To view this email as a web page, click here

June 08, 2017

Subscribe

Our Team

Contact Us

FierceBiotech Logo

 

Today's Rundown

  1. Roche ditches work on NewLink’s IDO cancer candidate

  2. Johnson & Johnson’s $30B buyout suffers setback as Actelion antibiotic fails in one phase 3, succeeds in another

  3. Merrimack poaches Ariad CMO after shake-ups for both companies

  4. [Sponsored] Mobile Health Data Considerations for Clinical Research

  5. Lilly pays $55M for rights to KeyBioscience’s diabetes assets

  6. Medtronic’s long-awaited ‘artificial pancreas’ makes U.S. debut

  7. Special Report—Top 10 diabetes drugs by 2016 sales

  8. Struggling Teva wants to pull in a veteran pharma CEO to clean up its mess

Featured Story

Roche ditches work on NewLink’s IDO cancer candidate

After a fairly disappointing ASCO, Roche is axing work on IDO medication indoximod and handing back the rights to partner NewLink Genetics.

Johnson & Johnson’s $30B buyout suffers setback as Actelion antibiotic fails in one phase 3, succeeds in another

Actelion has posted mixed late-phase data on its antibiotic cadazolid. The drug, which Johnson & Johnson is set to acquire in its $30 billion (€27 billion) takeover of Actelion, failed to match an old antibiotic in one study despite holding its own in another identical trial.

Merrimack poaches Ariad CMO after shake-ups for both companies

Following a major reorganization earlier this year that saw it sell off its marketed med and revert back to being a clinical-stage biotech, Merrimack is making major changes in its executive team, announcing today that former Ariad chief medical officer Sergio Santillana, M.D., will be its new medical lead.

[Sponsored] Mobile Health Data Considerations for Clinical Research

As the technology landscape of clinical trials evolves, apps are engaging patients in new ways and in real time, thus becoming an integral part of the healthcare infrastructure.

Lilly pays $55M for rights to KeyBioscience’s diabetes assets

Eli Lilly is paying $55 million upfront for the rights to KeyBioscience’s pipeline of treatments for Type 2 diabetes and other metabolic conditions. The agreement gives Lilly the global rights to phase 2 synthetic peptide dual amylin and calcitonin receptor agonist KBP-042 and other programs.

Medtronic’s long-awaited ‘artificial pancreas’ makes U.S. debut

Medtronic’s hybrid closed-loop system, the world’s first “artificial pancreas,” is hitting the U.S. market. The system is the only FDA-approved insulin pump that automatically delivers basal insulin to control blood glucose levels in people with Type 1 diabetes.

Special Report—Top 10 diabetes drugs by 2016 sales

Formulary exclusions, pricing, biosimilars and cardiovascular outcomes data have impacted the U.S. diabetes space. We’ve compiled last year’s U.S. sales rankings for you, along with some insight into what to expect for each of the top meds going forward.

Struggling Teva wants to pull in a veteran pharma CEO to clean up its mess

Israeli generics giant Teva Pharmaceutical Industries has chewed up three CEOs in just five years, as the company grappled with pricing pressure, declining sales growth, disappointing acquisitions and bribery investigations. Now the company says it not only wants an outsider chief, but a seasoned pharma CEO to take its helm.

News of Note

RNAi company Dicerna Pharmaceuticals has taken on industry vet and ex-Summit Therapeutic's CMO Ralf Rosskamp, M.D., as its new chief medical officer, working on clinical development, medical affairs and regulatory functions. Release

Sophiris Bio has dosed the first patient in its midstage test to assess the safety and tolerability of topsalysin in treating men with prostate cancer. Statement

Cancer biopharma CytRx Corporation says it has posted an update on the regulatory pathway for an NDA submission for its aldoxorubicin in soft tissue sarcomas. 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] Monitoring Risk for ICH GCP Compliance

The ICH GCP E6 guideline has been revised to address the complexities associated with today’s clinical trials, and this concise white paper will help you understand the recent guideline changes. Learn how use of risk-based monitoring can help you comply with the guidelines and achieve efficiency in clinical trial design, implementation and reporting.

[Whitepaper] Immuno-Oncology and the Role of Biomarkers, Companion and Complementary Diagnostics

The recent evolution of immunotherapies and their potential applications have greatly impacted patients’ options for effective oncology treatments. These advances have been powered in part by the use of biomarkers, companion diagnostics (CDx) and complementary diagnostics. Read the white paper.

[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

.