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May 31, 2018

Today's Rundown

Featured Story

Former Novartis U.S. oncology head Bill Hinshaw jumps ship to metabolic startup

Novartis continues its hemorrhaging of executives seeking new careers at smaller, younger biotechs as its EVP and head of U.S. oncology Bill Hinshaw takes the reins at Axcella Health.

Top Stories

Gilead, Galapagos hit goal in psoriatic arthritis phase 2

A phase 2 trial of Gilead and Galapagos’ filgotinib in psoriatic arthritis has met its primary endpoint. The midphase trial linked the JAK1 inhibitor to significant improvements on a symptom score, laying the groundwork for psoriatic arthritis to join the partners’ growing pot of late-phase opportunities.

Bayer could be sharpening the ax for R&D cuts: German media

Under the oddly code-named “Super Bowl,” German pharma company Bayer is said to be reviewing its R&D locations, with fears this may lead to the swinging of an ax across some ops.

Madrigal shares jump on midstage NASH results

Using an old Roche drug, Madrigal Pharmaceuticals has seen its stock soar 60% on its latest fatty liver disease trials data.

In a twist, new Arcturus board restores old CEO

In a settlement approved by an Israeli court, Arcturus and its ex-CEO Joseph Payne agreed to drop litigation against each other and to appoint a new board of directors. The new board rehired Joseph Payne and CSO/COO Pad Chivukula into their old roles.

Despite ASCO wobble, Syndax pals up with Nektar on entinostat combo trial

Syndax’s shares slid after an ASCO abstract revealed lackluster data with entinostat, but it's forging ahead with a new combination study with Nektar.

FDA puts Vertex, CRISPR sickle cell trial on hold

The FDA has placed a clinical hold on Vertex and CRISPR Therapeutics’ sickle cell disease candidate. Shares in CRISPR fell 15% as investors digested the delay to the start of the gene-editing startup’s first U.S. clinical trial.

Denali acquires F-star's blood-brain barrier bispecific antibody tech in deal worth up to $471M

Denali Therapeutics and F-star teamed up in 2016 on bispecific antibodies to deliver drugs across the blood-brain barrier. Now, Denali is acquiring the latter's F-star Gamma unit, picking up the rights to antibodies developed under their collaboration.

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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