| This week's sponsor is Premier Research. | | | Opportunity Knocks: Seizing the Promise of Orphan Drugs
Orphan drug developers enjoy more favorable regulatory conditions today than ever. Read our white paper for tips on maximizing this opportunity. Premier Research. It's what we do. Best. |
Today's Rundown After Kerrisdale predictions of failure, Prothena dumps AL amyloidosis drug Synthetic Biologics loses breakthrough status after FDA discovers death imbalance in trial data Dicerna to pay Alnylam $15M plus stock to settle RNAi trade secrets suit [Sponsored] Can the SEC step in to support small businesses if Congress stalls? Sanofi diabetes research chief takes CSO post at Grünenthal Amid troubles, ex-Rosetta CEO Berlin parachuted in as new Advaxis head FDA still not happy with Kamada inhaled AAT drug Targeting heart disease by focusing on a protein that dilates blood vessels After some Thursday drama, Shire weighs Takeda's cash-sweetened $61.5B offer Featured Story | | | Monday, April 23, 2018 Prothena missed primary and secondary endpoints in its key AL amyloidosis drug NEOD001 in a midstage test, with predictions it also wouldn’t cut it in phase 3, leading the company to dump work on the therapy. |
|
|
| This week's sponsor is Deloitte. | | | |
Top Stories Monday, April 23, 2018 Synthetic Biologics has lost its breakthrough designation for ribaxamase following a review of the data by the FDA. The review revealed an imbalance in patient deaths in a phase 2b trial of the drug, leading the FDA to conclude ribaxamase no longer meets the requirements for its breakthrough status. Friday, April 20, 2018 Dicerna and Alnylam are settling a yearslong spat over trade secrets relating to RNAi gene-silencing technology. Monday, April 23, 2018 Congress is debating whether to include small businesses in the Senate’s bank bill. But the SEC has an opportunity to take action on SOX 404(b) on its own. Monday, April 23, 2018 Sanofi is set to lose its global head of diabetes research and translational medicine to Grünenthal. Philip Just Larsen, M.D., Ph.D., will join the German pain specialist at the start of July, leaving Sanofi looking for a diabetes research chief and CSO for its Frankfurt hub. Monday, April 23, 2018 Kenneth Berlin and Andres Gutierrez will join Advaxis as CEO and CMO, while CFO Sara Bonstein and interim CEO and Chief Business Officer Tony Lombardo depart. Monday, April 23, 2018 Israeli biotech Kamada has hit another hurdle in its marathon bid to bring the first inhaled treatment for alpha-1 antitrypsin (AAT) deficiency to market as an alternative to intravenous drugs. Monday, April 23, 2018 Scientists at Scripps Research Institute have pinpointed a protein that can sense blood flow and prompt tiny blood vessels called arterioles to dilate. They believe the protein, called GPR68, could be a valuable target for drug development. Saturday, April 21, 2018 The third time wasn’t the charm for Takeda in its attempts to swallow Shire—but the fourth time might be. On Friday, the Dublin drugmaker said Japan’s largest pharma offered £47 per share, almost half of that in cash, or about £44 billion ($61.6 billion). | This week's sponsor is PharmaCord. | | | |
Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
|
|
Resources Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. 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: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Explore a new model for events management, and learn how to deliver more value. Sponsored by: WCG Small biopharma companies are conducting almost 50% of the clinical trials in the US today, yet they face unique challenges that large pharma do not. In this paper, we explore some of those challenges, and solutions that can reduce the pressure on small biopharma teams and timelines. Sponsored by: Halo Pharma Why does confidence matter when outsourcing Fixed-Dose Combination products? Download Halo Pharma’s white paper on the importance of product design, technology, and analyticals tools for FDC. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? Presented by: Patheon, part of Thermo Fisher Scientific Patheon's Stephen Lam reviews the formidable challenges and decisions facing biopharma manufacturing executives. Watch as he shares unique insights and perspectives and demonstrates how there is really no one-size-fits-all solution in biomanufacturing, regardless of company size. Presented by: Charles River How do you get your oncology therapy to the clinic? The path isn’t always clear. In vitro, ex vivo, xenograft, syngeneic, PDX, humanized models, immunology considerations, safety regulations – which do you need to plan for and when? 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 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
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 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 Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 