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TOP STORIES
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.
Of the 13 programs that the companies will advance, four will come from Hengrui Pharma and four from Bristol Myers Squibb. The remaining five assets will be jointly discovered.
Indirect comparisons between BridgeBio’s Attruby and Pfizer’s tafamidis products showed a numerical survival benefit with the biotech’s drug.
The FDA is looking to retool drugs with sufficient evidence to support their use in other indications, particularly those with unmet need.
While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment.
The widely covered impending ouster of FDA Commissioner Marty Makary not long after the exit of controversial biologics head Vinay Prasad highlights the severe turnover rates at the highest rungs of leadership at the health department.
Partner Therapeutics announced last week that the FDA had granted Bizengri a Commissioner’s National Priority Voucher to accelerate drug review.
Epidemiology, Next-Generation Vaccine Platforms, and the Critical Role of Prefusion F Antigens in RSV Research
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.
If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
PRESS RELEASES
Strategic Investments in the EU and US strengthen Vetter’s Global Footprint • Building permit application for German site submitted • Construction start is scheduled for the 2nd quarter 2026, with operational readiness in 2031 • Expansions in the US and Europe are included in a €1.5 billion investment plan
