Report library

Anemia in Chronic Kidney Disease Pricing & Reimbursement KOL Interview – US, Midwest

This interview with a US-based key opinion leader (KOL) provides insights into pricing and reimbursement dynamics and issues concerning anemia in chronic kidney disease, with a focus on the anticipated reimbursement of HIF stabilizers in the US.

June 30, 2020

Disease Analysis: Chronic Myeloid Leukemia (CML)

Chronic myeloid leukemia (CML) is defined as a cancer of the blood in which a mutation in myeloid hematopoietic stem cells causes the overproduction of immature and dysfunctional white blood cells (myeloblasts, also known as blasts), preventing the normal production and function of healthy white blood cells, red blood cells, and platelets.

June 20, 2022

Diffuse Large B-Cell Lymphoma (DLBCL) KOL Interview – US

A US-based key opinion leader (KOL) gives insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for DLBCL. Therapies discussed include Polivy, Monjuvi, Zynlonta, CD19-directed CAR-T therapy and CD20-directed bispecific antibodies.

April 21, 2022

Ampyra

Ampyra is a potassium channel blocker, marketed by Acorda Therapeutics and Biogen, which is

approved to improve walking ability in multiple sclerosis patients. Although Ampyra’s active molecule

fampridine (4-aminopyridine) is readily available, by using Elan’s Intestinal Protective Drug Absorption

System, Acorda has developed a sustained-released oral tablet formulation allowing twice-daily

dosing.

January 26, 2016

Interventional Cardiology: Peripheral Vascular Disease Therapeutic Devices

This comprehensive medical market and technology report provides an overview and in-depth market analysis of devices used in the treatment of peripheral vascular disease (PVD), including peripheral arterial disease (PAD) of the lower extremities; and deep vein thrombosis (DVT) and pulmonary embolism (PE).

May 28, 2020

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

Prevnar 13

Prevnar 13 is Pfizer’s follow-on vaccine to Prevnar 7, which was the first pneumococcal conjugate vaccine licensed in the US.

December 21, 2018

2020 Post-ESMO Report

The Annual European Society for Medical Oncology (ESMO) 2020 Congress was held virtually from September 19 to September 21, 2020 due to the COVID-19 pandemic.

October 5, 2020

Sarilumab

Sarilumab (Sanofi/Regeneron) is a human monoclonal antibody interleukin (IL)-6 receptor antagonist in Phase III development for rheumatoid arthritis.

March 24, 2015

omadacycline

Omadacycline (Paratek Pharmaceuticals) is the first agent of the aminomethycyclines class of antibiotics. The drug, which is a semisynthetic derivative of the tetracycline minocycline.

June 19, 2015

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

Inflammatory Bowel Disease (IBD) KOL Interview – US

A US gastroenterology expert dives into the treatment algorithm, critical unmet needs, and pipeline drugs for IBD, such as the Janus kinase inhibitors and sphingosine 1-phosphate (S1P) modulators.

March 1, 2021

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

Kinenza

Kinenza (enzastaurin) is an oral serine/threonine kinase inhibitor that suppresses signaling of protein kinase C (PKC)-beta to induce cell apoptosis, reduce cell proliferation, and suppress tumor-induced angiogenesis.

October 9, 2018

Tysabri

Tysabri is a humanized monoclonal antibody against the cellular adhesion molecule alpha-integrin.

July 31, 2018

Stalevo

Stalevo (Novartis/Orion), indicated for the treatment of Parkinson’s disease patients with end-of-dose wearing-off symptoms, contains a combination of the catechol-O-methyltransferase (COMT) inhibitor entacapone, levodopa, and an AADC inhibitor (carbidopa).

June 21, 2018

Interventional Cardiology: Implantable Cardioverter Defibrillators

This comprehensive medical market and technology report provides an overview and in-depth market analysis of implantable cardioverter defibrillators (ICDs) used to treat forms of cardiac arrhythmia and heart failure (HF).

July 8, 2019

Type 1 Diabetes KOL Interview – US, Midwest

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

Company Analysis: Gilead

$3,000.00

PharmaVitae explores Gilead’s prescription pharmaceutical performance and outlook over 2019–29. PharmaVitae analyses include quarterly earnings coverage and provide timely updates to company product forecasts. The full company profile encompasses analysis on corporate strategy, portfolio analysis, pipeline potential, and financial performance.

January 25, 2021

IMO-2125

IMO-2125 is a synthetic phosphorothioate oligonucleotide-based agonist of toll-like receptor 9 (TLR9) designed to mimic the bacterial DNA that normally activates TLR9.

May 23, 2018

Schizophrenia and Bipolar Disorder KOL Interview – US, Northeast

This interview with a US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, long-acting injectables, late-phase pipeline therapies, and unmet needs for schizophrenia and bipolar disorder. Key pipeline assets highlighted include Lybalvi (ALKS 3831), MIN-101, Nuplazid, Caplyta, BXCL501, and six-monthly paliperidone depot injection.

April 28, 2021

TetraVax-DV

TetraVax-DV is a lyophilized, tetravalent, live-attenuated chimeric vaccine currently in Phase II/III development.

January 4, 2018

U.S. Markets for Orthopedic Biomaterials for Bone Repair and Regeneration

$3,750.00

The United States (U.S.) market for orthopedic biomaterials for bone repair and regeneration, as covered by the scope of this report

May 1, 2013

Datamonitor Psoriatic Arthritis KOL Interviews

Datamonitor interviewed three rheumatologists, two based in the US and one in the UK, to determine their current treatment practices and views on pipeline and marketed drugs for psoriatic arthritis. The three interviews were combined into a single report.

December 12, 2016

Farletuzumab

Drug Overview Farletuzumab is a folate receptor alpha (FRa)-targeted monoclonal antibody being developed by Eisai. It is composed of grafted murine complementarity-determining regions on a human IgG1 kappa backbone. Inhibiting FRa can decrease cellular proliferation through inhibition of both Lyn kinase substrate phosphorylation and the interaction between Lyn tyrosine kinase and membrane signaling complexes; effectively […]

August 17, 2017

Head and Neck Cancer KOL Interview – US, Southeast

This interview with a US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for head and neck cancer. Disease stratification by staging and origin of the primary tumor, as well as unmet needs, are also discussed. Key pipeline assets highlighted include Imfinzi, Bavencio, tremelimumab, and Tecentriq.

April 14, 2020

Cyramza

Cyramza (ramucirumab; Eli Lilly/Shire) is a fully human vascular endothelial growth factor receptor (VEGFR)-2-directed immunoglobulin G1 monoclonal antibody that binds to the extracellular domain of VEGFR-2 found on tumor vasculature.

September 9, 2019

Q4 2017 Meddevicetracker Outlook Report

In this report, we cover catalysts from 9 devices expected to occur in Q4 2017, along with an overview of selected presentations from the upcoming Transcatheter Cardiovascular Therapeutics (TCT) Conference. The last page of this report contains an excel sheet of the Large Impact Catalysts expected to occur in Q4 2017.

October 2, 2017

Valoctocogene Roxaparvovec

Valoctocogene roxaparvovec (BioMarin), also known as valrox, is an adeno-associated virus-mediated gene therapy that delivers human B domain-deleted coagulation factor VIII (fVIII) to patients with hemophilia A.

May 20, 2018

Sofosbuvir/Velpatasvir/GS-9857

As the first triple combination to show strong efficacy in difficult to treat cirrhotic patients after just

eight weeks of treatment, sofosbuvir/velpatasvir/GS-9857 (Gilead) is expected to set the standard for

pan-genotypic regimens following its anticipated US and EU approvals in September 2017 and

November 2017, respectively.

April 22, 2016

Bronchitol

Bronchitol is an inhaled dry powder formulation of mannitol, a naturally occurring monosaccharide that also acts as a mucolytic agent.

September 3, 2018

Orthobiologics for Musculoskeletal Soft Tissue Replacement and Regeneration

This medical market and technology report provides a comprehensive discussion of the global market for orthobiologics for musculoskeletal soft tissue replacement and regeneration (including cell-based therapies and tissue scaffolds and grafts). Geographic markets covered by this analysis include the US, Japan, five major EU markets (France, Germany, Italy, Spain, and the UK), and the Rest of World (RoW), which includes all other countries.

October 11, 2019

Breast Cancer KOL Insight Interview

Physicians are starting to use Perjeta (Roche) as an add-on to Herceptin in the adjuvant setting due to a recent
change in NCCN (National Comprehensive Cancer Network, an alliance of major cancer centers) guidelines.

May 8, 2014

Ganaxolone

Marinus Pharmaceuticals is developing ganaxolone, a first-in-class synthetic neurosteroid drug for the adjunctive treatment of status epilepticus and pediatric orphan indications.

May 23, 2017

Advate

The recombinant factor VIII (rfVIII) therapy Advate was initially developed by Baxter and then marketed by the pharmaceutical spin-off Baxalta, which is now part of Shire. Advate is the first third-generation rfVIII, and is a follow-on product to Shire’s Recombinate.

May 4, 2018

Peretinoin

Peretinoin (Kowa/Chugai Pharmaceutical) is a synthetic acyclic retinoid inhibitor of transforming growth factor alpha (TGF-alpha) and platelet-derived growth factor receptor (PDGFR). TGF-alpha induces epithelial development, and is closely involved in hepatocarcinogenesis.

December 31, 2015

Celgene

$3,000.00

PharmaVitae explores Celgene’s prescription pharmaceutical performance and outlook, encompassing corporate strategy, marketed portfolio, pipeline potential, and financial performance over 2017–27.

October 8, 2018

Duaklir Pressair

Duaklir Pressair ([aclidinium + formoterol]; AstraZeneca/Circassia/Kyorin Pharmaceutical) is a twice-daily fixed-dose combination of the long-acting beta 2 agonist formoterol and the long-acting muscarinic antagonist aclidinium.

July 31, 2018

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

Market Spotlight: Neuroendocrine tumors (NET)

$1,318.00

This Market Spotlight report covers the Neuroendocrine Tumors (NETs) market, comprising key marketed and pipeline drugs, clinical trials, probability of success, upcoming and regulatory events, a 10-year disease incidence and prevalence forecast, and licensing and asset acquisition deals, as well as presenting drug-specific revenue forecasts.

April 21, 2022

Disease Analysis: Hepatitis C

Hepatitis C is a liver disease caused by chronic infection with hepatitis C virus (HCV), a hepacivirus belonging to the Flaviviridae family. HCV infects hepatocytes and is the leading cause of cirrhosis and hepatocellular cancer (HCC). Approximately 15−45% of people infected with HCV will spontaneously clear the virus, but the remaining 55−85% will develop chronic HCV infection. For those chronically infected with HCV, the risk of cirrhosis increases by 15–30% within 20 years.

March 9, 2022

Ad26.RSV.preF

Ad26.RSV.preF, in development by Johnson & Johnson, is a replication-deficient vector vaccine that encodes a prefusion form of the RSV F protein.

October 5, 2018

Key Questions in Immuno-Oncology

$1,099.00

This KOL survey answers key questions about current immunotherapy treatments and future trends in the immuno-oncology space.

August 8, 2018

Praluent

Praluent (alirocumab; Sanofi/Regeneron) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PSCK9) and is intended for the treatment of hypercholesterolemia.

November 20, 2019