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Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
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The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Life sciences talent acquisition teams are examining internal processes and thinking critically about their employer value proposition as they prepare for innovation and market swings.
Months after a denial of its rare eye cancer injection, Aldeyra Therapeutics is bracing for another potential rejection by the regulator, this time for its investigational dry eye disease treatment.
In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
The blockbuster PD-1 inhibitor’s label expanded further on Monday when the FDA greenlit Keytruda as a perioperative treatment for certain patients with earlier stages of non-small cell lung cancer.
The biopharma discontinued its late-stage study after an interim review found that its investigational treatment for immunoglobin A nephropathy did not achieve statistically significant improvement over placebo.
The company’s experimental lgG4 antibody met the primary endpoint in a late-stage study of the rare skin disease. AnaptysBio will submit an application to the FDA by the third quarter of 2024.
The regulator approved the combination of Pfizer’s Braftovi and Mektovi for the treatment of metastatic non-small cell lung cancer in adult patients with a BRAF V600E mutation.
The Danish pharma announced Monday that it is buying a Phase III hypertension candidate from Singapore-based KBP Biosciences. It is Novo Nordisk’s third high-value purchase in as many months.
Patients in a late-stage trial treated with Eli Lilly’s GIP and GLP-1 receptor agonist saw a 21.1% mean body weight reduction over 72 weeks following an intensive lifestyle intervention program.
A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.