"Some of the drugs allowed on the US market in 2012 included: Pfizer’s leukaemia drug Bosulif (bosutinib); Ariad Pharmaceutical’s leukaemia drug Iclusig (ponatinib); Johnson & Johnson’s multi-drug resistant TB drug Sirturo (bedaquiline); Roche’s new breast cancer Perjeta (pertuzumab); Pfizer and Bristol-Myers Squibb’s blood thinner Eliquis (apixaban); Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco (ivacaftor); Pfizer rheumatoid arthritis drug Xeljanz (tofacitinib); and Arena Pharmaceuticals Belviq (lorcaserin), the first prescription weight-loss pill in 13 years." (Más)
"...the agency enters 2013 with the additional power of the Food and Drug
Administration Safety and Innovation Act, passed this summer. The law confers a
“breakthrough therapy” label to drugs that may treat a serious or
life-threatening condition based on preliminary clinical evidence.
The agency granted two Breakthrough Therapy labels for 2012 as of December 10, and denied one. The agency's December 10 report also noted that it closed the year with an all-time high of New Molecular Entity first-cycle approval rates.
“What's most important is that from the patient's standpoint, 2012 was a good year. A lot of good new drugs were approved,” Pines said. (Más)
The agency granted two Breakthrough Therapy labels for 2012 as of December 10, and denied one. The agency's December 10 report also noted that it closed the year with an all-time high of New Molecular Entity first-cycle approval rates.
“What's most important is that from the patient's standpoint, 2012 was a good year. A lot of good new drugs were approved,” Pines said. (Más)
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