News
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Read our takes on the biggest stories happening in the industry.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
THE LATEST
In addition to missing the mark in overall survival, Gilead reported Thursday a higher number of deaths in the Trodelvy arm of the confirmatory metastatic urothelial cancer study.
Novartis’ Scemblix posted stronger results with fewer discontinuation rates than both its own Gleevec and a stronger second-generation TKI, positioning it for a potential first-line indication in chronic myeloid leukemia.
As evidenced by this week’s buyouts by J&J and Merck, Big Pharma appears to have found a sweet spot favoring smaller deals over megabillion-dollar acquisitions.
The American Society of Clinical Oncology annual meeting kicks off today in Chicago, with highly anticipated presentations that include reports on a bispecific antibody, an ADC and a BCMA-targeted CAR-T cell therapy.
The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
Tempting as it may be to turn to full automation to meet burdensome requirements, the potential for hallucination and other issues means biopharma companies must proceed with caution.
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
As BioNTech struggles to establish its footing in a post-pandemic world, the biotech has secured $145 million from the Coalition for Epidemic Preparedness Innovations to expand its mRNA operations in Rwanda.
Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.