Opinion

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Type Product title / description Pub Price
ResearchWire
ResearchWire

Bipolar disorder: divalproex most popular anticonvulsant for BD in US

Published By Datamonitor
16 Nov 2001
CommentWire
CommentWire

BioVex: Stateside switch should boost OncoVEX prospects

Following demonstration of substantial antitumor activity in early-phase clinical trials, the FDA has granted BioVex clearance to initiate a Phase II study of its cancer vaccine OncoVEX. OncoVEX is certainly a promising agent, and BioVex's recent relocation to the US should help it overcome a lack of commercialization experience that could otherwise prove an obstacle to the drug's development.

Published By Datamonitor
07 Jun 2005
Expert View
Expert View

Biovest/Accentia's BiovaxID revives hope for therapeutic cancer vaccines

Biovest, a subsidiary of Accentia, has announced positive data from a pivotal trial of BiovaxID in lymphoma, and the vaccine now stands a good chance of becoming the first therapeutic cancer vaccine to gain approval in the seven major markets. However, despite this breakthrough, a number of economical and logistical issues could prevent the vaccine from achieving significant market penetration.

Published By Datamonitor
18 Jul 2008
CommentWire
CommentWire

Biovail: court case may dent Wellbutrin revenues

Taiwan-based generics manufacturer Anchen Pharmaceuticals has submitted an abbreviated new drug application (ANDA) to the FDA for Biovail's [BVF.TO] Wellbutrin XL (bupropion). Should the application be accepted, Biovail, already suffering from the effects of generic competition from other variants of the brand, would face further revenue decline.

Published By Datamonitor
18 Nov 2004
CommentWire
CommentWire

Biotechnology: FDA rule changes could boost generics

The FDA's review of current good manufacturing practice (cGMP) seeks to improve standards of drug manufacture. At the same time, the regulations should reduce confusion over biotech-derived drug products. These changes may open the door to greater use of new manufacturing methods and long term, greater opportunities for biogenerics.

Published By Datamonitor
28 Aug 2002
Expert View
Expert View

Biotech: antibacterial development opportunity

Despite a growing unmet need for new antibacterial drugs, many of the world's largest pharmaceutical companies have been deterred from this area of R&D because of an increasingly problematic development process. As a result, smaller biotechnology companies are filling this void, both by identifying novel therapies and by picking up clinical programs abandoned by Big Pharma.

Published By Datamonitor
29 Sep 2009
CommentWire
CommentWire

Biotech mergers: a hot winter

It's just the latest in a rising tide of intra-biotech acquisitions, as companies in the sector try to create new profitable business models. With MedImmune, Millennium and now Amgen driving the charge, other leading players such as Genzyme and Chiron look set to follow.

Published By Datamonitor
19 Dec 2001
CommentWire
CommentWire

Biosimilars: US presidential candidates pledge support

As a part of their respective strategies to contain healthcare costs through the wider use of generic drugs, both Barack Obama and John McCain have pledged their support for shorter exclusivity periods for branded biologics. These announcements indicate that biosimilars are set to become a reality even in the US, placing additional pressure on biopharmaceutical revenues.

Published By Datamonitor
23 Sep 2008
CommentWire
CommentWire

Biosimilars: time for an approval pathway in the US

HR 1427 represents the latest attempt to secure legislation for a biosimilars approval pathway in the US. With a five year exclusivity period, the proposed bill will be viewed as pro-biosimilar and could therefore face considerable opposition from prescription drug manufacturers. However, given the escalating cost of healthcare in the US, the industry is under pressure to find a solution.

Published By Datamonitor
13 Mar 2009
Expert View
Expert View

Biosimilars in the EU: delivering the goods?

In January, leading pharmaceutical experts attended the 2009 Forum Institute seminar on biosimilars, and the challenges involved in their successful development and launch. While the main focus of the meeting the biosimilars market in the EU, it was widely agreed that developments in the US, and President Obama's handling of the generic biotech issue, will be the defining issue of 2009 and beyond.

Published By Datamonitor
05 Mar 2009

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