21:53 , Apr 13, 2018 |  BioCentury  |  Strategy

Self-driving CARs

Novartis AG, Gilead Sciences Inc. and now Pfizer Inc. have taken different approaches to managing their CAR T cell assets, but the three companies appear to be converging on the notion that developing the technology...
20:51 , Apr 6, 2018 |  BC Week In Review  |  Company News

NICE does not recommend Roche's Ocrevus for MS

The U.K.'s NICE published draft guidance recommending against the use of Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat relapsing forms of multiple sclerosis. The committee said the clinical trial data that Roche submitted did not...
01:40 , Jan 27, 2018 |  BioCentury  |  Strategy

Growing up Genzyme

The proposed acquisition of Bioverativ Inc. ticks multiple boxes on Sanofi’s to-do list for transforming itself into a top tier pharma, and solidifies the position of its Genzyme unit as the pharma’s growth engine. Olivier Brandicourt...
20:21 , Jul 21, 2017 |  BioCentury  |  Strategy

Accessing miracles

With unanimous backing of an FDA advisory committee, overwhelming efficacy and a robust REMS, all signs suggest Novartis AG’s tisagenlecleucel-T is headed to the market for children and young adults with a rare leukemia. The...
23:13 , Jan 27, 2017 |  BC Extra  |  Financial News

ICER finds Lemtrada most cost-effective in MS

In an evidence report evaluating disease-modifying therapies for multiple sclerosis, the Institute for Clinical and Economic Review said Lemtrada alemtuzumab from Sanofi (Euronext:SAN; NYSE:SNY) "consistently demonstrated improved health outcomes and good value" at a lower...
23:00 , Dec 14, 2016 |  BC Week In Review  |  Clinical News

Arzerra regulatory update

Genmab said the European Commission approved an expanded label for Arzerra ofatumumab from Novartis to include treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide. Arzerra is approved in the EU...
21:49 , Nov 14, 2016 |  BC Week In Review  |  Clinical News

Arzerra regulatory update

EMA’s CHMP recommended expanding the label of Arzerra ofatumumab from Novartis to include treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide. In the EU, Arzerra is approved in combination with...
07:00 , Oct 31, 2016 |  BioCentury  |  Politics, Policy & Law

Debating drug prices

  A recent debate pitting two of the Democratic Party’s leading health policy experts against pharma advocates provides a glimpse of how a Hillary Clinton administration would follow through on her promise to rein in prescription...
07:00 , Oct 28, 2016 |  BC Extra  |  Financial News

Sanofi gains despite complete response letter

Sanofi (Euronext:SAN; NYSE:SNY) shares rose Friday after the company reported earnings showing growth of its multiple sclerosis drugs, combined with double-digit gains from its vaccine business and rare disease portfolio, are offsetting continued headwinds in...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Arzerra ofatumumab regulatory update

FDA approved an sBLA from Novartis for Arzerra ofatumumab in combination with fludarabine and cyclophosphamide to treat relapsed chronic lymphocytic leukemia (CLL). Arzerra is approved in combination with chlorambucil in previously untreated CLL patients for...