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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Nuvation Bio Announces Appointment of Colleen Sjogren as Chief Commercial Officer
3/28/2024
Nuvation Bio Inc., a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced the appointment of Colleen Sjogren as Chief Commercial Officer.
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Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock Transaction
3/25/2024
Nuvation Bio Inc. and AnHeart Therapeutics Ltd. today announced that the companies have entered into a definitive agreement for Nuvation Bio to acquire AnHeart in an all-stock transaction (the Acquisition).
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AnHeart Therapeutics and Innovent Announce China’s NMPA has Accepted Second New Drug Application for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer
3/5/2024
AnHeart Therapeutics and Innovent Biologics, Inc. announced that the Center for Drug Evaluation of China’s National Medical Products Administration has accepted a second New Drug Application for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor.
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Innovent and AnHeart Therapeutics Announce the NMPA of China Has Accepted Second NDA for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer
3/5/2024
Innovent Biologics, Inc. and AnHeart Therapeutics announce that the Center for Drug Evaluation of China's National Medical Products Administration has accepted a second New Drug Application for taletrectinib adipate capsule, a next-generation ROS1 tyrosine kinase inhibitor.
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AnHeart Therapeutics and Innovent Announce China’s NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation
12/18/2023
AnHeart Therapeutics (“AnHeart”) and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review Designation for the New Drug Application (NDA) of taletrectinib.
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Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation
12/18/2023
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) and AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review Designation[1] for the New Drug Application (NDA) of taletrectinib.
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AnHeart Therapeutics and Foundation Medicine Announce Collaboration to Develop Tissue-Based and Liquid-Based Companion Diagnostics for Taletrectinib, a ROS1 Inhibitor
12/14/2023
AnHeart Therapeutics (“AnHeart”) and Foundation Medicine, Inc., today announced the companies have entered a strategic collaboration for the development and regulatory approval of Foundation Medicine’s tissue-based and liquid-based comprehensive genomic profiling tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States.
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Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor)
11/22/2023
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) and AnHeart Therapeutics ("AnHeart") announce that the New Drug Application (NDA) for taletrectinib, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
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AnHeart Therapeutics and Innovent Announce China’s NMPA Has Accepted a New Drug Application for Taletrectinib (ROS1 Inhibitor)
11/22/2023
AnHeart Therapeutics and Innovent Biologics, Inc. today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI).
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AnHeart Therapeutics Expands U.S. Leadership With Development and Commercial Leads
11/9/2023
AnHeart Therapeutics today announced the appointments of Guilin Huang as Senior Vice President, Development and Amy Muse as Vice President, U.S. Commercial.
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AnHeart Therapeutics Announces Exclusive License Agreement With Nippon Kayaku for Taletrectinib in Japan
10/30/2023
AnHeart Therapeutics today announced it has entered into an exclusive license agreement with Nippon Kayaku Co., Ltd (“Nippon Kayaku”) to market and distribute AnHeart’s lead investigational therapy, taletrectinib, in Japan.
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AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People With ROS1-Positive Non-Small Cell Lung Cancer Who Were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial
10/21/2023
AnHeart Therapeutics, a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, announced positive interim results from its global pivotal Phase 2 clinical trial, TRUST-II.
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AnHeart Therapeutics Appoints Charlotte Arnold as Chief Corporate Affairs Officer
9/28/2023
AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced the appointment of Charlotte Arnold as Chief Corporate Affairs Officer.
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AnHeart Therapeutics Announces Initiation of Global Phase 2 Trial Evaluating Safusidenib for IDH1-Mutant Glioma
9/7/2023
AnHeart Therapeutics Announces Initiation of Global Phase 2 Trial Evaluating Safusidenib for IDH1-Mutant Glioma.
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AnHeart Therapeutics Appoints Edward Lang Jr. as Chief Business Officer
4/3/2023
AnHeart Therapeutics (“AnHeart”), a clinical-stage global biopharmaceutical company developing novel precision oncology therapeutics, today announced the appointment of Edward Lang Jr. as Chief Business Officer.
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AnHeart Therapeutics Presents Updated Efficacy and Safety of Taletrectinib in Patients with ROS1-Positive Non–Small Cell Lung Cancer
3/31/2023
AnHeart Therapeutics (“AnHeart”) announced today updated efficacy and safety data from a regional Phase 2 clinical trial of taletrectinib (TRUST-I) in patients with ROS1-positive non-small cell lung cancer (ROS1+ NSCLC) in an oral presentation at the European Lung Cancer Congress (ELCC) 2023.
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AnHeart Therapeutics Announces Oral Presentation at the European Lung Cancer Congress (ELCC) 2023
3/13/2023
AnHeart Therapeutics today announced acceptance of an oral presentation at the European Lung Cancer Congress (ELCC) 2023, held in Copenhagen, Denmark and virtually, March 29 - April 1.
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AnHeart Therapeutics Announces Publication of Taletrectinib Global Phase 2 Clinical Trial (TRUST-II) Design in Future Oncology
3/9/2023
AnHeart Therapeutics announced today the publication of clinical trial design of TRUST-II, a global Phase 2 clinical study of taletrectinib in ROS1-positive non-small cell lung cancer and other solid tumors, in the peer-reviewed medical journal, Future Oncology.
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Guardant Health and AnHeart Therapeutics Announce Collaboration to Develop Guardant360® CDx and Guardant360 Tissue
2/2/2023
Guardant Health and AnHeart Therapeutics Announce Collaboration to Develop Guardant360 ® CDx and Guardant360 TissueNext™ as Companion Diagnostics for Taletrectinib in Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.