Government
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 scandal, dubbed Operation Varsity Blues, revolves around dozens of wealthy parents paying a college consultant to help cheat on entrance exams and falsify student athlete profiles, as well as bribing coaches at a number of prestigious universities.
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.
In the wake of the scandal caused by a Chinese researcher’s use of CRISPR-Cas9 gene editing to alter the DNA of embryos for seven couples, leading scientists called for a moratorium on heritable genome editing.
Shares of Insys plunged more than 25 percent in trading Wednesday after the company said in a filing with the U.S. Securities and Exchange Commission that it could soon run out of revenue and may have to resort to liquidating its assets.
In addition to the planned BioNTech IPO, many other pharma and biotech companies in Europe, Asia and elsewhere shared news for the week.
With a major lawsuit in Oklahoma targeting Johnson & Johnson and Purdue Pharma’s involvement in the opioid epidemic starting in May, many of the legal documents are being released, with strategies and sometimes incendiary rhetoric coming to light.
The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.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.
National Cancer Institute Director Norman “Ned” Sharpless will take over the role as acting commissioner of the FDA while the White House seeks a permanent replacement for the outgoing Scott Gottlieb.
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