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Drug Discovery

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...
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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...
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Drug Discovery

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...
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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...
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Drug Discovery

Biotechs dive deeper into targeted cancer research, despite costs

"It could become very challenging for a small biotech company, or even a pharma company, to cover that part of a clinical trial test,"...
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News

Opioid maker Insys to pay $225M to settle fraud charges

Wednesday's settlement follows last month's conviction of five former Insys executives, including the company's founder John Kapoor, for their involvement in bribing physicians to...
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From BIO meeting, Merck CEO backs capitalism, rebuts industry’s critics

In an era of criticism and scrutiny for biopharma companies, executives gathered at the 2019 BIO meeting have debated how the industry can push...
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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...
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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...
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Gilead to build manufacturing site in Maryland to boost cell therapy

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...
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Latest articles

CMS chief declines to provide details on Trump healthcare...

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The administration faces increasing pressure to release a concrete healthcare plan as Democratic presidential candidates are eager to keep the national conversation...
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Roche cancer drug the 3rd approved for pan-tumor use

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Aimed at the molecular catalysts of tumor growth, targeted therapies are treatment mainstays across a wide range of cancer types. 
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Novo faces shareholder suit over insulin sales disclosures

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Novo is best known for its insulin products like Levemir (insulin detemir) and Tresiba (insulin degludec), as well as other diabetes treatments...
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Celgene wins approval for drug key to Bristol buyout

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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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