Strategy analysis

Breakthrough Therapy Designation: Paving the Way for Innovation

$499.00

With the passage of the FDA Safety and Innovation Act of 2012 (FDASIA), the Breakthrough Therapy Designation (BTD) was introduced as the newest mechanism to facilitate expedited development and review. Here we provide an overview of the BTD pathway and its evolution over the past three years.

April 23, 2015

2015 PCSK9 Inhibitors Pulse

Following the approval of the first PCSK9 Inhibitor, Praluent (SNY, REGN), this 5- question survey of 23 cardiologists evaluated attitudes towards the class, projected usage prior to their CVOTs depending on insurance prior authorization, preference of Praluent vs Repatha (AMGN), and how the oral CETP inhibitors would impact PCSK9 usage under different outcomes study scenarios.

August 19, 2015

Datamonitor-Acute-Myelogenous-Leukemia-KOL-Interview

Acute Myelogenous Leukemia (AML) KOL Interview

Datamonitor interviewed three oncology specialists to determine the physicians’ views on marketed and pipeline therapies for Acute Myelogenous Leukemia. Two physicians were based in the US (Greater Midwest and Greater Boston areas) and one in the UK. The three interviews were combined into a single report.

August 19, 2016

Asthma and COPD KOL Interview

KOL thinks that the biggest challenge to treating COPD is cost, even with a very low population of uninsured people.

February 29, 2016

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

Biomedtracker Q3 2017 Outlook Report

In this report, we cover catalysts from 21 drugs expected to occur in Q3 2017. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.

August 2, 2017

Post-EASL KOL Interview

Highlights KOL believes elsbasvir and grazoprevir data will lead to approval and look similar to available drugs on the market (MRK). Post-liver transplant data for sofosbuvir and simpeprevir was positive (GLD, JNJ). Three DAA combination of -5816,-9857, and sofosbuvir looked good, but most physicians are erring on the side of conservative 12- week treatment regimens […]

May 29, 2015

Trends in Gene Therapy

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

Japan Pricing and Reimbursement

Pricing and reimbursement processes are closely connected in Japan, with drug pricing largely dependent on innovation. However, achieving premium pricing is difficult, thereby limiting sales potential.

November 4, 2016

Poland Pricing and Reimbursement

The average drug price in Poland is the lowest in the EU, mainly due to the high proportion of generic pharmaceuticals, low availability of innovative drugs, and high price pressure on reimbursed drugs.

November 4, 2016

Datamonitor Healthcare Chronic Heart Failure KOL Interview – US, West Coast

A US KOL provides insight into current and future therapies for chronic heart failure, as well as key unmet needs in this therapeutic area. Key marketed drugs are highlighted, including Corlanor and Entresto. Significant late-phase pipeline drugs are also covered, with a focus on SGLT-2 inhibitors.

February 4, 2019

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

Gastric Cancer KOL Interview – US

This interview with a US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for gastric cancer. Disease stratifications by staging and origin of the primary tumor, as well as unmet needs, are also discussed. Key therapies highlighted include Opdivo, Yervoy, Keytruda, Cyramza, Herceptin, and Enhertu.

August 5, 2020

Chronic Lymphocytic Leukemia (CLL) KOL Interview – US

A US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for CLL. Key pipeline assets highlighted include the CAR-T therapy Breyanzi, reversible BTK inhibitors MK-1026 and pirtobrutinib, and the PI3K inhibitor TG-1303.

October 1, 2020