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The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.

Takeda wanted to create something new in the cell therapy world by combining the technology with T cell engagers. A series of acquisitions in 2021 started the process.

As the industry loses one of its key female leaders in GSK CEO Emma Walmsley, BioSpace profiles the women leading the industry’s smaller biopharmas.

Drug pricing criticism often fixates on a price at a single point in time but drug pricing is never static.

Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.

MapLight laid out the terms of its planned IPO in a regulatory filing on Monday, providing greater detail about what the funds will be used for.

Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New York pharma, however, offered the smoothest transaction with the greatest likelihood of success.

Skye Bioscience’s nimacimab fell short of investor and company expectations, but showed encouraging weight-loss results when combined with Wegovy, according to analysts at William Blair.

Amgen will offer its lipid-lowering drug Repatha directly to patients for $239 per month, representing a nearly 60% reduction from the current wholesale acquisition cost of $527.70.

A new survey from CRB showed that most manufacturing initiatives in the U.S. made in response to tariffs are coming from Big Pharma companies, while smaller biotechs are left to hope “the situation doesn’t get worse.”

The inaugural 40 Under 40 cohort includes CEOs, leaders who have founded or co-founded their company and executives from a range of disciplines. Winners’ accomplishments include shaping drug development, achieving key FDA milestones and launching a new field of study.

Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.

Strong VINIA Momentum and New CDMO Win Delivers 39% Year-Over-Year GrowthCompany Fortifies Balance Sheet with Recent $19.9 Million Instiutional Equity Raise Following $14.7 Million Strengthening of Balance Sheet via Accelerated Warrant Exercises and Debt-to-Equity Conversions in September

Clinical Trial has Advanced to Fifth and Final Cohort at Maximum Dose of INSTASYL PH-762 in Skin Cancer Trial Positive Pathology Results at Maximum Dose: 100% Tumor Clearance (Complete Response) in One Patient, Greater than 90% (Near Complete Response) in Second Patient, Greater than 50% (Partial Response) in Third Patient Safety Monitoring Committee Issues Favorable Review of Safety Data at Maximum Dose of INTASYL PH-762 Warrant Inducement Financing in November 2025 for Expected Net Proceeds Totaling Approximately $12.1 million, Extending Cash Runway into the First Half of 2027

Session led by neurosurgeon Dr. Fraser Henderson and Hemostemix CEO Thomas Smeenk for the University of Florida’s Department of Surgery, Division of Vascular Surgery & Endovascular Therapy (Gainesville)

Once issued, this new U.S. patent covers the use of CardiolRx™ and CRD-38 for a broad range of cardiac disorders, including atherosclerosis and heart failure, significantly expanding intellectual property protection in the world’s largest pharmaceutical market. This allowance fortifies Cardiol’s global intellectual property portfolio, adding to granted and pending patent applications in Europe, Japan, Canada, Australia, and China.

Management to host conference call at 8:00 AM Eastern time on Thursday, November 13, 2025

Near-term applications include combinations with kinase inhibitors (KIs) that achieve enhanced concentration at target sites and synergistic delivery of multiple KIs to the same location