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FDA advisory setbacks for GSK and Otsuka drug approvals
Recent FDA advisory committee meetings have dealt significant blows to GSK and Otsuka’s drug approval plans. GSK’s attempt to reintroduce its multiple myeloma antibody-drug conjugate Blenrep in...
Scipher Medicine expands from rheumatoid arthritis diagnostics to precision immunology
Scipher Medicine, recently under new leadership, is transitioning beyond its commercial molecular assay for rheumatoid arthritis to broader personalized medicine applications across non-oncology...
FDA approvals and clinical updates signal activity in oncology, HIV, weight-loss, and inflammatory diseases
The FDA’s June approvals included 22 drugs, equaling the March total and pushing 2025 into the third-highest year on record for new drug approvals at midyear. Notable approvals include Gilead’s...
Biopharma financing trends and capital flows show mixed dynamics in 2025
The first half of 2025 witnessed a rise in seed and Series A funding in the biotech space, although the number of companies participating declined, reflecting concentrated investment. A prominent...
AI and computational innovations accelerate biotech and drug discovery
Artificial intelligence is increasingly reshaping biotech research and healthcare. New AI models have enabled advances in traditionally undruggable targets such as intrinsically disordered...
Ongoing safety and efficacy challenges for other pharmaceuticals
Several pharmaceutical programs face setbacks impacting clinical and regulatory outlooks. Bristol Myers Squibb’s anemia drug Reblozyl failed its Phase 3 trial in myelofibrosis-associated anemia,...
MedTech IPOs and manufacturing expansions reflect sector momentum
Heartflow Inc. recently submitted its S-1 filing to the SEC, adding to a growing list of medtech companies pursuing public offerings in 2025, signaling robust investor interest in the sector....
Regulatory and reimbursement shifts impact molecular diagnostics and transplant monitoring
MolDx program’s proposed local coverage determination (LCD) would restrict the frequency of molecular surveillance testing for transplant rejection, setting limits substantially below current...
Hormone therapy for menopause faces regulatory reconsideration
An FDA convened panel of medical experts urged the removal of black box warnings on menopausal hormone therapy (MHT), citing benefits outweighing risks in symptomatic relief and potential...
Sarepta Gene Therapy Faces Safety Scrutiny – Third Patient Death Reported
Sarepta Therapeutics is under increased scrutiny following the deaths of three patients linked to its gene therapies for muscular dystrophy. Two teenagers died after treatment with Elevidys, the...
FDA Vaccines and Drug Panels Shake Industry Norms
Recent FDA advisory committee votes have rejected Otsuka's PTSD drug Rexulti-Zoloft combination after concerns about failed Phase 3 trials and safety issues. Concurrently, a panel urged the...
Scipher Medicine Expands into Data-Driven Precision Medicine
Scipher Medicine is broadening its focus beyond diagnostics to drive precision medicine development. The company leverages the largest non-oncology clinical transcriptomic dataset, secured through...
Innovations in AI and Biotech Research Tools
The intersection of AI with biotech research advances therapeutic targeting and drug discovery. Nobel laureate David Baker's lab developed AI models to design binders for intrinsically disordered...
Biopharma Financing and Market Dynamics Slow Amid Patent Pressures
Venture funding for biotech startups declined sharply in Q2 2025, reflecting broader market contractions and fundraising difficulties. Despite this, late-stage financings and IPO activity...
Advances in Clinical Approvals and Therapeutics
June 2025 saw significant FDA activity including approvals for Gilead’s twice-yearly HIV preventive shot and Nuvation Bio’s ROS1 inhibitor for lung cancer, reflecting continued innovation in...
Biomanufacturing and Infrastructure Expansion in Boston and Beyond
GenesisM has commenced construction of a major 154,000 square-foot biomanufacturing facility in Bedford, Massachusetts, expanding capacity in the Boston area’s leading biopharma cluster. The...
Regulatory and Market Challenges Impact Oncologic and Diagnostic Firms
GSK faced an FDA advisory committee rejection over safety and dosage concerns for its multiple myeloma drug Blenrep, complicating its return to the U.S. market. Simultaneously, CareDx’s stock...
Artificial Intelligence Integrates Deeper Into Biopharma and Healthcare
Artificial intelligence is increasingly shaping biopharma innovation and clinical practice. From AI models diagnosing structural heart disease via ECG, to spatial transcriptomics projects...
Sarepta gene therapy deaths and FDA action
Sarepta Therapeutics faces major scrutiny following the deaths of three patients linked to its gene therapies for muscular dystrophies. Two teenage patients treated with Elevidys for Duchenne...
Sarepta CEO comments on gene therapy transparency and company strategy
Sarepta’s CEO Douglas Ingram addressed recent concerns around transparency, defending the company’s disclosure practices amid criticism over delayed public acknowledgement of patient deaths in...