Biotech

Shanghai fires two scientists after gene-editing death

Investigators found the scientists hid a 6-year-old's death and skipped safety warnings in a gene-editing study; two are now barred for five years.

HHS funds ibogaine research for veterans with PTSD

The $4.9 million investment targets a psychedelic drug with real promise and real heart risks.

Pitt-led study finds genes that change how drugs work

A Pitt-led analysis of nearly 100,000 people in NIH's All of Us program found genetic variants that change how the body handles common drugs.

Oura buys AI doctor startup Counsel Health for $625M

The smart-ring maker will pay $625 million for an AI-native primary care startup, pushing wearables straight into medical treatment.

FDA approves Bayer's Sunharbo to prevent repeat strokes

Sunharbo is the first approved drug in a new class that cut recurrent stroke risk 26% in a trial, without raising bleeding risk.

Vir's hepatitis D drug combo hits Phase 3 goal

Vir Biotechnology's two-drug combination cleared undetectable virus in 44% of hepatitis D patients, where today's treatments barely work at all.

FDA investigates cancer risk in Novartis gene therapy

The FDA is formally investigating tumors in children treated with Novartis's Zolgensma, after two cases showed the therapy's own DNA caused cancer.

FDA approves J&J's Rybrevant Faspro for head, neck cancer

The accelerated approval is the first new option for this hard-to-treat cancer in a decade, J&J says.

Novartis confirms tumors in 9 children given Zolgensma

The drugmaker says nine children treated with its spinal muscular atrophy gene therapy later developed tumors, seven of them never disclosed before.

CVS Health will split into two separate companies

The split undoes CVS's drugstore-insurer merger strategy, separating 9,000 pharmacies from Aetna and Caremark.

Servier's $1.55B muscular dystrophy drug fails trial

Servier paid $1.55 billion for sevasemten, then watched it miss its primary goal in a pivotal trial for Becker muscular dystrophy.

Bird flu kills a Washington state resident, first in a year

A Yakima County resident died after catching bird flu from infected dairy cattle — the first U.S. death from the virus in about a year.

Genmab drug halves death risk in head and neck cancer

Pairing the antibody petosemtamab with Keytruda cut the risk of death in half in a Phase 3 trial, Genmab said Oct. 28.

US bans imports from China's BGI over forced-labor claims

Customs will bar goods from BGI Group, BGI Genomics and MGI Tech over alleged Xinjiang forced labor. BGI Group denies the claim.

AstraZeneca targets $1.5B in yearly savings after sales beat

The drugmaker unveiled a three-year restructuring to fund its drug pipeline but gave few details, including whether jobs will go.

FDA maps approval path for one-patient gene editing drugs

The FDA outlined how companies can seek approval for gene editors built to fix one person's mutation, and draft rules would ease later updates.

Artiva shuts down after two deaths in cell therapy trial

The biotech laid off 94% of staff and dropped its off-the-shelf NK cell therapy for autoimmune disease after two patients died in a Phase 2a trial.

UC San Diego finds sea compound that fights brain amoeba

Rutamycin B, from a marine bacterium, beat the standard drug's speed in lab tests. It still has to be tried in live disease models.

Roche's divarasib beats rivals in lung cancer trial

In a head-to-head trial, Roche's divarasib cut the risk of death by 44% compared with Amgen's and Bristol Myers' already-approved KRAS G12C drugs.

Lung cancer drug combination extends survival in trial

In an interim phase 3 study, patients on Imdelltra plus Imfinzi lived a median 21.1 months, compared with 12.7 months on Imfinzi alone.

US proposes limits on overseas biotech investments

The Treasury wants to add certain biotechnology deals to restrictions on US investment in countries of concern, including China.

Vaccine plus Keytruda cuts melanoma relapse risk in trial

The investigational personalized mRNA vaccine, given with Keytruda, reduced recurrence or death by 42% versus Keytruda alone in a Phase 3 trial.

Roivant's eye drug clears two pivotal trials

Brepocitinib hit its goals in both Phase 3 trials for a rare eye disease, setting up a 2027 filing for approval.

OpenAI buys Orchestra Bio to push deeper into drug R&D

The deal folds a four-year-old startup's drug-development AI agents into Rosalind, OpenAI's life-sciences model, as rival labs race into biotech.

Merck KGaA buys UK biotech Silence for $1.3 billion

The German drugmaker is paying $1.3 billion for a London biotech whose gene-silencing drug just worked in a rare blood disease.

David Sabatini wins $6M in MIT misconduct case

A jury awarded the ousted MIT biologist $6 million, rejecting his accuser's harassment claims and finding she defamed him.

Legend's CAR-T hit 100% response before its FDA clearance

LB2501 posted a 100% response rate in a small China trial before clearing a U.S. FDA hurdle.

China drafts export bans covering AI, biotech, solar

The draft would ban or restrict 40 technologies, from gene therapy platforms to AI that can write malicious code.

AstraZeneca pays insitro $40M for AI drug deal

The deal could reach $1.5 billion as insitro's AI hunts for new drug targets in liver and heart disease.

Colossal's new AI hunts for dodo gene-editing targets

The de-extinction company's new AI platform, GenoMorph, flagged about 2,300 genes that could help recreate dodo traits in a living relative.