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Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.
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The Dutch biotech’s stock dropped about 10% Tuesday morning after the company reported that its injectable Vyvgart Hytrulo missed the primary and secondary endpoints in an immune thrombocytopenia study.
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The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.
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Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
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Advancements in asthma biologics spell future hope for patients with severe asthma.
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The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Keep up with the regulator’s latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Ambrx Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalation Study Evaluating ARX517, a Proprietary PSMA-Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer
11/28/2023
Ambrx Biopharma today announced a clinical update regarding its proprietary anti-PSMA antibody drug conjugate (ADC) ARX517 in the ongoing APEX-01 Phase 1 / 2 dose escalation and dose expansion clinical trial in metastatic castration-resistant prostate cancer (mCRPC).
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Vaxcyte Appoints Jacks Lee to Board of Directors
11/28/2023
Vaxcyte, Inc. today announced the appointment of Jacks Lee to its Board of Directors.
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Femasys Inc. Completes Enrollment of FemaSeed Pivotal Trial in Support of Commercial Launch
11/28/2023
Femasys Inc. today announced completion of enrollment in the LOCAL FemaSeed® pivotal clinical trial, designed to evaluate women undergoing FemaSeed cycles due to male factor infertility.
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Immunovant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential
11/28/2023
Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults.
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Roivant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential
11/28/2023
Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults.
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The Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company’s Broad-Spectrum Antiviral Drug, Has Successfully Completed the First Part (Phase 1a), Reports NanoViricides
11/28/2023
NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully.
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Anika Announces First Surgeries Performed using the Integrity™ Implant System, a Regenerative Hyaluronic Acid-Based Patch System for Rotator Cuff Repairs, Commencing Limited Market Release
11/28/2023
Anika Therapeutics, Inc. today announced that the first surgeries using the Integrity Implant System were successfully performed by Dr. Christopher Baker at the Florida Orthopaedic Institute in Tampa, FL.
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Derm-Biome Pharmaceuticals Announces Collaboration with Massachusetts General Hospital in Skin Cancer Study
11/28/2023
Derm-Biome Pharmaceuticals Inc is excited to announce that it is collaborating with Dr. Anna Mandinova from the Department of Dermatology at Massachusetts General Hospital in a skin cancer study.
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Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn
11/28/2023
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the U.S. commercial availability of VOQUEZNA® (vonoprazan).
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CellChorus Appoints Andrew Last, PhD, to Board of Directors
11/28/2023
CellChorus Inc., the leader in applying artificial intelligence to visually evaluate how cells perform and interact over time, announced the appointment of Andrew Last, PhD, to its board of directors.
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Rosalind Franklin University Innovation and Research Park Welcomes Three Squared Biosciences, Focused on Gut Microbiome Solutions for Chronic Diseases
11/28/2023
Rosalind Franklin University of Medicine and Science announces a new tenant in its Innovation and Research Park
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Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults
11/28/2023
Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.