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May 23, 2017

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Today's Rundown

  1. Bioverativ to buy True North for $400M upfront

  2. Donald Trump’s healthcare Budget outlines FDA, NIH cuts

  3. China’s CANbridge Life Sciences gains $25M Series B, plots new cancer trials

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

  5. Cancer resistance firm TP Therapeutics reaps $45M in third round

  6. Puma shares jump 40% after FDA review but brief leaves scope for AdComm grilling and neratinib rejection

  7. ViaCyte bags $10M for diabetes cell therapies

  8. AZ's Bydureon cleared a heart safety test, but didn't cut risks. Can it still vie with Novo?

Featured Story

Bioverativ to buy True North for $400M upfront

Bioverativ has struck a deal to buy True North Therapeutics. The deal will see the Biogen spinout pay $400 million upfront and up to $425 million in milestones to acquire the rare disease biotech and its clinical-phase treatment for cold agglutinin disease, TNT009.

Top Stories

Donald Trump’s healthcare budget outlines FDA, NIH cuts

President Donald Trump’s administration has released a breakdown of its attempts to cut back on healthcare and research spending across the government, with proposed cuts to governmental biomedical research centers and the drugs regulator laid down in the fleshed-out budget.

China’s CANbridge Life Sciences gains $25M series B, plots new cancer trials

Beijing-based CANbridge Life Sciences has pulled off a $25 million funding round, bringing its total two rounds up to $40 million as it plans new oncology trials and “additional strategic transactions” this year.

[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.

Cancer resistance firm TP Therapeutics reaps $45M in third round

California biotech TP Therapeutics has the funds on hand to take its drug for resistant cancer through the next stages of clinical development after raising $45 million in a series C financing.

Puma shares jump 40% after FDA review but brief leaves scope for AdComm grilling and neratinib rejection

Shares in Puma Biotechnology jumped 40% after the FDA trod lightly around doubts about its filing for approval of breast cancer drug neratinib. But the talking points raised ahead of Wednesday’s advisory committee meeting leave Puma open to a grilling over its trial modifications, neratinib’s side effect profile and its choice of population.

ViaCyte bags $10M for diabetes cell therapies

ViaCyte picked up $10 million to fund the clinical development of its stem cell-derived treatment for patients who have Type 1 diabetes and are at risk of complications.

AstraZeneca's Bydureon cleared a heart safety test, but didn't cut risks. Can it still vie with Novo?

AstraZeneca finally has some cardiovascular outcomes data it can tout in favor of one of its top diabetes contenders, the long-acting GLP-1 drug Bydureon. But its new results still don’t measure up to data posted by its competitors.

News of Note

Alexion says Martin Mackay, its EVP and head of R&D, will be retiring from the company at the end of the year amid of a slew of changes, cuts and departures, as a search is underway for a replacement. Release

Atox Bio says its phase 3 test looking at reltecimod in patients with necrotizing soft tissue infections will continue without any changes after a review by an independent Data Monitoring Committee. Statement

Jay Flatley, executive chairman of Illumina, has been appointed to the board of CAR-T biotech Juno Therapeutics. Release. Alexion says Martin Mackay, its EVP and head of R&D, will be retiring from the company at the end of the year amid of a slew of changes, cuts and departures, as a search is underway for a replacement. Release

Resources

[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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