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Moleculin issues acute myeloid leukemia drug data

Jim Cornall — Wed, 19 Jul 2023 09:24:12 +0000

Moleculin Biotech, Inc., a clinical stage pharmaceutical company with drug candidates targeting hard-to-treat tumors and viruses, has published data from its completed MB-105 European phase 1 clinical trial assessing the safety and efficacy of annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). ‘Results of a […]

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Crossbow Therapeutics launches with $80M to target cancer

Jim Cornall — Wed, 12 Jul 2023 09:57:20 +0000

Crossbow Therapeutics, Inc., a biotechnology company developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, has announced an $80 million Series A funding. The round was led by MPM BioImpact and Pfizer Ventures, with participation from Polaris Partners, BVF Partners, Eli Lilly and Company, Mirae Asset Venture […]

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Beyond Biotech podcast 52: Antiphospholipid syndrome

Jim Cornall — Fri, 30 Jun 2023 09:02:56 +0000

June is Antiphospholipid Syndrome (APS) Awareness Month. APS is a rare autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. There are two known forms. APS may occur in people with systemic lupus erythematosus, other autoimmune disease, or in otherwise healthy […]

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Key regulator of COVID viral receptor may be new drug target

Jim Cornall — Fri, 16 Jun 2023 08:45:00 +0000

Entry of the SARS-CoV-2 virus into human tissues depends on the activity of a host gene that regulates production of a key viral receptor, according to a study published in the open access journal PLOS Biology by Madison Strine and Craig Wilen of Yale University, U.S., and colleagues. The finding provides important new information on […]

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Nordic Bioscience cancer biomarker gets FDA go ahead

Jim Cornall — Thu, 15 Jun 2023 11:06:15 +0000

Danish biomarker company Nordic Bioscience says its PRO-C3 biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA). The letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies. Nordic Bioscience has a successful track record of developing and […]

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Sub-$100 genome sequencing the highlight of Complete Genomics’ 18th anniversary milestone

External Contributor — Thu, 15 Jun 2023 08:00:22 +0000

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CellCentric receives FDA Fast Track designation for relapsed refractory multiple myeloma drug

Jim Cornall — Tue, 13 Jun 2023 10:27:45 +0000

CellCentric has announced that the U.S. Food and Drug Administration (FDA) has granted its novel cancer drug, inobrodib, Fast Track designation for the treatment of patients with relapsed or refractory multiple myeloma. The FDA’s Fast Track designation is designed to aid the development of new treatments, expediting the review of drugs to treat serious conditions […]

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Kate Therapeutics launches with $51M to develop genetic medicines for muscle and heart diseases

Jim Cornall — Thu, 08 Jun 2023 09:45:00 +0000

Gene therapy company Kate Therapeutics Inc. (KateTx), has emerged from stealth mode with a $51 million Series A financing. In addition, the company has granted Astellas Pharma Inc. an exclusive, worldwide license to develop, manufacture and commercialize KT430 to treat X-linked myotubular myopathy (XLMTM). There are a large number of genetically defined and complex muscle […]

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von Willebrand disease treatment gets FDA orphan drug designation

Jim Cornall — Fri, 02 Jun 2023 08:50:00 +0000

The U.S. Food and Drug Administration (FDA) has granted Vega Therapeutics, Inc. orphan drug designation for its antibody therapy, VGA039, for the treatment of the rare bleeding disorder, von Willebrand disease (VWD). Vega Therapeutics is a clinical stage biotechnology company developing novel therapies for rare blood disorders. VGA039 is a first-in-class antibody therapy with a […]

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ElevateBio raises $401M for cell and gene therapies

Jim Cornall — Thu, 01 Jun 2023 09:30:00 +0000

ElevateBio, LLC (ElevateBio), a technology-driven company focused on cell and gene therapies, has closed its $401 million Series D financing. “We have made significant strides in scaling our technologies and end-to-end capabilities in our pursuit to become the world’s most indispensable cell and gene therapy technology company. We are thrilled to welcome Khalil to our […]

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Rocket Pharmaceuticals receives FDA designation for pyruvate kinase deficiency gene therapy

Jim Cornall — Fri, 26 May 2023 07:50:00 +0000

Rocket Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-L301, the company’s investigational lentiviral-based gene therapy for pyruvate kinase deficiency (PKD). PKD is a rare blood disorder characterized by severe anemia and excessive red blood cell breakdown. RMAT designation was granted based […]

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Ironwood acquires VectivBio in $1B deal

Jim Cornall — Tue, 23 May 2023 08:18:49 +0000

Ironwood Pharmaceuticals, Inc., a GI-focused healthcare company, and VectivBio Holding AG, a clinical-stage biopharmaceutical company pioneering novel, transformational treatments for severe rare gastrointestinal conditions, have entered into a definitive agreement for Ironwood to acquire VectivBio for $17.00 per share in an all-cash transaction with an estimated aggregate consideration of approximately $1 billion, net of VectivBio […]

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SiSaf siRNA therapy gets FDA designations to treat autosomal dominant osteopetrosis

Jim Cornall — Tue, 16 May 2023 09:00:00 +0000

SiSaf Ltd, an RNA delivery and therapeutics company, has announced that SIS-101-ADO, its siRNA therapeutic for patients with autosomal dominant osteopetrosis Type 2 (ADO2), has been granted orphan drug designation by the U.S. FDA. Also, due to the serious manifestations of this rare skeletal disorder in children, SIS-101-ADO has been granted rare pediatric disease designation […]

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New menopause drug gets FDA approval

Jim Cornall — Mon, 15 May 2023 15:15:00 +0000

The U.S. Food and Drug Administration has approved Astellas Pharma’s Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Astellas Pharma US, Inc.’s Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from […]

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Gilead boosts oncology pipeline with XinThera acquisition

Jim Cornall — Tue, 09 May 2023 14:00:00 +0000

Gilead Sciences, Inc. has announced the acquisition of all outstanding shares of XinThera, a privately held biotech company in San Diego. Gilead Sciences said the acquisition complements its existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Through the acquisition, Gilead Sciences gains the rights to a portfolio […]

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First drug discovered through 3D bioprinted tissue disease model

Jim Cornall — Wed, 03 May 2023 12:37:43 +0000

Viscient Bio, Inc. has announced it has identified the world’s first drug candidate discovered primarily using 3D bioprinted tissue models of disease formed from human cells. The company said it expects to develop the drug to treat non-alcoholic steatohepatitis (NASH), a growing epidemic disease that is believed to affect more than 10% of the U.S. […]

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Schizophrenia injection gets FDA approval

Jim Cornall — Tue, 02 May 2023 09:55:44 +0000

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell have announced the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls […]

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Six synthetic biology companies that have made a mark

Roohi Mariam Peter — Fri, 28 Apr 2023 11:10:20 +0000

The consequences of the climate crisis coupled with soil degradation and its impact on food and water security, seem dire. But, as ambitious as it may sound, synthetic biology companies could alleviate some of the environmental burden that the planet faces. As it involves the redesigning of organisms by genetically engineering them to have new, […]

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Vedanta Biosciences raises $106.5M for microbiome therapy

Jim Cornall — Thu, 27 Apr 2023 10:26:34 +0000

Vedanta Biosciences, a clinical-stage company developing a potential new category of oral therapies based on defined bacterial consortia, has raised $106.5 million. The funds will support pivotal-stage development of the U.S. company’s lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a phase 2 study of VE202 for ulcerative colitis, among […]

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Patients with asthma and other inflammatory lung diseases can be treated ‘in a fundamentally new way’

Jim Cornall — Thu, 27 Apr 2023 09:57:25 +0000

Arrowhead Pharmaceuticals Inc. has announced interim results from an ongoing phase 1/2 clinical study of ARO-RAGE, an investigational RNA interference (RNAi) therapeutic designed to reduce production of the receptor for advanced glycation end products (RAGE) as a potential treatment for inflammatory pulmonary diseases, such as asthma. These data represent the first clinical demonstration of the […]

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