Get the Daily Brief
Latest Biotech News
FDA Regulatory Developments and Approval Activity
The FDA approved 22 drugs in June 2025, tying a recent high and contributing to a strong first-half performance with 107 total approvals. Key regulatory decisions include the agency’s rejection of...
Sarepta Gene Therapy Setbacks Stir Duchenne Community and Industry Debate
Recent deaths linked to Sarepta's gene therapies have profoundly affected families of Duchenne muscular dystrophy patients, who have embraced experimental treatments amid the disease's fatal...
Emerging Technologies in Biotech: AI, Quantum Computing, and Biomarkers
Cutting-edge advances are reshaping biotech discovery and diagnostics. David Baker's lab applies AI to understand elusive proteins, revealing new therapeutic targets. Concurrently, quantum...
Biopharma Trial Updates and Clinical Developments
June 2025 brought key clinical updates including FDA approvals of Gilead's twice-yearly HIV prevention shot and Nuvation Bio’s ROS1 inhibitor for lung cancer. Arvinas and Pfizer submitted their...
Biopharma Industry Workforce and Structural Changes
Workforce dynamics reveal industry strain and restructuring efforts. GSK is cutting 150 jobs in Massachusetts amid strategic shifts. Sail Biomedicines reduced staff by 30% and trimmed leadership...
Med-Tech IPO Activity and Regulatory Oversight
Heartflow Inc. filed an S-1 with the SEC on July 17, joining a wave of 15 med-tech companies with IPOs in 2025, underscoring ongoing investor interest in healthcare innovation technologies. The US...
Molecular Diagnostics Expansion and Global Market Entry
India’s Genes2Me prepares US expansion with regulatory submissions for sepsis and antimicrobial resistance assays on its OnePCR system, which supports a broad menu of molecular tests including...
Sarepta’s Duchenne Gene Therapy Halted Amid Safety Concerns
The FDA is preparing to halt shipments of Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy due to safety concerns following multiple patient deaths from acute liver...
Sarepta’s Limb-Girdle Gene Therapy Death Sparks Industry Debate
A 51-year-old patient in Sarepta’s phase 1 limb-girdle muscular dystrophy gene therapy trial died of acute liver failure, marking the third fatality linked to the company’s AAV-based gene...
Scipher Medicine Expands from Diagnostics to Precision Medicine Platform
Scipher Medicine is shifting its strategy from solely offering molecular diagnostics to a broader data-driven precision medicine model targeting non-oncology disease areas like rheumatoid...
Bristol Myers Squibb’s Reblozyl Fails Late-Stage Anemia Trial
Bristol Myers Squibb announced that Reblozyl failed to meet the primary endpoint in a Phase III trial for anemia associated with myelofibrosis, missing statistically significant improvement in...
FDA Panel Votes Against Otsuka’s PTSD Rexulti-Zoloft Combo
The FDA’s Psychopharmacologic Drugs Advisory Committee voted overwhelmingly against approval of Otsuka Pharmaceutical’s combination of Rexulti with sertraline (Zoloft) for post-traumatic stress...
Xeltis Reports Positive Preliminary Clinical Data for Artificial Vascular Grafts
Xeltis BV announced encouraging preliminary safety and patency data from ongoing clinical trials of Xabg, its bioengineered coronary artery bypass conduit. The implant uses supramolecular...
GenesisM Breaks Ground on Multi-Tenant Biomanufacturing Facility in Boston
GenesisM, a joint venture between Bain Capital Real Estate and Botanic Properties, commenced construction of a 154,000-square-foot biomanufacturing facility in Bedford, Massachusetts, reinforcing...
Advancements in AI-Driven Targeting of Intrinsically Disordered Proteins
Researchers led by Nobel Laureate David Baker have developed novel AI-based methods to design protein binders targeting intrinsically disordered regions (IDRs), traditionally considered...
Medical University of Vienna Secures €2.5M Grant for Multiomic Biomarker Research
The Medical University of Vienna’s Organizational Unit Core Facilities received €2.5 million from the Austrian Research Promotion Agency to advance multiomics biomarker discovery and validation....
Genes2Me Prepares US Rollout of High-Multiplex PCR Diagnostic System
Indian molecular diagnostics company Genes2Me is gearing up for US market entry with its OnePCR sample-to-answer system, following CE marking of direct-from-blood assays for antimicrobial...
Sarepta gene therapy crisis intensifies: FDA moves to halt Duchenne treatment
Sarepta Therapeutics faces mounting challenges as the FDA prepares to request a halt to shipments of its gene therapy Elevidys for Duchenne muscular dystrophy. This decision follows the deaths of...
Scipher Medicine pivots to data-driven precision medicine beyond diagnostics
After a leadership change, Scipher Medicine has expanded its focus from diagnostics to data-driven precision medicine development, leveraging the world's largest clinical transcriptomic dataset...
FDA advisory panels deal setbacks to psychiatric and hematology drugs
Recent FDA advisory committee meetings have resulted in negative outcomes for multiple drug candidates. Otsuka Pharmaceutical's combination therapy for PTSD, Rexulti with Zoloft, failed to secure...