News
Less than two months after two FDA-related setbacks, Atara Biotherapeutics is again cutting its workforce in half. This time, it’s also hitting pause on two CAR T programs, including one affected by an FDA clinical hold in January.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
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The board of directors of Eli Lilly and Company has declared a dividend for the second quarter of 2023 of $1.13 per share on outstanding common stock.
FROM OUR EDITORS
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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Pfizer CEO Albert Bourla is in a tough spot as activist investor Starboard Value continues to call for a change in the company’s leadership. However, analysts are supportive of the embattled executive.
The French drugmaker’s newly launched respiratory syncytial virus antibody Beyfortus far exceeded analyst expectations, bringing in almost $700 million in the third quarter. Leerink Partners analyst David Risinger in a Friday note to investors said Sanofi expects Q4 Beyfortus sales similar to Q3.
The CDC’s vaccine advisors on Thursday maintained that respiratory syncytial virus immunization is only recommended for adults aged 75 and older, and in seniors 60 to 74 years who are at risk of severe disease.
Bank of America analysts said prior to Thursday’s readout that Tyra Biosciences’ TYRA-300 could rival Johnson & Johnson’s kinase inhibitor Balversa, which has suffered from safety concerns and poor tolerability.
Jefferies analyst Maury Raycroft said in a note to investors that Thursday’s mid-stage readout pointed to the “unprecedented” complete response rate of Intellia’s investigational in vivo gene editing therapy in the disorder.
Researchers have linked Novo Nordisk’s semaglutide to a 40% to 70% reduction in the risk of Alzheimer’s disease diagnosis in a study of medical records from 1 million patients.
With an upfront payment of $50 million from Roche, the partnership will leverage Dyno Therapeutics’ in vivo gene therapy delivery technology, which synthesizes virus capsids with better functionality and manufacturability.
In this episode of Denatured, Lori and guests from Teva Pharmaceuticals and TOWER Capital review the investment landscape this year and the policies influencing investment heading into 2025.
The group of like-named companies that include Novo Holdings and Novo Nordisk—the two tied to a multibillion-dollar buyout of Catalent currently under FTC review—ultimately send proceeds to the Novo Nordisk Foundation, one of the world’s largest charitable foundations.
While the regulator has not approved their use in type 1 diabetes, off-label prescribing for GLP-1 receptor agonists has sharply increased, according to researchers, who warn about the risk of serious side effects such as ketoacidosis.