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March 01, 2018

Today's Rundown

Featured Story

Rubius raises $100M in crossover round as cell therapies near human testing

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.

Top Stories

Oxford BioTherapeutics raids Celgene for CMO as I-O trial plan takes shape

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.

With $36M series B, Finch goes full speed ahead in microbiome therapy

The funding will propel Finch's C. difficile treatment through phase 2 and advance its earlier-stage pipeline.

[Sponsored] Launch Excellence: Is It Achievable?

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.

FDA pushes back PDUFA date on Allergan’s uterine fibroid drug

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.

Pancreatic stem cell discovery opens door to regenerative treatments for diabetes

Scientists at the Diabetes Research Institute have confirmed the existence of stem cells in the pancreas that can develop into insulin-producing beta cells.

PPD to run ‘patient concierge’ trial service

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

[Whitepaper] Medical Device Innovation: Are You Outrunning The Competition?

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?

[Webinar] Driving Market Access through Patient Advocacy: Trends & Opportunities

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!

[Whitepaper] How Life Sciences Companies Use Box for Regulated Content in the Cloud

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.

[Whitepaper] CFO's, Is This Part Of Your Corporate TO DO List?

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

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals.

[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

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.

[Webinar] Validating a 7 Day Membrane Filtration Sterility Test using Celsis®

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.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

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.

Events

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