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May 30, 2018

Today's Rundown

Featured Story

Venter to leave Human Longevity as turnover at the top continues

Craig Venter, Ph.D., is leaving Human Longevity Inc. Venter’s decision to step down as CEO and return to research at the J. Craig Venter Institute continues the turnover at the top of HLI, which has now lost two CEOs and a CMO in the past six months.

Top Stories

Sage postpartum depression drug gets priority review at FDA, teeing up 2018 approval

The FDA has awarded priority review designation to Sage Therapeutics’ postpartum depression drug brexanolone. Securing the status positions Sage to receive a decision from the FDA by the end of the year.

Crescendo cuts psoriasis drug deal with China’s Zai Labs

Just weeks after closing a $70 million second-round financing, U.K. biotech Crescendo Biologics has signed another partner for its slimline antibody-like drug candidates, this time outside its core cancer focus.

Northwest Bio's long-awaited glioblastoma vaccine data see stock roller coaster

Northwest Bio unveiled interim phase 3 data showing its dendritic cell vaccine improved survival rates in patients with newly diagnosed glioblastoma. Its low-cost stock shot up 35% on the news, but then fell nearly 10% after-hours.

AzurRx brings on longtime drug developer James Pennington as CMO

James Pennington has joined AzurRx BioPharma as its chief medical officer as the company aims to launch a phase 2 clinical trial of its lead candidate in cystic fibrosis later this year. During his time as Bayer’s VP for biological clinical research in the late '90s, Pennington helped secure 10 FDA approvals and 10 approvals overseas.

Titan, Braeburn end licensing deal for implanted drug for opioid addicts

Titan Pharmaceuticals and Braeburn are parting ways over an opioid treatment licensing deal inked in 2012.

WuXi AppTec warns traders to cool off after 6-fold stock price increase in 3 weeks

WuXi AppTec reminded traders to consider the risks of investing in CROs after its stock price increased by the daily maximum of 10% for 15 straight trading sessions following its Shanghai IPO earlier this month. That vaulted its market cap to over $21 billion.

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

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