Takeda

DBV Technologies Reports First Quarter 2024 Financial Results and Business Update

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火曜日, 5月 7, 2024
FDA, Takeda, Safety, GSK plc, Quality assurance, Quality, DBV, Senior, Food, DBV Technologies, Doctor of Pharmacy, Regulatory affairs, ViroPharma, Bank statement, Takeda Oncology, Therapy, Pharmaceutical industry

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the first quarter 2024.

Key Points: 
  • DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the first quarter 2024.
  • The quarterly financial statements were approved by the Board of Directors on May 7, 2024.
  • DBV has strengthened its regulatory expertise by appointing Robert Pietrusko, PharmD, to the position of Chief Regulatory Officer.
  • “Bob brings to DBV extensive regulatory affairs and quality expertise, and his leadership is an important addition to the company,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies.

Beaconcure Appoints Christine Oliver as Chief Executive Officer

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火曜日, 5月 7, 2024
Data Management, Biotechnology, Technology, FDA, Other Health, Health, General Health, Pharmaceutical, Artificial Intelligence, Clinical Trials, Electronic Design Automation, Sale, Takeda, IP, Parexel, Trial of the century, Growth, Automation, ChromeOS, Labcorp, Multimedia, COVID-19, Biometrics, Management

Beaconcure , Inc., a leader in AI-enabled clinical data validation and automation, announces that Christine Oliver has been appointed as Chief Executive Officer, effective May 6, 2024.

Key Points: 
  • Beaconcure , Inc., a leader in AI-enabled clinical data validation and automation, announces that Christine Oliver has been appointed as Chief Executive Officer, effective May 6, 2024.
  • Mr. Bar has been appointed to the newly created position of Chief Innovation Officer and will continue to contribute to the successful development and deployment of the company’s core technologies.
  • View the full release here: https://www.businesswire.com/news/home/20240507746177/en/
    Christine Oliver, Chief Executive Officer at Beaconcure (Photo: Business Wire)
    Beaconcure was founded in 2016 by Mr. Bar with co-founder Ilan Carmeli, the company's Chief Operating Officer.
  • Since then, Beaconcure has emerged as a global leader in developing innovative solutions for the Biometrics and Life Sciences industry.

EQS-News: Abivax reports 2023 financial results and operational update

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水曜日, 4月 10, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Abivax reports 2023 financial results and operational update

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火曜日, 4月 2, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Scilex Holding Company Announces a Settlement Agreement with Takeda Pharmaceuticals to Resolve the Paragraph IV Patent Infringement Lawsuit Relating to Scilex’s Filing of a sNDA with the FDA Seeking to Expand the Label for its FDA-Approved Liquid Colchici

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水曜日, 3月 20, 2024
Paragraph, Gout, Vexatious litigation, Shanda, Chronic pain, Settlement, PALO, Justice, Takeda, License, FDA, Federal Trade Commission, Nursing

That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba®, a preventive treatment for gout.

Key Points: 
  • That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba®, a preventive treatment for gout.
  • As part of the Settlement Agreement, the Scilex Parties entered into a License Agreement with Takeda granting the Company and its affiliates a non-exclusive license to certain patents owned by Takeda.
  • The Settlement Agreement is subject to approval by the district court, and by both the Federal Trade Commission and the U.S. Department of Justice, as is required in Paragraph IV patent case settlements.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com .

CRISPR Therapeutics Proposes New Appointment to the Board of Directors

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水曜日, 3月 13, 2024
Development, Gene editing, Growth, Regeneron Pharmaceuticals, Biotechnology, Science and nature, Merck Serono, Patient, Branches of microbiology, Acquisition, Virology, Executive Committee, Max Planck Society, CRISPR Therapeutics, University, Senior, Bayer, Publication, Therapy, Takeda, CRISPR, Amgen, CRSP, Medicine, Pharmaceutical industry

“We are thrilled to welcome Christian to our Board of Directors,” said Samarth Kulkarni, Ph.D., Chief Executive Officer and Chairman of the Board of CRISPR Therapeutics.

Key Points: 
  • “We are thrilled to welcome Christian to our Board of Directors,” said Samarth Kulkarni, Ph.D., Chief Executive Officer and Chairman of the Board of CRISPR Therapeutics.
  • Dr. Rommel currently serves as Executive Vice President, Global Head of Research & Development and a Member of the Executive Committee of Bayer Pharmaceuticals, Inc.
  • He joined Bayer from Roche, where he was most recently Senior Vice President, Global Head of Oncology, Pharma Research and Early Development (pRED).
  • He has authored more than 70 publications, including papers in Science and Nature, and is an inventor or co-inventor of 18 patents.

Rachael Brake, PhD, Joins Zephyr AI as Chief Scientific Officer

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火曜日, 4月 2, 2024
Cardiology, Data Management, Biotechnology, Technology, Health, Pharmaceutical, Oncology, Health Technology, Software, Artificial Intelligence, Clinical Trials, Translational research, Australian National University, Communication, Corbus, Associate, Takeda Oncology, University, Research, Artificial intelligence, Cancer, Head, Doctor of Philosophy, Molecular biology, Medicine, Biochemistry, Brake, Takeda, Medical research, Interim, Multimedia, Zephyr, Medical device

Zephyr AI, Inc. (“Zephyr AI”), a healthcare technology company committed to developing fast and explainable artificial intelligence (AI) solutions to democratize precision medicine, today announced the appointment of Rachael Brake, PhD, as its new Chief Scientific Officer.

Key Points: 
  • Zephyr AI, Inc. (“Zephyr AI”), a healthcare technology company committed to developing fast and explainable artificial intelligence (AI) solutions to democratize precision medicine, today announced the appointment of Rachael Brake, PhD, as its new Chief Scientific Officer.
  • View the full release here: https://www.businesswire.com/news/home/20240401145891/en/
    “Having spent decades working in big pharma and biotech spanning roles in research, development and commercial, Rachael comes to Zephyr with a unique breadth of experience,” said Jeff Sherman, Zephyr AI Co-Founder, Interim CEO, and Chief Technology Officer.
  • Prior to her work at Corbus, Brake spent 11 years at Takeda Oncology, most recently as Head of U.S. Medical Affairs Oncology.
  • I’m thrilled to be joining the incredibly talented Zephyr AI team at such a pivotal time in clinical research.”

IDRx Appoints David P. Kerstein, M.D., as Chief Medical Officer

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水曜日, 3月 27, 2024
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Sumitomo Pharma, Takeda Pharmaceutical Company, Tufts University, Patient, Therapy, Takeda, GIST, ARIAD Pharmaceuticals, Pharmaceutical industry

IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision therapies, today announced the appointment of David P. Kerstein, M.D., as Chief Medical Officer.

Key Points: 
  • IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision therapies, today announced the appointment of David P. Kerstein, M.D., as Chief Medical Officer.
  • Dr. Kerstein brings to IDRx deep experience in early- and late-stage oncology drug development, including multiple precision oncology medicines.
  • He joins the founding IDRx R&D leadership team of Jessica Christo, Chief Development Operations Officer, and Vivek (Vic) Kadambi, Ph.D., Chief Product Development Officer.
  • Before Theseus, Dr. Kerstein served as Chief Medical Officer of Anchiano Therapeutics Ltd.

AffyImmune Therapeutics Appoints Matt Britz as Chief Executive Officer and Pete Gelinas as SVP of CMC

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火曜日, 3月 19, 2024
Research, Genetics, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, CALD, Control, Thyroid cancer, Growth, Bluebird bio, MAA, Drug discovery, Business, MIT, Britz, Patient, SVP, Marketing Authorisation Application, Merck, MSAT, Business development, Acquisition, CMC, Betibeglogene autotemcel, Technology transfer, Senior, MBA, CMCF, Therapy, Takeda, Equinox Group, Dana–Farber Cancer Institute, Multimedia, Chemical engineering, DFCI, Partnership, Biology, BLA, Pharmaceutical industry

AffyImmune Therapeutics, Inc ., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls.

Key Points: 
  • AffyImmune Therapeutics, Inc ., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls.
  • Matt is well-suited to lead AffyImmune as CEO as the Company accelerates clinical development of AIC100 in thyroid cancer, and in other indications with high unmet medical need.
  • Matt Britz joined AffyImmune in June 2021 as Senior Vice President (SVP), Business Development and was promoted to Chief Operating Officer in January 2022.
  • Pete Gelinas brings over 15 years of extensive experience in Manufacturing and CMC Product Development to AffyImmune.

DiaMedica Therapeutics Provides a Business Update and Announces Full Year 2023 Financial Results

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火曜日, 3月 19, 2024
Health, FDA, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Epilepsy, TPA, AIS, Patient, Tissue plasminogen activator, Stroke, G&A, Investment, Therapy, Pharmacovigilance, Nektar Therapeutics, Research, KLK1, Biostatistics, NKTR, Trial of the century, DSM-IV codes, NIHSS, Amgen, Data management, Pharmacy, Food, Cubist Pharmaceuticals, Neurology, Rankine scale, Shanghai Pharmaceuticals, DMAC, Acquisition, University, Yale University, Psychiatry, MRS, ASTN, Takeda, Patent, Bangladesh Technical Education Board, Probability, Pharmaceutical industry

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the year ended December 31, 2023.

Key Points: 
  • DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the year ended December 31, 2023.
  • Management will host a conference call Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and full year 2023 financial results.
  • Other income, net, was $1.9 million for the year ended December 31, 2023 compared to $0.4 million for 2022.
  • DiaMedica Management will host a conference call and webcast to discuss its business update and full year quarter 2023 financial results on Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time: