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August 08, 2017

Today's Rundown

  1. Roche in part-sale of mixed bag lebrikizumab to Dermira

  2. Sellas snags Nasdaq listing in reverse merger with Galena

  3. FibroGen soars as idiopathic pulmonary fibrosis data paint pamrevlumab as a blockbuster, spark talk of big partnership

  4. [Sponsored] Understanding the Power of Natural Killer Cells and New Nonradioactive Assay Approaches

  5. Juno executives investigated over trial deaths disclosure by law firm

  6. Cellular ‘garbage disposal’ units fingered in Alzheimer’s development

  7. Boston Sci backs neuromodulation startup focused on postamputation pain

  8. Valeant gets 2nd CRL for eye drug, stung again by manufacturing failings

  9. In 10 years of M&A, which were stars—and which were duds? We want you to decide

  10. News of Note—Kite IND, RXi I-O targets and Mitobridge DMD test

Featured Story

Roche in part-sale of mixed bag lebrikizumab to Dermira

Dermira will take on exclusive, worldwide rights to IL-13 monoclonal antibody lebrikizumab from Roche, although the Big Pharma holds on to its rights for the medication in certain indications.

Top Stories

Sellas snags Nasdaq listing in reverse merger with Galena

Sellas Life Sciences has snagged itself a Nasdaq listing by merging with Galena Biopharma. The deal gives Sellas a route to public investors as it seeks to guide its Wilms tumor 1-targeting drug through phase 3 trials in acute myeloid leukemia and mesothelioma.

FibroGen soars as idiopathic pulmonary fibrosis data paint pamrevlumab as a blockbuster, spark talk of big partnership

FibroGen has convinced investors it has another potential blockbuster on its hands. Shares in the West Coast biotech shot up 60% after it posted top-line phase 2 pamrevlumab data that suggest the anti-connective tissue growth factor (CTGF) antibody can muscle in on a market fought over by Boehringer Ingelheim and Roche.

[Sponsored] Understanding the Power of Natural Killer Cells and New Nonradioactive Assay Approaches

Natural killer (NK) cells first earned their title as “killers” nearly 40 years ago when researchers observed the rapid immune response of these lymphocytes as they destroyed host cells infected with a virus or tumor cells. It seemed that NK cells could attach spontaneously without prior activation. Over time, researchers have learned more about the molecular mechanisms that regulate their activation and function.

Juno executives investigated over trial deaths disclosure by law firm

Last year, Juno was hit by a string of deaths in a test for its experimental CAR-T med; now its top-level executives are being investigated about whether they failed shareholders by not telling them more about the fatalities.

Cellular ‘garbage disposal’ units fingered in Alzheimer’s development

Lysosomes break down old material in cells so the body can dispose of it. Now, scientists at Yale University are zeroing in on lysosomes in the brain, and they believe they’ve discovered how these “garbage disposal” units may contribute to the buildup of the amyloid plaques characteristic of Alzheimer’s disease.

Boston Sci backs neuromodulation startup focused on postamputation pain

Neuros Medical raised $20 million to complete the pivotal study of its neuromodulation device for the management of postamputation pain.

Valeant gets 2nd CRL for eye drug, stung again by manufacturing failings

For a second time, the FDA has turned its back on Valeant Pharmaceuticals' NDA for a new eye drug because of manufacturing issues at a Bausch + Lomb plant. 

In 10 years of M&A, which were stars—and which were duds? We want you to decide

Over the past 10 years, we’ve covered scores of deals—and rumors of deals—be they small, large or mega. Some paid off. Some didn't. Which M&A moves were the decade's best and which were the worst? We're asking you to decide. Nominate your picks this week.

News of Note—Kite IND, RXi I-O targets and Mitobridge DMD test

Tuesday's dose of your biopharma news of note.

Resources

[Webinar] Results from the 2017 Unified Clinical Operations Survey

Learn why 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up.

[Video] API Discussion with Dr. Robert DeWit, CEO of MPI Research

FierceBiotech interviews Dr. DeWit to discuss a common cause for drug development delays, and strategies to avoid these costly setbacks.

[Whitepaper] Industry Report: Findings from the 2017 Unified Clinical Operations Survey

Learn why 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up.

[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.

[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.

Events

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