Food and Drug Administration (FDA)

NEWS
As an outbreak of the Ebola virus in the Democratic Republic of the Congo worsens, a team of health officials has taken four experimental vaccines to the front lines and begun to administer it to patients who may have been exposed to the deadly virus.
On Friday, the FDA approved Merck’s Keytruda, an anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with the chemotherapy drug sorafenib.
Clinical data for a fish-oil-based drug from Amarin Corporation PLC confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.
FDA
The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.
Months after the U.S. Food and Drug Administration (FDA) rejected Insys Therapeutics’ buprenorphine sublingual spray for moderate-to-severe acute pain, the Arizona-based company is assessing strategic alternatives for its opioid-related assets as it continues to shift its focus to a new therapeutic – cannabinoids.
Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), provided an update on the agency’s Expanded Access program.
In the wake of a Complete Response Letter issued by the FDA, Trevana, Inc. is slashing one-third of its workforce. On Wednesday, Merrimack Pharmaceuticals also announced it was terminating 60 percent of its staff as the company narrows its research and development focus.
Boston Business Journal recently created a list of 15 Massachusetts life science companies that in their third-quarter reports, allocated the highest percentage of total costs to research and development. Here’s a look.
Plenty of biotech companies will be releasing their third-quarter financial reports next week. Let’s take a quick look at some of these companies and their top stories they reported through 3Q2018.
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