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Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
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.
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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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Founded by George Church, known by many as the Father of Genomics, Manifold Bio launched with a $40 million Series A financing round to advance its “protein barcoding” platform.
CytoDyn Inc. has tapped Cyrus Arman as its new president and he is expected to take over the reins of the company as chief executive officer and be added to the board of directors within six months.
Beigene and Novartis announced the FDA has deferred action on the BLA for tislelizumab until inspections of facilities in China can be completed.
Regeneron Pharmaceuticals and Sanofi announced positive results from a Phase III trial of Dupixent (dupilumab) in kids ages one to 11 years with eosinophilic esophagitis (EoE).
Under the terms of the deal, Theravance and Innoviva are surrendering 85% and 15% of their stakes in Trelegy in exchange for $1.1 billion and $282 million from Royalty, respectively.
The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
At the end of June, Novartis announced the latest data readouts in a long string of successes for tislelizumab. BioSpace spoke with Ken Kato, an investigator on the most recent RATIONALE 306 trial.
Kyowa Kirin announced it is dropping its Parkinson’s disease candidate, KW-6356, a follow-up to Nourianz, despite promising Phase II data that showed the drug is “potentially effective.”
The agreement with Merck brings $290 million upfront to Orion to access the latter’s investigational candidate, ODM-208, for mCPRC and other related drugs.
Aviv Clinics reported data from a study that suggests hyperbaric oxygen therapy may alleviate long COVID symptoms, particularly those associated with cognition.