Industry

DUBLIN–(BUSINESS WIRE)–The “FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges” training has been added to ResearchAndMarkets.com’s offering. In this two-day Virtual Seminar you will learn about FDA’s expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work. You will learn in detail about … [Read more…]

Presentations to highlight role of liquid biopsy tests and real-world data in identifying resistance mechanisms to therapy, demonstrating impact of specific mutations on treatment efficacy, and informing therapeutic strategies in lung cancer PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that studies utilizing its portfolio of blood tests … [Read more…]

NEW YORK–(BUSINESS WIRE)–Kallyope, Inc., a leading biotechnology company focused on identifying and developing therapeutics involving the gut-brain axis, today announced the formation of its inaugural Clinical Development Advisory Board. The board is composed of four distinguished physicians and scientists who will contribute insights from their vast experience as Kallyope advances its proprietary drug discovery platform, … [Read more…]

Pre-NDA (New Drug Application) Meeting with the U.S. Food and Drug Administration (FDA) Scheduled for the Third Quarter of 2022 to Discuss NDA Submission of Reproxalap for the Treatment of Dry Eye Disease Pre-NDA Meeting with the FDA Planned for the Second Half of 2022 to Discuss NDA Submission of ADX-2191 for the Treatment of … [Read more…]

Announced analyses from Phase I study of etavopivat in sickle cell disease indicated reduction of reported pain-related adverse events, supporting potential to reduce vaso-occlusive crises Recently entered into an exclusive license agreement with Rigel Pharmaceuticals, Inc. for olutasidenib, a mutant IDH1 inhibitor for the potential treatment of relapsed or refractory acute myeloid leukemia Highlighted progress … [Read more…]

NEW YORK–(BUSINESS WIRE)–Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that Randall Stanicky, Chief Financial Officer, will present at the Canaccord Genuity 42nd Annual Growth Conference on Thursday, August 11, 2022 at 12:30 p.m. ET. Company management will also participate in one-on-one meetings during the conference, which will … [Read more…]

NATICK, Mass.–(BUSINESS WIRE)–Pillar Biosciences, the leader in Decision Medicine™, which develops and distributes next-generation sequencing (NGS) products and technologies to localize testing and reduce time to treatment initiation and overall testing costs, today announced that Randy Pritchard, Chief Executive Officer, will participate in the “Liquid Biopsy in Clinical Practice” panel discussion at the 2022 UBS … [Read more…]

Net sales of $118.1 million, a decrease of 3% on a reported basis and flat on a constant currency basis over prior year Global Orthopedics net sales growth of 11% on a constant currency basis driven by new products and channel investments GAAP EPS of $0.12 and adjusted EPS of $0.08 Executed partnership with CGBio … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Neurovascular Thrombectomy Devices Market Size (Value, Volume, ASP) by Segments, Share, Trend and SWOT Analysis, Regulatory and Reimbursement Landscape, Procedures, and Forecast, 2015-2030” report has been added to ResearchAndMarkets.com’s offering. The model discusses in detail the impact of COVID-19 on Neurovascular Thrombectomy Devices market for the year 2020 and beyond. Neurovascular thrombectomy devices … [Read more…]

Extension allows for satisfaction of the HSR Condition as outlined in the Merger Agreement Epizyme stockholders are encouraged to tender their shares to the offer today PARIS–(BUSINESS WIRE)–Regulatory News: Ipsen S.A. (Euronext: IPN; ADR: IPSEY) today announced that Hibernia Merger Sub, Inc. (Purchaser), its wholly owned indirect subsidiary, has extended the expiration time for the … [Read more…]