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...

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. Analysts...

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 then...

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...
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...
Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 
Lartruvo (olaratumab) was the first new drug approved for soft tissue sarcoma in more than four decades, at the time offering patients with the...

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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...

Amicus widens UPenn gene therapy collaboration

Biopharma companies wanting to treat rare diseases are increasingly pressed to be invested in gene therapy. Novartis and Roche have recognized this with their...

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...

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...

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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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