News

FDA’s Woodcock defends accelerated approvals and talks of culture shift in clinical trials

Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of...

Early cancer drug data give Amgen hope it has ‘cracked KRAS code’

CHICAGO — Decades of research have failed to uncover a therapeutic answer to one of the most well-known genetic drivers of cancer. Yet Amgen...

The gene therapy era has arrived. So have the challenges.

A landmark regulatory approval has vaulted the cell and gene therapy space to the front of the drug industry's mind. But speedy progress has...

FTC demands could mean months-long delay for Roche-Spark deal

Roche's $4.8 billion takeout of gene therapy specialist Spark Therapeutics looked like a typical biopharma transaction — that is, until the Federal Trade Commission...

Bluebird sets $1.8M price tag for blood-disease gene therapy

Bluebird declined to release the Zynteglo price when the agent received European Commission conditional approval last week. The price announcement Friday coincided with a...

AstraZeneca gets immuno-oncology win in a disease that Merck doesn’t rule

Dive Insight: Anytime a PD-(L)1 inhibitor can beat Keytruda (pembrolizumab) to the market in a specific type of cancer, it should be celebrated as a...

Pfizer muscular dystrophy gene therapy stumbles on safety

Dive Brief: Pfizer's Duchenne muscular dystrophy gene therapy improved physical function in two patients measured one year after treatment, but also led to one patient...

MacroGenics dives as breast cancer drug shows small improvement

MacroGenics stock took a beating Tuesday, dropping far more than any other biotech on the iShares NASDAQ Biotechnology Index as the ASCO conference closed....

FDA’s Woodcock defends accelerated approvals and talks of culture shift in clinical trials

Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of...

R&D leaders worry pharma reputation risks losing talent

PHILADELPHIA — It's not artificial intelligence or creative corporate structures that some of the biopharma industry's leaders see as the best way to boost...

Latest articles

CMS chief declines to provide details on Trump healthcare...

The administration faces increasing pressure to release a concrete healthcare plan as Democratic presidential candidates are eager to keep the national conversation...

Roche cancer drug the 3rd approved for pan-tumor use

Aimed at the molecular catalysts of tumor growth, targeted therapies are treatment mainstays across a wide range of cancer types. 

Novo faces shareholder suit over insulin sales disclosures

Novo is best known for its insulin products like Levemir (insulin detemir) and Tresiba (insulin degludec), as well as other diabetes treatments...

Celgene wins approval for drug key to Bristol buyout

Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 

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