STAT+: A patent win for Pfizer and BridgeBio
A change to FDA clinical trial data review, Rocket sells its priority review voucher, and more biotech news from The Readout
A change to FDA clinical trial data review, Rocket sells its priority review voucher, and more biotech news from The Readout
The FDA announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen
Immunology med Skyrizi charted sales growth of 30.9% over 2026's first quarter, bringing in $4.48 billion as AbbVie's top earner.
As regulatory delays continue to plague Regeneron's Eylea franchise, quarterly sales for the eye disease medicine have dropped below $1 billion for the first time since the second quarter of 2018.
In GSK’s first quarter with Luke Miels as CEO, the company’s flagship shingles vaccine Shingrix set a new quarterly sales record while its closely watched asthma launch Exdensur showed “early signals” of commercial progress despite a recent trial flop.
Patient groups’ perceptions of drugmakers with large U.S. footprints have shifted in the past year as the businesses have contended with political pressures, PatientView said.
A report released Wednesday highlights successes in reducing health disparities in U.S. states between 2022 and 2024.
The committee met for the first time since Kennedy fired most of the committee’s scientific experts and replaced them with activists and advocates.
A decades-old drug once used to treat sleeping sickness is now showing surprising promise against an ultra-rare and life-threatening genetic disorder called Bachmann-Bupp syndrome (BABS). Early patient treatments suggest the drug, DFMO, may ease severe symptoms by targeting the underlying genetic malfunction. Researchers have already treated a handful of patients with encouraging results, but prog
A troubling new study from MIT reveals that a common environmental contaminant, NDMA—found in polluted water, certain medications, and even processed foods—may pose a far greater cancer risk to children than adults. In experiments with mice, young animals exposed to the chemical developed significantly more DNA damage and cancer, despite experiencing the same initial exposure as adults. The key di
Committee members largely blamed the other party’s health care policies for driving U.S. health care prices to levels inaccessible to many Americans.
Monitoring trials in real time may help shorten the time interval between trial phases.
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“For the first time, FDA regulators will be able to see what’s happening in a clinical trial, looking at endpoints in the cloud as they occur,” writes FDA commissioner.
Novartis CEO Vas Narasimhan says that Europe needs a “complete rethink” on how it prices its drugs, warning that the entrance of new pharmaceuticals into its markets could be delayed.
Pfizer now anticipates its Vyndamax sales to remain “relatively stable” from 2028 through mid-2031, it said.
The FDA has released briefing documents detailing its concerns for AstraZeneca’s cancer drugs camizestrant and Truqap ahead of an upcoming advisory committee meeting, the first such gathering in about nine months.
The FDA has told Amgen that it is proposing to withdraw the approval of the rare disease drug Tavneos. The FDA cited new information that indicates that data was "manipulated" to facilitate the approval of Tavneos. In addition, the FDA is “increasingly concerned about the safety of Tavneos,” pointing to cases of serious drug-induced liver injury.
Rocket Pharmaceuticals has offloaded its lucrative FDA rare pediatric disease priority review voucher, striking a $180 million sale that reflects the high market demand for a speedy FDA review.
Scientists at MIT discovered that chaotic laser light can spontaneously form a highly focused beam instead of scattering—if the conditions are just right. This “pencil beam” enabled them to image the blood-brain barrier in 3D at speeds 25 times faster than existing techniques. The method also lets researchers watch how drugs move into brain cells in real time. It could dramatically accelerate the