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Darzalex Faspro, in combination with an anti-cancer triplet, is the first anti-CD38-based regimen for newly diagnosed patients with multiple myeloma, regardless of eligibility for stem cell transplantation.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.
At some point in your research career, you may find yourself transitioning from academia to industry or vice versa. To best set yourself up for success, adapt your approach to the specific scientific culture where you work.
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment, but CEO Vlad Coric looked for the brighter side at JPM, specifically emphasizing a serendipitous discovery that could get the company in the obesity game.
In November, Pfizer was reportedly looking to divest its stake in BioNTech, though the German biotech at the time denied these rumors.
The arrangement will boost AstraZeneca’s cell therapy portfolio as the pharma targets $80 billion in revenue by 2030.
The star of the acquisition, anti-IgE antibody ozureprubart, is being tested as a prophylactic treatment for food allergies, potentially setting up a competition for GSK with Roche’s Xolair.
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.
Henry Gosebruch, who has $3.5 billion in capital to deploy, is thinking broad as he steers the decades-old biotech out of years of turmoil.