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 Share WhatsApp Twitter Linkedin Email
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 Share WhatsApp Twitter Linkedin Email
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 Share WhatsApp Twitter Linkedin Email
News and Trends 3 May 2023 First drug discovered through 3D bioprinted tissue disease model 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. […] May 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 May 2023 Schizophrenia injection gets FDA approval 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 […] May 2, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
Best in Biotech 28 Apr 2023 Six synthetic biology companies that have made a mark 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, […] April 28, 2023 - 8 minutesmins - By Roohi Mariam Peter Share WhatsApp Twitter Linkedin Email
News and Trends 27 Apr 2023 Vedanta Biosciences raises $106.5M for microbiome therapy 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 […] April 27, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Apr 2023 Patients with asthma and other inflammatory lung diseases can be treated ‘in a fundamentally new way’ 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 […] April 27, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Apr 2023 Biogen ALS drug gets FDA ok The U.S. Food and Drug Administration (FDA) has approved Biogen’s QALSODY (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients […] April 27, 2023 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 20 Apr 2023 FDA approves Genentech’s lymphoma drug Genentech, a member of the Roche Group, has announced the U.S. Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP). The approval covers the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell […] April 20, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 17 Apr 2023 Aer Therapeutics raises $36M to tackle lung diseases Aer Therapeutics, a joint University College Dublin (UCD) and University of California, San Francisco (UCSF) biopharmaceutical spin-out company developing novel inhaled treatments for muco-obstructive lung diseases, has announced the closing of a $36 million Series A financing round.Funding was received from a syndicate of premier life science industry investors, including Canaan, OrbiMed, and Hatteras Venture […] April 17, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 4 Apr 2023 New research may lead to gene therapies for kidney disease Autosomal dominant polycystic kidney disease (ADPKD) is the most common potentially lethal genetic disease—about a half million people in the U.S. alone suffer from the condition. There is currently no cure, but new research could open the door to new gene therapies for treating most cases of this kidney disease. For several decades, researchers have […] April 4, 2023 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email