Opinion on Manufacturing Services and Outsourcing

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Type Product title / description Pub Price
Expert View
Expert View

Pharmacovigilance solutions: essential for the future of healthcare

Although many newer pharmacovigilance solutions are still in the nascent stages, and despite pharmaceutical companies' reluctance to adopt them, it is becoming increasingly obvious that these tools will play an essential role in protecting public health. As drug safety regulations increase, signal detection technologies will aid in the costly act of identifying and managing adverse drug events.

Published By Datamonitor
06 Jun 2008
Expert View
Expert View

Is cost containment impacting pharmaceutical innovation?

With the cost of healthcare provision spiraling, governments and payers across the seven major markets are applying cost-cutting measures, putting even greater pressure on pharmaceutical companies. In the UK, the National Institute of Clinical Excellence recently rejected four new kidney cancer therapies on the basis of cost effectiveness, effectively denying patients access to these novel drugs.

Published By Datamonitor
04 Sep 2008
Expert View
Expert View

Are the US and emerging markets ready for the generic drug boom?

One of Barack Obama's key goals as president is to reduce healthcare costs, particularly those related to prescription medications, by increasing the importation of generic drugs. However, the majority of these, or their ingredients, are manufactured in China, and to build confidence in such products, which are often considered unsafe, the FDA will require updated IT systems and solutions.

Published By Datamonitor
17 Nov 2008
Expert View
Expert View

Pandemic flu: gaps in preparedness remain

The current outbreak of influenza A (H1N1) is testing pandemic preparedness strategies across the globe. While widely implemented strategies seem to have prepared the world better than ever before, important gaps regarding the logistics of drug and vaccine distribution remain.

Published By Datamonitor
08 May 2009
Expert View
Expert View

US and EU regulators close in on pharmaceutical pay-for-delay deals

The evolving relationship between branded and generics pharmaceutical companies is set to undergo considerable change as regulators in both the US and EU move to restrict 'pay-for-delay' deals in a bid to increase generics cost-savings. As deals that delay the market entry of generics come under increasing scrutiny, the industry may find that its best option is to cease such practices altogether.

Published By Datamonitor
13 Jan 2010
CommentWire
CommentWire

AstraZeneca: ready to take on Pfizer in novel small molecule development for rheumatoid arthritis

News of AstraZeneca's Phase III clinical trial program signifies the company's serious intent to enter the rheumatoid arthritis market with its small molecule Syk inhibitor, fostamatinib disodium. While there is an unmet need for oral small molecules, Datamonitor expects that the drug will face stiff competition from Pfizer's tasocitinib, the most advanced novel small molecule in the pipeline.

Published By Datamonitor
30 Sep 2010
CommentWire
CommentWire

AusBiotech 2010: national conference looks to create "global solutions"

AusBiotech 2010, the annual conference of the Australian biotechnology industry, has sought to educate attendees about recent trends in the global pharmaceutical market, and how they can best take advantage of current conditions. This includes exploring opportunities with regional Asia Pacific neighbors, with a potential collaboration between Australia and India one of the key talking points.

Published By Datamonitor
25 Oct 2010
CommentWire
CommentWire

EMA: draft biosimilar MAb guidelines will see case-by-case approvals

The European Medicines Agency's latest draft guidelines on monoclonal antibodies offer some flexibility for producers, but development costs are still expected to be high. With the instructions likely to be interpreted on a case-by-case basis, communication with the agency will be critical for success.

Published By Datamonitor
30 Nov 2010
CommentWire
CommentWire

Orexigen: Contrave joins the list of failed weight-loss drugs

The FDA has issued a Complete Response Letter informing Orexigen that its developmental obesity therapy Contrave will require additional clinical study if it is to reach the market. The financial burden of an outcomes study and uncertainties regarding the drug's effect on blood pressure is likely to prevent Contrave from entering the market.

Published By Datamonitor
02 Feb 2011
CommentWire
CommentWire

UK budget: uncertainty remains over intellectual property legislation

George Osborne, the UK chancellor of the exchequer, has attempted to appease branded pharmaceutical manufacturers in his 2011 budget announcement by introducing lower corporate tax rates and increasing R&D incentives. However, it is still unclear as to whether he will go even further and reform the Bolar exemption, which could harm generic drug producers, and lead to a rise in NHS drug spending.

Published By Datamonitor
25 Mar 2011

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