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Hits, but mostly misses for Roche’s 4 late-stage trials of GI drug hopeful etrolizumab Battered and bruised Seres Therapeutics see shares skyrocket on phase 3 win AbbVie infectious disease exec jumps ship to COVID antiviral biotech WCLC: Xcovery's Xalkori challenger shines in phase 3 lung cancer showdown Dyne Therapeutics grabs $115M to ramp up muscle disease pipeline Don't forget to nominate 2020's fiercest women in life sciences GigaGen’s polyclonal antibody against COVID-19 outperforms plasma in lab tests FDA approves Guardant’s tumor-sequencing blood test as a Tagrisso lung cancer diagnostic Featured Story | By Ben Adams Roche’s batch of phase 3 tests of its experimental GI drug etrolizumab has not gone to plan, with “mixed results” highlighting a murky picture for its ulcerative colitis program. read more |
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Top Stories By Ben Adams Seres Therapeutics has endured a tough few years of trials setbacks, cuts and new management, but the GI biotech is hoping with its new set of broadly positive late-stage data it can finally file for an approval. read more By Ben Adams AbbVie and Roche alum Janet Hammond, M.D., Ph.D., Sc.M., F.C.P. has nabbed the chief development officer role at infectious disease biotech Atea Pharmaceuticals. read more By Amirah Al Idrus Xcovery pitted its ALK inhibitor against Pfizer’s Xalkori—the first FDA-approved drug of that class—and came out on top. The drug, ensartinib, shrank tumors in three-quarters of lung cancer patients, compared to Xalkori’s 67%, and staved off cancer for two years, more than double the time Xalkori logged. read more By Amirah Al Idrus Dyne Therapeutics is back at the VC well—this time, it’s raising $115 million to bankroll a pipeline of treatments for muscle diseases including its lead programs for Duchenne muscular dystrophy and two other muscle-wasting diseases. The company is looking at cardiac and metabolic muscle diseases in its discovery-stage work. read more By Amirah Al Idrus There’s still time to send us your nominations for this year’s Fiercest Women in Life Sciences! We’re looking for women in biotech, pharma and medtech who, in spite of challenges both unique to the industry and to being female, stand out as leaders, innovators and mentors. Submissions close next Monday. read more By Arlene Weintraub San Francisco startup GigaGen team took plasma from 50 COVID-19 survivors in Louisiana and used it to quickly create a polyclonal antibody to fight the disease. The antibody was 100 times more protective against the disease than convalescent plasma in lab tests and is headed to clinical trials early next year. read more By Conor Hale Guardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, High Quality, GMP) manufacture for pre-clinical to commercial supply. Now part of the Cognate BioServices family, Cobra has rebranded – look around our updated website. |
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Resources Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. 18th Annual Discovery on Target Virtual September 16-18, 2020 Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now. | COVID19 provisions – training will be on-site as normal. | New – may be possible for some individuals to access the training virtually in real time. | 