Report library

Delafloxacin

Delafloxacin is a novel broad-spectrum fluoroquinolone that prevents bacterial DNA synthesis through its equal inhibitory effect against the enzymes topoisomerase II (DNA gyrase) and IV.

September 10, 2014

Midostaurin

Midostaurin is a multiple kinase inhibitor, which interferes with cellular signal transduction pathways. While the drug exhibits efficacy against a number of kinases, its efficacy against FLT3 is of particular relevance to AML.

April 22, 2014

Q3 2021 Outlook Report

In this report, we cover catalysts from 27 drugs, devices, diagnostics, and deals expected to occur in the third quarter of 2021. 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. These data points were provided using a combination of Pharmapremia, Informa’s drug development benchmarking product utilizing Biomedtracker’s LOA data to assist in informed decisions about drug pipeline prioritization, partnerships, and acquisitions, and drug approval data from Biomedtracker.

June 2, 2021

Disease Analysis Atopic Dermatitis

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic, relapsing inflammatory dermatological condition. The condition usually begins during early infancy and childhood, but can persist into, or start during, adulthood.

April 22, 2022

Market Spotlight: Mantle Cell Lymphoma

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This Market Spotlight report covers the Mantle Cell Lymphoma (MCL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

August 25, 2022

Corlanor

Corlanor (ivabradine; Servier/Amgen/Ono Pharmaceutical) blocks f-channels and inhibits the f-current, a modulator of the heart’s pacemaker activity.

December 11, 2017

Lovaza

Lovaza (omega-3-acid ethyl esters; GlaxoSmithKline/AbbVie/Takeda) was the first omega-3 fatty acid formulation to receive approval from the US Food and Drug Administration for the treatment of severe hypertriglyceridemia.

June 22, 2018

Waylivra

Waylivra (volanesorsen; Ionis Pharmaceuticals) is an antisense drug that inhibits the translation and production of ApoC-III.

November 20, 2019

Yescarta

Yescarta (axicabtagene ciloleucel; Gilead) became the first chimeric antigen receptor T-cell (CAR-T) therapy to launch for the treatment of diffuse large B-cell lymphoma (DLBCL) when it gained US approval for relapsed/refractory patients in October 2017.

January 30, 2019

Pain Management Devices Market

This comprehensive medical market and technology report provides an overview of the medical devices (eg, electrical stimulators and analgesia infusion pumps) used in the management of chronic pain, and includes an in-depth market analysis. This global report covers the US, European, and Rest of World (RoW) markets.

The report provides the following useful information:

pain management overview
key statistics on pain prevalence in major world regions
medical device product portfolios offered by leading manufacturers
top selling products, as well as emerging products under development
in-depth market and competitive analyses

Medical devices covered in this report include:

electrical nerve stimulators (transcutaneous electrical nerve stimulators [TENS] and neurostimulation products including spinal cord stimulators [SCSs], discussed in Chapter 2)
analgesia infusion pumps and accessories (implantable analgesia infusion pumps and external analgesia infusion pumps, discussed in Chapter 3)

June 1, 2017

Vosevi

Vosevi ([sofosbuvir + velpatasvir + voxilaprevir]) is Gilead’s third-generation, pan-genotypic, interferon-free regimen. The fixed-dose combination contains the hepatitis C virus nucleotide NS5B inhibitor sofosbuvir, a second-generation NS5A inhibitor (velpatasvir), and the company’s NS3 protease inhibitor (voxilaprevir).

November 6, 2017

Afinitor

Afinitor (everolimus; Novartis) is an orally available analog of the mammalian target of rapamycin (mTOR), which mediates the signal transduction pathways required for cell cycle progression from G1 to S phase.

March 6, 2019

Sotagliflozin

Sotagliflozin (Lexicon/Sanofi) is an orally administered drug currently being investigated for the treatment of type 1 and type 2 diabetes. It is a dual inhibitor of the sodium-glucose cotransporter-1 (SGLT-1) and SGLT-2 transporters.

November 7, 2017

Entyvio

Entyvio (vedolizumab; Takeda) is a humanized monoclonal antibody approved for the treatment of Crohn’s disease and ulcerative colitis.

August 2, 2018

Disease Analysis: Schizophrenia

The current dynamics of the antipsychotic market show domination by atypical antipsychotics, mainly oral agents, but there is also increasing uptake of long-acting injectable (LAI) neuroleptics, which will continue. Oral atypical antipsychotics that were historical blockbusters are now facing intense generic erosion. The highest-selling oral antipsychotic is Latuda, one of the newer atypical drugs, but its market exclusivity is only set to last until 2023.

November 7, 2022

Genvoya

Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate [TAF]; Gilead) is a single-tablet regimen (STR) approved for the treatment of HIV-1 infection.

June 28, 2019

Disease Analysis: Chronic Obstructive Pulmonary Disease (COPD)

The “ABCD” GOLD treatment guidelines focus on exacerbation risk and patient-reported outcomes to determine pharmacological treatment strategies, independent of spirometric value. Dual bronchodilator combinations are being considered as the new gold standard over long-acting muscarinic antagonist Spiriva in the treatment of more severe COPD.

June 15, 2022

Asthma Pricing, Reimbursement, and Access

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The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.

October 17, 2016

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

Live-attenuated RSV vaccines

In collaboration with the National Institute of Allergy and Infectious Diseases, AstraZeneca is developing a portfolio of three live-attenuated vaccines for the prevention of serious lower respiratory tract infections.

October 5, 2018

Neuromodulation: Deep Brain Stimulation and Vagus Nerve Stimulation Devices Market

This report provides an overview of primary neurological diseases/disorders treated with deep brain stimulation (DBS) and vagus nerve stimulation (VNS), as well as overviews of DBS and VNS neuromodulation technologies, competitors, sales, forecasts, and competitive and market analysis. Markets covered by this analysis comprise the US, Japan, the five major European markets (France, Germany, Italy, Spain, and the UK), and the Rest of World (RoW) markets.

May 26, 2022

Global Markets for Hospital-Based Point-of-Care Diagnostic Products

In 2015, the global point-of-care (POC) clinical diagnostic products market was valued at $14.7bn, comprising 28% of the total in-vitro diagnostics (IVD) market. The market is projected to grow at a somewhat slower rate than the overall IVD market, due mainly to a decline in the overall blood glucose self-testing segment, which comprises more than half of the POC diagnostics market.

November 11, 2016

Rubraca

Rubraca (rucaparib) is a small molecule poly (ADP-ribose) polymerase (PARP) inhibitor developed by Clovis Oncology for the treatment of recurrent ovarian cancer patients with known BRCA mutations or other homologous recombination gene alterations.

January 18, 2018

Datamonitor Healthcare Meningococcal and Pneumococcal Vaccines KOL Interview – UK

An interview with a UK key opinion leader (KOL) on meningococcal and pneumococcal vaccination coverage rates, vaccination rate trends in main risk groups, key marketed vaccines, pipeline approaches, and addressing unmet needs.

November 12, 2018

Global Markets for Infection Control and Biosafety Products, October 2016

This analysis includes a discussion of products, current/forecast markets, competitors, and opportunities in the global medical waste disposal, device reprocessing, standard and safety needle/syringe, sharps disposal, and sterilization equipment and services markets.

October 7, 2016

Schizophrenia and Bipolar Disorder Payer Interview – US, South

This interview with a US-based key opinion leader (KOL) provides insights into pricing and reimbursement dynamics and issues concerning schizophrenia and bipolar disorder, with a focus on oral antipsychotics and long-acting injectables.

April 28, 2021

Onzeald

Onzeald (etirinotecan pegol; Nektar Therapeutics) is a polyethylene glycol (PEG) conjugate of irinotecan, a prodrug that is metabolized via enzymatic cleavage into the biologically active metabolite 10-hydroxy-7-ethyl camptothecin, also known as SN-38. SN-38 inhibits DNA topoisomerase 1 during the S-phase of the mitotic cycle.

February 26, 2020

Cotellic

Cotellic (cobimetinib; Exelixis/Roche) is a selective inhibitor of mitogen-activated protein kinase kinase (MEK), a serine/threonine kinase that is a component of the RAS/RAF/MEK/ERK pathway.

May 23, 2018

Datamonitor Healthcare Hepatocellular Carcinoma (HCC) KOL Interview – US, South #2

This interview provides a thorough description of hepatocellular carcinoma (HCC) treatment in the US. All targeted therapies available for HCC treatment are discussed, as well as a discussion of Phase III pipeline drugs and the potential impact these therapies would have if they gain approval.

February 6, 2019

INOpulse

INOpulse (Bellerophon Therapeutics) is a drug-device combination being developed to deliver a continuous, pulsed dose of nitric oxide via intranasal inhalation.

October 29, 2018

Pharma-Payer Partnerships in Emerging Markets

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Payer partnerships are becoming widespread as emerging markets become wealthier, but access challenges remain. Partnerships with proven success include “strategic philanthropy,” patient access programs, tiered pricing, and service support models.

July 26, 2017

RVT-101

RVT-101 is a once-daily oral 5-HT6 receptor antagonist being developed by Axovant Sciences for the
treatment of mild to moderate Alzheimer’s disease. The 5-HT6 receptor is found exclusively in the
central nervous system and predominates in regions of the brain associated with cognition and
behavior (Woolley et al., 2004).

September 2, 2016

Alpelisib

Alpelisib is a p110-alpha isoform-specific PI3K inhibitor. PI3K signaling plays a fundamental role in tumorigenesis, governing cell proliferation, survival, and motility, as well as angiogenesis.

February 5, 2016

Breast Cancer KOL Interview – US, Midwest

A US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies across all three subtypes of breast cancer. Key pipeline assets highlighted include Enhertu, Trodelvy, Cosela, and enobosarm.

July 18, 2022

Biomedtracker / Meddevicetracker Q3 2020 Outlook Report

In this report, we cover catalysts from 27 drugs, devices, diagnostics and deals expected to occur in Q3 2020. 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.

July 1, 2020

Tymlos

Tymlos (abaloparatide; Radius Health) is a synthetic peptide analog of human parathyroid hormone-related protein (PTHrP), which binds to the same receptor as parathyroid hormone (PTH). Endogenous PTHrP plays a central role in the regulation of endochondral bone development, with knockout mice not surviving past birth due to lack of proper bone development.

March 9, 2018

Tildrakizumab

Tildrakizumab is a monoclonal antibody that targets IL-23. IL-23 is part of the IL-12 cytokine family,
the master regulator of the TH1 pathway which drives major chronic inflammatory diseases

August 10, 2016

Schizophrenia and Bipolar Disorder KOL Interview – Germany

This interview with an EU-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

Disease Analysis: Rheumatoid Arthritis

The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition. The EU market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance of biosimilars compared to other countries. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence builds, with long-term data supporting biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars, and encourage uptake.

September 15, 2022

Social Media in Pharma

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While social media is still relatively new, it has been heralded as one of the most significant changes in the way that people communicate with one another. Despite this, the pharmaceutical industry has been slow to become involved with social media, fearing compliance and regulatory breaches and preferring to stay with the more traditional routes of communication, such as representative visits and emails. However, the growing popularity of social media, combined with a number of positive examples from both within and outside the pharmaceutical industry, has led to an increasing number of pharmaceutical companies looking to grow their social media presence and build on the unique opportunities these platforms offer.

January 27, 2017

Pediatric Acute Leukemias (AML/ALL) KOL Interview

Highlights Current manufacturing turnaround times for CAR-T products (2-3 weeks) for ALL are not a major limitation for pediatric leukemia patients. CAR-T treatments may be more acutely toxic than transplant immediately after infusion, but patients may have fewer medium- and long-term complications. Agents that target the cell cycle (CDK inhibitors, Aurora kinase inhibitors) will likely […]

April 1, 2015

2016 Biomedtracker Post-EASL Hepatitis C Survey

We performed a 9-question survey of 29 EU and 31 US hepatologists and gastroenterologists after the European Association of the Study of the Liver (EASL) International Liver Conference (ILC) from April, 2016 in Barcelona to gauge current and projected prescribing practices for hepatitis C virus (HCV) infection.

May 16, 2016

Upadacitinib

Upadacitinib (AbbVie) is an oral small molecule inhibitor of Janus kinase (JAK)-1 that is being developed in several indications including Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, and ulcerative colitis.

August 2, 2018

Arcapta

Novartis has developed Arcapta (indacaterol; marketed as Onbrez outside the US) for use in its Breezhaler/Neohaler dry-powder inhaler for the treatment of chronic obstructive pulmonary disease (COPD).

July 31, 2018