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Regulatory dispute: FDA rejects breakthrough-designated melanoma therapy
Replimune’s oncolytic immunotherapy RP1, engineered from a modified herpesvirus, has faced additional FDA hurdles after the agency declined approval twice despite the program holding breakthrough...
Funding and IPOs: continued capital formation in biotech
Three biotechs priced upsized IPOs in a single window, totaling more than $850 million combined, and moved into public trading with gains in the aftermarket. Seaport Therapeutics, Hemab...
Business platform: SCADA integration for biopharma manufacturing
Cytiva and Rockwell Automation launched Figurate SCADA, a supervisory control and data acquisition layer meant to reduce digital bottlenecks across biopharmaceutical manufacturing. The...
Company leadership: diagnostics and precision medicine appointments
Guardant Health announced that Craig Eagle, the company’s chief medical officer, will resign effective May 8, after stints including Roche’s Genentech and Pfizer. Delfi Diagnostics appointed...
Cell therapy strategy: Johnson & Johnson axes CAR-T programs
Johnson & Johnson scrapped two CAR-T cell therapy programs for B-cell lymphoma as the company cited an evolving market shaped by years of approvals across cell therapies and antibody-based...
Healthcare reimbursement and access: semaglutide generic in Canada
Canada approved a generic semaglutide product as a Wegovy/Ozempic alternative, supplied by Dr. Reddy’s Laboratories and sold by prescription, making it the first G7 country to greenlight a...
Cell biology: EV DNA transfer boosts antitumor immunity in mice
A study from Weill Cornell Medicine reports that activated T cells secrete extracellular vesicles (EVs) containing DNA that can enter other immune and tumor cells to enhance antigen processing and...
Manufacturing and regulatory oversight: FDA label work on Moderna Covid vaccines
Moderna said it is in talks with the FDA about Phase 4 Covid vaccine post-marketing data after regulators narrowed the label for the products last year. The company’s stated aim is to restore...
Breast cancer PROTAC approval and companion diagnostics
The FDA approved Arvinas and Pfizer’s PROTAC vepdegestrant (Veppanu) for a defined group of adults with metastatic estrogen receptor-positive, HER2-negative breast cancer whose disease has...
Long-term Phase 1/2 efficacy update in RET fusion-positive NSCLC
Rigel Pharmaceuticals published the final data from its Phase 1/2 ARROW study of pralsetinib (Gavreto) in metastatic RET fusion-positive NSCLC in the Journal of Clinical Oncology. The report adds...
FDA rejects breakthrough-designated oncolytic melanoma therapy on multiple attempts
The FDA rejected Replimune Group’s oncolytic immunotherapy RP1 twice despite earlier ‘breakthrough therapy’ designation based on promising trials in melanoma. The company is still pursuing...
Alzheimer’s agitation label expansion for Auvelity
Axsome Therapeutics won FDA approval to expand Auvelity’s label to include Alzheimer’s disease agitation. The approval provides access for patients with a condition affecting up to about...
Seaport Therapeutics lists on Nasdaq after going public
Seaport Therapeutics began trading on the Nasdaq after executives rang the opening bell, following its initial public listing. The company is associated with a leadership bench largely drawn from...
Upsized biopharma IPO pricing and continued IPO momentum
Hemab Therapeutics priced an upsized IPO at $18 per share to raise gross proceeds of about $301.5 million, at the high end of its range. The company is set to begin trading on Nasdaq under ticker...
New HIFU system study opens in the US after Series A
Sonire Therapeutics started its U.S.-based Sunrise II study of Suizenji, an ultrasound-guided high-intensity focused ultrasound (HIFU) system intended to ablate pancreatic tumors. The trial...
Digital manufacturing infrastructure for biopharma with open SCADA connectivity
Cytiva and Rockwell Automation launched the figurate SCADA system to reduce digital bottlenecks across biopharmaceutical manufacturing. The platform is designed to integrate equipment and data...
Gene therapy and immunology platform: T-cell EV DNA boosts antitumor immunity
Weill Cornell Medicine researchers reported preclinical evidence that activated T cells secrete extracellular vesicles containing DNA that can enter tumor and immune cells to stimulate antigen...
Gene therapy scaling conversation: AAV and manufacturing constraints
Industry-focused reporting highlighted that gene therapy has moved into a phase defined as much by manufacturing and safety systems as by clinical breakthroughs. The article argues that scalable...
FDA approvals—breast cancer protein degradation
The FDA approved Arvinas and Pfizer’s PROTAC breast cancer therapy Veppanu (formerly vepdegestrant) for a defined subgroup of adults with metastatic estrogen receptor-positive, HER2-negative...
FDA approvals—Alzheimer’s agitation expansion
Axsome Therapeutics’ Auvelity expanded its U.S. label to include Alzheimer’s disease agitation, giving the company access to a second major FDA-approved indication for its...