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News and Trends 16 Jun 2023

Key regulator of COVID viral receptor may be new drug target

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 […]

June 16, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 15 Jun 2023

Nordic Bioscience cancer biomarker gets FDA go ahead

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 […]

June 15, 2023 - 3 minutesmins - By Jim Cornall

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

June 15, 2023 - 8 minutesmins - By External Contributor

News and Trends 13 Jun 2023

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

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 […]

June 13, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 8 Jun 2023

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

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 […]

June 8, 2023 - 4 minutesmins - By Jim Cornall

blood bleeding disorders von Willebrand disease

News and Trends 2 Jun 2023

von Willebrand disease treatment gets FDA orphan drug designation

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 […]

June 2, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 1 Jun 2023

ElevateBio raises $401M for cell and gene therapies

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 […]

June 1, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 26 May 2023

Rocket Pharmaceuticals receives FDA designation for pyruvate kinase deficiency gene therapy

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 […]

May 26, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 23 May 2023

Ironwood acquires VectivBio in $1B deal

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 […]

May 23, 2023 - 5 minutesmins - By Jim Cornall

Osteopetrosis ADO2 radiopaedia case ID 8037

News and Trends 16 May 2023

SiSaf siRNA therapy gets FDA designations to treat autosomal dominant osteopetrosis

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 […]

May 16, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 15 May 2023

New menopause drug gets FDA approval

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 […]

May 15, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 9 May 2023

Gilead boosts oncology pipeline with XinThera acquisition

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 […]

May 9, 2023 - 3 minutesmins - By Jim Cornall

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