This week's sponsor is Premier Research. | | Powerful Partners: The Growing Role of Patient Advocates We salute patient advocates on the vital role they play on Rare Disease Day, and every day. Read our white paper on how these patient groups are changing clinical research. Premier Research. It's what we do. Best. | Today's Rundown I-O biotech EpimAb poaches Novartis China cancer chief as CMO Generation Bio raises $100M for ‘druglike’ gene therapy DBV climbs as messy milk allergy data open door to phase 3 [Sponsored] Launch Excellence: Is It Achievable? NEA powers next-generation cell and gene therapy startup Senti to $53M series A round New York-based immunotherapy startup Quentis comes to life with $48M Anti-inflammatory biotech Aldeyra teams up with Janssen VolitionRx’s blood test spots 80% of early colorectal cancers Fresenius' $4.3B buyout of Akorn threatened by data integrity probe Featured Story | Tuesday, February 27, 2018 Early stage Chinese bispecific biotech EpimAb Biotherapeutics has snapped up Bin Peng, M.D., Ph.D, as its first chief medical officer. |
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| Top Stories Tuesday, February 27, 2018 Gene therapy startup Generation Bio has lost no time raising the resources it needs to take its programs forward into the clinic, closing a $100 million second-round financing just over a month after its $25 million series A. Tuesday, February 27, 2018 DBV Technologies has posted results from a midphase trial of its milk allergy candidate Viaskin Milk. The study detected a statistically significant desensitization to milk among a subgroup of participants, although the overall data set leaves questions unanswered as DBV prepares to discuss the next steps with regulators. Monday, February 26, 2018 Excellence is within reach. Learn how to earn distinction in today’s competitive healthcare marketplace by delivering the right drug to the right patient at the right time. Tuesday, February 27, 2018 New Enterprise Associates (NEA) has led a $53 million bet on the future of cell and gene therapies. The series A round sets up JLABS resident Senti Bioscience to use advances in synthetic biology to create more targeted, controllable therapies than are advancing down clinical pipelines today. Tuesday, February 27, 2018 Quentis Therapeutics is working on new and improved cancer immunotherapies by targeting the endoplasmic reticulum stress response, which has been linked to poor outcomes in certain tumor types. Tuesday, February 27, 2018 Aldeyra Therapeutics and Janssen inked a pact to develop new drugs for autoimmune and other inflammatory diseases. For a limited time, Janssen has the option to license any compounds developed under the deal. Tuesday, February 27, 2018 A blood test developed by VolitionRx detected 80% of stage 1 colorectal cancer cases and 66% of precancerous, high-risk adenomas at 78% specificity in a screening study. Tuesday, February 27, 2018 Fresenius’ $4.3 billion deal to buy out U.S. generics maker Akorn is in jeopardy as the two companies investigate allegations that Akorn violated FDA data standards during drug development. Resources 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: MK&A There’s no magic bullet to successful access but insights from patient advocates and industry experts can help shape future strategies. Learn how in this webinar. Sign up now! 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 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 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 Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! |