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According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.
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From revenue to R&D investment, Novo and Lilly and their mega-blockbuster weight loss drugs Zepbound and Wegovy have moved into a new pharma stratosphere, far eclipsing their rivals.
Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
BioSpace Senior Editor Annalee Armstrong headed to the J.P. Morgan Healthcare Conference with a months-long story idea brewing. Unfortunately, it was one she’s written before.
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Halozyme Therapeutics, Inc. announced that Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the U.S. FDA for their Biologics License Application for the subcutaneous formulation of Opdivo® co-formulated with ENHANZE®.
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In a recent BioSpace LinkedIn poll, nearly half of respondents predicted the job market won’t turn around until 2027 or later. It’s easy to see why people are skeptical, especially when you consider recent hiring activity and layoffs.
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The company, launched with help from ex-Novartis executives, is targeting glutamate signaling in the brain to help treat alcohol- and cocaine-use disorders, among other indications.
Novo will license UTB251, a triple hormone receptor agonist that in mid-2023 achieved 24% weight reduction at 48 weeks in a mid-stage study.
The investments come amid an ongoing insurance fraud probe into AstraZeneca’s former China head Leon Wang—and despite mounting pressure from President Trump for pharma companies to re-shore their manufacturing operations.
AbbVie claims that Genmab turned a blind eye to trade secret theft allegedly used to support the development of ProfoundBio’s investigational antibody-drug conjugates. Genmab acquired ProfoundBio in May 2024.
In attempt to keep R&D costs low, the vivarium business model has emerged as a crucial solution for drug developers.
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.
Since 2016, the FDA has approved three disease-modifying treatments for spinal muscular atrophy, with several companies—including Novartis, Scholar Rock and Biogen—progressing novel candidates through clinical trials.
It’s early days for xenotransplantation, but eGenesis, Eledon, United Therapeutics and more are working to develop solutions to make this approach a viable option and help ease the organ shortage crisis.
Johnson & Johnson follows Eli Lilly in spending billions on U.S. manufacturing after President Donald Trump threatened major tariffs on pharmaceutical products. Pfizer has also promised a similar commitment.