Altesa BioSciences Raises $75M to Advance Repurposed Lung Antiviral
Summary:
Altesa BioSciences has secured $75 million in Series B funding to advance vapendavir, a rhinovirus-targeting antiviral being developed to prevent COPD flare-ups, with a larger mid-stage trial set to begin soon. Led by former Trump official Brett Giroir, the company is reviving a drug that previously failed in asthma under Aviragen Therapeutics, arguing a reformulated version shows improved properties and renewed promise.
FDA Moves to Make Single Pivotal Trial the Default for Drug Approvals
Summary:
In a New England Journal of Medicine article, FDA Commissioner Marty Makary and deputy Vinay Prasad announced that the U.S. Food and Drug Administration will generally require only one pivotal trial – rather than two – as the default standard for new drug approvals, arguing that modern science can ensure safety and efficacy with well-designed single studies. While officials say the change will lower development costs and speed innovation, critics warn it could raise safety concerns and add uncertainty amid broader regulatory shifts under Donald Trump’s administration.
National Institutes of Health Halts Rivaroxaban Arm in Stroke Trial
Summary:
The National Institutes of Health has stopped the low-dose rivaroxaban arm of the CAPTIVA stroke trial after an independent safety board found increased adverse events and evidence the treatment was unlikely to outperform standard care. The large, ongoing study – funded by National Institute of Neurological Disorders and Stroke – continues to evaluate other therapies for preventing recurrent stroke in high-risk patients.
Supreme Court of the United States Strikes Down Trump’s Emergency Tariff
Summary:
In a 6–3 decision, the Supreme Court of the United States ruled that Donald Trump overstepped his authority by using the International Emergency Economic Powers Act to impose sweeping import tariffs, saying such fiscal powers rest with Congress. The decision invalidates key emergency tariffs affecting global trade – including pharmaceuticals – while Trump vowed to pursue alternative legal avenues to reinstate import taxes.
White House Pressure and FDA Reversal on Moderna Flu Vaccine
Summary:
Reports from Politico and CNN say White House frustration – reportedly voiced by Donald Trump toward FDA Commissioner Marty Makary – contributed to the FDA’s swift reversal of its refusal-to-file decision on Moderna’s mRNA-1010 flu vaccine application. After initially rejecting the filing over standards-of-care concerns, the U.S. Food and Drug Administration accepted an amended, age-split application and is set to decide by Aug. 5.
