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October 05, 2018

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

Special Report—FierceBiotech's 2018 Fierce 15

All of our Fierce 15 winners care deeply about biomedical science and understand the unique pressure to translate every penny they've raised into something truly innovative for patients. And it seems this passion is infectious when it comes to luring investors.

Top Stories Of The Week

Nektar’s long-acting IL-2 NKTR-214 has 'zero value,' claims analyst

Nektar Therapeutics is a multibillion-dollar biotech with most of its value tied to a single drug—and that drug simply doesn’t work, according to a just-published report.

Teva launches first U.S. generic Cialis as Eli Lilly braces for loss of its ED blockbuster

Look out, Eli Lilly: Teva is launching its generic version of the erectile dysfunction drug Cialis in the U.S. Sales of the heavily advertised branded version, which brought in $2.3 billion last year, are expected to fall to $55 million by 2022, putting pressure on Lilly to forge into new and lucrative markets.

Roche bags anti-cancer bispecific from GO Therapeutics

Roche has licensed an anti-cancer bispecific antibody from GO Therapeutics. The deal gives Roche a license for antibodies generated against a novel cancer target and the right to develop a bispecific antibody.

Next on the split-up agenda? Bayer, if it wants pharma growth, analyst says

Bayer’s divisions are trading at a discount, and a breakup could not only rev that up but also focus the company and potentially free up cash for deals that would beef up its less-than-exciting pharma pipeline, a Bernstein analyst figures.

Personalized cancer vaccine represents new approach to treating HER2-positive tumors

More than a decade ago, scientists at the National Cancer Institute began investigating the idea of using patients’ own immune cells to treat their HER2-positive cancers. Now they are reporting promising results from a small trial of the technique in patients whose tumors overexpress the protein.

Roche, Novartis grab FDA OK for new version of aging blockbuster Xolair

Roche and Novartis are hoping to keep aging Xolair competitive for as long as possible, and they recently took a big step forward in doing just that.

Sanofi-backed Click Therapeutics gains industry veterans in executive boost

Digital therapeutics company Click has been on a small hiring spree, bringing new medical and regulatory executives into the fold. Randall Kaye, M.D., and Austin Speier have joined the young company’s top ranks, the former as its chief medical officer and the latter as its chief strategy officer.

Merck runs out of Parkinson’s disease drug Sinemet as manufacturing issues, forecasting miss lead to shortage

Merck & Co. is out of stock and dealing with back orders of some of its Sinemet Parkinson’s disease drug products that won't be resolved until next year. The issues have resulted from manufacturing problems at the CMO that produces the drug for Merck, and because the drugmaker badly missed its forecast for demand.

Recardio puts the brakes on new heart drug trials in U.K. over Brexit concerns

San Francisco-based clinical-stage life science company Recardio is halting clinical trials in the U.K. of a new heart drug due to concerns about Brexit and how new drugs will be approved.

EMA, MHRA and GlaxoSmithKline blast BMJ’s ‘flawed’ pandemic flu vaccine safety report

European drug regulators and GlaxoSmithKline have quickly rallied their rebuttals to a BMJ report, calling it “flawed and misleading.” The report questioned the safety profile of GSK’s now-unavailable pandemic flu vaccine Pandemrix, as well as the lack of transparency over drug information.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Research] Linguistic and Cultural Considerations When Implementing a Global BYOD Study

Examine the linguistic and cultural considerations of global eCOA and BYOD.

[Infographic] Flexible. Scalable. Proactive.

Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries.

[eBook] Healthcare and Life Sciences - Data Value Chain

Download our new eBook to learn how Healthcare and Life Sciences organizations are taking advantage of solutions from AWS and the AWS Partner Network to obtain value from critical data.

[Case Study] FSP Insourcing – Relationship Growth Built on Results, Trust

Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries.

[POCKET GUIDE] 3 Steps To Supercharge Your Literature Search

Go from Search to Full-Text Scientific Papers in a Single Click!

[eBook] Digital Workflows: How to Focus Investment to Cut Costs and Drive Growth

Life sciences companies must immediately identify and realize productivity gains to drive down operational costs—or risk seeing more nimble competitors disappear into the distance. Where to begin?

[Whitepaper] How to Re-Design your Regulatory Capabilities

A top 20 pharma and growing biotech re-engineer regulatory processes.

[Whitepaper] The Future of Pharmacovigilance: Leveraging Technology and Automation

Are automation, big data and artificial intelligence (AI) a key part of your company’s pharmacovigilance strategy? Read this whitepaper to know what they should be!

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.

[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.

[eLearning] BIOAVAILABILITY 101

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

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