Opinion on Biotech in North America

Published within

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Type Product title / description Pub Price
Expert View
Expert View

Zelboraf's approval demonstrates a significant shift toward personalized cancer therapy

The FDA has approved Zelboraf and Roche's companion diagnostic test for BRAF V600E mutation-positive metastatic melanoma. The joint approval is the first example of co-development and demonstrates the movement toward personalized cancer therapy, and Zelboraf's impressive efficacy data and the availability of a test will ensure rapid uptake.

Published By Datamonitor
18 Aug 2011
CommentWire
CommentWire

Vertex Pharmaceuticals: strong evidence for VX-770 as a potential novel treatment method

Vertex Pharmaceuticals' novel cystic fibrosis treatment VX-770 has demonstrated strong efficacy in a Phase III trial, meeting the primary endpoint and key secondary endpoints. VX-770 targets the underlying cause of the disease, and, if approved, would offer a novel treatment approach.

Published By Datamonitor
25 Feb 2011
CommentWire
CommentWire

US: industry skeptical of new US drug safety bill despite record recalls

Additional drug safety responsibilities could be placed on pharmaceutical companies with the introduction of a new US bill in the Senate. The bill, which comes in the wake of record product recalls, aims to strengthen manufacturing standards and better equip the FDA to oversee the pharmaceutical supply chain. However, if passed, the legislation would create considerable costs for drug makers.

Published By Datamonitor
10 Aug 2010
CommentWire
CommentWire

UCB: Cimzia's indication expansion hindered by FDA

Although the FDA's complete response letter for Cimzia in rheumatoid arthritis will delay its US approval, Datamonitor believes UCB has the experience to handle the setback and the drug may still reach the market by the second half of 2009. Ultimately however, the delay will not be a major impediment as extensive uptake is not expected at launch due to poor differentiation in a mature drug class.

Published By Datamonitor
07 Jan 2009
CommentWire
CommentWire

Top pharmaceutical and biotech companies face slowdown in sales growth over 2008-14

A Datamonitor report has identified that the leading pharmaceutical and biotech companies face a major slowdown in sales growth out to 2014, primarily a result of the imminent patent expiries facing many blockbusters and the subsequent threat from generics. Prescription sales are expected to rise at a compound annual growth rate of just 1.2% over 2008-14, compared to a historical rate of 10.5%.

Published By Datamonitor
01 Mar 2010
Expert View
Expert View

Teva/Cephalon: acquisition bolsters branded portfolio

On May 2, 2011, Teva announced that it was to acquire US-based Cephalon for $6.8bn. The consolidation of Cephalon will accelerate Teva's strategy of an increased presence in the branded pharmaceutical market. Given that Cephalon's pipeline is heavily focused on oncology, an area in which Teva has no major branded presence, the deal will also prompt future therapeutic diversification.

Published By Datamonitor
18 May 2011
CommentWire
CommentWire

Takeda/Seattle Genetics: hopes of pipeline drug boost collaboration agreement

Encouraged by a partnership that has to date been successful, Millennium has invested further into Seattle Genetics' antibody-drug conjugate technology. As the wait for the first commercially successful antibody-drug conjugate therapeutic continues, pharmaceutical players are actively populating their pipelines with this innovative monoclonal antibody class.

Published By Datamonitor
17 Mar 2011
Expert View
Expert View

Success for Adcetris could spark further interest in antibody-drug conjugate technology

The FDA has recommended accelerated approval for Adcetris for relapsed/refractory Hodgkin's lymphoma and relapsed/refractory systemic anaplastic large cell lymphoma. Treatment options for these indications are limited, and the advisory panels were unanimous in backing Adcetris's approval. Commercial success for the drug could attract further investment in antibody-drug conjugate technology.

Published By Datamonitor
15 Jul 2011
CommentWire
CommentWire

Seattle Genetics/Millennium: promising immunotherapy for relapsed/refractory Hodgkin's lymphoma

Seattle Genetics and Millennium: the Takeda Oncology Company have announced encouraging results from a Phase II trial of brentuximab vedotin in relapsed or refractory Hodgkin's lymphoma. Full results of the trial are yet to be published, but the candidate looks set to become the first immunotherapy approved for the disease.

Published By Datamonitor
29 Sep 2010
CommentWire
CommentWire

Sanofi/Genzyme: Lemtrada eclipses Rebif in reducing disability

Sanofi and Genzyme have presented additional data analysis demonstrating Lemtrada's superiority over Rebif in reducing disability in MS. However, due to Lemtrada's potential to lead to the development of autoimmune adverse events, Datamonitor expects that the drug will be used at later lines of therapy and in patients with severe forms of MS.

Published By Datamonitor
30 Apr 2012

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