News
AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
FEATURED STORIES
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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Pfizer Inc. announced that David M. Denton will join the Company as Chief Financial Officer and Executive Vice President effective May 2, 2022.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The Pharma Proteomics Project isn’t the first precompetitive collaboration between pharma companies, but it’s one of the largest. Members recently published associations they’ve uncovered in UK Biobank data.
In its first financial report since the Kenvue consumer health spinoff, Johnson & Johnson beat analyst expectations fueled by strong pharmaceutical sales including Darzalex, Erleada and Stelara.
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.