Another late-stage miss knocks Gilead from its leading NASH position

Gilead is part of a small group of drugmakers with late-stage NASH assets. But misfires in the STELLAR program have dimmed the prospects of...

Sarepta may have seen off another rival in Wave

Wave Life Sciences has joined the biopharma sector's gold rush to treat DMD, a genetic disorder that causes progressive musculoskeletal disability in boys. So far, a...

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...

Clovis shares slide on Rubraca trial discontinuation

Clovis' Rubraca (rucaparib) was given an accelerated approval in December 2016 for advanced and pretreated ovarian cancer. However, the Colorado-based biotech still lags behind...
Pharma's recent slump in R&D productivity — the rate of success in relation to the time and effort invested in drug development — has...
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...
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...

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Pfizer, Novartis partner in hunt to find drugs for...

Neither Pfizer or Novartis are among the handful of companies at the leading edge of NASH drug development, which has yet to advance a...

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

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...

In R&D, small biotechs hold their own against big...

Despite spending billions on R&D, big pharma doesn't punch its weight in discovering the new molecules that eventually make it to market. Instead, it's...

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)...

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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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