Sovaldi Aside, Declining Economic Returns On New Drugs Threaten Innovation – Study
Lifetime total costs exceeded expected revenues for novel products launched from 2005-2009, according to a paper published in Health Affairs. Focusing solely on recent successful launches like Gilead’s hepatitis C drug ignores the commercial fate of other once-promising drugs that turned out to be “dogs,” MIT researcher says.
You may also be interested in...
Head Of The Class: A Star Stands Out Among 2014 Drug Launches
Gilead’s Sovaldi earned a spot in the record books – and the hearts of drug marketers – generating $8.55 billion in the first nine months of 2014. Despite controversy over Sovaldi’s high price, Gilead defended the drug’s value and executed flawlessly on the launch. Other 2014 drug launches were slow out of the gates, as the bar for new drugs continues to grow.
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.