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Early Access to Medicines in the US and Europe

$2,995.00

Faced with pressure from stakeholders – particularly patients – governments, regulators, and some countries have introduced new options and/or processes to speed up access to medicines. This includes access before marketing authorization, and speeding up the marketing authorization, or less often, the health technology assessment processes.

July 15, 2019
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Argentina Regulatory Issues

$2,995.00

With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
November 2, 2016
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Managed Entry Agreements

$2,995.00

Managed entry agreements (MEAs) describe a range of mechanisms by which pharmaceutical firms and payers share some of the financial and clinical risk associated with the introduction of a new medicine.
November 4, 2016
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Indonesia Generics and Biosimilars

$2,995.00

In 2011, branded generics accounted for 89% of Indonesia’s overall prescription pharmaceutical market, which was valued at IDR25.04tn ($2.84bn). The overwhelming dominance of generics – both branded and unbranded – leaves very little room for innovative products, other than those whose patents have already expired (i.e. “long-listed drugs”).
November 3, 2016
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Indonesia Pharmaceutical Market Dynamics

$2,995.00

Kalbe Farma is the leading player by some margin, with a market share of 13% in 2011, while GlaxoSmithKline is the largest foreign player with a 3% share.
November 2, 2016
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US Specialty Drug Market Access

$2,995.00

High-touch specialty drugs for complex, chronic, high-cost, or rare diseases are an increasingly significant component of the US pharmaceutical market. A sharp growth in regulatory approvals accompanied by high prices has driven rapid increases in expenditure on specialty therapies by both public and private payers.
November 4, 2016
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Generics: Regulatory Update

$2,995.00

Regulatory measures continue to shape the generics landscape. Cost-containment strategies continue to impact generics.
November 4, 2016
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Drug Pricing in the US

$2,995.00

Drug prices in the US have been the subject of intense debate over the past 2–3 years, following a surge in spending on prescription medicines and steep price increases in some categories
July 5, 2017
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Beyond-the-Pill Services and Solutions: Pharma’s Next Frontier?

$2,995.00

Payers and governments are striving toward cost-effective treatment outcomes and more efficient care, and waves of new digital health technologies are offering patients unprecedented opportunities to be more engaged in their own health management.
November 2, 2016
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Russia Pharmaceutical Market Dynamics

$2,995.00

With the Russian economy recovering from the recession experienced in 2009, the pharmaceutical market has also returned to growth.
November 2, 2016
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Germany Regulatory Issues

$2,995.00

Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.
November 2, 2016
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Key Potential Drug Launches in 2020

$2,995.00

As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2020.

May 28, 2019
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Gene Therapy Deal-Making Trends, 2012–17

$2,995.00

A robust deal-making market has enabled gene therapy drug development to be advanced and adequately funded through alliances and financings, and in many cases has provided exits for investors through acquisitions.
February 14, 2018
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ISPOR Europe 2018 Whitepaper

$2,995.00

Datamonitor Healthcare attended the ISPOR 21st Annual European Congress held in Barcelona on 10–14 November. Here, we present some of the hot topics discussed at the event.

November 23, 2018
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Biosimilar Commercial Strategies and Tactics

$2,995.00

The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.
May 14, 2019
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