CMO Roberts to Succeed Chang as Allogene CEO
Allogene Therapeutics announced that Chief Medical Officer Michael Roberts will replace co‑founder David Chang as chief executive officer, effective July 1. Roberts, who has overseen the company’s clinical development program since 2021, brings deep expertise in allogeneic CAR‑T technology. The transition occurs as Allogene prepares to file additional INDs and advance its lead candidates toward FDA approval. The biotech, valued at roughly $2.5 billion, will maintain its strategic partnership with Pfizer under the new leadership.
Busy June at FDA with 11 Upcoming PDUFA Dates
The FDA has a packed June agenda with 11 PDUFA decision dates, covering at least eight new drug approvals and three new indication expansions. Among the high‑profile reviews is Ionis Pharmaceuticals’ antisense therapy Tryngolza, currently approved for familial chylomicronemia syndrome....
Post-IPO, Kailera Looks Beyond Obesity to MASH
Kailera Therapeutics completed the largest biotech IPO on NASDAQ, raising $718.8 million after the greenshoe. In its first post‑IPO update, the company disclosed Phase I data for KAI‑4729, a triple GLP‑1R/GIPR/GCGR agonist developed with Jiangsu Hengrui. The early trial in healthy volunteers...
Science Spotlight: Silencing Seizures by Fixing Gene Mutations
Two independent research teams reported in Science Translational Medicine that in‑vivo gene editing can repair disease‑causing SCN1A mutations in mouse models of severe epilepsy. The University of Zurich used AAV‑delivered prime editing to correct the K1270T Nav1.1 mutation in neonatal...
ASCO to Spotlight Pancreatic Cancer Innovation Beyond KRAS
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As Griffith Retires, Dittrich Returns to Amgen, Takes CFO Role
Amgen announced that long‑time executive Thomas Dittrich will rejoin the company as executive vice president on July 1 and assume the chief financial officer role on September 1, succeeding retiring CFO Peter Griffith. Dittrich previously served in various finance positions at Amgen...
Dueling Memos Are a Case Study in the Politicization of Scientific Data
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What’s Next for FDA
The Biden administration swiftly removed most of the ideological appointees installed by former FDA commissioner Marty Makary, reinstating career officials to restore institutional norms. HHS advisor Chris Klomp led the overnight purge, signaling a shift from political loyalty to administrative competence....
MHRA’s Pound on Aligning Clinical Trial Regulation with Innovation
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is rolling out clinical‑trial reforms aimed at more than just faster approvals. Interim director of innovation James Pound says the agency is pursuing international alignment and horizon‑scanning to anticipate emerging therapies....
Pfeifer Retiring as AC Immune CEO — and More Biotech C-Suite Moves
Andrea Pfeifer is retiring after more than 23 years as CEO of AC Immune, the Swiss neurology biotech she co‑founded. She will remain on the board as honorary chair and co‑chair of the scientific advisory board, while chairman Martin Zügel...
Serif: Non-Viral DNA Delivery with Goldilocks Durability
Serif, a Flagship Pioneering spin‑out, has unveiled a non‑viral DNA‑based therapeutic platform that pairs AI‑designed DNA sequences with mRNA co‑factors. The approach leverages lipid‑nanoparticle delivery to achieve expression durability longer than conventional mRNA but without the permanent genome integration of...
A Big Year for Ionis
Ionis Pharmaceuticals, a pioneer in antisense oligonucleotide (ASO) therapeutics, is transitioning from a licensing‑focused model to directly commercializing its own drugs. The breakthrough approval of Spinraza for spinal muscular atrophy validated the ASO approach and unlocked a pipeline of both...
Incretins Continue to Dominate Obesity Conferences
Recent obesity conferences were dominated by incretin‑based therapies, with GLP‑1 receptor agonists such as semaglutide and the dual GIP/GLP‑1 agent tirzepatide taking center stage. New trial data presented showed weight‑loss results of 15‑20 percent, reinforcing the clinical potency of these...
Biogen Finds Alzheimer’s Path for Tau ASO Despite Mixed Data
Biogen reported Phase 2 data for its tau‑targeting antisense oligonucleotide (ASO) in Alzheimer’s disease, showing a roughly 30% reduction in cerebrospinal fluid tau levels. Cognitive endpoints, however, delivered only modest, statistically non‑significant improvements versus placebo. The safety profile remained clean,...
Hengrui’s 13-Program BMS Deal Is Latest Move Toward Globalization
Jiangsu Hengrui Pharmaceuticals signed a two‑way licensing agreement with Bristol Myers Squibb, marking another milestone in the Chinese firm’s global expansion. The deal provides Hengrui with $600 million upfront and $350 million in near‑term payments, with two $175 million installments due in 2027...