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May 10, 2017

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Today's Rundown

  1. AstraZeneca asthma drug misses endpoint in phase 3

  2. INC Research and inVentiv Health merge in another major CRO deal

  3. Sage highlights ‘signal of activity’ in Parkinson’s data, but questions linger

  4. [Sponsored] A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

  5. Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma

  6. Oxford Genetics licenses CRISPR tech to power synbio push

  7. Boston Scientific gets FDA nod for long-life cardiac implant

  8. Move over, AstraZeneca. Pfizer and Merck KGaA are the newest bladder cancer drugmakers in town

Featured Story

AstraZeneca asthma drug misses endpoint in phase 3

AstraZeneca headquartersA phase 3 trial of AstraZeneca’s tralokinumab in patients with severe, uncontrolled asthma has missed its primary endpoint. The anti-interleukin-13 human monoclonal antibody failed to cut the annual asthma exacerbation rate by more than placebo, forcing AstraZeneca to hitch its hopes for the drug to the planned analysis of a subpopulation of patients.

Top Stories

INC Research and inVentiv Health merge in another major CRO deal

Quintiles and IMS Health came together last year in a massive $19 billion megamerger, and now INC and inVentiv are looking to follow suit, combining into one new major company that will according to the pair make it the second largest biopharmaceutical outsourcing provider in the world.

Sage highlights ‘signal of activity’ in Parkinson’s data, but questions linger

Sage Therapeutics posted phase 2 results from its Parkinson’s disease study yesterday in which it said its experimental med could help tremors, but the top-line data were met with confusion by Bio Twitter, and its shares fell more than 3% in normal hours trading.

[Sponsored] A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

Biosimilars development in the U.S. is still rapidly growing and shifting. We discuss the key issues sponsors face today – from nonclinical testing to commercialization – along with considerations for a strategic regulatory approach.

Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma

As expected, Scott Gottlieb, M.D., has been confirmed as the new head of the FDA, about four months after his Obama-picked predecessor Robert Califf stepped down.

Oxford Genetics licenses CRISPR tech to power synbio push

Oxford Genetics has licensed CRISPR gene editing technology from ERS Genomics. The agreement gives the British synthetic biology service provider the right to use CRISPR technology to improve gene therapy viral vectors and develop cell lines.

Boston Scientific gets FDA nod for long-life cardiac implant

Boston Scientific has received FDA approval for its Resonate line of high-voltage cardiac devices. The regulatory nod clears Boston Scientific to start selling devices it thinks can overcome reticence among physicians to use multipoint pacing products by diminishing concerns about battery life.

Move over, AstraZeneca. Pfizer and Merck KGaA are the newest bladder cancer drugmakers in town

AstraZeneca’s Imfinzi won its bladder cancer approval just last week—but it’s no longer the newest immuno-oncology med for the condition.

News of Note

AbbVie has posted what it calls "promising results" from its CELEST phase 2 study for its JAK1 inhibitor upadacitinib (ABT-494) in Crohn's disease. Release

Fragile X syndrome-focused biotech Fulcrum Therapeutics has secured additional Series A funding from Alphabet’s Google Ventures. Statement

NantHealth has promoted former Caris Life Sciences executive Sandeep Reddy, M.D., to chief medical officer. Release

Resources

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[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.

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