To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

December 06, 2017

Today's Rundown

Featured Story

Biotech veteran Gilman is back, heading up next-gen CAR-T startup Obsidian

Michael Gilman went into retirement when Bristol-Myers Squibb bought out his Padlock Therapeutics venture last year, but has made a comeback at the helm of a new company promising to transform cell and gene therapies.

Top Stories

After Synta merger, Madrigal’s NASH drug hits liver fat in midstage test

Madrigal Pharmaceuticals has seen some positive snapshot data coming out of its phase 2 fatty liver disease test using an old Roche medication.

U.K.’s Brexit skeptic defying biopharma deal splash fizzles 

The United Kingdom government has unveiled its highly anticipated deal with the life sciences sector. As previously leaked, the document details planned investments from drug developers including GlaxoSmithKline, although many of the commitments are vague or already known.

Amgen, Carmot ink backloaded $240M Parkinson’s pact

Amgen has struck a deal with Carmot Therapeutics worth a potential $240 million. The alliance tasks Carmot with using its lead-identification technology to provide Amgen with a stream of prospects against conditions including Parkinson’s disease.

Galectin plunges on NASH cirrhosis midstage miss

Galectin Therapeutics was down nearly 50% in premarket trading Tuesday on the news that its lead fibrosis candidate missed the primary endpoint of a phase 2b trial in NASH cirrhosis.

Quebec's Amorchem sets up $44M+ life sciences VC

With the launch of its $44.2 million life sciences venture capital fund, the AmorChem Group now has $86 million under management.

On back of Roche pact, newly formed Ncardia wins iPSC deal with Evotec

Less than three months after coming to life via a merger of Pluriomics and Axiogenesis, human-induced pluripotent stem cell expert Ncardia has signed disease-modeling licensing deals with Roche and Evotec.

FDA releases long-awaited guidance on 3D printed products

In a much-anticipated action, the FDA released its first-ever technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue.

Resources

[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 biopharma companies are bolstering R&D pipelines through deal-making

Sourcing research externally seems to be the preferred path for biopharma companies to strengthen their R&D pipeline.

[Whitepaper] 5 Steps to Managing Quality Globally

Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives.

[Whitepaper] Growing Regulatory’s Strategic Value: The Value of a Holistic RIM Capability

Read Deloitte Consulting's whitepaper on the value of a holistic RIM capability, covering the potential cost savings and revenue gains from doing RIM right.

[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.

[Whitepaper] eClinical Landscape Study from Tufts Center for the Study of Drug Development

See the results from one of the largest, most in-depth surveys of clinical data management professionals on data management practices, performance, and challenges.

[Whitepaper] Modernize Quality Management

Gain a complete, real-time view of quality and streamline operations. Incorporate partners into processes for critical oversight and 30% greater efficiency, and transform cross-functional processes like change control.

[Whitepaper] DSM Looks to Challenge Traditional Stent Graft Materials with its Dyneema Purity® Membrane Edit

Discover DSM's Dyneema Purity® membrane, an effective and efficient material to construct stent grafts used in minimally invasive surgeries to treat both cardiovascular and peripheral arterial diseases.

[Whitepaper] Meeting the Challenge of Appropriate Safety Report Distribution

As clinical trials become more complex, safety document distribution to investigative sites has reached the point that demands a solution.

[Webinar] Discover tested and proven solutions to manage territory vacancies

December 5, 2017 | 2pm EST / 11am PST

Join this webinar to learn methods that maintain and build sales momentum despite turnover.

[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

.