A six-year Mylan employee, Dayakar Mallu, is facing up to six years in jail after pleading guilty to insider trading and tax offence charges.

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.