Life Science Connect Blog

  1. FDA News Roundup: Kythera Bio, Boehringer Ingelheim, GW Pharma, And More 5/1/2015

    What recent FDA decisions did you miss?

  2. Clinical Trial Data Transparency: The Dangers Of “Putting It In Layman's Terms” 4/27/2015

    It’s been an exciting and tumultuous few months for ALS patients and the small biotech Genervon. The lengthening saga among the company, the FDA, and the army of eager, treatment-seeking ALS patients culminated recently in an order from the FDA that Genervon publicly release all data from the Phase 2 trial of its ALS candidate GM604. In a statement released early this week, Genervon said it had submitted all required data to the FDA for review. 

  3. FDA News Roundup: AstraZeneca, Pfizer, AbbVie, Actavis, And More 4/24/2015

    What FDA decisions did you miss this week?

  4. Leadership Lessons From 23andMe's Jump Into Drug Discovery 4/17/2015

    23andMe has been the center of attention quite a bit recently — not only because of its high profile partnerships with Pfizer and Genentech, but also because of the recent FDA approval of its carrier test for Bloom Syndrome. However, perhaps the biggest news for the company as of late was the announcement it is jumping into the drug discovery space.

  5. FDA News Roundup: Teva, AstraZeneca, Amgen, Medicines Company, And More 4/17/2015

    What FDA decisions did you miss this week?

  6. Takeda's Velcade Replacement: Future Patient-Centric Blockbuster? 4/10/2015

    Last month, right before the approval of the first U.S. biosimilar, Amgen announced a victory for its myeloma drug, Kyprolis. In the Phase 3 ENDEAVOR clinical trial, injectable Kyprolis, taken in combination with low-dose dexamethasone, outperformed Takeda’s rival injectable Velcade plus dexamethasone. Multiple myeloma patients lived twice as long without their disease worsening when taking Kyprolis. However, recent news suggests Takeda isn’t backing down without a fight.

  7. FDA News Roundup: Novo Nordisk, AstraZeneca, Merck, And More 4/10/2015

    What FDA decisions did you miss this week?

  8. FDA News Roundup: AstraZeneca, Teva, Amgen, And More 4/2/2015

    What regulatory decisions did you miss this week?

  9. FDA, EMA Drug Approval Stats: Are We Measuring Success The Wrong Way? 3/27/2015

    While approval stats spark declarations of excitement from each regulatory agency and make news headlines, the differences in approval times in particular aren’t necessarily a cause for celebration; rather, they illuminate something much more concerning about the state of global drug development.

  10. FDA News Roundup: Merck, Actavis, Vertex, And More 3/20/2015

    What FDA decisions did you miss this week?