To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

May 03, 2019

Today's Rundown

Featured Story

Acacia gets 2nd FDA rejection as manufacturing fault drags on

Acacia Pharma has suffered its second FDA rejection in seven months. The British drug developer moved quickly to bounce back from the complete response letter it received in October, only to be hit with a second rejection after its contract manufacturer failed to resolve the problems.

Top Stories

Eisai installs new Alzheimer's clinical trial leadership team

Eisai has put Michael Irizarry in charge of its Alzheimer’s disease clinical development programs. The ex-Eli Lilly and GlaxoSmithKline researcher is taking on the role in the wake of aducanumab’s failure. 

Need to model aging in a hurry? Do it in outer space

What do you do when you’re studying age-related diseases but can’t hang about waiting for tissue models to reach a ripe old age? You blast them into outer space, naturally. The NIH and International Space Station U.S. National Laboratory sent up a second batch of tissues-on-a-chip, including chips modeling the kidney, lung and the blood-brain barrier.

[Sponsored] Emerging Biotechs are Here to Stay; CRO Models Will Permanently Change

The prominence of emerging biotech looms large on the drug development landscape. CROs continue to adjust their core competencies and cultural mindset to tailor services for specific biotech needs.

Celgene reports 'durable' responses to multiple myeloma CAR-T in early trial despite relapses

Interim data from a phase 1 study of Celgene and Bluebird Bio's CAR-T treatment for multiple myeloma, bb2121, showed median progression-free survival of about a year. But a high relapse rate could compound concerns about the durability of the treatment, which is a key asset in Bristol-Myers Squibb's $74 billion buyout of Celgene.

Amgen taps Syapse to infuse real-world data into its cancer clinical trial designs

Precision medicine software developer Syapse has launched a collaboration with its one-time Big Pharma benefactor Amgen, with the goal of mining real-world evidence for insights into cancer drug development.

EuroBiotech Report—AZ-Transgene, Bicycle IPO, Alentis round, ReNeuron and trial transparency

In this week's EuroBiotech Report, AstraZeneca inks oncolytic virus deal, Bicycle files for IPO and Alentis raises series A round. 

FiercePharmaAsia—AZ’s China business; BeiGene CEO’s $28M pay; Kangmei’s $4.4B accounting error

AstraZeneca warns of slower China growth after losing out to local generic in a procurement plan. BeiGene chief becomes the second-highest-paid biopharma CEO in 2018. China's Kangmei Pharma faces potential delisting after a $4.4 billion accounting "error." And more.

Chutes & Ladders—CMO walks out on troubled Immunomedics

CMO Iannone walks out on troubled Immunomedics; uBiome CEOs take administrative leave following FBI raid; and longtime Gilead CFO announces plans to retire, leaving the new CEO with a hole to fill. Those moves plus more hirings, firings and retirings throughout the industry.

Resources

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

Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs.

[Whitepaper] Delivering oral solid dose product to Phase I Clinic in 14 weeks

Designed with speed & flexibility,Quick to Clinic™ for Oral Solid Dose helps deliver products to Phase I Clinic in as little as 14 weeks.

[Paid Marketplace] Accelerating DoD’s Fielding of Prototypes for Medical Countermeasures

MCS is currently seeking broad-based industry/academia collaboration on research and prototype work in technical areas related to developing medical countermeasures for the Joint Warfighter.

[Whitepaper] Agile Competitive Intelligence: A 3-Step Mobile Research Strategy

What is agile competitive intelligence, and how can help healthcare researchers stay ahead of the curve?

[Whitepaper] Now Companies Can Move Validated, Mission Critical Apps To The Cloud

Learn how the cloud can support the performance and security requirements for validated, mission-critical applications historically designed and implemented exclusively via on-premises deployment.

[Whitepaper] How the Internet of Things Creates Smarter Labs

Learn how cloud-connected IoT sensors are transforming operations in leading life science labs. Read our white paper “The Smart Lab”.

[Whitepaper] Personalized Test for Treatment Prediction in Depression

Total Brain Announces Personalized Test for Treatment Prediction in Depression with 80% Accuracy.

[Whitepaper] Observed Impact of Medication Price Transparency on Patients and Practices

Prescription price transparency technology is here – but is it making a difference? Find out HERE.

[Whitepaper] Redefining Your Value to Win Empowered Patients: Six Steps to Success

Every life sciences firm talks about patient-centricity, but are you doing what it takes to deliver?

[Whitepaper] Key Life Sciences Trends, 2019 and Beyond

The year’s biggest compliance and technology trends in life sciences. Learn about the latest trends impacting the biotech, medical device and pharmaceutical industries.

[Whitepaper] The New World of Allosteric Modulation: Another Shot on Goal

Learn how to utilize allosteric modulation to maximize its full potential in drug discovery programs. Download this white paper to learn more.

[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.

Events