To view this email as a web page, click here

June 16, 2017

Subscribe

Our Team

Contact Us

FierceBiotech Logo

 

Today's Rundown

  1. Idorsia spins out of Johnson & Johnson-Actelion with $1B and multidrug pipeline, sees shares jump 30% on first day of trading

  2. Checkmate raises $27M, adds operations veteran as I-O program gathers pace

  3. Bavarian Nordic delays phase 3 cancer vaccine data again, pushing back Bristol-Myers opt-in decision date

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

  5. Parexel, Sanofi explore use of wearables for remote clinical trial data collection

  6. Merck KGaA taps Human Longevity to discover melanoma response biomarkers to MEK inhibitor following mixed data

  7. Bristol-Myers selling Ireland plant to South Korean company with large aspirations

  8. EuroBiotech Report—Medicxi’s $300M fund, diabetes data, U.K. election shock, LifeArc fund and OSE-MSK alliance

  9. FiercePharmaAsia—Intercontinental antibiotic program, SK gets Bristol-Myers Squibb's API plant, JSR buys Selexis

  10. Chutes & Ladders—Biogen’s longtime CFO Clancy leaves for Alexion

Featured Story

Idorsia spins out of Johnson & Johnson-Actelion with $1B and multidrug pipeline, sees shares jump 30% on first day of trading

Idorsia has spun out of Actelion after Johnson & Johnson wrapped up its $30 billion takeover of the Swiss biotech. The new company starts life with $1 billion in cash, multiple clinical-phase drugs and a deal with J&J, strengths that prompted traders to drive up its share price by 30% in its first hours on the Swiss stock exchange.

Top Stories

Checkmate raises $27M, adds operations veteran as I-O program gathers pace

A new funding round for Checkmate Pharma will fund additional trials of immuno-oncology drug CMP-001, currently paired with Merck's Keytruda in a phase 1b melanoma trial.

Bavarian Nordic delays phase 3 cancer vaccine data again, pushing back Bristol-Myers opt-in decision date

Bavarian Nordic has again delayed the release of data from a phase 3 trial of Prostvac. Top-line data on the Bristol-Myers Squibb-partnered prostate cancer vaccine are now due to drop in the fourth quarter, with the delayed third interim analysis penciled in for September.

[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?

Parexel, Sanofi explore use of wearables for remote clinical trial data collection

Six years after Pfizer's landmark REMOTE trial, Parexel and Sanofi are teaming up in a pilot study to revisit the idea of using wearables in clinical trials.

Merck KGaA taps Human Longevity to discover melanoma response biomarkers to MEK inhibitor following mixed data

Merck KGaA has teamed up with J. Craig Venter’s Human Longevity, Inc. to identify biomarkers that suggest melanoma patients will respond to pimasertib. The agreement follows a two-year lull in development of the MEK1/2 inhibitor precipitated by mixed data from a phase 2 trial.

Bristol-Myers selling Ireland plant to South Korean company with large aspirations

Bristol-Myers Squibb, which is shifting its focus toward biologics manufacturing, will unload an API plant in Ireland to a South Korean company that has aspirations of becoming a big deal in contract manufacturing.

EuroBiotech Report—Medicxi’s $300M fund, diabetes data, U.K. election shock, LifeArc fund and OSE-MSK alliance

In this week's EuroBiotech Report, Medicxi unveils $300 million fund, Sanofi partner posts data, the U.K. election rocks biotech and more.

FiercePharmaAsia—Intercontinental antibiotic program, SK gets Bristol-Myers Squibb's API plant, JSR buys Selexis

Drug regulators from Europe, the U.S. and Japan have come together to boost antibiotic development, South Korea's SK Biotek has purchased an API plant from Bristol-Myers Squibb, and Japan's JSR has acquired Swiss cell line developer Selexis.

Chutes & Ladders—Biogen’s longtime CFO Clancy leaves for Alexion

Biogen lost its longtime CFO Paul Clancy to Alexion but poached Jean-Paul Kress from Sanofi Genzyme to head its operations outside the U.S., and life sciences VC Flagship brought on J.P. Morgan vet Stephen Berenson as an executive partner. Plus more hirings, firings and retirings throughout the industry.

News of Note

Xencor posted a snapshot of data from its ongoing midstage test of XmAb 5871 in patients with active IgG4-related disease, showing that 93% of patients achieved a response to therapy. Statement

Cancer biotech Mersana Therapeutics plans to raise $75 million by offering 5 million shares at a price range of $14 to $16 apiece. Renaissance Capital article

PharmaMar said that its latest cancer drug PM1183 (lurbinectedin), its third molecule of marine origin and analogue of marketed medication Yondelis, will go by the name Zepsyre. Release

Resources

[Webinar]Going Digital: Connecting Submission Documents and Regulatory Data

Hear three innovative leaders explain how regulatory can “go digital” in their operations by leveraging the data-handling capabilities in their RIM systems.

[Whitepaper] Enable better radiation therapy study results

Discover the factors that contribute to differential radiation sensitivity between the Rag2 and SCID models.

[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

.