Intra-Cellular’s depression drug goes 1 for 2 in Phase 3 studies

Intra-Cellular's success and failure demonstrate the difficulty of developing psychiatric drugs. Unqualified clinical success in depression is particularly challenging, as high placebo responses can...

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 biologics...

Gilead firms up path to market for key arthritis drug

A filing this year for filgotinib could set up a potential market launch in 2020, which would be one to two years earlier than some...

Once ‘bodies for hire,’ CROs are finding a new role as data specialists

Drugmakers want better designed, less expensive clinical trials. The demand is so great that contract research providers, often called CROs, are building out their...
As Humira (adalimiumab) goes, so goes AbbVie. And it may require quite a few new products to replace the rheumatoid arthritis giant, which earned...
Dive Insight: Biogen took the most severe blow in its history last month, losing more than $20 billion in market capitalization on the announcement that...
TherapeuticsMD decided against diluting its shareholders again in order to get Bijuva (estradiol and progesterone) and Annovera (segesterone acetate and ethinyl estradiol) off the...

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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. 

Aducanumab’s failure puts pressure on field to look beyond...

The plaques are considered hallmarks of Alzheimer's disease, formed in the brain from sticky clusters of a misfolded protein fragment called beta-amyloid. For the past...

Safety setback for Pfizer, Lilly pain drug should have...

The U.S. opioid crisis breathed new life into clinical development of the nerve-growth factor (NGF) inhibitors tanezumab and fasinumab. The drug class had been...

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....

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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