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An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The partnership dates back to 2015, when Incyte paid $60 million upfront for access to four checkpoint programs, including TIM-3, LAG-3, OX40 and GITR.
Gilead beat consensus estimates in Q4 with $7.6 billion in revenue, driven largely by its HIV drug Biktarvy and CAR T therapies Trodelvy and Yescarta.
As the Q4 2024 pharma earnings period rolls on through the first month of President Donald Trump’s second term, executives find themselves faced with policy questions ranging from the Inflation Reduction Act to RFK Jr.
Novartis, Eli Lilly and more put on their deal-making caps, Bristol Myers Squibb targets $2 billion in savings through 2027, sales continue to soar for Lilly and Novo Nordisk’s GLP-1s and Regeneron sues Sanofi over an alleged failure to provide adequate information about Dupixent sales.
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.
French biotech Inventiva’s layoffs and pipeline shift are expected to help keep the company operational into the second half of 2026.
A paper inadvertently published on the website of an ASCO conference revealed good results for mevrometostat in treating castration-resistant prostate cancer.
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.
Novartis is paying $925 million upfront to acquire Anthos Therapeutics, whose launch the pharma backed in February 2019.
Following an initial report from Reuters, Merck KGaA confirmed that it is in talks with SpringWorks for a potential acquisition, though details of its offer have yet to be revealed.