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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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Mirati Therapeutics tapped David Meek, the former chief executive officer of Ipsen, as its new CEO. He replaces company founder Charles Baum.
The company announced Friday that clinical studies have been placed on hold following the development of tumors in mice in a non-clinical study.
Patients with different forms of breast cancer could soon have different treatment options following multiple presentations at the European Society of Medical Oncology meeting.
The Phase II/III trial showed a favorable safety profile and “robust” neutralizing antibody responses in children five to 11 years old who received two 10 µg doses of the vaccine at 21 days apart.
Three weeks after snagging approval in the UK, the U.S. FDA approved Samsung Bioepis and Biogen’s biosimilar drug. Byooviz is the first Lucentis copycat biologic to hit the market.
It is the largest venture capital fund in Europe focused on the life sciences.
Lung cancer is a particularly difficult cancer to treat, but several companies presented very promising data at this year’s European Society of Medical Oncology (ESMO) Congress 2021.
The vote to offer a booster to those 65 and older, as well as immunocompromised individuals at high risk of developing severe COVID-19, was a unanimous “yea” at 18-0.
One constant throughout the conversation is that the industry is at a different stage of adapting to the “new normal.”
From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.