Policy
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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Albert Bourla, Pfizer’s CEO, took home a salary of $1.69 million in 2021. To Pfizer, he’s undoubtedly worth it, having led the company to its COVID-19 vaccine success.
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Martin Shkreli will not be able to delay paying nearly $25 million he owes from a civil lawsuit that he and his company employed on Daraprim.
Although there is talk of a fourth shot of the COVID-19 vaccine the data so far suggest the benefits may be modest. Continue reading for details and more COVID-19 news.
A closer look at legal action against executives from the company formerly known as JHL Biotech who recruited scientists from Genentech to steal trade secrets related to several cancer drugs.
Sir Mene Pangalos said the company was considering not submitting it to the FDA if it finds it is “banging its head against a brick wall indefinitely.”
U.S. and Chinese regulators are edging toward a cooperation plan on Chinese companies that have stock listed on U.S. stock exchanges.
Alexion will pay Chugai $775 million in the second quarter of 2022 in exchange for the Japanese firm withdrawing the patent infringement lawsuits it filed in Europe, Japan and the U.S.
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.