This week's sponsor is Premier Research. | | New Insights in the Battle Against Alzheimer’s Thanks to awareness efforts like World Alzheimer’s Day this Friday, there’s a relentless focus on finding breakthrough therapies for this ravaging disease. Our new white paper looks at how we’re combating this growing epidemic. Premier Research. It’s what we do. Best. | Today's Rundown TG stock sinks after setback to blood cancer trial Morphic raises $80M to test its oral integrin-based drugs Reata’s bardoxolone hits goals in phase 2 kidney disease trial AzurRx’s chronic pancreatitis drug hits the mark in phase 2 Arena 3 for 3 as Crohn’s drug meets proof-of-concept test Gemphire cuts 33% of staff, including CFO, CMO Novartis whacking nearly 2,000 manufacturing jobs to pump up margins Special Report—The top 10 drugmakers of 2024 Featured Story | Tuesday, September 25, 2018 TG Therapeutics has abandoned plans to seek accelerated FDA approval of its ublituximab-umbralisib combination in chronic lymphocytic leukemia. The biotech made the decision because its phase 3 overall response rate data “were not sufficiently mature to conduct the analysis.” |
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| Top Stories Tuesday, September 25, 2018 Morphic Therapeutic brought in $80 million to carry its two lead integrin-targeting programs through their clinical proof-of-concept studies, as well as to help move several additional programs into the clinic. Tuesday, September 25, 2018 Reata Pharmaceuticals’ bardoxolone has improved kidney function in patients with IgA nephropathy and Type 1 diabetic chronic kidney disease. The phase 2 trial linked the Nrf2 activator to improvements in estimated glomerular filtration rate, a measure of kidney damage. Monday, September 24, 2018 AzurRx Biopharma, along with partner Mayoly Spindler, announced that its lead asset met its primary and secondary endpoints in a phase 2a trial. The drug, a recombinant lipase, is designed to treat an enzyme condition linked to chronic pancreatitis. Tuesday, September 25, 2018 Arena Pharma says its cannabinoid receptor-targeting drug olorinab could help treat the pain associated with Crohn’s disease, one of the most debilitating symptoms of the inflammatory bowel disorder. Tuesday, September 25, 2018 Gemphire is cutting its staff in a bid to cut costs and save cash after the FDA requested more preclinical data for its only drug, gemcabene, in dyslipidemia indications. Tuesday, September 25, 2018 Novartis’ traditional pill manufacturing will shoulder the brunt of a cost-cutting effort announced Tuesday as it looks to a future in biologic drugs and higher margins. Tuesday, September 25, 2018 The top 10 drugmakers in 2024 will hold 35% of the total biopharma market share, or more than $420 billion in sales that year. This week's sponsor is ExL Events. | | | Resources Presented by: Catalent Learn the best strategies for attracting investors in early phases of development and for overcoming formulation challenges. Sponsored by: Amazon Web Services Download our new eBook to learn how Healthcare and Life Sciences organizations are taking advantage of solutions from AWS and the AWS Partner Network to obtain value from critical data. Sponsored by: Reprints Desk, Inc. Go from Search to Full-Text Scientific Papers in a Single Click! Sponsored by: Covance FSPx Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries. Sponsored by: Covance FSPx Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries. Sponsored by: Docusign Life sciences companies must immediately identify and realize productivity gains to drive down operational costs—or risk seeing more nimble competitors disappear into the distance. Where to begin? Sponsored by: Veeva A top 20 pharma and growing biotech re-engineer regulatory processes. Sponsored by: Sciformix Are automation, big data and artificial intelligence (AI) a key part of your company’s pharmacovigilance strategy? Read this whitepaper to know what they should be! Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. Sponsored by: Patheon, part of Thermo Fisher Scientific When developing a parenteral, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. Sponsored by: Baxter Baxter BioPharma Solutions’ whitepaper offers a method to address the challenges of tech transfer for lyophilized products from lab-scale to commercial-scale. Sponsored by: Blue Matter A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them. Sponsored by: AWS and Tableau Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children. Sponsored by: AWS and Reltio Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS. Presented by: AWS and Druva Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Drug Development Boot Camp® 2018 – Registration closes 30 October - Register Now! November 14-15, 2018 | Boston, MA | Registration closes on the 30 of October 2018 due to the need for participants to complete pre-Boot Camp preparations. Register now and start preparing for this intensive training in drug development. AI World Conference and Expo 2018 Monday, December 3, 2018 | 10/5/18 – Early Deadline 2018 Latin America Healthcare Compliance Certification Program September 24-27, 2018 | Sao Paulo, Brazil FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL Fierce Innovation Awards: Life Sciences Edition 2018 Welcome to the inaugural Neuromuscular Drug Development Summit October 29-31, 2018 | Boston, MA, USA FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Understanding Commercialization Within Biopharma Nov 7-8, 2018 | Boston, MA Drug Development Immersion December 5-6, 2018 | San Diego, CA Understanding Drug Pricing and Reimbursement December 12, 2018 | Boston, MA |