News and Trends 5 Dec 2022 First subject dosed in inflammation phase I study Innovent Biologics, Inc. and UNION therapeutics A/S have announced that the first Chinese healthy volunteer has been successfully dosed in the phase I study of orismilast, a potential best-in-class PDE4 inhibitor in global clinical phase II stage. This study is a multiple dose escalation phase I study in healthy volunteers aiming to evaluate the pharmacokinetic […] December 5, 2022 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
Interview 5 Dec 2022 Interview: why the recently approved fecal microbiome product is causing a rumble The news last week of the FDA approving Ferring Pharmaceuticals’ first fecal microbiome product, Rebyota, caused quite a stir in the field. The news was described as a huge step, a giant leap forward and simply fantastic. Paul Feurstadt is the director of non-inflammatory bowel disease research at the Medical Research Center of Connecticut. He also […] December 5, 2022 - 5 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 2 Dec 2022 Khondrion’s sonlicromanol produces encouraging results for next stage of study Biopharma company, Khondrion, has marked announced improvements from patients with MELAS spectrum disorders taking its lead asset, sonlicromanol. Updates were provided by the company from a 28-day double-blind, randomized placebo-controlled, three-way cross-over phase 2b study called KHNERGYZE in which 27 took part. It also reported updates on the ongoing, open-label extension KHEREREXT phase 2b study […] December 2, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 1 Dec 2022 FDA clears SparingVision’s investigational new drug application to treat ocular diseases SparingVision today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for SPVN06. The genomic medicine company has had its developing vision-saving treatments for ocular diseases, lead gene independent therapy for the treatment of retinitis pigmentosa (RP), a form of rod-cone dystrophy (RCD) and the most prevalent […] December 1, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 1 Dec 2022 Trial for HPV16 positive oropharyngeal cancer completes enrolment for phase 2 Netherlands-based ISA Pharmaceuticals B.V., has announced that it has completed enrolment in its phase 2 clinical trial. Named OpcemISA. The trial aims to checkpoint inhibitor therapy in patients with metastatic/advanced 1st and 2nd line HPV16 positive oropharyngeal cancer (OPC). The clinical stage biotech company is developing immunotherapies to treat cancers and infectious diseases, and has […] December 1, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
More News! 30 Nov 2022 FDA grants Sensorion Orphan Drug Designation for hearing loss drug Sensorion a clinical-stage biotechnology company has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to OTOF-GT, its lead gene therapy program for hearing loss. The drug is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion is on track to file a clinical trial application (CTA) […] November 30, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 30 Nov 2022 ‘Best hope yet’ as results from Alzheimer’s drug trial reveal huge step forward A huge step forward in dementia research has been hailed a truly historic moment by researchers working to find a cure for people with Alzheimer’s Disease. This is the first time a drug being trialed, lecanemab, has shown a reduction in the disease in the brain while slowing memory decline. Dr Susan Kohlhaas, director of […] November 30, 2022 - 6 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 28 Nov 2022 Molecure to conduct cancer treatment trial in Poland Molecure S.A. says the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has given the company permission to conduct the first clinical trial of OATD-02. The planned phase I trial will be an open-label, multi-center, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the […] November 28, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Nov 2022 Lyvgen and Bristol Myers Squibb commitment to transform cancer care Lyvgen Biopharma announced yesterday that it has started a phase 2 trial of LVGN7409 plus docetaxel or, in collaboration with Bristol Myers Squibb, nivolumab in patients with advanced/metastatic non-small cell lung cancer (NSCLC). “Lyvgen clinical collaboration with Bristol Myers Squibb underscores our commitment to exploring combination regimens from our portfolio with complementary mechanisms of action […] November 28, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 28 Nov 2022 STORM Therapeutics doses first patient with drug targeting solid tumors STORM Therapeutics Ltd, announced today that the first patient in a phase 1 study had been dosed with a drug targeting solid tumors. The biotech company works on discovering and developing new small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases. The patient was dosed with STC-15, STORM’s clinical candidate. It […] November 28, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
Interview 23 Nov 2022 What recent mixed clinical results can teach about Alzheimer’s disease 2022 has provided mixed fortunes for companies aiming to slow Alzheimer’s disease. Ulrich Dauer, CEO of the German biotech Vivoryon, explains the lessons these events provide. The quest for a treatment to slow the progression of Alzheimer’s disease has endured decades of disappointments. The most common treatment strategy — clearing up harmful deposits, or “plaques,” […] November 23, 2022 - 7 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 23 Nov 2022 Khondrion’s mitochondrial diseases treatment producing positive results Clinical-stage pharmaceutical company, Khondrion, discovering and developing therapies targeting primary mitochondrial diseases announced yesterday (November 22) its wholly-owned lead asset sonlicromanol for MELAS spectrum disorder has demonstrated positive treatment results. MELAS spectrum disorder is a rare progressive mitochondrial disease and sonlicromanol will move into a phase 3 registrational study supported by favorable benefit-risk profile. The […] November 23, 2022 - 5 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email