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...

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. 

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. 

Sarepta may have seen off another rival in Wave

Wave Life Sciences has joined the biopharma sector's gold rush to treat DMD, a genetic disorder that causes progressive musculoskeletal disability in boys. So far,...
The new facility should help the big biotech meet some of the unique challenges of manufacturing CAR-T therapies. The process is complex and time...
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...
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...

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Wave delays key data readout for Huntington’s therapy

Investors reacted negatively to the pushed-back readouts, sending shares of the Singapore-based biotech down nearly 20% between Tuesday's market close and Wednesday's. Wall Street analysts,...

Amgen bone drug application knocked back in Europe

Expectations for Evenity (romosozumab) are modest, and the rejection by the EMA is a "minor setback" for Amgen, according to RBC Capital Markets analyst...

Sangamo hemophilia A progress boosts shares

While BioMarin and Spark remain out in front, Sangamo's data appear strong enough to warrant consideration of the biotech's therapy in the discussion of...

Sanofi inks research deal with Denali in neurological, inflammatory...

Denali started 2018 with one research agreement with Takeda and is now ending the year with another big pharma collaboration. The Takeda deal, announced in...

Latest articles

CMS chief declines to provide details on Trump healthcare plan

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

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 like...

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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