Sam – Page 581 – biolegacy

The high court will review Bristol-Myers Squibb’s appeal of a California Supreme Court ruling that grants the state’s courts jurisdiction to hear lawsuits filed by non-state residents. Source: Drug Industry…

McKesson to Pay Record Fine of $150 Million for Not Reporting Suspicious Opioid Orders

Post author:Sam
Post published:January 19, 2017
Post category:Drug Industry Daily

McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids.…

Mallinckrodt to Settle FTC Monopoly Charges for $100 Million

Post author:Sam
Post published:January 19, 2017
Post category:Drug Industry Daily

Mallinckrodt will pay $100 million to settle FTC charges that the company maintained a U.S. monopoly for the only approved adrenocorticotropic hormone (ACTH) drug, Acthar, by acquiring the rights to…

Chinese Drugmaker Cited for Failing to Disclose Info to FDA

Post author:Sam
Post published:January 19, 2017
Post category:International Pharmaceutical Regulatory Monitor

The FDA handed Chinese manufacturer Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with…

International Drugmakers Earn Warning Letters Over Quality Controls

Post author:Sam
Post published:January 19, 2017
Post category:International Pharmaceutical Regulatory Monitor

The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Source: International Pharmaceutical Regulatory Monitor

Califf, FDA Officials Temper Expectations for Real-World Evidence

Post author:Sam
Post published:January 19, 2017
Post category:International Pharmaceutical Regulatory Monitor

Fifteen FDA officials, including Commissioner Robert Califf, called for the broader uses of research methodologies in real-world settings, but cautioned against expectations for “quick wins” in efficiency and savings. Source:…