Featured Story | By Annalee Armstrong While basking in the glow of the controversial approval for its Alzheimer’s treatment, Biogen has slipped in other news, announcing that a gene therapy candidate failed a late-stage clinical trial—yet again. The news marks Biogen's second gene therapy to fail in an eye disorder. The company said in an after-market release Monday that timrepigene emparvovec did not correct vision at month 12 in the rare genetic retinal disease choroideremia, which causes progressive vision loss and eventually blindness. read more |
| |
|---|
|
Top Stories By Kyle LaHucik Ex-FDA Commissioner Stephen Hahn, M.D., is joining Moderna incubator Flagship Pioneering six months after granting the company an emergency use authorization for its COVID-19 vaccine. read more By Nick Paul Taylor AstraZeneca’s anti-SARS-CoV-2 antibody combination has failed a phase 3 clinical trial designed to assess its ability to prevent symptomatic COVID-19 in people recently exposed to the pandemic coronavirus. However, while the study missed its primary endpoint, a subgroup analysis of people who were PCR-negative at baseline offered encouragement to AstraZeneca. read more Sponsored by: RBC Capital Markets Take a closer look at the SPAC phenomenon with Dr. David Hung, Founder and CEO of Nuvation Bio and Michelle Doig, Omega Funds Partner and President of its Omega Alpha SPAC. read more By Annalee Armstrong Biogen and Sage reported that the phase 3 Waterfall study met its main goal of improving depression symptoms over placebo in adult patients with major depressive disorder. But the effect of the therapy may wear off too quickly and some secondary goals were not met, raising a red flag about the treatment called zuranolone. read more By Amirah Al Idrus Umoja Biopharma emerged last November with $53 million and a mission to push past the limits of today’s immunotherapies. Now, the company is raising another $210 million to get its lead programs in bone cancer and blood cancer into the clinic. read more By Kyle LaHucik Alentis Therapeutics wants to bring the first anti-fibrotic treatment to address underlying liver and kidney diseases into the clinic, and a new cash infusion of $67 million will help. French private equity firm Jeito Capital and Chinese venture firm Morningside Venture Investments led the series B financing alongside existing backers like BioMed Partners. Alentis wants to advance into the clinic therapies that go after the novel target Claudin-1 to treat liver fibrosis, kidney fibrosis, hepatobiliary cancers and potentially other indications. read more By Kyle LaHucik CAMP4 Therapeutics, named for the camp closest to the top of Mount Everest, scaled closer to the peak of its solo mission Tuesday with $45 million in fresh capital. The company has spent the past 18 months quietly reinventing itself from a bioinformatics startup to a biotech that looks to restore gene expression through what it calls regulatory RNAs—ditching Big Pharma in the process. read more By Kyle LaHucik RayzeBio returns for round three of financing with a $108 million raise to go after radiopharmaceuticals in what the company bills as a better, more targeted approach to radiation. read more By Nick Paul Taylor VectorY Therapeutics has raised €31 million ($38 million) to fund preclinical work on gene therapies against amyotrophic lateral sclerosis (ALS) and Alzhiemer’s disease. Forbion led the seed financing in the Dutch developer of vectorized antibodies with the support of other investors including Eli Lilly. read more By Amirah Al Idrus Terns Pharmaceuticals is gearing up for a trial combining two NASH treatments, after one of them moved the needle on some non-invasive measures of the disease in a phase 2a study. The company plans to kick off the new trial in the first half of 2022. read more By Arlene Weintraub The 27-year-old diabetes drug metformin has been studied for its potential use in a wide range of other disorders, including heart disease and cancer. Now researchers led by the University of California, San Diego say the diabetes mainstay might help prevent lung inflammation in patients with COVID-19. read more By Noah Higgins-Dunn The Alzheimer's Association, which has been a leading advocate for Biogen's drug Aduhelm, said the drugmaker's roughly $56,000 per year list price is "simply unacceptable" and called on the company to change it. read more By Andrea Park After closing a handful of deals this year worth more than $1.7 billion, Exscientia is ready to start spending that hard-earned cash. First on its shopping list? Allcyte, an Austrian company developing an AI platform to predict how well cancer treatments will work. read more |  | LabConnect is the leader in innovative central laboratory services for cell and gene therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. |
Resources Sponsored by: Thermo Fisher Scientific Learn how the diagnostics industry is being fundamentally transformed with point-of-care molecular testing. Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by SDG Group Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. | 
