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The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
FEATURED STORIES
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
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After withdrawing ALS drug Relyvrio from the U.S. and Canadian markets and laying off 70% of its workforce, the Cambridge, Mass.–based biopharma got a much-needed win in Wolfram syndrome.
Cullinan Oncology, now renamed Cullinan Therapeutics, is riding the growing wave of interest in autoimmune disorders by refocusing its bispecific T cell-engager CLN-978 for systemic lupus erythematosus.
On the heels of a Phase IIb win, Arrowhead Pharmaceuticals’ plozasiran could fulfill a critical unmet need in dyslipidemia treatment bringing in $707 million in sales by 2032, according to data analytics firm GlobalData.
At this week’s American Academy of Neurology annual meeting, Amylyx provided additional data from its Phase III amyotrophic lateral sclerosis study showing the full extent of Relyvrio’s failure.
Amylyx looks to the future after Relyvrio withdrawal, ADCs continue to attract investment and the drug shortage persists in the U.S.
Read the latest overview of people coming and going from executive positions at biopharma companies covered by BioSpace.
The German biopharma company on Tuesday announced ambitious pipeline plans that include starting 10 new Phase II and III trials over the next 12 to 18 months.
Novartis on Monday shared late-stage data for its potential multibillion-dollar drug Fabhalta, in what the company contends is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in IgA nephropathy patients.
Already approved in schizophrenia and bipolar depression, Intra-Cellular Therapies reported strong late-stage data Tuesday for its antipsychotic Caplyta in major depressive disorder.
Despite the strong performance of its cancer portfolio, Johnson & Johnson on Tuesday reported Stelara sales of $2.45 billion in the first quarter of 2024, falling short of Wall Street expectations of $2.6 billion.