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...

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...

Sanofi inks research deal with Denali in neurological, inflammatory diseases

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 January,...

Bayer backs cell therapy startup with $215M in funding

First-generation cell therapies, such as those developed by Novartis and Gilead, rely on immune cells collected from each individual patient. A painstaking manufacturing process...
Zolgensma (onasemnogene abeparvovec) wasn't the first gene therapy approved in the U.S. That milestone belongs to Spark Therapeutics' Luxturna (voretigene neparvovec), a treatment for...
Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of...
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...

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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...

FDA’s Woodcock defends accelerated approvals and talks of culture...

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

Don’t worry about Humira biosimilars, the pipeline will deliver,...

As Humira (adalimiumab) goes, so goes AbbVie. And it may require quite a few new products to replace the rheumatoid arthritis giant, which earned...

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 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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