| 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 Celgene slips as FDA refuses to review critical multiple sclerosis drug ozanimod AstraZeneca spinout bags $250M, pipeline headed by late-phase autoimmune drug Novo Holdings ponies up $165M for superbug venture fund [Sponsored] Launch Excellence: Is It Achievable? Inscripta bags $55M+ to push forward full CRISPR suite AI and facial diagnosis company FDNA sets up genomics coalition Xencor extends collaboration with Selexis to advance bispecific antibody programs Grail said to be planning IPO in Hong Kong to raise $500M Biogen, Novartis, Sanofi catch a break with holdup to Celgene MS prospect Featured Story | | | Wednesday, February 28, 2018 The FDA has refused to review a filing for approval of Celgene’s key pipeline prospect ozanimod. The agency hit the big biotech with the embarrassing refusal-to-file notice after concluding it had failed to provide the necessary preclinical and clinical pharmacology information on the multiple sclerosis drug. |
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Top Stories Wednesday, February 28, 2018 AstraZeneca has carved off six inflammation and autoimmune assets to create a new biotech, Viela Bio. The startup put together a $250 million series A round and a management team from its parent company to guide the mix of clinical and preclinical programs forward. Wednesday, February 28, 2018 Over a period of three to five years, Novo Holdings' new VC fund will invest between $20 million and $40 million per year in companies developing drugs against antimicrobial resistance. 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. Wednesday, February 28, 2018 Inscripta offers its CRISPR enzymes free of charge for R&D use, so the biotech is banking on selling instruments, software and reagents to customers to make its money. Wednesday, February 28, 2018 Boston biotech FDNA has teamed up with several research organizations to create a consortium that will try to apply artificial intelligence and machine learning to the development of new medicines—and it's looking for other partners. Wednesday, February 28, 2018 Monoclonal antibodies developer Xencor gained nonexclusive license to use Selexis-generated cell lines for the development, manufacture and commercial sale of XmAb antibody drug candidates. Wednesday, February 28, 2018 Grail, which seeks to develop liquid biopsies to catch cancer early, is looking at an initial public offering in Hong Kong, Bloomberg reported. Wednesday, February 28, 2018 Companies expecting competition from Celgene multiple sclerosis candidate ozanimod just got a reprieve. The big biotech revealed late Tuesday that the FDA refused to accept its approval application because of “incomplete” pharmacology data. And that means more time for its future rivals to rack up sales unchallenged. Resources 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! | 