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The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries.
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The Most Favored Nation order is unlikely to deliver broad, sustained savings without triggering legal challenges, administrative friction and unintended consequences for both the healthcare sector and patient access.
The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
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AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates.
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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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In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million.
Merck has characterized its cost-cutting initiative as more of a reallocation of resources to support other, higher-growth areas of its business.
In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.
For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU.
Move over Humira, Skyrizi and Rinvoq are expected to beat the former megablockbuster’s peak sales by the end of this year.
Rumors of Biogen’s disagreements with Eisai have been greatly exaggerated, CEO Chris Viehbacher said during a second quarter earnings call. The partnered Alzheimer’s drug Leqembi saw sales climb 20% for the period.
The announced reduction of hundreds of staff came a day ahead of Moderna’s Q2 earnings report.
While Eli Lilly’s diabetes blockbuster was non-inferior to its older incretin therapy Trulicity in a highly anticipated Phase III cardiovascular outcomes trial, analysts had hoped for statistical significance in reducing major events such as cardiovascular death, heart attack and stroke.