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...

BioMarin confirms timeline for hemophilia gene therapy, putting pressure on rivals

Hemophilia has become one of the most competitive battlegrounds in the emerging field of gene therapy. While BioMarin remains the frontrunner to market, a key...

Pharma returns on R&D ebb to new low, Deloitte finds

Deloitte's annual report on R&D productivity, while limited in scope, is an indicator of the challenges faced by large pharmaceutical firms in bringing new molecules...

3 takeaways from cancer’s biggest conference

The cancer field's largest conference has come and gone, and with it a window into the thousands of clinical trials being run in hopes...
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 move by PhRMA and its members to address calls for more transparency on drugs prices came to a head in October, when the...
In gene therapy, where dramatic results in deadly diseases can hasten clinical testing, studies tend to be smaller, with greater significance put on each...

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No news is bad news for Tocagen

Brain cancers are among the most difficult to treat, as Tocagen's struggles follow late-stage study failures earlier this month from AbbVie and Bristol-Myers Squibb. The...

Lilly to withdraw FDA-approved cancer drug after clinical failure

Lartruvo (olaratumab) was the first new drug approved for soft tissue sarcoma in more than four decades, at the time offering patients with the...

Another late-stage miss knocks Gilead from its leading NASH...

Gilead is part of a small group of drugmakers with late-stage NASH assets. But misfires in the STELLAR program have dimmed the prospects of...

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...

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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