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September 25, 2017

Today's Rundown

  1. Pfizer launches upstart with $103M, phase 3-ready drugs

  2. FDA rejects Johnson & Johnson’s rheumatoid arthritis drug sirukumab on safety grounds, demands more data

  3. AstraZeneca, NewLink pen PD-L1 and IDO combination pact

  4. [Sponsored] Mindful Clinical Trials: What’s Risk-Based Monitoring Got to Do With It?

  5. Boost for Exelixis as partner Daiichi Sankyo cues up hypertension drug filing

  6. Gelesis’ pivotal obesity trial hits one endpoint, misses another

  7. Sensor captures bacteria's movements to measure antibiotic efficacy

  8. Bristol-Myers' I-O star Opdivo steps up to challenge Bayer's Stivarga in liver cancer

Featured Story

Pfizer launches upstart with $103M, phase 3-ready drugs

In a first for the Big Pharma and as part of a new model, Pfizer is taking drugs from its shelves and licensing them to, while investing in, its SpringWorks Therapeutics startup.

Top Stories

FDA rejects Johnson & Johnson’s rheumatoid arthritis drug sirukumab on safety grounds, demands more data

The FDA has delivered its expected rejection of Johnson & Johnson’s rheumatoid arthritis drug sirukumab. J&J is now assessing what it will take to quell the agency’s concerns about the safety of the IL-6 monoclonal antibody before deciding on a path forward.

AstraZeneca, NewLink pen PD-L1 and IDO combination pact

AstraZeneca has struck a deal to combine its anti-PD-L1 drug with NewLink Genetics’ IDO pathway inhibitor. The collaborators will jointly fund a phase 2 trial of the combination in pancreatic cancer patients.

[Sponsored] Mindful Clinical Trials: What’s Risk-Based Monitoring Got to Do With It?

RBM shouldn’t be a point of concern, but rather a point of validation of what matters. It’s, above all, an opportunity to practice mindfulness in collecting clinical trial data within the site-and patient-centric environment.

Boost for Exelixis as partner Daiichi Sankyo cues up hypertension drug filing

With a positive phase 3 trial in hand, Japan’s Daiichi Sankyo plans to file its essential hypertension therapy esaxerenone in its home market next year.

Gelesis’ pivotal obesity trial hits one endpoint, misses another

Gelesis has claimed success in a pivotal trial of its obesity candidate. More than half of participants who took the swelling hydrogel particles lost weight, encouraging Gelesis to file for approval despite missing the other co-primary endpoint.

Sensor captures bacteria's movements to measure antibiotic efficacy

Scientists at the National Institute of Standards and Technology have created a rapid test that indicates if an antibiotic fights a given infection, which could speed up treatments and reduce improperly prescribed antibiotics.

Bristol-Myers' I-O star Opdivo steps up to challenge Bayer's Stivarga in liver cancer

Bristol-Myers Squibb’s Opdivo has won another FDA approval—and the right to take on Bayer in liver cancer. The immuno-oncology standout is now cleared for patients who've already been treated with Bayer’s Nexavar, the same group targeted by the German drugmaker's follow-up drug Stivarga.

Resources

[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] Five ways to make your patient support program a success

Join this webinar to learn how to design, deliver, and measure a successful patient support program. Presented by Nareda Mills, Ashfield's SVP of Patient Services in the US, you’ll discover how to improve adherence and improve patient outcomes using 5 key methods.

[Whitepaper] The Impact of Contraceptive Requirements on Pediatric Clinical Trials

Children participating in pediatric clinical trials are included in the contraceptive requirements applied to women of child-bearing potential, creating significant challenges for sponsors, parents, investigators and study staff.

[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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