Policy
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
FEATURED STORIES
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.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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The FDA is keeping busy as summer winds down, with approvals, Orphan Drug Designations and other actions. Here’s what the agency has been up to this week.
Moderna announced it is filing lawsuits against Pfizer and BioNTech, alleging that the companies’ COVID-19 vaccine infringes patents covering its mRNA technology.
The United States and China are reportedly close to an agreement that would allow the PCAOB to audit companies listed on the U.S. stock exchange, per the Wall Street Journal.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
Of the 1,400 jobs Novartis plans to eliminate in Switzerland, about half will include leadership and management positions, the company reported Monday.
A day after Pfizer and partner BioNTech submitted an EUA request to the FDA for their booster shot targeting Omicron variants BA.4 and BA.5, the regulator appears close to approving it.
Shares of Foghorn are tumbling after the FDA placed a full clinical hold on a Phase I dose escalation study that had already been subject to a partial hold following a patient death.
Drug development can be done better, faster and less expensively. The industry is facing up to that reality, moving a variety of disruptive innovations forward with the blessing of regulators.