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Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014.

Findings from the Phase III VESALIUS-CV study reinforce the cholesterol-lowering benefit of Repatha in high-risk patients without prior cardiovascular disease, for which the drug was approved in August 2024.

Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.

Regulatory documents show how 89bio’s board pushed Roche hard for a deal valued at $20 per share in upfront and milestone payments.

Looking for a biopharma job in Boston? Check out the BioSpace list of six companies hiring life sciences professionals like you.

In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.

Both Halozyme and Elektrofi have partnered with several Big Pharma companies to provide drug delivery technologies.

President Donald Trump last week announced that 100% pharma tariffs would come Oct. 1, but a White House official has clarified that that’s when the government will “begin preparing” the levies.

Takeda is looking to offload its cell therapy platform and preclinical assets to a yet-unidentified external partner. 137 employees will be let go as part of the move.

With layoffs happening at biopharma companies of all sizes, some may wonder which jobs are safest. Talent acquisition experts spoke to BioSpace about the areas and roles they recommend to biotech and pharma professionals hoping to avoid staff cuts.

At the heart of the agreement is Pfizer’s $70 billion commitment to U.S.-based manufacturing and an exemption from tariffs for three years. While the reaction was mostly positive from Wall Street, other observers noted that the benefits for patients are unclear at best.

As with recent rejections for Biogen and Scholar Rock, manufacturing issues stymied a regulatory bid from Fortress Biotech and Sentynl Therapeutics. Fortress said the FDA did not flag problems with the drug’s safety or efficacy.

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