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Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

04/05/2024

Deep Cyclic Inhibitor of the MAPK pathway demonstrated strong tumor growth inhibition in preclinical studies of RAF or RAS mutant tumors, both as monotherapy and in combination – – Phase 1 portion of the Phase 1/2a trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IMM-6-415 and establish a candidate recommended…

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Nabriva Therapeutics Announces Positive Topline Results from Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

12/01/2022

– PK Data and Safety Profile Consistent with Previous Studies in Healthy Subjects – – Results Support Potential Utility of Lefamulin in Patients with Cystic Fibrosis – Excerpt from the Press Release: DUBLIN, Ireland and FORT WASHINGTON, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the…

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Guardant Health COSMOS Study Published in Clinical Cancer Research Validates Utility of Guardant Reveal™ Liquid Biopsy Test for Predicting Recurrence in Colorectal Cancer

08/15/2024

Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced Clinical Cancer Research, a journal of the American Association for Cancer Research, will publish results today from the COSMOS study confirming the high sensitivity and specificity of the Guardant Reveal blood test in predicting recurrence…

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BridgeBio Pharma Announces Dosing of First Patient in Phase 1/2 Trial of Investigational Gene Therapy for Congenital Adrenal Hyperplasia (CAH)

02/03/2022

– If successful, BridgeBio’s investigational gene therapy BBP-631 would be the first therapy for CAH to restore the body’s hormone and steroid balance by enabling people with CAH to make their own cortisol and aldosterone -Initial Phase 1/2 data readout anticipated in the second half of 2022 -BridgeBio’s gene therapy portfolio also includes a clinical stage…

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Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

09/29/2023

First Phase III results in breast cancer for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan Plans for global regulatory submissions underway Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival…

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Spero Therapeutics Announces Positive Topline Results from its Phase 3 ADAPT-PO Clinical Trial of Oral Tebipenem HBr in Complicated Urinary Tract Infection and Acute Pyelonephritis

09/08/2020

Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet medical need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced positive topline results from ADAPT-PO, the pivotal Phase 3 clinical…

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Kintara Presents Updates on Two Phase 2 Clinical Studies at the 2021 Society for Neuro-oncology Annual Meeting

11/23/2021

Excerpt from the Press Release: SAN DIEGO, Nov. 18, 2021 /PRNewswire/ — Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced data from two scientific posters for its Phase 2 clinical studies of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM). …

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The FDA’s Digital Health Center Of Excellence: Why It Matters And What It Means To You

11/23/2020

Excerpt from the Article: Last month, the US Food and Drug Administration (FDA) launched the Digital Health Center of Excellence (DHCoE), bolstering the shift toward digital that the healthcare industry has already been embracing. Investment in digital health is at an all-time high. The market cap created from nine IPOs in 2019 from companies in…

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CuraSen Therapeutics Announces Successful Completion of Phase 2 Safety, Tolerability and Proof of Concept Study in Patients with Parkinson’s Disease or Mild Cognitive Impairment (MCI) with CST-103/CST-107 Treatment

01/04/2023

Unique Combination of Beta2 Adrenoceptor Agonist (CST-103) and Beta Blocker (CST-107) Eliminated Known Agonist Adverse Events, Establishing Foundation for Longer-Term Clinical Studies Excerpt from the Press Release: SAN CARLOS, Calif.–(BUSINESS WIRE)–CuraSen Therapeutics, Inc., a clinical-stage company developing small molecule therapies to treat neurodegenerative disease, announced today positive top-line safety, tolerability and proof of concept data,…

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Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

11/09/2021

Excerpt from the Press Release: SAN FRANCISCO and SUZHOU, China, Nov. 4, 2021 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application…

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