To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

May 29, 2018

Today's Rundown

Featured Story

Axovant poaches Allergan CMO to lead R&D recovery

Axovant has put Gavin Corcoran in charge of its R&D recovery. Corcoran is stepping down as CMO of Allergan to take up the position, which will see him try to guide Axovant back from the implosion of its Alzheimer’s R&D strategy.

Top Stories

FDA starts speedy review of Loxo’s site-agnostic cancer drug larotrectinib

Loxo Oncology is preparing for a November verdict from the FDA on larotrectinib as a treatment for solid tumors carrying a specific mutation—regardless of where they appear in the body

EMA lays cornerstones for new Amsterdam headquarters

The European Medicines Agency has begun laying the foundation for its new Amsterdam headquarters, aiming to finish construction by November 2019.

Arcturus and ex-CEO put monthslong legal scuffle to rest

In a settlement approved by Israeli District Court on Sunday, Arcturus Therapeutics and its ousted CEO Joseph Payne agreed to end litigation against each other. The deal comes nearly four months after the RNA biotech's board voted to terminate Payne.

Looking to unseat Sanofi and Shire drugs, Atlas gene therapy startup Avrobio files for $86M IPO

Avrobio has filed for an $86.25 million IPO. The offering would give the Atlas Venture-backed startup the means to run clinical trials of gene therapies designed to supplant enzyme replacement therapies from Sanofi, Shire and Pfizer.

European cancer vaccine startup Nouscom poaches Pfizer I-O executive

Swiss oncology biotech Nouscom has nabbed Pfizer’s former global clinical leader of early and late stage immuno-oncology/hematology Adrian Woolfson, M.D., Ph.D., as its new CMO.

Johnson & Johnson's Darzalex ambitions take a hit with scrapped I-O trials

Drugmakers have raced to pair their cancer drugs with immuno-oncology therapies, hoping to see an improved benefit from a combination. But that’s not how things are looking for Darzalex partners Genmab and Johnson & Johnson.

Resources

[Whitepaper] Compliance Certificate and Training for Life Sciences Professionals

4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics.

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

There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development.

[Whitepaper] Risk-based Approach to Change Management of GxP Systems

Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems.

[Whitepaper] Regulatory Transformation at UCB

UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off.

[Whitepaper] Five Tracking Spreadsheets it’s Time for Regulatory to Retire

Find out how to eliminate regulatory’s tracking spreadsheets for good.

[Whitepaper] A Simpler Approach to RBM in Clinical Trial Management

Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

Events

.