Safety setback for Pfizer, Lilly pain drug should have Regeneron and Teva feeling nervous

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...

Amgen invests $66M in genetic sequencing company Oxford Nanopore

Dive Insight: While California sequencing company Illumina is larger, Oxford's kept itself relevant and recently attracted new cash to fund an expansion. Amgen's seen the sequencing company...

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...

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...
Dive Insight: Anytime a PD-(L)1 inhibitor can beat Keytruda (pembrolizumab) to the market in a specific type of cancer, it should be celebrated as a...
SAN FRANCISCO — Developing new medicines isn't a resource-efficient endeavor. Estimates vary, but most molecules selected to begin clinical development won't end up on pharmacy...
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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Once ‘bodies for hire,’ CROs are finding a new...

Drugmakers want better designed, less expensive clinical trials. The demand is so great that contract research providers, often called CROs, are building out their...

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....

Array gets a win in colorectal cancer

Array's combination of Braftovi (encorafenib) and Mektovi (binimetinib) already appears well received in the small clinical setting of advanced melanoma with BRAF V600E or...

Audentes lays down marker in muscular dystrophy

Audentes Therapeutics is trying to show Sarepta isn't the only game in town when it comes to DMD. The collaboration with Nationwide's Children Hospital...

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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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