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September 24, 2018

Today's Rundown

Featured Story

With positive phase 2 data, Akcea, Ionis could pocket $150M from Novartis

Akcea Therapeutics reported topline data showing its hyperlipoproteinemia drug lowered lipoprotein(a) levels in a phase 2 study in patients with cardiovascular disease. If partner Novartis licenses the drug, Akcea and Ionis would get a $150 million payout.

Top Stories

Sarepta DMD gene therapy hold lifted in ‘record time’

Two months after Sarepta was hit with a clinical hold by the FDA, the rare disease biotech has seen this lifted after sorting out a quality blip.

FDA lifts hold on Epizyme cancer drug, shares surge

The FDA has lifted a partial clinical hold from Epizyme’s tazemetostat. Epizyme got the green light to resume enrollment in trials of the EZH2 inhibitor after showing the FDA data on the risk of secondary malignancies.

Nightstar posts early-phase data on retinal gene therapy

Nightstar Therapeutics has presented early clinical data on its gene therapy treatment for X-linked retinitis pigmentosa. Around half of the patients in higher-doses cohorts experienced vision improvements, encouraging Nightstar to move NSR-RPGR into the larger phase 2 portion of the trial.

AnaptysBio’s lead IL-33 antibody clears midstage test in asthma

Next-generation antibody company AnaptysBio has positive data for its lead pipeline drug etokimab in a third indication, adding asthma to its earlier wins in peanut allergy and atopic dermatitis.

Former Merck clinical research VP Arthur Santora joins Entera Bio as CMO

Former Merck clinical research leader Arthur Santora, M.D., Ph.D., is coming out of retirement to serve as the new chief medical officer of Entera Bio to help the company develop its oral hormone-based treatments for osteoporosis and hypoparathyroidism.

Foundation, Roche launch new 70-gene cancer blood test following June buyout

Roche and Foundation Medicine have launched a new blood test in the U.S. that analyzes 70 genes known to drive solid tumor growth, as well as microsatellite instability high status, to help guide the use of precision cancer treatments and immunotherapies.

CRISPR screen identifies Zika-fighting gene

CRISPR gene editing is being widely adopted as a tool for genome-scale screening, and a team at the University of Texas Southwestern Medical Center just used it to pinpoint a gene that helps human cells resist infection from flaviviruses like Zika.

Resources

[Webinar] Value Creation in the Early Phase

Learn the best strategies for attracting investors in early phases of development and for overcoming formulation challenges.

[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.

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

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

[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.

[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.

[Whitepaper] Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

When developing a parenteral, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages.

[Whitepaper] Scale-Up and Technical Transfer for Lyophilized Products

Baxter BioPharma Solutions’ whitepaper offers a method to address the challenges of tech transfer for lyophilized products from lab-scale to commercial-scale.

[Whitepaper] Addressing the Special Commercial Challenges in Rare Diseases

A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them.

[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.

Events

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