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...

Clinical biomarkers expected to lift R&D productivity: Iqvia

Pharma's recent slump in R&D productivity — the rate of success in relation to the time and effort invested in drug development — has been...

Rival accuses Kaleo of cybersquatting in ‘elaborate scheme’

Cybersquatting was most common in the 1990s and early 2000s, with someone snatching a domain and then selling it to the trademark holder for an...

Former FDA head Gottlieb joins Pfizer board

While past FDA chiefs have joined drugmaker boards following their tenure, Gottlieb's move to Pfizer is both rapid and more high-profile than that of...
Takeda, on the cusp of closing its deal to acquire Shire, is also working to ramp up its efforts in emerging fields of cancer...
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...
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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Pfizer muscular dystrophy gene therapy stumbles on safety

Dive Brief: Pfizer's Duchenne muscular dystrophy gene therapy improved physical function in two patients measured one year after treatment, but also led to one patient...

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,"...

Clinical biomarkers expected to lift R&D productivity: Iqvia

Pharma's recent slump in R&D productivity — the rate of success in relation to the time and effort invested in drug development — has...

Medicare proposes raising CAR-T pay, but reimbursement solution years...

CAR-T therapies represent a significant clinical advance for patients with certain types of advanced lymphoma. In clinical testing, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel)...

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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