News

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not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.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

In patients with severe to very severe COPD and a history of exacerbation, the risk of moderate or severe exacerbations during 1 year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids (ICS) and those who discontinued ICS therapy in a step-wise manner, as long as patients continued to receive maintenance treatment with long-acting bronchodilators (tiotropium and a long-acting beta agonist [LABA]), according to data presented at the European Respiratory Society (ERS) International Congress 2014 and also published in The New England Journal of Medicine.

FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.

Adding pertuzumab (Perjeta, Roche) to trastuzumab (Herceptin, Genentech) and docetaxel chemotherapy extended the lives (overall survival; OS) of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8 months), according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.