| This week's sponsor is LabVantage. | | | |
Today's Rundown Celgene spinoff debuts with big names, big bucks and big hopes Biogen tweaks Alzheimer’s phase 3, sparking stock slide Vertex’s big week continues as nonopioid pain drug clears second phase 2 test Santhera, reeling from DMD blow, lands cystic fibrosis drug Arbutus, Roivant in talks to launch new RNAi delivery company Cancer Research UK in $63M clinical trial boost FDA gives J&J's Erleada a quick push over the finish line with first-ever nonmetastatic prostate cancer nod Featured Story | | | Thursday, February 15, 2018 A Celgene spinout known as Celularity with some of the biggest names across biotech and Silicon Valley has raised an eye-watering $250 million for its work in cancer. |
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Top Stories Thursday, February 15, 2018 Biogen has spooked investors by disclosing midstudy changes to its late-phase Alzheimer’s program. The biotech is adding 510 patients to the phase 3 aducanumab trials after seeing more “variability” than expected in a sample size re-estimation. Thursday, February 15, 2018 Vertex Pharma now has a pair of studies backing up its new drug VX-150, suggesting it can provide opioidlike pain relief without the addiction risks. Thursday, February 15, 2018 Santhera Pharmaceuticals has licensed a clinical-phase cystic fibrosis asset from Polyphor. The Swiss biotech penned a CHF 127.5 million ($138 million) deal for the human neutrophil elastase inhibitor to expand its clinical pipeline. Thursday, February 15, 2018 Roivant and Arbutus Biopharma are negotiating the terms and conditions of setting up a new company to jointly develop the latter’s nucleic acid delivery platform. Thursday, February 15, 2018 British-based oncology R&D charity Cancer Research UK will inject £45 million ($63 million) across its clinical trial network in the U.K. Wednesday, February 14, 2018 Johnson & Johnson just got a head start over Pfizer and Astellas in nonmetastatic prostate cancer. J&J’s new drug apalutamide won FDA approval Wednesday, months ahead of schedule, and it’s now ready to scoop up market share before its rivals win a new, similar approval for their treatment, Xtandi. 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 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 | 