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August 28, 2018

Today's Rundown

Featured Story

Affimed lands big, backloaded immunotherapy deal with Genentech, sending its stock into overdrive

Genentech is handing over $96 million (€82 million) in upfront and near-term payments to work with Affimed on NK and T cell engagers. The deal features $5 billion in milestones and royalties that could land in Affimed’s bank account if the immunotherapies succeed.

Top Stories

FDA nixes Akcea’s volanesorsen despite favorable AdComm

The FDA rejected Akcea Therapeutics’ volanesorsen three months after the drug squeaked past an FDA advisory committee that voted 12-8 to recommend its approval.

CRISPR biotech Editas to lose CMO as it continues push for clinical trials

Editas Medicine is to lose Gerald Cox, M.D., Ph.D., its chief medical officer, at the end of the year, as the search is on for a new clinical leader.

Second time lucky? Alzheon tries for much-reduced IPO

After an aborted attempt earlier this year, Alzheon is having another go at an IPO to help fund new trials of its Alzheimer’s candidate tramiprosate.

Roivant appoints NEA partner Torti to oversee its ‘vant’ subsidiaries

Roivant Sciences named New Enterprise Associates partner Frank Torti, M.D., as Vant investment chair to assist in overseeing its family of biopharma subsidiaries by serving as one of two Roivant-appointed representatives on its companies’ boards.

Urovant adds gene therapy to overactive bladder pipeline

Urovant Sciences picked up the global rights to a gene therapy from Ion Channel Innovations for patients with overactive bladder for whom oral drugs do not work.

Roche Diagnostics head Roland Diggelmann to step down

The leader of Roche’s diagnostics division, Roland Diggelmann, announced plans to leave the company, effective Sept. 30. Roche Diagnostics accounted for nearly a quarter of the Swiss giant's sales, growing 5% in 2017 to bring in about $12.4 billion.

Resources

[Webinar] Enabling precision medicine with Tableau and AWS

Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children.

[Webinar] Build a holistic data management strategy for Life Sciences

Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS.

[Webinar] Safeguard your Life Sciences data with Druva and AWS

Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data.

[Whitepaper] Evolving Approaches to Drug Value Assessment in Global Markets

The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch.

[Whitepaper] Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.

[Whitepaper] HOW TO POSITION YOUR PATIENT SUPPORT PROGRAM FOR SUCCESS

When was the last time your patient support program perfectly aligned with the patient journey, solving all the critical gaps in positioning your brand for success? Follow the 3-D approach to your solution design, and you will achieve a better outcome for your patients.

[Whitepaper] Avoid Enrollment Pitfalls: Find Your Best-fit Clinical Trial Sites

Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals.

[Survey] Industry Report: Findings from the 2018 Unified Clinical Operations Survey

Industry Research: See new results from one of the industry's largest, global clinical operations surveys.

[Whitepaper] Building the Business Case for RIM Transformation

Ready to modernize your RIM environment? Secure buy-in with these tips.

[eLearning] BIOAVAILABILITY 101

Develop a basic understanding of principles and concepts of bioavailability of oral drugs.

Events

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