City of Hope's PANXEON liquid biopsy shows 87 percent sensitivity for early pancreatic cancer. Now, tough regulatory and reimbursement questions could decide if it ever reaches patients.
Phase III clinical trials now generate 5.9 million data points per protocol on average, with data volumes rising 11 percent annually since 2020 and operational models straining to keep pace.
Cardinal Health is aiming for 13 to 15 percent adjusted EPS growth in fiscal 2027, driven by momentum in its specialty segment and investments in oncology, urology, and autoimmune care.
Ireland’s cell therapy industry is growing quickly, but nearly all detachable activation beads are imported. Rising GMP-grade demand and new allogeneic therapies are reshaping the market, but supply chain risks persist.
CAR-T therapy offers a lifeline for patients with relapsed blood cancers, but the real challenge is getting the treatment before time and logistics run out.
Gujarat Themis Biosyn Limited has closed its Rs 1,200 crore deal to acquire MicroBiopharm Japan, gaining new biologics capabilities and a direct presence in regulated global markets.
A coalition of scientists and farmers is urging the Indian government to stop gene edited rice, warning of health, environmental, and economic risks, and calling for a return to Dr Richharia’s sustainable approach to agriculture.
Many cell and gene therapies remain out of reach for patients long after FDA approval. The real barriers are built years earlier, in the choices made around manufacturing, trial design, and regulatory strategy.
North Carolina’s life sciences sector is taking a measured approach to growth, favoring smaller, risk-managed deals and targeted expansions, while a few major players make billion-dollar commitments.
Arovella Therapeutics has received FDA clearance to begin Phase 1 clinical testing of its allogeneic cell therapy ALA-101 targeting CD19-positive blood cancers.
Certara is betting that catching data standard problems at the source can save clinical trial sponsors months of costly remediation and regulatory headaches.
