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...

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 trade...

Hunting productivity, drugmakers pitch new ‘pillars’ of R&D

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 shelves...

J&J invests in integrin therapies via Morphic deal

Four months after Morphic reached an R&D deal with AbbVie, the Waltham, Massachusetts-based biotech has found another drugmaking giant to partner with. Morphic and AbbVie...
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 have been a business boon to contract manufacturers, Catalent included. Large-molecule drugs are such a focus, in fact, that last year Catalent split its...
The RDC prosecution could serve as a warning to the drug distribution industry, potentially impacting litigation against the three largest players: McKesson, AmerisourceBergen and...

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The gene therapy era has arrived. So have the...

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...

J&J invests in integrin therapies via Morphic deal

Four months after Morphic reached an R&D deal with AbbVie, the Waltham, Massachusetts-based biotech has found another drugmaking giant to partner with. Morphic and AbbVie...

BioMarin confirms timeline for hemophilia gene therapy, putting pressure...

Hemophilia has become one of the most competitive battlegrounds in the emerging field of gene therapy. While BioMarin remains the frontrunner to market, a...

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....

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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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