To view this email as a web page, click here

June 12, 2017

Subscribe

Our Team

Contact Us

FierceBiotech Logo

 

Today's Rundown

  1. Celgene bags option on NK cell-based blood cancer assets

  2. FDA rejects Amgen biosimilar from Coherus, stock plummets

  3. Shock U.K. election result creates uncertainty for biotech

  4. [Sponsored] Patient Centricity and the Role of the CRO

  5. Regulus hit as AstraZeneca hands back rights to one drug, R&D revamp culls two more

  6. Helsinn gives up on Zealand’s GI candidate elsiglutide after trial flop

  7. Mass General scientists gain insight into how a TB vaccine may reverse diabetes

  8. Merck, Pfizer trot out more support for latecomer SGLT2 candidate ertugliflozin

  9. Sanofi and Regeneron's Praluent safely smacks LDL in high-risk diabetics

Featured Story

Celgene bags option on NK cell-based blood cancer assets

​​​​​​​Celgene has landed an option on four natural killer cell-based blood cancer therapeutics in a deal with Dragonfly Therapeutics. The agreement sees Celgene hand over $33 million and commit to more in milestones to access next-generation immuno-oncology candidates aimed at some of its core therapeutic areas.

Top Stories

FDA rejects Amgen biosimilar from Coherus, stock plummets

Coherus' copycat version of Amgen’s blockbuster drug Neulasta (pegfilgrastim) has been rejected by the FDA.

Shock U.K. election result creates uncertainty for biotech

The British biopharma industry is facing further uncertainty after last week’s general election left the country without a clear ruling party. Early polls suggested Theresa May’s Conservatives would win by a landslide, empowering them to implement a hard Brexit and a biotech-friendly industrial strategy. But such certainties were dashed by a public that yet again threw politicians a curve ball.

[Sponsored] Patient Centricity and the Role of the CRO

“Patient centricity must be grounded in an engagement approach for the patients … ” Jonathan Zung, PhD, Covance. How do clinical research organizations (CROs) respond and support this increasing focus on patient-centric practices?

Regulus hit as AstraZeneca hands back rights to one drug, R&D revamp culls two more

Embattled biotech Regulus Therapeutics suffered another blow today after revealing AstraZeneca handed back rights to a clinical-stage drug for nonalcoholic steatohepatitis (NASH).

Helsinn gives up on Zealand’s GI candidate elsiglutide after trial flop

Swiss biopharma Helsinn will stop working on Zealand’s troubled cancer side effects medication elsiglutide after a major study failure last year.

Mass General scientists gain insight into how a TB vaccine may reverse diabetes

Massachusetts General Hospital scientist Denise Faustman has been on a quest since the late 1990s to transform an old tuberculosis vaccine into an entirely new way to treat Type 1 diabetes. On Saturday, Faustman presented the latest milestone in that effort—strong evidence that the vaccine increases the activity of beneficial genes that prevent the immune system from attacking normal tissues in the body.

Merck, Pfizer trot out more support for latecomer SGLT2 candidate ertugliflozin

Sanofi’s Toujeo has plenty of competition in the basal insulin market, but new real-world data shows it may outdo its peers at cutting the risk of hypoglycemia for older patients. And Sanofi's planning three real-world follow-ups, a "major shift" from its usual data approach.

Sanofi and Regeneron's Praluent safely smacks LDL in high-risk diabetics

Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent. But the pair now has results in hand suggesting the med can safely cut "bad" cholesterol in Type 2 diabetes patients at high risk of CV problems.

News of Note

On the back of some positive ASCO data last week, Chi-Med and partner Eli Lilly have submitted an NDA with the China FDA for fruquintinib in advanced colorectal cancer. Release

Concert Pharmaceuticals has inked a $30 million venture debt financing deal with Hercules Capital as it looks to boost its cash runway. Release

Biogen spinoff Bioverativ said the FDA has accepted its IND app for pipeline med BIVV001, which is set for tests to treat hemophilia A. Release

Resources

[Webinar] Outsourcing complex microsurgeries – is it worth the risk?

Performing a sophisticated surgery to create a myocardial infarction model. Join us on June 7th at 11:00 AM EDT.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

[Whitepaper] Make Your Clinical Trials a Success

Gain critical insights into how to design and implement pragmatic trials and generate relevant, high-level real-world evidence. Learn when to conduct PTs, design considerations, ethical regulatory issues — and more.

[Webinar] Leveraging Medical Insights for Better Healthcare Engagement

Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape.

[Whitepaper] The Paperless Future of Healthcare and Life Sciences

DocuSign’s eSignature solutions modernize healthcare and life science organizations by eliminating paper and antiquated signature processes while meeting compliance requirements and reducing costs and errors.

[Whitepaper] DocuSign Life Sciences eBook: Reducing Cycle Time with Digital Transaction Management

The patients who rely on your scientific leadership are expecting more.

[Whitepaper] Streamline Regulatory Compliance in Life Sciences with Digital Transaction Management

The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

Events

.