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M&A & pipeline – oncology big deal aftermath
GSK has acquired Nuvalent in a $10.6 billion buyout, positioning the company to deepen its oncology pipeline with a targeted strategy. The report frames the transaction around questions that...
Biotech IPO wave – record listings
Parabilis Medicines’ Nasdaq IPO landed at $670 million, extending a record-breaking run of biotech public listings and signaling that investor appetite is returning to the sector’s highest-profile...
Funding – ultrasound-mediated genetic medicine platform
SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated delivery of genetic medicines into clinical development. The round was led by Vida Ventures with...
Gene therapy – first-in-human partial reprogramming trial
Life Biosciences in Boston has treated the first participant in a gene therapy trial designed to partially reprogram aged cells, a “reverse aging” approach aimed at restoring youthful cellular...
Cancer immunotherapy – engineered oncolytic virus for metastatic ovarian cancer
Researchers have unveiled ErbB-OSV, an engineered vesicular stomatitis virus (VSV) variant designed to selectively target and destroy metastatic ovarian cancer cells while sparing normal tissue....
Regulatory risk – Amgen seeks FDA review over Tavneos approval
Amgen is seeking an independent review to defend Tavneos (avacopan) as the FDA weighs potential withdrawal of the rare disease drug. The dispute is tied to FDA concerns about safety and alleged...
Clinical results – phase III psoriasis readout
Takeda’s zasocitinib (TAK-279) has shown statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a phase III Latitude Atlas readout for moderate-to-severe plaque...
Deals & regulatory markets – China clears HER2 bispecific in gastric cancer
China’s National Medical Products Administration (NMPA) approved Suzhou Alphamab’s HER2 bispecific antibody anbenitamab (KN-026) through priority review for adults with locally advanced or...
Financing – Conformal peptides for hard-to-modulate targets
Parabilis Medicines closed its IPO at $770.5 million, extending the record pace for biotech capital raising and solidifying its position as a publicly traded conformationally stabilized peptide...
Regulatory approvals and label changes
FDA approval has been granted for an adjuvant pembrolizumab–belzutifan combination in high-risk, post-surgery clear cell kidney cancer, according to a Dana-Farber-backed report. The regimen pairs...
Clinical trial results reshape the competitive landscape
Takeda’s zasocitinib scored statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a top-line Phase 3 readout for moderate-to-severe plaque psoriasis, reported from the...
Financing and IPO momentum in biotech
Parabilis completed a $770.5 million IPO after underwriters exercised their full overallotment option, according to the company’s public-equity reporting. The conformationally stabilized peptide...
Oncology pipeline and next-generation immunotherapy
Oricell advanced its GPC3-directed strategy in liver cancer, moving its autologous CAR T therapy Ori-C101 into a confirmatory registration Phase 2 trial in patients with GPC3-positive advanced...
New platform funding for gene medicines
SonoThera raised an oversubscribed $125 million in Series B financing, using the capital to advance ultrasound-mediated delivery genetic medicines into clinical development. The round was led by...
Companion diagnostics gain FDA green light
Guardant Health received FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The...
Regulatory and legal pressure on biopharma supply and trial integrity
Amgen escalated its dispute with the FDA over Tavneos (avacopan), seeking an independent review to keep the rare vasculitis drug on the market. The FDA’s action is tied to concerns triggered by...
Biopharma market signals: demand for innovation incentives
Industry groups pushed for stronger competitiveness incentives under the EU Biotech Act framework, arguing current provisions are insufficient to restore Europe’s position in biopharma. The call...
Company expansion in diagnostics and AI-enabled pathology
Leica Biosystems expanded its strategic collaboration with AstraZeneca and Daiichi Sankyo to scale a TROP2 biomarker assay and computational image analysis workflow for non-small cell lung cancer....
Targeted delivery tech attracts venture-scale interest
Eli Lilly-backed Abridge expanded its position in clinical trial recruitment and broadened its use cases in life-sciences workflows, backed by an investment through Lilly’s venture arm. The...
In vivo CRISPR Phase 3 milestone
Amsterdam UMC has reported the successful conclusion of what it describes as the world’s first Phase 3 trial of an in vivo CRISPR-based therapy, bringing CRISPR gene editing closer to broader...