| 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 Geron shares crater as Janssen bows out of imetelstat pact once worth up to $935M Alnylam eyes quickie givosiran filing after hitting interim goal Decibel adds first clinical candidate with Oricula license deal F-Prime, Atlas lead cancer startup Akrevia to $30M A round Bayer’s Americas pharma head takes CEO job at Selecta Biosciences FDA proposes stiff fines for pharmaceutical companies and CROs that fail to post clinical trial results online Antibody combo controls HIV for months Featured Story | | | Thursday, September 27, 2018 After a “strategic portfolio evaluation,” Janssen is quitting its imetelstat partnership with Geron, sending the latter's stock down 68% in premarket trading. |
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Top Stories Thursday, September 27, 2018 Alnylam is set to file for accelerated FDA approval of givosiran on the strength of interim data from a phase 3 trial. The readout linked the ALAS1-targeted RNAi to a statistically significant drop in urinary aminolevulinic acid, a biomarker Alnylam and the FDA think may predict clinical benefit. Thursday, September 27, 2018 Decibel just transformed itself into a clinical-stage biotech by licensing a phase 1 candidate from Seattle startup Oricula Therapeutics. Thursday, September 27, 2018 Akrevia Therapeutics has raised a $30 million series A round led by F-Prime Capital Partners and Atlas Venture. The financing sets up a team led by ex-Ariad and Intellia executives to advance a pipeline of immuno-oncology candidates. Thursday, September 27, 2018 Bayer’s Carsten Brunn, Ph.D., has been named president and CEO of Selecta Biosciences. He will take over following the retirement of Werner Cautreels, Ph.D., effective Dec. 1. Wednesday, September 26, 2018 In a draft guidance statement, the FDA proposed levying heavy fines on pharmaceutical companies and CROs that don’t post clinical trial results online. Wednesday, September 26, 2018 Many HIV patients have had a hard time adhering to their daily antiretroviral therapies. Now scientists have shown that combining two HIV antibodies could keep the virus in check for months, potentially relieving patients of their daily pill-taking routine. | This week's sponsor is ExL Events. | | | |
Resources 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 PepTalk: The Protein Science Week January 14, 2019 | October 19, 2018 – Early Deadline
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 Drug Development Immersion November 1-2, 2018 | Boston, MA Understanding Commercialization Within Biopharma Nov 7-8, 2018 | Boston, MA Drug Development Immersion December 5-6, 2018 | San Diego, CA BioBasics: Biotech For The Non-Scientist December 5-6, 2018 | Boston, MA Understanding Drug Pricing and Reimbursement December 12, 2018 | Boston, MA | 