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...

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...

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 selonsertib...

Wave delays key data readout for Huntington’s therapy

Investors reacted negatively to the pushed-back readouts, sending shares of the Singapore-based biotech down nearly 20% between Tuesday's market close and Wednesday's. Wall Street analysts,...
A filing this year for filgotinib could set up a potential market launch in 2020, which would be one to two years earlier than...
Denali started 2018 with one research agreement with Takeda and is now ending the year with another big pharma collaboration. The Takeda deal, announced in...
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...

Follow RXMonthly

News

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...

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

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...

FDA’s Woodcock defends accelerated approvals and talks of culture...

Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of...

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...

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. 

Subscribe to our newsletter