Delivers real-time biopharma news and signals — powered by AI, curated for professionals.
Verily, the life sciences arm of Alphabet, has announced a significant collaboration with UCHealth and the University of Colorado Anschutz Medical Campus, marking a major step forward in the application of artificial intelligence to clinical research and patient care. This partnership aims to leverage Verily's advanced technology platform to accelerate biomedical research and improve healthcare delivery across multiple therapeutic areas.
BioNTech's ambitious project to establish mRNA vaccine production in Africa has received a substantial financial boost from European Union institutions. The initiative, which aims to create a self-sustaining vaccine ecosystem on the continent, is set to benefit from a combined commitment of up to 95 million euros ($109 million) in grants and potential loans.
Denali Therapeutics has become the latest biotech company to face a delay in the U.S. Food and Drug Administration's (FDA) review process, as the agency pushes back its decision on the company's enzyme replacement therapy for Hunter syndrome. This development underscores a growing pattern of regulatory delays in the pharmaceutical industry, affecting multiple companies and potential breakthrough treatments.
Regeneron Pharmaceuticals is poised to make a significant leap in the treatment of genetic hearing loss, with plans to file a regulatory application for its gene therapy DB-OTO by the end of the year. This move follows compelling results from a Phase I/II clinical trial that demonstrated marked improvements in hearing for children with a rare form of genetic deafness.
The Centers for Disease Control and Prevention (CDC) has been thrust into the spotlight once again, as a series of dramatic staffing changes and leadership shake-ups continue to roil the agency. In a move that has sent shockwaves through the public health community, the Trump administration initiated a sweeping round of layoffs at the CDC, only to partially reverse course within 24 hours.
The U.S. Food and Drug Administration (FDA) has updated the label of Johnson & Johnson (J&J) and Legend Biotech's multiple myeloma treatment, Carvykti, with a boxed warning for a potentially fatal intestinal inflammatory disorder. This development marks a significant safety update for one of the leading CAR-T cell therapies in the market.
In a significant move that underscores the ongoing trend of pharmaceutical manufacturing investments in the United States, German pharmaceutical technology specialist LTS Lohmann has announced its acquisition of U.S. contract development and manufacturing organization (CDMO) Renaissance Lakewood. This strategic purchase, for an undisclosed sum, is set to bolster LTS's CDMO capabilities and strengthen its position in the global drug delivery solutions market.
Excellergy, a newly unveiled California-based biotech company, has burst onto the pharmaceutical scene with a substantial $70 million Series A funding round and ambitious plans to redefine allergy treatment. The company's innovative approach centers on a novel drug class called effector cell response inhibitors (ECRIs), which aim to stop allergic responses at their source.
Tvardi Therapeutics, a recently public biotech company, has encountered a significant setback in its clinical development program. The company's STAT3 inhibitor, TTI-101, failed to demonstrate efficacy in a phase 2 trial for idiopathic pulmonary fibrosis (IPF), while also exhibiting high dropout rates due to adverse events.
Oura, the company behind the popular health-tracking Oura ring, has secured a staggering $900 million in Series E funding, propelling its valuation to $11 billion. This substantial investment comes on the heels of exponential growth in sales and revenue, solidifying Oura's position as a leader in the wearable health technology market.
Kardigan, a nascent cardiovascular biotech company, has successfully raised $254 million in a Series B funding round, bringing its total financing to over half a billion dollars. The investment will support the development of the company's late-stage clinical assets, positioning Kardigan as a significant player in the cardiovascular disease treatment landscape.
Almac Group, a leading contract development and manufacturing organization (CDMO), has announced a significant $48 million investment in its clinical technologies arm. The centerpiece of this investment is the launch of the Almac Trial Coordinator, a novel interoperable clinical trial technology platform designed to address key challenges faced by contract research organizations (CROs) and clinical sites.
