News

FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm.

Zykadia (ceritinib) is a tyrosine kinase inhibitor that was approved by FDA on April 29, 2014, as a medication for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.

Dallas Ebola victim dies

Responding to requests from treating physicians, FDA has okayed brincidofovir for Emergency Investigational New Drug Applications (EIND), allowing it to be used in the treatment of the Ebola virus disease.

Bristol-Myers Squibb (BMS) will not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.

Earlier this year, IMS Health released a report indicating that overall drug spend in the United States increased by 3.2% in 2013.1 That increase stands in contrast to the 1% decline in drug spend in 2012.1 IMS noted that primary drivers of the increase include fewer patent expirations, drug price increases, expensive new drug therapies, and greater use of the healthcare system. Considering these drivers, all indications are that drug spend will continue to increase in the years to come.

In recent months, the CDC has cautioned that individuals with Ebola virus disease (EVD) in West Africa may travel to the United States, exhibit signs and symptoms of EVD, and present to US facilities.1,2 Now, the first case of a patient presenting with EVD to a US hospital has been reported and some others identified as being in contact with this patient are at risk.3

Genentech has announced a major change in the distribution process for their 3 top cancer drugs: Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab). Now, distribution of the drugs to hospitals and clinics will be restricted to authorized specialty distributors.