Celgene to Create BioPharma Incubator on New Jersey R&D Site
Fresh off its $7B acquisition, Celgene is planning to open a biopharma incubator on its corporate campus in New Jersey. Source: BioSpace
5 Healthcare Systems to Launch New Generic Drug Company
The 2016 U.S. presidential election was marked by aggressive and often shrill attacks on the biopharma industry over drug pricing. Source: BioSpace
GlaxoSmithKline CEO Continues Restructuring With Job Cuts in Africa
This Latest move is a wide-ranging effort to boost competitiveness. Source: BioSpace
Imprimis Hit With Warning Letter Amidst Lawsuit
The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created…
GAO: Medicare’s Opioid Use Monitoring Lets At-Risk Patients Fall Through the Cracks
The federal government’s guidance for monitoring opioid use among Medicare beneficiaries does not go far enough in identifying which beneficiaries are most at risk and the Centers for Medicare &…
Medical Countermeasures Are an FDA Priority, Gottlieb Tells Lawmakers
Enabling access to medical countermeasures for material threats is a top FDA priority, according to Commissioner Scott Gottlieb, who reviewed the agency’s efforts before a Senate committee Wednesday. Source: Drug…
Common Rule Revisions Delayed for Six Months, But Certain Changes Can Continue
The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to…
483 Roundup: FDA Cites Italian, Indian and Chinese Firms
The FDA flagged facilities in Italy, India and China for noncompliances including inadequate testing, complaint handling, and quality data, among other violations. Source: Drug GMP Report
Warning Letter Roundup: FDA Targets Firms for GMP, Other Violations
The FDA issued warning letters to eight drug manufacturers for adulterated products, misbranding and unapproved drug products, among other violations. Source: Drug GMP Report
Dr. Reddy’s Settles Unsafe Packaging Case With Justice Department
Dr. Reddy’s agreed to pay $5 million to settle claims it sold products without sufficient safety testing of the packaging. Source: Drug GMP Report
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