Articles by Anna Rose Welch
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FDA News Roundup: AstraZeneca, Pfizer, AbbVie, Actavis, And More
4/24/2015
What FDA decisions did you miss this week?
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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.
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FDA News Roundup: Teva, AstraZeneca, Amgen, Medicines Company, And More
4/17/2015
What FDA decisions did you miss this week?
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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.
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FDA News Roundup: Novo Nordisk, AstraZeneca, Merck, And More
4/10/2015
What FDA decisions did you miss this week?
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Where Did The Biobetters Buzz Go?
4/2/2015
The past few weeks, it seems the word on everyone’s tongue — including my own — has been biosimilars. Since the approval of Novartis’ Zarzio in the U.S., there’s been a lot of discussion and speculation about how this important approval will affect current blockbusters on the market and who will enter the space next. But I’m left with another question: What happened to the buzz over biobetters?
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FDA News Roundup: Sanofi Pasteur, GSK, Lilly, And More
3/27/2015
What FDA decisions did you miss this week?
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How Will AbbVie, J&J, And Amgen Handle The Biosimilar Age?
3/20/2015
Following the approval of the first biosimilar last week, there were a number of questions circulating throughout the industry. My blog from last week addressed two questions about where the biosimilars market is headed, but I also wanted to address a third question I’ve seen cropping up: What are companies with blockbusters going to do to keep revenues intact now that they’re facing biosimilar competition?
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What's Next For The Biosimilars Market?
3/13/2015
Late last week, the FDA approved the first biosimilar from Novartis’ company, Sandoz. The drug, Zarxio (filgrastim), is the biosimilar to Amgen’s Neupogen, which is indicated to treat cancer patients suffering from neutropenia — a condition characterized by the loss of neutrophils (a common type of infection-fighting white blood cells). While the approval is certainly good news from a costs and innovation standpoint, the industry is still asking some key questions.
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FDA News Roundup: Bristol-Myers Squibb, Bayer, Astellas, And More
3/11/2015
What FDA decisions have you missed in the last week?