News and Trends 5 Oct 2022 Transcenta monoclonal antibody gets FDA clearance Transcenta Holding Limited says its TST004 humanized monoclonal antibody targeting MASP2, has received IND clearance from the U.S. Food and Drug Administration (FDA). MASP2, mannose-binding protein-associated serine protease 2, is a key enzyme in the lectin pathway initiation of complement activation. Studies have shown that lectin pathway activation contributes to multiple human diseases such as […] October 5, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 4 Oct 2022 Aeglea BioTherapeutics updates homocystinuria program Aeglea BioTherapeutics, Inc. says dosing in the third cohort of the phase 1/2 clinical trial of pegtarviliase for the treatment of classical homocystinuria is under way. Patients in this cohort are receiving 1.35 mg/kg of pegtarviliase once weekly administered via subcutaneous injection; patients in cohorts 1 and 2 received doses of 0.15 mg/kg and 0.45 […] October 4, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 4 Oct 2022 FDA gives $1.3M grant to Biologics & Biosimilars Collective Intelligence Consortium The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review. The study, “Improving the Efficiency of […] October 4, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Oct 2022 FDA clears Kira Pharmaceuticals’ phase 2 trial for SLE-TMA treatment Kira Pharmaceuticals says the US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KP104, a first-in-class bifunctional biologic that selectively and synergistically targets the alternative and terminal complement pathways. A phase 2 trial will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with […] October 3, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Oct 2022 Poxel granted orphan drug designation for kidney disease treatment French biopharma company Poxel SA says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator – and is also a phase 2 ready ADPKD asset, subject […] October 3, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 29 Sep 2022 Treatment for adults with chronic skin condition approved by FDA The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases […] September 29, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 27 Sep 2022 Protocol for treatment of neurotrophic keratopathy submitted to FDA by ReGenTree Protocol for a second phase 3 clinical trial for a treatment for neurotrophic keratopathy (NK) – a degenerative disease of the corneal epithelium resulting from impaired corneal innervation, has been submitted. RegeneRx Biopharmaceuticals reported that its U.S. joint venture partner and licensee, HLB Therapeutics, together called ReGenTree, made the submission to the U.S. Food and […] September 27, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 26 Sep 2022 Acticor Biotech enrolls first U.S. patient in study for people with acute ischemic stroke The first U.S. patient was enrolled in a study evaluating glenzocimab in those with acute ischemic stroke. Acticor Biotech, a clinical stage biotech company, made the announcement today (September 26). The patient was enrolled at the CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by neurologist, Ruchir Shah. Significant potential He said: “I am very […] September 26, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 26 Sep 2022 Commercial launch of monkeypox PCR test for research use in laboratories worldwide A newly developed molecular polymerase chain reaction (PCR) test for monkeypox is now commercially available globally for research use only applications. Becton, Dickinson and Company (BD) and CerTest Biotec made the announcement today (September 26) that the test can be used in laboratories. The teams leveraged the BD MAX System open architecture reagent suite to develop […] September 26, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 23 Sep 2022 Knockback for drug to treat patients with relapsed or refractory multiple myeloma A Swedish biotech company says it believes its treatment could be the ‘canary in the coalmine’ despite a knockback. The Oncologic Drugs Advisory Committee (ODAC) has said it does not consider the treatment for patients with relapsed or refractory multiple myeloma (RRMM) favorable in a benefit-risk profile. Oncopeptides AB has been trialing Pepaxto in the […] September 23, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 22 Sep 2022 New phase 1 biomarker results reported by Glyscend Therapeutics for diabetes drug A U.S.-based biotech yesterday (September 21) reported additional biomarker results for a treatment of type 2 diabetes (T2D) from a phase 1 study. Glyscend Therapeutics, has been looking at orally administered drug GLY-200, which is a gut-restricted therapeutic. The company also received clearance from the U.S. Food and Drug Administration (FDA) on an Investigational New […] September 22, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 21 Sep 2022 FDA clears Cellenkos ALS drug for trial Cellenkos, Inc., a clinical stage biotech company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a phase 1 safety study followed by a phase 1b randomized, double blind, placebo control trial of CK0803, neurotrophic allogeneic Treg cells, in patients with amyotrophic lateral sclerosis […] September 21, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email