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May 22, 2018

Today's Rundown

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Featured Story

Spark hemophilia B gene therapy clears test en route to Pfizer-sponsored phase 3

Spark Therapeutics has presented data on hemophilia B patients who received a version of its gene therapy manufactured using a modified process. Early data on the patients suggest the new batch of therapies is at least as effective as its predecessor, clearing away a potential pitfall on Spark’s path to market.

Top Stories

Celgene pays Evotec $65M to access source of solid tumor drugs

Celgene is paying $65 million upfront to secure an option on cancer drugs discovered by Evotec. The strategic partnership tasks Evotec with applying its R&D toolkit to the discovery of solid tumor drugs that Celgene will then pick up and advance.

Allergan acquires NMDA depression drug from Aptinyx collaboration

Allergan has acquired an investigational NMDA receptor modulator discovered by Aptinyx, exercising its option under an ongoing collaboration, and plans to pair it with its rapastinel depression therapy currently under development.

[Sponsored] Growing Requirements for Medicines for Children

Progress has been made in developing medicines for children with the passing of pediatric regulation, but gaps still exist. Here’s what you need to know about recent updates from an expert at Synteract.

New year, new name, new bladder cancer data for Sesen Bio

Sesen Bio presented three-month data showing that the antibody-drug conjugate Vicinium had a 43% complete response rate in patients with non-muscle-invasive bladder cancer.

Gates Foundation and U.K. pledge $50M to superbug treatment drive

A project that aims to reinvigorate the search for drugs to treat antimicrobial-resistant infections has just picked up two more deep-pocketed backers.

Icon launches new electronic financial disclosure form software

Icon has launched a paperless solution for managing the clinical investigator financial disclosure forms mandated by the FDA.

Celgene, stricken by setbacks, bids a quiet goodbye to deal-making czar Golumbeski

Celgene's business development head George Golumbeski left the company in April, at a time when the big biotech is struggling to recover from a series of setbacks and stumbles over the last year.

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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