Archive for April 2018

A Massachusetts judge ruled that Biogen must face a False Claims Act lawsuit brought by former employees alleging the company paid healthcare providers kickbacks to prescribe Biogen’s multiple sclerosis products, including Avonex, Tecfidera and Tysabri. Source: Drug Industry Daily

The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Source: Drug Industry Daily

Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to two Ropes and Gray attorneys. Source: Drug Industry Daily

In a move applauded by domestic drug groups, the U.S. Trade Representative added Canada to its priority watch list of countries with lax intellectual property protections or market access barriers for drugs. Source: Drug Industry Daily

Citing concerns among stakeholders including the FDA, the U.S. Pharmacopeia decided not to move forward with proposed revisions to its nomenclature for biologics. Source: Drug Industry Daily

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended three medicines for approval and eight extensions at its April 23-26 meeting. Source: Drug Industry Daily

The FDA warned Lijiang Yinghua Biochemical and Pharmaceutical for serious data management failures and quality unit errors. Source: Drug Industry Daily

Citing a Merck in-house attorney’s dishonesty under oath, the Federal Circuit upheld a 2016 ruling that dismissed a $200 million verdict against Gilead, affirming that Merck unethically obtained the rights to two patents. Source: Drug Industry Daily

The International Brotherhood of Teamsters — shareholders in McKesson — expressed skepticism about the outcome of a probe that cleared the drug company’s leadership of contributing to the opioid epidemic. Source: Drug Industry Daily

Drug manufacturer Degasa did not adequately test its products or include all necessary data in laboratory records, according to a warning letter from the FDA. Source: Drug Industry Daily