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November 30, 2017

Today's Rundown

Featured Story

After R&D spree, Bayer changes up research unit as Busch heads for the door

After penning research deals potentially worth billions of dollars this month, German pharma Bayer is looking internally as it rings in the changes.

Top Stories

Semma scoops $114M to trial curative diabetes cell therapy

Semma Therapeutics has raised $114 million to take a potentially-curative Type 1 diabetes cell therapy through clinical proof of concept. The round positions Semma to start learning whether its insulin-producing cells can control blood sugar levels in diabetics. 

Novartis-backed resTORbio raises $40M for aging disease trials

Boston biotech resTORbio has pocketed another $40 million from a second-round financing that it hopes gives it enough cash to move its lead candidate for respiratory tract infections in elderly patients into phase 3.

[Sponsored] What makes a modern-day biotech?

Blue Latitude Health interviews 6 biotech leaders to reveal the commercial challenges and opportunities in 2018 and beyond, including big data, FDA approvals, combination therapies, empowered patients and the skills crisis.

MorphoSys sells China rights to Darzalex rival in $120M deal

MorphoSys has found a buyer for the Chinese rights to multiple myeloma candidate MOR202. The deal puts I-Mab Biopharma in charge of developing the CD38 antibody in China and neighboring territories in return for $120 million in upfront and milestone payments.

IDSA warns: Tax reform will hit infectious disease R&D

The Infectious Diseases Society of America warns that potential new tax changes from the government could hit biomedical research in major public health areas.

AliveCor gets first FDA nod for an Apple Watch accessory

AliveCor has gained clearance to sell a medical device accessory for Apple Watch. The regulatory nod covers AliveCor’s KardiaBand, a device that clips onto Apple’s smartwatch and performs EKG readings.

J&J, Gates Foundation and NIAID launch efficacy study for their 'global' HIV vaccine

As the scientific community continues to advance efforts to solve the global HIV and AIDS problem, Johnson & Johnson and partners on Thursday pushed their promising "mosaic" vaccine candidate into efficacy testing.

Gilead taps X-Chem’s DNA-encoded libraries for drug discovery

Gilead Sciences has teamed up with privately held X-Chem, which will screen its DNA-encoded libraries containing over 120 billion small molecules, in the hope of finding new drugs in antiviral and other therapeutic areas.

Resources

[Whitepaper] Accessing Scientific Literature Doesn’t Have To Be Like Scaling A Mountain

SO CLOSE AND YET SO FAR. Is that how many documents seem to you? Getting what you want—when, where, and how you want it—can be a real pain. That’s why we created this concise guide to getting around the obstacles that stand between you and the information your organization needs. Download the whitepaper to learn more.

[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] Accessing Scientific Literature Doesn’t Have To Be Like Scaling A Mountain

SO CLOSE AND YET SO FAR. Is that how many documents seem to you? Getting what you want—when, where, and how you want it—can be a real pain. That’s why we created this concise guide to getting around the obstacles that stand between you and the information your organization needs. Download the whitepaper to learn more.

[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.

[Whitepaper] Veeva 2017 Annual CRO Report: CROs lead the drive to a unified clinical model

CROs are leading an industry wide shift to modernize clinical systems and clinical trial processes.

[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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