News
FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
FEATURED STORIES
New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
The company is hoping the topline results for Veozah, which won FDA approval in May, will support health technology assessments for reimbursement negotiations in Europe.
The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.
Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.
The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
The pharma giant is paying $9 million upfront to Phenomic AI to develop targets for stroma-rich cancers, some of the hardest cancers to treat, utilizing its single-cell RNA computing platform.
BioSpace spoke to analysts and players in the contract manufacturing and development organizations space to assess the challenges this year and what lies ahead in 2024.
This week on The Weekly we talk struggles with GLP-1 drug shortages and what that might mean for Novo and Lilly competitors; Regeneron and Sanofi positive results for Dupixent in COPD. Plus, Merck buys Caraway, Beigene’s deal with Ensem, ups and downs for Flagship.