Stock Analysts

Bristol-Myers’ Daklinza-Sovaldi Label Expanded in the EU

Bristol-Myers Squibb Company BMY announced that the European Commission has expanded the use of Daklinza, in combination with Gilead Sciences Inc.’s GILD Sovaldi (sofosbuvir), to include three new patient populations for the treatment of chronic hepatitis C (HCV). The approval allows the Daklinza-Sovaldi combination to be used with or without ribavirin, depending on the indication and HCV genotype, to treat HCV patients with decompensated cirrhosis, HIV-1 (human immunodeficiency virus) coinfection, and post-liver transplant recurrence of HCV. […]

Stock Analysts

Merck’s HCV Drug Zepatier Gets FDA Nod; Sets Lower Price

The highly lucrative and competitive hepatitis C virus (HCV) market is back in focus with Merck & Co. Inc. MRK gaining FDA approval for Zepatier – a once-daily, fixed-dose combination of elbasvir (50 mg; NS5A inhibitor) and grazoprevir (100 mg; NS3/4A protease inhibitor) for the treatment of adults suffering from chronic HCV genotype (GT) 1 or GT4 infection with or without ribavirin. […]

Stock Analysts

AstraZeneca’s Lynparza Gets Breakthrough Therapy Status

AstraZeneca plc AZN announced that the FDA has granted Breakthrough Therapy designation to its PARP inhibitor, Lynparza (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (Zytiga or Xtandi). We note that Breakthrough Therapy designation requires preliminary clinical evidence demonstrating that a drug may have substantial improvement over available therapy on at least one clinically significant endpoint. The status for Lynparza in this patient population means that the FDA will speed up the review of submission of data within 60 days of receipt. […]

Stock Analysts

Airlines Feel the Pinch of Zika Fears: More Trouble Ahead?

In the midst of the fourth-quarter 2015 earnings season, carriers seem to have a fresh challenge to cope with. The spread of the mosquito-borne Zika virus in more than 20 countries, particularly in South and Central America, has set off alarm bells causing many carriers to offer rescheduling/refunds for tickets purchased for travel to areas where the virus is now wreaking havoc. […]