News
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.
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
Data from two mid-stage studies show HI-Bio’s investigational therapy felzartamab lowers pathogenic antibody titers in patients with primary membranous nephropathy (PMN).
Karuna Therapeutics’ KarXT and Acadia Pharmaceuticals’ pimavanserin are sparking hope that a treatment for the negative symptoms of schizophrenia could be on the horizon.
In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
The Boston Business Journal reported the layoffs would affect the multiple sclerosis team, but Biogen declined to confirm the details.
AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica in mantle cell lymphoma and marginal zone lymphoma, the companies announced Thursday.
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials.
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.
At the World Vaccine Congress this week, Novavax presented data suggesting that its protein nanoparticle booster generated immune responses that could protect against severe infection.