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The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.
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The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the market for cancer, influenza and more.
It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
Analysts expressed skepticism about plans detailed by Moderna’s R&D chief Stephen Hoge to trim research spending in preparation for the launch of up to 10 new products.
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Regeneron Pharmaceuticals, Inc. announced the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology Congress 2023 from October 20 to 24 in Madrid, Spain.
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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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Analysts were happy with batoclimab’s performance in the chronic autoimmune disorder, but Immunovant said it will continue to focus on another next-gen asset for the indication.
With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff.
The French pharma is getting Black Diamond’s de-prioritized molecule for non-small cell lung cancers with specific mutations whose development had been paused to save money.
Roche’s up to $1 billion investment will provide access to Oxford BioTherapeutics’ antibody-drug conjugate platform for undisclosed cancer targets.
The biotech is exploring opportunities for a reverse merger or other business combinations. CFO and now interim CEO Anup Radhakrishnan will take charge of these negotiations.
The CDC budget cuts could pose headwinds for HIV drugmakers like Gilead and Merck but are unlikely to severely cripple their HIV divisions, according to analysts.
Layoffs leave more than empty desks—they leave uncertainty, guilt and anxiety. Three simple steps will help you regain control of your work, well-being and career.
Sarepta will update Elevidys’ label after a patient died following treatment; the FDA issues flu vaccine recommendations without advisor input; Trump CDC nominee Dave Weldon pulled at last minute; and FDA decisions expected for Alnylam’s Amvuttra in ATTR-CM and Milestone’s etripamil in tachycardia.
The explosion of GLP-1 weight loss drugs is reminiscent of the early days of PD-1 inhibitors, but key market differences suggest history may not repeat itself.
The ongoing conflicts between Ukraine and Russia, as well as Israel and Palestine, have sent ripples across various industries, including pharma. Medical science liaisons can help.