Record number of new medicines in 2015: The FDA’s Center for Drug Evaluation and Research’s (CDER) fifth annual Novel New Drugs Summary approved a record 45 new medicines in 2015, marking the highest number of approvals in almost two decades. More than a third of the medicines approved were first-in-class treatment options - offering a completely new way to treat disease – and nearly half were for the treatment of rare disease. Learn more about how these and other new medicines are giving patients even greater hope for the future.
And according to a new analysis from the Personalized Medicine Coalition (PMC), 2015 was also a banner year for the approval of personalized medicines. Personalized, or precision, medicines made up 28 percent of novel new drugs approved by the FDA last year. Find out more about how this era of targeted therapy is rapidly transforming care for patients.
Medicare Monday: We recently highlighted the top successes of the Medicare Part D program 10 years after its implementation. This week, learn more about how Part D has expanded coverage to millions of seniors who previously didn’t have access to comprehensive drug coverage.
ASCO on clinical pathways: The American Society for Clinical Oncology (ASCO) recently published a statement on clinical pathway programs amid concerns that clinical pathways are being implemented in a way that hinders the effective delivery of high-quality cancer care. Learn more about ASCO’s recommendations to improve these pathways to support informed choices by providers and patients without jeopardizing quality of care.Biosimilar labeling guidance: In partnership with the Biotechnology Innovation Organization (BIO), PhRMA filed a Citizen Petition urging the FDA to include a number of key safety and transparency features as the agency develops regulatory guidance on the issue of biosimilar labeling. Read more about our requests.