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May 26, 2017

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Today's Rundown

  1. Gottlieb ends FDA hiring freeze, lays out R&D priorities

  2. Safety profile will help bring ozanimod to multiple sclerosis market, says Celgene

  3. Signaling protein could be the target that stops heart failure in its tracks

  4. [Sponsored] The Impact of Data and Informatics Technologies Throughout the Clinical Trial Journey

  5. Medical device industry 'not doing enough on cybersecurity'

  6. EuroBiotech Report—Iterum-Pfizer, J&J incubator fund, Merck KGaA-Ablynx, Redx suspended and Debiopharm

  7. FiercePharmaAsia—Gardasil’s Chinese approval, Lupin’s financials, CANbridge’s $25M Series B

  8. Chutes & Ladders—Alexion’s C-suite overhaul involves CFO, R&D head

Note: FierceBiotech will not publish on Monday due to the Memorial Day holiday, but will be back in your inbox on Tuesday, May 30.

Featured Story

Gottlieb ends FDA hiring freeze, lays out R&D priorities

Scott Gottlieb, M.D., has ended the hiring freeze President Donald Trump imposed on the FDA. The action means Gottlieb can fill vacancies to shape an agency capable of enacting his plans for how safety and efficacy information are gathered during development.

Top Stories

Safety profile will help bring ozanimod to multiple sclerosis market, says Celgene

Missing a secondary endpoint in the RADIANCE trial won't hinder the launch or commercial success of ozanimod, CFO Peter Kellogg tells Barclays analysts.

Signaling protein could be the target that stops heart failure in its tracks

There is no cure for heart failure, but scientists at Nagoya University have identified a protein on the surface of heart cells that could be targeted to stop the condition from getting worse.

[Sponsored] The Impact of Data and Informatics Technologies Throughout the Clinical Trial Journey

With pressures to fast-track clinical development, the pharmaceutical industry recognizes the value of improving internal clinical data management processes. Learn how using comprehensive analytical capabilities helps to advance clinical trial execution.

Medical device industry 'not doing enough on cybersecurity'

The medical device industry appears to be under siege by cybercriminals, but it isn't taking steps to defend itself, according to two separate reports.

EuroBiotech Report—Iterum-Pfizer, J&J incubator fund, Merck KGaA-Ablynx, Redx suspended and Debiopharm

In this week's EuroBiotech Report, Iterum raises $65 million for a phase 3 trial, J&J incubator gets a dedicated VC fund, Merck KGaA accepts an Ablynx asset and more.

FiercePharmaAsia—Gardasil’s Chinese approval, Lupin’s financials, CANbridge’s $25M series B

Merck's HPV shot Gardasil is set for a head-to-head competition with GSK's Cervarix in China, Lupin's Q4 sales in North America fell 13%, China’s CANbridge gained $25M series B to advance immunotherapies, and more.

Chutes & Ladders—Alexion’s C-suite overhaul involves CFO, R&D head

Alexion experienced a major C-suite overhaul that included its CFO, CCO, R&D head and HR chief; Van Oene's title as Illumina's CCO was finalized; and INC Research unveiled its entire executive team after the megamerger with inVentiv Health.

News of Note

Eye disease biotech Aerie Pharmaceuticals has priced its public offering of $75 million of its common stock at $53.75 per share. Release

Immune Pharmaceuticals said it received a written notice from Nasdaq that it has now regained compliance with the minimum bid price rule. Statement

The number of new drugs given the green light in the U.S. and Europe is booming in 2017 after a rough 2016. Reuters Health story

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] Run the Trial You Want with Modern EDC

To thrive in a fiercely competitive market, life sciences companies need to set themselves apart by designing and executing the best trial and successfully deliver drugs to market first. Learn how a modern EDC can help.

[Whitepaper] Solving the Knowledge Management Puzzle in Biopharma

Puzzled by Scientific Literature Access? Here is your guide for navigating knowledge management’s twists and turns! If yours is a small- or medium-sized biopharma business, we can help you putting the pieces together. Learn the secrets of top knowledge management experts who will show you how to search, discover, acquire and manage knowledge in new ways.

[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

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