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FDA pivots: single pivotal trials and bespoke therapies gain runway
The U.S. Food and Drug Administration announced major shifts in evidentiary expectations: endorsing reliance on one well‑controlled pivotal trial in appropriate circumstances and publishing draft...
Beam launches PKU base‑editing program – $500M financing pact in tow
Beam Therapeutics launched BEAM‑304, a liver‑targeted base‑editing program aimed at correcting the most common PAH mutations that cause phenylketonuria (PKU). Beam said preclinical data normalized...
Astellas pays up — $1.3B pact with Vir for masked CD3 T‑cell engager
Astellas Pharma and Vir Biotechnology struck a global co‑development agreement worth up to $1.37 billion plus near‑term payments to advance VIR‑5500, a PRO‑XTEN dual‑masked CD3 T‑cell engager...
CareDx pivots to cell‑therapy surveillance – validation data in hand
CareDx said it will prioritise a cell therapy surveillance testing pipeline in 2026 after reporting solid quarterly revenue growth. The company published validation data from the ACROBAT...
Gossamer’s Phase III miss sends stock tumbling – program under review
Gossamer Bio reported a pivotal Phase III miss for seralutinib in pulmonary arterial hypertension (PAH), with the study failing to meet its primary endpoint amid an outsized placebo response. The...
New polymers degrade ‘undruggable’ MYC and KRAS – HYDRACs show preclinical activity
Researchers at Northwestern reported a new class of protein‑like polymers—HYDRACs—that recruit cellular degradation machinery to selectively eliminate intrinsically disordered, 'undruggable'...
Flagship’s Generate eyes blockbuster IPO — platform play in public markets
Flagship Pioneering’s Generate:Biomedicines is aiming for a major public debut that could value the company in the multibillion‑dollar range, raising capital to fund late‑stage programs and...
Pharma groups ready legal fight over CMS pricing demos — industry aligns
Pharmaceutical trade associations and drugmakers are preparing legal challenges to two proposed Medicare pricing demonstration models that would align U.S. prices with other wealthy nations,...
Gilead snaps up Arcellx for $7.8B – Bets on CAR‑T lead
Gilead Sciences agreed to acquire Arcellx for $7.8 billion in cash, taking full control of anito‑cel, the BCMA‑directed CAR‑T therapy nearing FDA review. The deal consolidates co-development...
Novo’s next‑gen miss and price cuts reshape obesity market
Novo Nordisk’s experimental obesity combo CagriSema failed to meet non‑inferiority versus Eli Lilly’s Zepbound in a head‑to‑head Phase 3 trial, prompting fresh investor concern and strategic...
FDA unveils bespoke therapy pathway: plausible‑mechanism draft
The U.S. Food and Drug Administration published draft guidance laying out a new 'plausible mechanism' pathway to speed individualized and ultra‑rare therapies, including bespoke gene‑editing...
Beam expands base editing to PKU – BEAM‑304 enters IND path
Beam Therapeutics launched BEAM‑304, a liver‑targeted base‑editing program designed to correct pathogenic PAH mutations that cause phenylketonuria (PKU), and secured a $500 million strategic...
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...