Free website hits

The Food and Drug Administration found problems during a recent inspection of a Bristol Myers Squibb (BMY) facility in Bothell, Wash., but a Wall Street analyst believes the findings were not serious enough to complicate approval of a cancer drug the company acquired in its $74 billion buyout of Celgene.

In an October report known as a 483, the regulator found “relatively mild” issues with the manufacturing plant, according to Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. The Bothell plant is one of two facilities that are expected to produce a CAR-T therapy for treating large B-cell lymphoma.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


What is it?

STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What’s included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.


Leave a Reply

ArabicChinese (Simplified)EnglishFrenchGermanItalianJapanesePortugueseRussianSpanish

[mc4wp_form id="449"]