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Northwestern engineers polymers to degrade MYC and KRAS…
Researchers at Northwestern reported a new class of protein‑like polymers—HYDRACs—that recruit cellular degradation machinery to eliminate traditionally 'undruggable' oncogenic drivers such as MYC...
Astellas pays up to $1.3B for Vir’s masked CD3 engager
Astellas and Vir Biotechnology struck a global co‑development and licensing pact to advance VIR‑5500, a PRO‑XTEN dual‑masked CD3 T‑cell engager targeting PSMA for prostate cancer. The deal...
Generate targets big IPO to fund antibody trials – $425M on deck
Flagship Pioneering’s Generate:Biomedicines filed to raise up to $425 million in an IPO to finance late‑stage development of its lead anti‑TSLP antibody and expand its platform. The raise would...
FDA halts MacroGenics enrollment after fatal toxicity event
The U.S. Food and Drug Administration ordered a partial clinical hold and froze enrollment in MacroGenics’ Phase 2 lorigerlimab trial after a patient death and multiple life‑threatening adverse...
GSK inks siRNA pact with Frontier – $1B potential to expand oligo reach
GSK agreed to acquire global rights to two siRNA candidates from Frontier Biotechnologies with a deal that starts with a $40 million upfront payment and could total nearly $1 billion in...
Merck splits oncology into standalone unit – Strategy for post‑Keytruda era
Merck reorganized its human health business, creating a dedicated oncology division separate from a specialty, pharma and infectious diseases unit as it braces for Keytruda’s looming loss of...
Gilead inks $7.8B buyout: Takes full control of CAR‑T
Gilead agreed to acquire Arcellx in a definitive deal valuing the company at roughly $7.8 billion to secure full control of anito‑cel, a BCMA‑directed CAR‑T therapy nearing regulatory review. The...
FDA shifts to single‑trial approvals: 'Two‑trial dogma' ends
The U.S. Food and Drug Administration announced a formal shift away from the historic default requiring two pivotal trials for drug approvals, signaling that one well‑controlled study plus...
Novo cuts list prices — CagriSema falls short vs Lilly
Novo Nordisk said it will lower list prices for its GLP‑1 medicines to $675 per month beginning in 2027 and concurrently reported midstage triple‑agonist weight‑loss data, as the company grapples...
Astellas‑Vir pact: $1.3B for masked CD3 prostate engager
Astellas and Vir Biotechnology announced a global co‑development and commercialization agreement centered on VIR‑5500, Vir’s PRO‑XTEN dual‑masked CD3 T‑cell engager targeting PSMA in prostate...
Beam launches PKU base‑editing push — $500M financing attached
Beam Therapeutics unveiled BEAM‑304, a liver‑targeted base‑editing program designed to correct pathogenic PAH mutations responsible for phenylketonuria (PKU), and said it secured a $500 million...
FDA halts MacroGenics trial: Safety probe after patient death
The U.S. Food and Drug Administration ordered a pause on enrollment and placed a partial clinical hold after a patient death and multiple severe adverse events in MacroGenics’ Phase 2 study of...
Madrigal buys siRNA assets in $4.4B Ribo deal
Madrigal Pharmaceuticals agreed to acquire six preclinical siRNA candidates from Ribo Life Science and Ribocure in a transaction valued at up to $4.4 billion tied to milestones. The acquisition...
Generate eyes up to $425M IPO: Platform funds antibody Phase‑3
Flagship Pioneering‑backed Generate:Biomedicines filed to raise up to $425 million in a Nasdaq IPO to finance its lead anti‑TSLP antibody through two late‑stage severe asthma trials and to advance...
Slate nets $130M: Anti‑PACAP migraine program moves to clinic
Slate Medicines closed a $130 million Series A to advance SLTE‑1009, an anti‑PACAP antibody licensed from China‑based DartsBio, into clinical testing for migraine prevention. The financing, led by...
Innovacell lists in Tokyo: ¥14.16B IPO to back cell therapies
Innovacell Inc. launched a ¥14.16 billion (about US$91.2 million) initial public offering on the Tokyo Stock Exchange to finance clinical development of its cell therapies targeting urinary...
Gilead to buy Arcellx for $7.8B: Stakes on CAR‑T anito‑cel
Gilead agreed to acquire Arcellx for $7.8 billion in cash to gain full control of anito‑cel, Arcellx’s BCMA‑directed CAR‑T therapy for relapsed or refractory multiple myeloma. The deal values...
Novo’s CagriSema falls short – Lilly’s Zepbound wins head‑to‑head
Novo Nordisk disclosed that its next‑generation obesity candidate CagriSema failed to demonstrate noninferiority to Eli Lilly’s Zepbound in a head‑to‑head Phase 3 comparison. Reported weight‑loss...
FDA endorses single‑trial approvals: Agency updates pivotal evidence standard
The U.S. Food and Drug Administration signaled a policy shift by endorsing approval based on a single well‑controlled trial supplemented with confirmatory evidence, authors at the agency argued in...
FDA unveils plausible‑mechanism draft: Roadmap for individualized therapies
The FDA released draft guidance detailing the ‘plausible mechanism’ pathway to advance individualized cell and gene therapies for extremely rare genetic conditions. The framework outlines the...