Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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 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.
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 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.