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Immunology platforms and next-generation preclinical models
FDA endorsement of animal-replacement toxicity testing is moving from policy to practice. The EMA is poised to approve its first “new approach methodology” (NAM) to replace live animal controls in...
Oncology supportive care
Interim results from the phase II COCOON trial show a targeted strategy to reduce dermatologic toxicity in EGFR-mutant frontline NSCLC. The study, led by Bishal Tiwari of Nassau University Medical...
Cell therapy manufacturing and regulation
The U.K. clinical cell-therapy pipeline continues to internationalize as manufacturing and scale-up collaborations expand. In one spotlight, iXCells Biotechnologies announced a multi-party effort...
Diabetes therapeutics: funding and translational push
Aspect Biosystems, a Canadian cell-therapy startup, secured $79 million from the Canadian government to support its diabetes programs. The funding is positioned as a way to keep next-generation...
Cancer immunotherapy and innate immune targeting
A new line of cancer immunotherapy research centers on restoring immune “gatekeeper” function. In a Science study, researchers at St. Jude Children’s Research Hospital reported that tumors can...
Biopharma M&A momentum
Takeover activity kept exerting upside pressure on biotech investors as deals accelerated into a new quarter. A STAT+ recap attributed the sharp end-of-quarter rebound in the XBI to major...
Regulatory and policy: U.S. pharma tariffs shift
U.S. policy makers escalated tariff pressure on imported branded drugs, but carveouts and “most-favored nation” agreements are shaping the near-term impact. Trump signed an executive order...
CRISPR intellectual property: Supreme Court ends Agilent challenge
The U.S. Supreme Court denied Agilent Technologies’ request to revisit CRISPR patent invalidation in its dispute with Synthego. The decision leaves intact a June 2025 Federal Circuit ruling that...
Oncology biomarker and treatment monitoring
Relapsed or refractory SCLC testing is getting a sharper biomarker focus as early trial data emerge for AZD2811. A phase I dose-expansion study reported how biomarker analysis tracked treatment...
Peptide drug platforms: major Series B closes
Syneron Bio closed a $150 million Series B round to support its macrocyclic peptide drug discovery platform. The company said the financing follows a prior round of nearly $100 million and...
US drug tariff crackdown targets branded medicines—carveouts hinge on domestic manufacturing deals
The Trump administration signed an executive order imposing 100% ad valorem tariffs on imported brand-name drugs and active pharmaceutical ingredients, positioning the policy as a national...
FDA decision timeline looms for COVID-19–era MCED adoption after endpoint miss in NHS trial
Clinicians are offering early access to Grail’s multi-cancer early detection (MCED) test while awaiting a full NHS trial readout and a concurrent FDA regulatory decision after the program missed a...
Reimbursement and dispute pressure heats up around 340B and CMS DSH safety-net payments
The regulatory and reimbursement fight continued on multiple fronts: the U.S. Department of Justice weighed in favor of pharma positions in a yearslong 340B contract pharmacy dispute, adding...
CRISPR patent battle reaches a final stop as Supreme Court denies Agilent appeal
The U.S. Supreme Court denied Agilent Technologies’ request to review invalidation of two CRISPR-related patents in its legal battle with Synthego. The denial leaves in place a Federal Circuit...
Next-gen obesity race: FDA clears Eli Lilly’s oral GLP-1 Foundayo as Novo pushes oral Wegovy narrative
The FDA approved Eli Lilly’s oral obesity pill Foundayo (orforglipron), formally extending the market’s shift to oral GLP-1 receptor agonists. Analysts and company messaging immediately set up a...
Major biotech M&A shakes sentiment as Biogen prepares to buy Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals in a $5.6 billion deal, extending Biogen’s push into nephrology and complement-driven disease biology. The acquisition follows Biogen’s earlier...
Ambrosia raises $100M Series B to push oral obesity small-molecule pipeline into Phase 1
Ambrosia Biosciences secured an oversubscribed $100 million Series B to advance its preclinical oral obesity drug pipeline into Phase 1. The financing will support development of the company’s...
FDA clearance for campus-developed CAR T marks a milestone for next-gen academic cell therapy
The University of Colorado Anschutz Gates Institute received IND clearance from the FDA for a campus-developed CAR T-cell therapy, described as the first CAR T therapy developed entirely within a...
Proactive supportive care in EGFR-mutant lung cancer cuts dermatologic toxicity by half
The phase II COCOON trial reported interim results showing proactive skincare reduced dermatologic toxicity by 50% in patients with EGFR-mutant non-small cell lung cancer (NSCLC) receiving...
TriNetX and Regeneron expand data link-up to scale genomic and proteomic discovery
TriNetX and Regeneron announced a data partnership to link genomic and proteomic information for drug discovery and development. TriNetX will provide Regeneron exclusive, secure access to...