GSK's DoJ Settlement Requires Execs To Forfeit Bonuses If Misconduct Occurs GlaxoSmithKline pleads guilty to promoting Paxil and Wellbutrin off-label and failing to report Avandia safety data to FDA; civil portion of settlement resolves off-label and kickback allegations involving nine products. New corporate integrity agreement gives OIG authority to require a recall.
AstraZeneca, BMY To Target Disease Management And Primary Care Synergies With Amylin Acquisition In acquiring Amylin at a hefty premium, Bristol-Myers Squibb and its partner AstraZeneca are highly optimistic about prospects for Amylin's GLP-1 franchise, and also hope to leverage their existing infrastructure as their fledgling diabetes franchise struggles to meet expectations.
NPS Rewrites Royalty Agreement With Amgen To Get Near-term Cash The New Jersey-based orphan drug company has reworked the terms of its agreement with partner Amgen to obtain cash to launch its first two products.
FDA Helps Makena With Statement Against High-Volume Compounding Agency says it could take enforcement action against pharmacies producing large quantities of the preterm birth drug and physicians should prescribe an approved drug before a compounded version.
Johnson & Johnson Files NDA Seeking Accelerated Approval Of Bedaquiline In Tuberculosis The compound, a diarylquinolone, would be the first therapy approved for TB offering a new mechanism of action in 40-plus years.
Lack Of Device Clock Synchronization Vexes Physicians, Hospitals Synchronized clocks aid medical decision making immensely. However, many medical devices do not have a common understanding of time and create problems for clinicians.
NICE Scientific Advice Program May Seek Broader Application Through Boosting Regulator Link-Up NICE's scientific advice program, now in its third year, may need refocusing and increased co-operation with regulators to appeal to small and medium-sized companies.
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