Month: July 2023

C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer

07/17/2023

Excerpt from the Press Release: WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA)…

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Oxford BioTherapeutics brings Phase Ib trial with OBT-076 to Europe

07/14/2023

Oxford BioTherapeutics expanded its US-based trial investigating OBT-076 as monotherapy and combination treatment to European sites. Excerpt from the Press Release: UK-based oncology company Oxford BioTherapeutics has initiated a Phase Ib trial evaluating OBT-076 in patients with solid tumours at a European site. The company dosed the first patient with its CD205 targeting antibody-drug conjugate…

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Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage will likely follow

07/13/2023

Excerpt from the Press Release: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who…

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Blue Lake Biotechnology Doses First Child in Clinical Trial of Novel Intranasal Vaccine Against Respiratory Syncytial Virus

07/12/2023

Excerpt from the Press Release: ATHENS, Ga. and LOS GATOS, Calif., June 29, 2023 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of…

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Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the treatment of NRG1+ pancreatic cancer

07/11/2023

Excerpt from the Press Release: UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 29, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment…

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Panavance Therapeutics Announces Publication of Encouraging Preclinical Data Evaluating GP-2250 for the Treatment of Merkel Cell Carcinoma (MCC)

07/10/2023

Data indicate that GP-2250 has anti-neoplastic effects in virus-negative MCC cells as evidenced by tumor cell viability, proliferation and migration GP-2250 demonstrated ability to downregulate protein expression of aberrant tumorigenic pathways in virus-negative MCC cell lines Excerpt from the Press Release: BERWYN, Pa., June 29, 2023 (GLOBE NEWSWIRE) — Panavance Therapeutics Inc. (“Panavance” or the…

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Capricor Therapeutics Announces Positive 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy

07/07/2023

-Improvements in Left Ventricular Ejection Fraction (LVEF) for the M ajority of Patients Suggest Preservation of Cardiac Function- -Results in Performance of the Upper Limb PUL v2.0 Continue to Show Long-Term Benefit in Skeletal Muscle Function (p=0.02)- -Safety and Efficacy Results Continue to Suggest Potential Disease Attenuation in Duchenne Muscular Dystrophy (DMD) Excerpt from the…

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CAAP® – Building Companies | Application deadline: August 6, 2023

07/06/2023

The OBIO® Capital Access Advisory Program (CAAP®) operates downstream from existing entrepreneurship programs and focuses on accelerating technology commercialization, working towards Series A financing and strategic partnerships. OBIO’s CAAP® creates high value deal flow for both companies and investors, culminating with a presentation at the OBIO® Investment Summitin 2024. Click the button below to read…

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ArteraAI Announces First-Ever AI-Derived Biomarker for Predicting Androgen Deprivation Therapy (ADT) Benefit in Prostate Cancer

07/06/2023

Data published in the NEJM Evidence shows promise for personalized use of short-term ADT in men with predominantly intermediate-risk prostate cancer Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–ArteraAI, the developer of multimodal artificial intelligence-based predictive and prognostic cancer tests, announced today the publication of data in the NEJM Evidence, validating the first-ever predictive AI…

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New Data Demonstrating Stable Biochemical and Symptom Levels with Two-Years of Oral Paltusotine Administration Presented at ENDO 2023

07/05/2023

Early-Stage Candidates for Primary Hyperparathyroidism and Thyroid Eye Disease Also Featured Crinetics’ Founder & CEO, Scott Struthers Accepted John D. Baxter Prize for Entrepreneurship from ENDO President Excerpt from the Press Release: SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) presented efficacy, safety and patient-reported outcome (PRO) data at ENDO 2023…

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