Regulatory
Allergan, which has been a leader in the migraine space, hopes to have a new treatment available for patients using a new mechanism of action for acute treatment of migraine.
Legislation aims to provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests
Auris Medical Holding AG announced that it has filed its Annual Report on Form 20-F for the year ended December 31, 2018, with the U.S. Securities and Exchange Commission.
It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
During his relatively brief tenure as Commissioner of the U.S. Food and Drug Administration (FDA), Scott Gottlieb has worked to streamline and advance guidelines for clinical trials. As something of a parting shot, Gottlieb made a statement criticizing the industry’s reluctance to take advantage of them.
The White House budget proposal released earlier this week that slashed spending on the National Institutes of Health and Medicare programs has put members of the administration, including Health and Human Services Secretary Alex Azar on the defensive.
GENFIT S.A. announced its intention to issue and sell, subject to market and other conditions, 5,000,000 of its ordinary shares in a global offering to specified categories of investors, comprised of an initial public offering of American Depositary Shares, each representing one ordinary share, in the United States, and a concurrent private placement of ordinary shares in Europe and other countries outside of the US.
In addition to the planned BioNTech IPO, many other pharma and biotech companies in Europe, Asia and elsewhere shared news for the week.
The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
The FDA issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year.
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