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.
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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
Phase IIa data showed AI Therapeutics’ ALS candidate increased expression of a target engagement biomarker and led to a 73% reduction in a toxic protein aggregate.
Farallon Capital Management is waging a proxy battle with Exelixis over R&D spending. The hedge fund issued a letter to the company’s board of directors on Wednesday.
NLRB General Counsel Jennifer Abruzzo issued a memo to all field offices clarifying the board’s recent ruling in a case regarding severance agreements.
Phase III data for Pfizer’s respiratory syncytial virus vaccine candidate showed high levels of protection for older adults and infants.
AstraZeneca’s Imfinzi and Lynparza met primary endpoint markers in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to data released Wednesday.
Proxygen added Merck to its partner roster on Wednesday, garnering an undisclosed upfront payment plus a potential $2.55 billion in milestones.
The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
The Inflation Reduction Act contains provisions designed to influence drug prices. These policies might affect drug development and the prioritization of new drugs.
The Centers for Medicare and Medicaid Services released details about the patient registry it will require physicians to use to prescribe Leqembi, should it be approved by the FDA.
The money saved on canceling the existing studies is intended to fund the advancement of two other oncology pipeline assets.