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ADC financing: Sidewinder secures Series B to move bispecific payload platform into clinic
Sidewinder Therapeutics, a San Diego startup focused on next-generation antibody-drug conjugates, raised an oversubscribed $137 million Series B led by OrbiMed and backed by other major investors....
Regulatory and policy pressure around drug pricing and access
Biotech policy groups escalated their critique of U.S. drug pricing frameworks after BIO’s March Coffee Chat highlighted how price controls can increase costs for some patients even when nominal...
Pulmonary fibrosis biotech eyes public markets to fund Phase 3 inhaled IPF pipeline
Avalyn Pharma filed for an IPO as it prepares to move inhaled pulmonary fibrosis assets into Phase 3. The Cambridge, Massachusetts-based biotech’s lead program, AP01, is an inhaled formulation of...
Diagnostics and screening: Waters wins FDA clearance for at-home HPV self-collection
Waters received FDA 510(k) clearance for the BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay, enabling HPV screening through at-home specimen collection. The company said the...
Rare disease growth: Neurocrine to buy Soleno in $2.9B Prader-Willi therapy deal
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion, adding Vykat XR (diazoxide choline) to bolster its marketed endocrinology and rare disease franchise. The transaction...
Regulatory modernization and trial entry: FDA budget proposes permanent rare disease vouchers
The FDA’s 2027 budget proposal would make the rare pediatric disease priority review voucher program permanent and introduce a new “clinical trial notification pathway” to ease entry into Phase 1...
Clinical trials and readouts in oncology: advancement targets genomic vulnerabilities
Research at The University of Texas MD Anderson Cancer Center identified DPY30 as a key epigenetic regulator that maintains genomic stability during replication stress in pancreatic tumors,...
Early cancer detection in the clinic: Grail expands Galleri test ordering via Epic EHR
Grail partnered with Epic to embed ordering for its Galleri multi-cancer early detection test directly into Epic’s electronic health record platforms. The collaboration is designed to reduce...
M&A and platform buildouts in oncology
Gilead Sciences agreed to buy Tubulis for up to $5 billion, expanding the pharma’s antibody-drug conjugate (ADC) toolkit beyond its Trodelvy and strengthening clinical ADC depth. The deal includes...
Large European private biotech funding
Jeito Capital closed its second flagship fund at more than €1 billion ($1.2 billion), exceeding targets and marking a record for an independent European biopharma-focused fund. The vehicle, Jeito...
New oncology therapeutics funding and pipeline progression
Sidewinder Therapeutics emerged from stealth with an oversubscribed $137 million Series B to advance bispecific antibody-drug conjugate programs toward the clinic. The San Diego company’s plan...
Regulatory and reimbursement policy shifts in the US
Biotechnology industry advocates warned that drug price controls resembling Most Favored Nation (MFN) policies could worsen affordability and access. In BIO’s March Coffee Chat, Karin Hoelzer,...
IPO activity for late-stage formulation strategies
Avalyn Pharma filed for an IPO to fund late-stage development of inhaled formulations of approved pulmonary fibrosis drugs. The company is preparing to move AP01 (inhaled pirfenidone) from an...
Targeted immunotherapy progress in cutaneous lupus
Biogen reported a second Phase II success for litifilimab in cutaneous lupus erythematosus (CLE), reinforcing BDCA2 as a therapeutic target in refractory disease. The company said the latest...
FDA device access expansion and self-sampling diagnostics
Waters received FDA 510(k) clearance for the BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay, enabling at-home self-collection for high-risk HPV screening. The company said the...
Oncology trial updates and safety signals
Amplia Therapeutics halted recruitment in its Phase II Amplicity trial in advanced pancreatic cancer after three dose-limiting toxicities tied to the modified FOLFIRINOX chemotherapy backbone...
Diagnostics integration for early cancer detection
Grail and Epic reached an integration milestone to expand ordering of the Galleri multi-cancer early detection test inside Epic electronic health records. Grail said clinicians will be able to...
Private-sector diagnostics M&A closure
Blackstone and TPG completed their acquisition of Hologic, taking the molecular diagnostics company private after a deal valued at up to $18.3 billion announced in October 2025. Hologic...
Gilead expands ADC platform with Tubulis buyout
Gilead Sciences agreed to acquire German biotech Tubulis for $3.15 billion upfront and up to $1.85 billion in milestone payments, adding next-generation antibody-drug conjugate (ADC) capabilities...
Neurocrine buys Soleno to broaden rare disease and endocrinology revenue
Neurocrine Biosciences agreed to acquire Soleno Therapeutics in a $2.9 billion deal designed to expand its marketed endocrinology and rare disease portfolio. The transaction includes Vykat XR...