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Alzheimer’s disease – anti-tau clinical readout and next steps
Biogen’s phase 2 Celia trial of tau-lowering antisense oligonucleotide diranersen (BIIB-080) showed a cognitive signal that—despite a phase 2 dose-response miss—supported moving the program into...
Oncology – FDA greenlights first PAM-pathway breast cancer drug
Celcuity won U.S. FDA approval for Revtorpyk (gedatolisib), the company’s first commercial product, clearing a new therapeutic entry in hormone receptor–positive, HER2-negative advanced or...
Oncology – AstraZeneca licensing deal for Dizal’s EGFR exon 20 inhibitor
AstraZeneca agreed to license global rights to Dizal Pharmaceutical’s marketed lung cancer drug Zegfrovy (sunvozertinib) in a deal valued up to $1.5 billion, extending AstraZeneca’s reach in...
Multiple myeloma – randomized evidence challenges indefinite lenalidomide maintenance
ECOG-ACRIN ENDURANCE, a phase 3 trial coordinated through Mayo Clinic, reported that extending lenalidomide maintenance beyond two years did not improve overall survival in patients with...
Radiopharmaceuticals – AdvanCell raises to fund Pluvicto challenger buildout
AdvanCell secured a $315 million Series D to advance a lead-based prostate cancer radiopharmaceutical candidate and to strengthen U.S. manufacturing for a potential Pluvicto challenger. The round...
Diagnostics – Qiagen wins CE-IVD certification for bloodstream infection AMR panel
Qiagen announced CE-IVD certification for its QiaStat-Dx BCID GN Plus AMR Panel for bloodstream infection testing, designed to detect 13 gram-negative pathogen targets and 18 antimicrobial...
Policy and regulation – BIO and other stakeholders push back on OMB grant rule
The Biotechnology Innovation Organization (BIO) opposed a proposed Office of Management and Budget (OMB) rule governing federal financial assistance, arguing it would destabilize biomedical...
Cell & gene therapy manufacturing – automating engineered Treg production
Cellares and Sonoma Biotherapeutics agreed to automate manufacturing of SBT-77-7101, an engineered regulatory T (Treg) cell therapy in phase I development for poly-refractory rheumatoid arthritis....
Biotech financing and IPO pipeline – Neko’s $700M Series C for U.S. expansion
Neko Health raised $700 million in a Series C to support expansion in the U.S., with the round co-led by Lightspeed Venture Partners and O.G. Venture Partners and participation from major growth...
Biotech funding – Radiopharma and AI-driven discovery capital continues
AdvanCell’s $315 million radiopharma Series D is part of a broader pattern of sustained funding for asset-heavy, execution-focused biotech. In parallel, multiple AI-driven discovery and platform...
Oncology regulatory approvals and launch dynamics
Celcuity’s Revtorpyk (gedatolisib) won a key FDA approval for HR-positive/HER2-negative locally advanced or metastatic breast cancer patients without a PIK3CA mutation after progression on...
Large oncology partnerships and licensing deals
AstraZeneca struck a licensing deal for Dizal Pharmaceutical’s EGFR exon 20 insertion lung cancer pill Zegfrovy (sunvozertinib), expanding the pharma’s oral targeted-therapy footprint. The...
Clinical evidence revisiting standard-of-care duration
A Mayo Clinic-led cooperative group trial found that extending lenalidomide maintenance beyond two years did not improve overall survival in standard-risk multiple myeloma, challenging the...
FDA and federal policy signals affecting biotech operations
The FDA continued to rewind actions tied to former leadership’s approach to disseminating guidance through restricted-circulation medical journal articles. In an update, the agency said the prior...
Biotech funding and dealmaking for capital formation
AdvanCell raised a $315 million Series D to advance a lead-based radiopharmaceutical prostate cancer agent as well as to support U.S. manufacturing for Pluvicto challengers. The financing is...
Alzheimer’s tau targeting gets fresh phase 2 evidence
Biogen’s anti-tau antisense oligonucleotide diranersen (BIIB-080) showed cognitive slowing in its phase 2 Celia trial presentation, reinforcing the company’s decision to advance into phase 3. At...
Cell therapy manufacturing automation and regulatory-grade scale
Cellares and Sonoma Biotherapeutics agreed to automate engineered regulatory T cell (Treg) manufacturing for SBT-77-7101, which is in Phase I development for poly-refractory rheumatoid arthritis...
Immune oncology mechanism work shaping checkpoint response
New preclinical findings in Nature Communications indicate that complement component C3 can shape immune checkpoint blockade efficacy by acting locally within the tumor microenvironment. The...
Diagnostics and lab-platform expansion in infection testing
Qiagen said its QiaStat-Dx BCID GN Plus AMR Panel for bloodstream infection testing received CE-IVD certification, enabling use in markets that recognize the designation. The panel is designed to...
AI-accelerated drug discovery and manufacturing push
Insilico Medicine and Bora Pharmaceuticals announced a multi-target strategic alliance pairing Insilico’s AI-driven discovery capabilities with Bora’s manufacturing depth, aiming to connect...