple clinical trials, Graspa showed promising results for patients, and we were encouraged by the dialog with
Drugs
AstraZeneca says new Phase 3 data on Farxiga (dapagliflozin) demonstrated a mortality benefit compared to placebo in patients with heart failure (HF). These results were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain and simultaneously published in Nature Medicine. “The reduction in risk of cardiovascular (CV)
Devices
Intera Oncology has recalled its Intera 3000 Hepatic Artery Infusion Pump after receiving three reports that the pumps were delivering medications (flow rate) faster than expected. “If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-
Drugs
Bristol Myers Squibb and Janssen Pharmaceuticals announced 8/28 that they are planning to begin a Phase 3 trial of their investigational oral factor XIa (FXIa) inhibitor, milvexian, after reporting results from the Phase 2 AXIOMATIC-SSP dose-ranging study that showed a 30% relative risk reduction in recurrent symptomatic
Devices
FDA has issued a safety alert about Philips Respironics recalling certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. “If that plastic is in the device motor, it may release certain chemicals of
Biologics
Moderna has filed a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 vaccine. Moderna alleges that the vaccine “infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s
Drugs
FDA has made available two International Council for Harmonization draft guidances on drug analytical procedures. A draft entitled Validation of Analytical Procedures Q2(R2) discusses the elements for consideration during the validation of analytical procedures included as part of regulatory submissions. It provides recommendations on how to derive and evaluate
Devices
FDA has removed N95 respirators from its medical device shortage list, which it says signals that “demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. This action is the result of increased domestic manufacturing of N95 respirators,
Drugs
FDA has released a final guidance entitled “E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Questions and Answers.” The International Council for Harmonization (ICH) document is intended to clarify key issues related to implementing earlier guidances on clinical evaluations of QT/QTc interval
Devices
Integra LifeSciences has begun a global product removal of all CereLink intracranial pressure monitors as a result of customer reports about The devices recording out-of-range pressure readings. The company believes that the out-of-range readings are caused by electrical interference from the external environment and/or interference
Drugs
FDA has approved an Incyte supplemental NDA for Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor for treating adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. The rare blood cancers affect about 1 in 100,000 people in the U.S. annually, according to
Devices
FDA says the Medtronic 6/28 recall of 23,372 HeartWare Ventricular Assist Device (HVAD) batteries for electrical faults that cause battery failure is Class 1. An agency notice says the batteries were distributed from 1/1/09 to the present. The notice says batteries with an electrical fault may
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) FY 2021 annual report says the data and analyses in the report “provide a picture of a high state of pharmaceutical quality for U.S. consumers and patients with the expectation for continuing improvement.” The report contains key data used to characterize drug
Drugs
Novartis says it is temporarily suspending the dosing of branapalm in the Phase 2b VIBRANT-HD study of the drug in adults with Huntington’s Disease. The decision, which was made by an independent data monitoring committee and supported by the VIBRANT-HD steering committee, was made because early signs
Biologics
Iovance Biotherapeutics has begun a rolling BLA for lifileucel, a tumor infiltrating lymphocyte therapy for use in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. The company
Drugs
A 9/20-9/24/21 FDA inspection at Oregon’s Wild Harvest, Redmond, OR, found serious violations of FDA regulations for current good manufacturing practice (CGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements. An 8/8 Warning Letter says specific violations were: * failing to establish product
Drugs
A joint reflection paper released by the International Coalition of Medicines Regulatory Authorities, of which FDA is a member, with the International Council for Harmonization, International Pharmaceutical Regulators Program, and Pharmaceutical Inspection Cooperation Scheme, outlines the groups’ multi-stakeholder approach to the harmonization work required to support the development of