This week's sponsor is LabVantage. | | | Today's Rundown Kadmon clinical POC data raise expectations for IPF drug BTI files for $69M IPO to run trials in Alzheimer's and cancer Erytech doubles down on solid tumor trials for red cell drug therapy More executive reshuffling at Arcturus as CSO/COO resigns Charles River to acquire MPI Research for $800M, posts 10% 2017 revenue growth Celgene ex-CEO Hugin launches Senate run in New Jersey amid protest from drug-price critics Pfizer taps BC for real-world cardiovascular research drive Featured Story | Tuesday, February 13, 2018 Kadmon has posted clinical proof-of-concept data on its idiopathic pulmonary fibrosis (IPF) candidate KD025. The ROCK2 inhibitor had a stronger effect on forced vital capacity than standard of care, but the small, open-label nature of the study and lack of detail in the top-line data leave scope for doubts about its efficacy. |
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| Top Stories Tuesday, February 13, 2018 BioXcel Therapeutics (BTI) has filed to raise $69 million through a Nasdaq IPO. BTI will spend the cash on phase 2 trials of a once-failed cancer asset and an old drug repurposed for use in Alzheimer’s and schizophrenia. Tuesday, February 13, 2018 After disappointing data in leukemia, France’s Erytech is refocusing its red blood cell-encapsulated drug therapy to solid tumors—and will target triple-negative breast cancer in its next trial. Tuesday, February 13, 2018 Arcturus Therapeutics is losing its second executive in as many weeks: Pad Chivukula, the RNA biotech’s chief scientific officer and chief operating officer, is stepping down. He will take an advisory role. Tuesday, February 13, 2018 Following the recent acquisitions of Brains On-Line and KWS BioTest, Charles River Laboratories is once again mobilizing its M&A war chest, taking in nonclinical contract research organization MPI Research for about $800 million in cash. Tuesday, February 13, 2018 After weeks of speculation, former Celgene CEO Bob Hugin is confirming that he’s left Big Pharma to enter politics: He's announcing his candidacy for the U.S. Senate Tuesday. But the prospect of a pharma veteran running for Congress has been met with a mix of optimism and scorn. Tuesday, February 13, 2018 Pfizer has teamed up with BC Platforms to generate real-world evidence on cardiovascular diseases. The collaboration will leverage BC’s technology and Finnish health records to better understand atrial fibrillation patients. Resources Presented by: Box and USDM Life Sciences Learn how biopharma and medical device companies can now collaborate on, manage and distribute regulated clinical, lab and manufacturing content in Box. That means all of your content is standardized on a single content repository that meets regulatory and compliance standards, so you can eliminate inefficient silos, enable seamless collaboration and accelerate the validation process. Sponsored by: RBC Wealth Management Employee stock option trading & administration, Restricted stock transactions (Rule 144), Affiliated trading plans (10b5-1), Directed share plans, Equity comp plan administration — private to public Presented by: Patheon Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties. Presented by: SDC and Stiris Research What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? From study delays to quality issues, sponsors can find their studies at risk with no clear solution. Watch this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue. 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 Boot Camp® 2018 November 14-15, 2018 | Boston, MA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel BioBasics: Biotech for the Non-Scientist March 29-30, 2018 | Boston, MA Healthcare Internet of Things February 13-14, 2018 | Moscone South Convention Center | San Francisco, CA PEGS: The Essential Protein Engineering Summit April 30-May 4 | Boston, MA Partnering for Growth 2018 March 20th | 7:30 am-6 pm March 21st | 7:30 am-1:15 pm |