Policy
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
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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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China’s proposed guidelines for bioethics say that organizations outside of China cannot collect and preserve Chinese human genetic resources inside China or take them out of the country.
Amgen held its earnings conference call on Wednesday for Q1 of 2022. Most notably, the company provided updates on its ongoing litigation with the Internal Revenue Service.
The Q1 results for Voxzogo gave BioMarin the confidence to raise its 2022 full-year guidance to between $100 million to $125 million (net product revenue) for the drug.
Weeks after Gilead Sciences raised concern over counterfeit HIV drugs, Johnson & Johnson has taken similar action against the distribution of counterfeit prescription drugs.
The U.S. Congress is calling for the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.
David Sabatini, who was ousted last year by the Whitehead Institute over allegations of sexual harassment, may have found a new home at the NYU Grossman School of Medicine.
Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
How many boosters are enough to protect against COVID-19 infection? This question has been at the forefront of the minds of everyone as news crops up about yearly boosters.
Gamida Cell reported that the FDA had lifted its clinical hold on its cryopreserved formulation of GDA-201. It expects to launch a Phase I/II drug trial for those indications this year.
The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.