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ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
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The companies’ antibody-drug conjugate improved progression-free survival with a “trend in improvement” for overall survival in patients with HR-positive, HER2-low or negative breast cancer.
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The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
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Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
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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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In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.
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A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
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Morphic to Present Positive EMERALD-1 Phase 2a Data for MORF-057 in Patients with Moderate to Severe Ulcerative Colitis in Abstract for UEGW 2023
9/22/2023
Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the publication of an abstract discussing new EMERALD-1 phase 2a primary results.
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Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV
9/22/2023
Pfizer Inc. (NYSE: PFE) shared today it has broadened its portfolio of respiratory vaccines recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) following a favorable vote for ABRYSVO™ [Respiratory Syncytial Virus Vaccine], the company’s bivalent RSV prefusion F (RSVpreF) vaccine, as a maternal immunization.
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Conduit Pharmaceuticals and Murphy Canyon Acquisition Corp. Announce Completion of Business Combination
9/22/2023
Conduit Pharmaceuticals Limited and Murphy Canyon Acquisition Corp., a special purpose acquisition company (Nasdaq: MURF) (“MURF”), announced today the completion of the previously announced business combination (the “Transaction”).
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Abbott Completes Acquisition of Bigfoot Biomedical
9/22/2023
Abbott (NYSE: ABT) today announced it has completed the acquisition of Bigfoot Biomedical, a leader in developing smart insulin management systems for people with diabetes.
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US FDA approves Jardiance® for the treatment of adults with chronic kidney disease
9/22/2023
The U.S. Food and Drug Administration (FDA) has approved Jardiance.
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Vizient Announces Top Performers in Clinical Quality, Supplier Diversity and Environmentally Preferred Sourcing Excellence
9/22/2023
Vizient, Inc. today announced 2023’s top performers in clinical quality and supply chain excellence.
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Aidoc's AI Solution for Pulmonary Embolism Clinically Proven to Reduce Hospital Stay Duration and Improves Patient Access to Treatment
9/22/2023
University of Texas Medical Branch, Jamaica Hospital Medical Center and University of Chicago unveiled new impact data during the Pulmonary Embolism Symposium illustrating the importance of artificial intelligence in PE care.
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Qihan Biotech announces the completion of pre-Series B financing for developing stem cell-derived cell therapy products with high-throughput multiplexable genome editing
9/22/2023
Hangzhou Qihan Biotech Co., Ltd. today announced the successful completion of a pre-Series B financing exceeding $16 million funded by a new investor, Zhejiang Industrial Fund Co., Ltd., with participation from other existing investors.
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Vibrant Wellness Unveils Groundbreaking Toxin Genetics Test for Personalized Detox Protocols
9/22/2023
Vibrant Wellness introduces the Toxin Genetics Test, a cutting-edge addition to its suite of advanced functional lab tests.
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Coya Therapeutics Licenses Exclusive Worldwide rights to Exosome Engineering Technology (EET) from Carnegie Mellon University (CMU)
9/22/2023
Coya Therapeutics, Inc. today announced licensing of the exclusive, worldwide rights of a proprietary Exosome Engineering Technology from CMU with potential applications across multiple indications, including neurodegeneration, autoimmune, and oncology.
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Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
9/22/2023
Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze ® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma.
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Hillstream BioPharma Progressing Towards Acquiring Clinical Stage Asset and Announces Corporate Name Change to Tharimmune, Inc.
9/22/2023
Hillstream BioPharma Inc., announced a corporate name change to Tharimmune, Inc.
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Alex Hamlow Joins Seno Medical as Chief Revenue Officer
9/22/2023
Alex Hamlow has joined Seno Medical Instruments, Inc. as Chief Revenue Officer. Seno Medical is the leader in improving the process of diagnosing breast cancer and the pioneer of the Imagio® Breast Imaging System with opto-acoustic/ultrasound (OA/US) imaging technology.