Pharmaceutical Strategy Analysis l Report Store l Pharma Intelligence

Spain Healthcare System and Drug Regulatory Analysis

The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.

November 2, 2016

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Spotlight on Antibody-Drug Conjugates

$2,995.00

The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.

September 20, 2019

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Surviving a Scandal: How to Expect the Unexpected

$5,000.00

The Institute of Crisis Management defines a crisis as “any problem or disruption that triggers negative stakeholder reaction and that could impact the organization’s financial strength and ability to do what it does.” In the pharmaceutical setting, a crisis could mean an adverse clinical trial event, the bankruptcy of an essential service provider, or a serious product recall. It could be an event that is within the company’s control and has been mishandled, or an external situation that forces the business to change its strategic course, either temporarily or permanently.

November 3, 2016

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The Contract Biomanufacturing Market Outlook to 2017

$5,000.00

The biologic drug market is growing at nearly twice the pace of the overall pharmaceutical market, driven by major therapeutic fields under research such as oncology and autoimmune diseases. The forecasted 20% annual increase in biologic active pharmaceutical ingredient (API) demand between 2011 and 2017 combined with the growth of biosimilars will generate a positive environment for the biologics contract manufacturing organization (CMO) market to grow at 9% per year over the same period.

November 3, 2016

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The Evolution of Pharmaceutical Sales Strategies Continues

$2,995.00

Pharmaceutical sales forces have evolved from the traditional structure, which was dominated by considerable numbers of field-based representatives detailing a range of products to different physicians on a regular basis.

November 1, 2016

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The Growing Impact of Real-World Evidence

$2,995.00

Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.

July 14, 2017

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Treatment of VTE – EU KOL Interview

$599.00

This interview with an EU vascular physician explores the dynamics in the 5 major European markets regarding the introduction of novel/direct oral anticoagulants (NOAC, DOAC) in the treatment of venous thromboembolism (VTE) and prevention of recurrence.

November 4, 2015

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Treatment of VTE – US KOL Interview

$599.00

This interview with a US hematologist focuses on the changing dynamics with the introduction of novel/direct oral anticoagulants (NOAC, DOAC) in the treatment of venous thromboembolism (VTE) and prevention of recurrence.

November 2, 2015

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Trends in CNS Dealmaking, 2012–16

$2,995.00

Diseases of the central nervous system (CNS) offer considerable opportunity to drug developers and marketers.

August 8, 2017

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Trends in Gene Therapy

$2,995.00

Datamonitor Healthcare has carried out a comprehensive analysis of gene therapy products in commercial development worldwide based on information derived from Pharmaprojects.

October 14, 2016

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Triple Negative Breast Cancer KOL Interview

$599.00

“It [Abraxane] is so easy to give. Women tolerate it so well. It works pretty good, it doesn’t work all the time, it works pretty well, and the patients don’t get so fatigued, they don’t have side effects, they don’t need premeds, and they rarely need to be boosted for white cells decrease. Whereas in the Eribulin, you know they’re gonna be coming back. It’s a pretty easy drug to give. Patients tolerate it fairly well… I use it [Abraxane] as first line and I go back to it. Even if I have somebody that progresses, if they’ve been off of it for a while, I will often even go back to it.”

February 9, 2016

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Triple-Negative Breast Cancer KOL Interview – UK

$599.00

A UK-based key opinion leader providers insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for triple- negative breast cancer. Diagnostic testing, biomarker disease segmentation, and unmet needs are also discussed. Key pipeline assets highlighted include balixafortide, Keytruda, sacituzumab govitecan, trastuzumab deruxtecan, and veliparib.

October 31, 2019

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Triple-Negative Breast Cancer KOL Interview – US

$599.00

A US-based key opinion leader providers insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for triple- negative breast cancer. Diagnostic testing, biomarker disease segmentation, and unmet needs are also discussed. Key pipeline assets highlighted include balixafortide, Keytruda, sacituzumab govitecan, trastuzumab deruxtecan, and veliparib.

October 3, 2019

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Turkey Pricing and Reimbursement

$2,995.00

To contain overall healthcare expenditure and to rein in the rapid growth of pharmaceutical expenditure, in 2004 Turkey introduced price-setting procedures using an external reference system based on 5–10 reference countries (all from the EU).

November 4, 2016

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Turkey Regulatory Issues

$2,995.00

The mandatory requirement imposed by the Turkish authorities for overseas manufacturers exporting pharmaceutical products to Turkey to obtain Good Manufacturing Practice (GMP) certification issued by the Turkish Ministry of Health is causing inordinate delays in the registration of new pharmaceutical products in Turkey. However, these delays can be resolved once the US Food and Drug […]

November 1, 2016

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Type 1 Diabetes KOL Interview – UK

$599.00

This interview with a UK Key Opinion Leader (KOL) provides insight into current therapies for type 1 diabetes.

January 8, 2020

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Type 1 Diabetes KOL Interview – US, Midwest

$599.00

This interview with a US Key Opinion Leader (KOL) provides insight into current therapies for type 1 diabetes, as well as pricing pressures within the diabetes market.

January 8, 2020

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Tyvaso for Pulmonary Arterial Hypertension

$89.00

The literature search was undertaken via multiple search engines and strategies with review of cited and associated articles to provide a comprehensive discussion on the topic. Expert opinion: While safe and well tolerated, inhaled treprostinil sodium should be limited, based on available data, to use as add-on therapy for patients with Group I pulmonary hypertension not effectively controlled on oral therapy.

November 29, 2016

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UK Generics and Biosimilars

$2,995.00

Prescribing by international non-proprietary name, pharmacist incentives, and the high price differential between the brands and their generic alternatives are the key drivers of the generics market in the UK.

November 2, 2016

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UK Healthcare System Overview

$2,995.00

Reform of the NHS is underway despite widespread controversy and opposition from physicians, and will necessitate a change in the way pharmaceutical companies work with key stakeholders.

November 2, 2016

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UK Regulatory Issues

$2,995.00

Recently there have been several new regulatory changes in the UK aimed at reducing the regulatory burden and allowing earlier access to medicines which are seen as a positive development for the pharmaceutical industry.

November 2, 2016

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Ulcerative Colitis (UC) KOL Interview – UK

$599.00

A UK expert in the ulcerative colitis (UC) field dives into the treatment algorithm, critical unmet needs, and pipeline drugs, such as the Janus kinase inhibitors and sphingosine 1-phosphate (S1P) modulators.

March 1, 2021

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US Healthcare System Overview

$2,995.00

Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.

November 2, 2016

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US Pricing and Reimbursement

$2,995.00

Historically, few pricing controls have been implemented in the US; however, there is greater pressure to implement controls to help contain costs associated with the expansion of public healthcare provision.

November 2, 2016

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US Regulatory Issues

$2,995.00

Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.

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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Vaccines Market Access in Emerging Markets

$3,000.00

Emerging markets account for approximately 18% of the global vaccines market, which is valued at more than $24bn. However, there are indications that this is an underestimate, and some observers forecast that the overall marketplace will reach $50bn by the mid2020s.

August 29, 2019

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Value-Based Pricing – Evolution Rather Than Revolution

$5,000.00

A new value-based assessment (VBA) process is scheduled to come into effect in the UK in late 2014. There have been significant delays in determining how this would work in practice, reflecting VBA’s complexity.

November 4, 2016

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Value-Based Reimbursement in the US

$2,995.00

The US healthcare environment has been witnessing a slow albeit continuous shift from volume- to value-based reimbursement over the past couple of decades

August 22, 2018

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When Deals Go Wrong: Lessons from Failure

$2,995.00

July 12, 2019

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Zontivity Approval: Views on Efficacy/Bleeding and Projected Usage Survey

$599.00

Zontivity was approved (May 8, 2014) for use with clopidogrel/aspirin, its label was relatively benign, not reporting bleeding in the overall trial, which included stroke/TIA patients who had excessive bleeding with the drug, or in ACS trial, where there was also excessive bleeding.

May 13, 2014

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Strategy analysis

Spain Healthcare System and Drug Regulatory Analysis

Spotlight on Antibody-Drug Conjugates

Surviving a Scandal: How to Expect the Unexpected

The Contract Biomanufacturing Market Outlook to 2017

The Evolution of Pharmaceutical Sales Strategies Continues

The Growing Impact of Real-World Evidence

Treatment of VTE – EU KOL Interview

Treatment of VTE – US KOL Interview

Trends in CNS Dealmaking, 2012–16

Trends in Gene Therapy

Triple Negative Breast Cancer KOL Interview

Triple-Negative Breast Cancer KOL Interview – UK

Triple-Negative Breast Cancer KOL Interview – US

Turkey Pricing and Reimbursement

Turkey Regulatory Issues

Type 1 Diabetes KOL Interview – UK

Type 1 Diabetes KOL Interview – US, Midwest

Tyvaso for Pulmonary Arterial Hypertension

UK Generics and Biosimilars

UK Healthcare System Overview

UK Regulatory Issues

Ulcerative Colitis (UC) KOL Interview – UK

US Healthcare System Overview

US Pricing and Reimbursement

US Regulatory Issues

US Specialty Drug Market Access

Vaccines Market Access in Emerging Markets

Value-Based Pricing – Evolution Rather Than Revolution

Value-Based Reimbursement in the US

When Deals Go Wrong: Lessons from Failure

Zontivity Approval: Views on Efficacy/Bleeding and Projected Usage Survey