In 2015, First-Of-A Kind Drug Approvals On The Rise
This trend reflected an industry-wide focus on drugs for rare and hard-to-treat diseases. Meanwhile, Gilead's hepatitis C combo drug gets a Food and Drug Administration priority review, a gene-editing drug maker files for an IPO and some testing of another drug is suspended.
The Washington Post:
First-Of-A-Kind Drug Approvals Continued Rise In 2015
Approvals for first-of-a-kind drugs climbed last year, pushing the annual tally of new U.S. drugs to its highest level in 19 years. The rising figures reflect an industry-wide focus on drugs for rare and hard-to-treat diseases, which often come with streamlined reviews, extra patent protections and higher price tags. (Perrone, 1/4)
The Wall Street Journal:
Gilead Gets FDA Priority Review Of Hepatitis C Combo Drug
Gilead Sciences Inc. said the U.S. Food and Drug Administration granted a priority review of its experimental hepatitis C combination drug. The Foster City, Calif., drugmaker filed a new drug application for the treatment—a combination of the biopharmaceutical company’s Sovaldi with velpatasvir—in late October. The FDA is expected to decide whether to approve the combination therapy by June 28. (Stynes, 1/4)
Bloomberg:
Gene-Editing Drugmaker Backed By Google, Gates Files For IPO
Editas Medicine Inc., the drugmaker whose backers include Bill Gates and Google Ventures, filed to become the first publicly traded company to specialize in a new technology to edit flaws in genes. The company, which uses a gene-editing technique called Crispr, filed Monday for the IPO with an initial size of $100 million. That’s a placeholder amount used to calculate fees and will probably change. (Chen and Barinka, 1/4)
The Wall Street Journal:
Heart Incidents End Parts Of Two Studies By Teva, Active Biotech
Teva Pharmaceutical Industries Ltd. and Active Biotech AB said Monday they were ending the higher-dose portions of two multiple-sclerosis studies with the drug Laquinimod after eight patients suffered nonfatal cardiovascular events. The companies said the incidents occurred in the higher-dose components of a phase 3 and a phase 2 clinical trial. The lower-dose and placebo components of the tests will continue. (Hufford, 1/4)
