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November 27, 2017

Today's Rundown

Featured Story

Innate hopes dosing tweak will save BMS-partnered lirilumab

Innate Pharma has admitted that it can’t see an obvious way to bring its cancer antibody lirilumab forward in development after it flunked a second clinical trial.

Top Stories

Regeneron scraps Eylea combination after phase 2 setbacks

Regeneron has halted development of an ophthalmic combination of nesvacumab and Eylea. The decision follows data from two phase 2 trials that tested angiopoietin 2 antibody nesvacumab in combination with Eylea.

Biogen inks Alkermes deal to defend multiple sclerosis turf

Biogen has struck a deal to protect its blockbuster multiple sclerosis franchise Tecfidera from the threat of Alkermes’ ALKS 8700. The deal gives Biogen the exclusive worldwide rights to a candidate designed to match the efficacy and better the safety of a cornerstone of its commercial operation.

[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.

Merck places £1B bet on R&D in post-Brexit Britain

Merck is set to invest about £1 billion ($1.3 billion) to open a drug discovery facility in London. The decision is a vote of confidence in the United Kingdom at a time when it is struggling to convince companies they will thrive in the country after Brexit.

Riding on booming drug sales, AstraZeneca forms $133M China joint venture

As fellow Big Pharma GlaxoSmithKline, Eli Lilly and Pfizer are scaling back some of their activities in China, AstraZeneca is doubling down on the market through a new drug development joint venture with a state-backed private equity firm.

After rare disease failure, Biohaven pushes the gas on oral migraine drug

Biohaven Pharma has completed patient recruitment in a late-stage trial of migraine candidate rimegepant, which is looking like its best pipeline prospect after its rare-disease candidate hit a snag last month.

Merck will delay filing Ebola vaccine for approval until 2018, company confirms

Despite a frantic effort to rush Ebola vaccines through testing during a deadly epidemic, Merck & Co. will fall short of its goal to file its candidate for FDA approval this year, the company confirmed Tuesday. Merck is now aiming for next year.

More bad news for Bayer/Nektar inhaled antibiotic alliance

Just days after their lead drug-device combination was voted down by FDA advisors, Nektar and Bayer have been hit by a phase 3 failure in another partnered program.

Resources

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[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.

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

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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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