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...

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

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) induced...

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 the...

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...
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,...
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...
Zolgensma (onasemnogene abeparvovec) wasn't the first gene therapy approved in the U.S. That milestone belongs to Spark Therapeutics' Luxturna (voretigene neparvovec), a treatment for...

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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,...

From BIO meeting, Merck CEO backs capitalism, rebuts industry’s...

In an era of criticism and scrutiny for biopharma companies, executives gathered at the 2019 BIO meeting have debated how the industry can push...

PhRMA’s DTC defense rolls out on airwaves and online

The move by PhRMA and its members to address calls for more transparency on drugs prices came to a head in October, when the...

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,"...

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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