Today's Rundown Pfizer eyes ATTR cardiomyopathy filing for tafamidis after acing phase 3 trial Esperion’s cholesterol drug cuts LDL-C in phase 3 Y-mAbs preps $92M IPO to push lead assets through regulatory filing Chinese biotech Harbour lands $85M to run cancer trials Novartis farms out rare disease drug to LifeMax Labs Substance abuse, neurological disease and more can speed up brain aging With Kymriah nod in EU, Novartis is building a plant with up to 450 jobs Featured Story | | | Monday, August 27, 2018 Pfizer’s tafamidis for the rare disease transthyretin amyloidosis (ATTR) has hit the mark in a phase 3 trial, setting up regulatory filings and a challenge to rival ATTR drug developers Alnylam and Ionis/Akcea. |
|
|
Top Stories Monday, August 27, 2018 A phase 3 trial has found that adding Esperion’s bempedoic acid to Zetia lowers LDL cholesterol more than the statin alone. The result sets Esperion to file for approval in the U.S. early next year, although a delay to its closely watched safety trial means doubts about its prospects will linger until October. Monday, August 27, 2018 Y-mAbs Therapeutics filed to raise up to $92 million in its IPO to advance a clutch of monoclonal antibodies for childhood cancers, including a pair of pivotal-stage medications for brain cancers, through to regulatory submission. Monday, August 27, 2018 Shanghai-based biotech Harbour BioMed has raised $85 million (€73 million). The series B equips a leadership team that cut its teeth at leading multinational drugmakers to advance autoimmune and cancer candidates through the clinic. Monday, August 27, 2018 Novartis is licensing a treatment for Netherton syndrome, a rare genetic disorder, to LifeMax Laboratories, a biotech based in the San Francisco area looking to address diseases that have limited treatment options. Monday, August 27, 2018 Decreased blood flow and destruction of blood vessels in the brain have been linked to aging and age-related dementia. Using a large-scale brain imaging study that looked at cerebral blood flow, researchers have identified several conditions that cause the brain to age faster. Monday, August 27, 2018 With the approval in Europe of its CAR-T cancer drug Kymriah, Novartis figures demand will call for more production. To crank that capacity up, the drugmaker will build a plant in Switzerland that eventually may employ 450 workers. | This week's sponsor is ExL Events. | | Let’s talk about success: Technology transfer with a CMO partner | ExL's 5th Technology Transfer for Biologics Conference
Gain expert insights on how to create successful partnerships with CMOs and the partnership management skills needed to maintain biologics quality at every step of process transfer.
View the full agenda —Save 15% with code FIERCE |
Resources 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: Health Strategies Group The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch. Sponsored by: Patheon, part of Thermo Fisher Scientific “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure. Sponsored by: PharmaCord When was the last time your patient support program perfectly aligned with the patient journey, solving all the critical gaps in positioning your brand for success? Follow the 3-D approach to your solution design, and you will achieve a better outcome for your patients. Sponsored by: WCG Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online RESI HealthTech Week September 5-7, 2018 | Boston, MA 2018 Latin America Healthcare Compliance Certification Program September 24-27, 2018 | Sao Paulo, Brazil Drug Development Immersion September 26-27, 2018 | West Windsor, NJ 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 2018 BIO Investor Forum October 17-18, 2018 | Westin St. Francis, San Francisco, CA FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation Field Service Amsterdam November 27-28, 2018 | NH Collection Amsterdam Grand Hotel Krasnapolsky | 