| This week's sponsor is Premier Research. | | | ICH GCP guideline updates. Looking for the best insights?
The ICH Good Clinical Practice guidelines have been updated to reflect profound changes in how clinical trials run. Our white paper covers what you need to know. Premier Research. It's what we do. Best. |
Today's Rundown Lilly seeks to quickly advance—and if needed kill—novel drugs to avoid ‘pile-on effect’ in hot targets With Pfizer's 'pipeline surprise,' there's a new kid on the ATTR block Cash reserves running low at KemPharm [Sponsored] Highlighting Women Pioneers in Science & Medicine Gene therapy could promote healing in brain, spinal cord injuries EuroBiotech Report—Ablynx fail, MorphoSys IPO, Redx trial halt, NMD financing and C4XD Chutes & Ladders—Gilead’s oncology clinical director jumps to Compugen FiercePharmaAsia—Takeda’s Shire bid, WuXi AppTec’s and Aslan’s IPOs Featured Story | | | Friday, March 30, 2018 Eli Lilly is doubling down on novel mechanisms of action to steer clear of the “pile-on effect” seen in PD-1/PD-L1 and other hot targets. The Big Pharma wants to hightail novel approaches into the clinic and up to proof of concept before its rivals—and then kill off programs that fail to wow in phase 2. |
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Top Stories Thursday, March 29, 2018 Pfizer reported positive results from a phase 3 trial of tafamidis in transthyretin cardiomyopathy, a form of ATTR. The news drove down stocks for Alnylam and Ionis, both of which are developing drugs for hereditary forms of ATTR. Friday, March 30, 2018 Money is getting tight at KemPharm, with its liquid cash reserves—currently around $48.5 million—not expected to last through the first quarter of 2019. Monday, March 26, 2018 As leaders in science and business, two high-profile female CEOs have been instrumental in advancing medical breakthroughs and are champions for issues that affect women around the world. Thursday, March 29, 2018 Switching on the LZK gene in mice with spinal cord injuries resulted in a smaller scar, which UT Southwestern researchers hope will improve recovery. Thursday, March 29, 2018 In this week's EuroBiotech Report, Ablynx lupus drug fails midphase trial, MorphoSys files for $150 million IPO, Redx halts trial and more. Friday, March 30, 2018 Gilead’s director of oncology clinical research jumped to Compugen as CMO, a longtime Teva executive will become Dr. Reddy's new COO, Astellas named a new head of ethics & compliance, plus more hirings, firings and retirings throughout the industry. Friday, March 30, 2018 Takeda is weighing a potentially difficult buyout bid for Shire that could be worth $52 billion, WuXi AppTec wins approval for its $900 million-plus IPO in Shanghai, Aslan Pharma aims to raise $86 million through an IPO on Nasdaq and more. Resources Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. Sponsored by: DocuSign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Reprints Desk The competitive landscape in medical device R&D is tough. And simply investing in R&D is no guarantee for profitability. So how do you accelerate time-to-market? Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Presented by: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. Presented by: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented by: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented by: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented by: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored by: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA Understanding Drug Pricing and Reimbursement April 3,2018 | Washington, DC IRT Europe – Interactive Response Technologies in Clinical Trials April 10th-11th, 2018 | Brussels, Belgium Field Service USA 2018 April 17-April 20, 2018 | JW Marriott Palm Desert Resort & Spa, CA
Drug Development Immersion April 25-26, 2018 | New York City Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA BIO International Convention June 4-7, 2018 | Boston, MA
BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | Toronto, Canada BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | West Windsor, NJ Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 