Get the Daily Brief
Latest Biotech News
M&A
Vertex Pharmaceuticals said it will buy Crinetics Pharmaceuticals in a $10 billion deal, positioning the Boston drugmaker to expand its commercial endocrinology footprint. Under the agreement,...
ADC deals
Novartis is stepping up in antibody-drug conjugates via a $1.1 billion upfront acquisition of Myricx Bio, paying up to $400 million more in milestones. The London-based preclinical ADC specialist...
Regulatory policy
CMS has published a proposed rule aimed at reducing Medicare outpatient reimbursement for 340B drugs, a move that would effectively restart a policy rejected by the U.S. Supreme Court in...
Clinical trial inclusion and DEI guardrails
U.S. GOP lawmakers are pushing for changes to how Trump’s FDA handles clinical trial diversity, arguing that enrollments should better match the demographics of the patients who will use the...
FDA and product approvals/clearances
FDA has cleared Visby Medical’s at-home molecular test for flu and COVID-19, marking the first 510(k) clearance for a multi-virus OTC PCR assay. The Visby test differentiates influenza A,...
Biotech listings and compliance risk
Mdxhealth disclosed it has received a Nasdaq noncompliance notice after failing to meet the exchange’s minimum $1.00 bid-price requirement. The company said it has fallen below the threshold for...
Epigenetics and multi-omics tools for diagnostics
Arima Genomics said Active Motif will distribute its Hi-C kits for non-formalin-fixed paraffin-embedded research samples, supporting 3D genome studies in areas including epigenetics and gene...
Organ-on-chip and space bioscience for personalized medicine
NASA’s Artemis II included astronaut bone marrow housed in organ-chip format, and researchers are now using the material to study how radiation and microgravity affect the body at molecular...
Preclinical immunology for allergy therapy
Researchers in Switzerland reported preclinical evidence that chimeric allergen receptor regulatory T cells can suppress birch pollen-driven allergic asthma in mice. In work published in the...
Company pipeline and financing
Celea Therapeutics, a PureTech Health spinout, secured $180 million to support a pivotal Phase 3 study of deupirfenidone in idiopathic pulmonary fibrosis. The company plans a head-to-head trial...
Company dealmaking and pipeline build
Roche moved to deepen its breast cancer pipeline by striking an early-stage deal with Otsuka’s subsidiary Astex, according to reporting on the transaction. The arrangement centers on Astex...
Regulatory setbacks in oncology confirmatory trials
Bristol Myers Squibb disclosed that a confirmatory study for Krazati failed in colorectal cancer, providing an update on the drug’s evidence package. The company said patients taking Krazati in...
FDA cleared diagnostics at home
FDA clearance has been granted to Visby Medical for an at-home, multi-virus PCR test covering flu and COVID-19, positioning the product as the first such assay cleared via 510(k). Visby’s test...
Clinical-stage funding for pulmonary fibrosis
Celea Therapeutics secured $180 million to fund a pivotal Phase 3 head-to-head study of deupirfenidone in idiopathic pulmonary fibrosis, focusing on an oral small-molecule comparison against...
Big pharma acquisition and deal value expansion
AbbVie moved to acquire Apogee Therapeutics after years of discussions, setting up a $10.9 billion deal structure described in coverage of the transaction. The report also notes additional...
Oncology economics and policy pressure
CMS published details of its proposed 2027 outpatient payment rule that would pair a base rate increase with steep cuts tied to 340B drug payments and changes expanding site-neutral payment...
Massive ADC platform buy-in by Novartis
Novartis agreed to pay $1.1 billion upfront to buy Myricx Bio, aiming to expand its antibody-drug conjugate pipeline with a payload approach described as differentiating from incumbent ADC...
Biotech IPO filing for in vivo gene editing
Scribe Therapeutics disclosed plans to pursue an initial public offering after revealing details of its Nasdaq strategy in a Securities and Exchange Commission filing. The company, led by CEO...
Late-stage/therapeutic update and investor read-through in ulcerative colitis
Abivax shares rose sharply after updated data provided reassurances for investors following earlier safety-related volatility tied to obefazimod in ulcerative colitis. The stock movement tracked...
Regenerative medicine acquisition
United Therapeutics agreed to acquire Thymmune Therapeutics in a $300 million regenerative medicine deal, adding preclinical thymic cell therapy development to its portfolio. Under the terms...