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 Rubius raises $100M in crossover round as cell therapies near human testing Oxford BioTherapeutics raids Celgene for CMO as I-O trial plan takes shape With $36M series B, Finch goes full speed ahead in microbiome therapy [Sponsored] Launch Excellence: Is It Achievable? FDA pushes back PDUFA date on Allergan’s uterine fibroid drug Pancreatic stem cell discovery opens door to regenerative treatments for diabetes PPD to run ‘patient concierge’ trial service Featured Story | Thursday, March 1, 2018 Rubius Therapeutics has pulled in another $100 million to fund the advance of its red blood cell therapies. The crossover round, which brings Rubius’ nine-month haul to $220 million, comes as the Flagship Pioneering startup races to get its manufacturing and clinical development activities up and running. |
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| Top Stories Thursday, March 1, 2018 Oxford BioTherapeutics has lured Abderrahim Fandi, M.D., Ph.D., away from Celgene to serve as its CMO. The appointment puts Fandi in charge of developing OBT’s immuno-oncology candidates. Thursday, March 1, 2018 The funding will propel Finch's C. difficile treatment through phase 2 and advance its earlier-stage pipeline. 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. Thursday, March 1, 2018 Allergan's ulipristal acetate aced a pair of phase 3 trials, prompting the company to submit an NDA in 2017. The company anticipated the PDUFA date would fall in the first half of the year. Wednesday, February 28, 2018 Scientists at the Diabetes Research Institute have confirmed the existence of stem cells in the pancreas that can develop into insulin-producing beta cells. Thursday, March 1, 2018 As biopharmas continue to struggle to recruit and retain patients in their clinical trials, PPD and Acurian are hoping to make the process easier by running a new “concierge service.” 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 BioBasics: Biotech for the Non-Scientist March 29-30, 2018 | Boston, MA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! |