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With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins.
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After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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.
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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.
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Florida District Judge Roy Altman earlier this week ruled against Eli Lilly, finding that the drugmaker cannot use state law to block reformulated versions of its blockbuster weight-loss and diabetes medication tirzepatide.
Data presented at the American Association for Cancer Research’s annual meeting sparked hope that we could be getting closer to treating pancreatic cancer, glioblastoma and other particularly difficult tumors.
The job response rate has risen year over year, according to BioSpace data, indicating competition for roles posted on our website has increased.
The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data.
Moderna Thursday said it paused plans to build an mRNA manufacturing facility in Kenya to buy time to assess vaccine demand after being hit with $1 billion in losses and write-downs due to canceled orders.
Novartis on Thursday announced that it is making $150 million in upfront payments to protein degradation biotech Arvinas, while separately revealing that its tender offer for MorphoSys has begun.
GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
On the heels of withdrawing Relyvrio from the U.S. and Canadian markets, Amylyx is now charting a path in Wolfram syndrome with promising interim Phase II data for its lead asset AMX0035.
Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year.
The U.S. Department of Justice has filed a complaint against Regeneron alleging that the pharma knowingly omitted credit card price concessions for Eylea to inflate Medicare reimbursement rates.