Articles by Anna Rose Welch

31. FDA News Roundup: Valeant, Pfizer, Boehringer Ingelheim, And More 5/29/2015

    What FDA decisions have you missed recently?

32. FDA News Roundup: Baxter, Celgene, Agios, And More 5/22/2015

    What FDA decisions have you missed recently?

33. FDA News Roundup: Vertex, Merck KGaA , Bayer, And More 5/15/2015

    What recent FDA decisions have you missed lately?

34. Keeping Tabs On Gene Therapy? Big Pharma Is Closing In 5/12/2015

    Some good news for Big Pharma in recent weeks was GSK’s filing with the European Medicines Agency for approval of its gene therapy for ADA Severe Combined Immune Deficiency (ADA-SCID), also known as “bubble boy disease.”

35. FDA News Roundup: Biogen Idec, GSK, Roche, And More 5/8/2015

    What regulatory decisions have you missed lately?

36. Breakthrough Therapy Designation: Worth The Development Time Crunch, Experts Say 5/4/2015

    When I hear the words “Breakthrough Therapy Designation” (BTD), I immediately picture a gold-embossed certificate with a blue ribbon. After all, the designation is reserved for those candidates that, early on in clinical studies, promise more extraordinary benefits than the current standard-of-care treatments for a disease. Judging from the recent buzz I’ve noticed in the industry, the increasing number of treatments boasting this designation is in no way eliminating its prestige.

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

    What recent FDA decisions did you miss?

38. 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. 

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

    What FDA decisions did you miss this week?

40. 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.