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September 25, 2018

Today's Rundown

Featured Story

TG stock sinks after setback to blood cancer trial

TG Therapeutics has abandoned plans to seek accelerated FDA approval of its ublituximab-umbralisib combination in chronic lymphocytic leukemia. The biotech made the decision because its phase 3 overall response rate data “were not sufficiently mature to conduct the analysis.”

Top Stories

Morphic raises $80M to test its oral integrin-based drugs

Morphic Therapeutic brought in $80 million to carry its two lead integrin-targeting programs through their clinical proof-of-concept studies, as well as to help move several additional programs into the clinic.

Reata’s bardoxolone hits goals in phase 2 kidney disease trial 

Reata Pharmaceuticals’ bardoxolone has improved kidney function in patients with IgA nephropathy and Type 1 diabetic chronic kidney disease. The phase 2 trial linked the Nrf2 activator to improvements in estimated glomerular filtration rate, a measure of kidney damage.

AzurRx’s chronic pancreatitis drug hits the mark in phase 2

AzurRx Biopharma, along with partner Mayoly Spindler, announced that its lead asset met its primary and secondary endpoints in a phase 2a trial. The drug, a recombinant lipase, is designed to treat an enzyme condition linked to chronic pancreatitis.

Arena 3 for 3 as Crohn’s drug meets proof-of-concept test

Arena Pharma says its cannabinoid receptor-targeting drug olorinab could help treat the pain associated with Crohn’s disease, one of the most debilitating symptoms of the inflammatory bowel disorder.

Gemphire cuts 33% of staff, including CFO, CMO

Gemphire is cutting its staff in a bid to cut costs and save cash after the FDA requested more preclinical data for its only drug, gemcabene, in dyslipidemia indications.

Novartis whacking nearly 2,000 manufacturing jobs to pump up margins

Novartis’ traditional pill manufacturing will shoulder the brunt of a cost-cutting effort announced Tuesday as it looks to a future in biologic drugs and higher margins.

Special Report—The top 10 drugmakers of 2024

The top 10 drugmakers in 2024 will hold 35% of the total biopharma market share, or more than $420 billion in sales that year.

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.

[POCKET GUIDE] 3 Steps To Supercharge Your Literature Search

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

[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.

[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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