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Azeliragon
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Azeliragon is an orally available small molecule that acts as an inhibitor of the receptor for advanced glycation endproducts (RAGE).
September 2, 2016
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Namenda
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Namenda’s (memantine; Allergan/Lundbeck/Daiichi Sankyo) global sales have peaked at approximately

$2.3bn in 2014, making it the current leader in the Alzheimer’s disease market.
September 2, 2016
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Vargatef
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Boehringer Ingelheim will hope to increase Vargatef’s (nintedanib) market share at second-line despite

rising competition in this setting.
August 30, 2016
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Tagrisso
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Tagrisso (osimertinib) is a third-generation epidermal growth factor receptor (EGFR) inhibitor developed by AstraZeneca.
August 30, 2016
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Dovobet
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Leo Pharma developed and launched Dovobet (also known as Daivobet, Taclonex, Xamiol, and LEO-80185), a dermatological ointment formulation of the vitamin D analog calcipotriol and the corticosteroid betamethasone dipropionate, for the treatment of…
August 28, 2016
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Sorilux
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Following its 2010 launch, Sorilux (calcipotriene; Stiefel/GlaxoSmithKline) has experienced slow

uptake in the psoriasis market, despite having the financial support of GlaxoSmithKline. This comes as

no surprise as the US psoriasis market is saturated with several types of established calcipotriene

formulations, limiting Sorilux’s uptake.
August 26, 2016
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Silkis/Vectical
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Silkis/Vectical’s (calcitriol; Horizon Pharma/Galderma) more favorable side-effect profile compared to

calcipotriol-based vitamin D brands Dovobet (calcipotriol/betamethasone; Leo Pharma/Kyowa Hakko

Kirin) and Dovonex (calcipotriol; Leo Pharma)
August 26, 2016
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ABBV-066
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ABBV-066 (risankizumab; AbbVie/Boehringer Ingelheim) is a humanized anti-interleukin(IL)-23 subunit p19 monoclonal antibody that binds and neutralizes the p19 subunit of IL-23.
August 26, 2016
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Dovonex
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Dovonex, a topical vitamin D derivative, reduces excessive skin cell production and therefore helps improve the symptoms of psoriasis. It is sold under the brand name Daivonex in certain European, South American, and Asian markets…
August 26, 2016
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Tildrakizumab
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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
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Betrixaban
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Betrixaban (Portola Pharmaceuticals) is an oral, once-daily inhibitor of factor Xa that catalyzes conversion of prothrombin to thrombin, preventing thrombosis. Betrixaban is currently in Phase III development…
August 2, 2016
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Vasotec
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Vasotec’s (enalapril; Merck & Co/Valeant) role in chronic heart failure (CHF) is severely limited by

competition from generic equivalents.
August 2, 2016
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Lovenox
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Lovenox (enoxaparin; Sanofi/Kaken Pharmaceutical) is a subcutaneous low molecular weight heparin approved for the prophylaxis of deep vein thrombosis (DVT)…
August 2, 2016
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Coumadin
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Coumadin is an orally available vitamin K antagonist (VKA) indicated for the prophylaxis and

treatment of deep vein thrombosis and pulmonary embolism.
August 2, 2016
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GS-5745
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GS-5745 (Gilead) is a humanized monoclonal antibody designed to selectively target the matrix metalloproteinase-9 (MMP9) enzyme. MMP9 plays a key role in the regulation of processes.
July 21, 2016
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Nimotuzumab
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Nimotuzumab is a humanized MAb that binds to the extracellular domain of the EGFR, a signaling protein involved in the regulation of cell growth and differentiation (Hynes and Lane, 2005; Alvarez et al., 2007).
July 21, 2016
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Perjeta
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Perjeta is a humanized MAb that binds to subdomain II of the extracellular part of the HER2 protein.
July 21, 2016
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MEDI-7510
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MEDI-7510 (AstraZeneca) is a Phase II intramuscular vaccine consisting of soluble respiratory

syncytial virus (RSV) fusion (F) protein with a glucopyranosyl lipid adjuvant (GLA). MEDI-7510 is being

targeted at the elderly population, which is in contrast to the company’s portfolio of live-attenuated

vaccines for which it is pursuing approval for use in infants.
July 7, 2016
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Potiga
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The novelty and clinical efficacy of Potiga (ezogabine; GlaxoSmithKline) are its greatest strengths. Its

novel mechanism of action on potassium channels is a key clinical differentiator in the competitive

epilepsy market.
July 6, 2016
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Bococizumab
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Bococizumab is an antidyslipidemic humanized antibody that inhibits PCSK9. PCSK9 is a protease involved in the intracellular and extracellular regulation of LDL receptor (LDLR) expression…
June 29, 2016
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LixiLan
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LixiLan is a once-daily, injectable combination product comprising a fixed ration of Sanofi’s long-lasting basal insulin, Lantus, and glucagon-like peptide-1 (GLP-1) receptor agonist, Lyxumia (lixisenatide).
June 23, 2016
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Semaglutide (Oral)
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Novo Nordisk’s semaglutide is an orally available GLP-1 agonist currently being investigated in Phase
III trials for the treatment of type 2 diabetes. GLP-1 agonists are incretin mimetics, mimicking the
endogenous gut hormone GLP-1, which stimulates insulin-secreting beta cells in the pancreas.
June 23, 2016
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Semaglutide (Injectable)
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Injectable semaglutide (Novo Nordisk) is a once-weekly glucagon-like peptide-1 (GLP-1) agonist currently seeking approval for the treatment of type 2 diabetes.
June 23, 2016
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Briviacti
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Briviact (brivaracetam; UCB) is a follow-on product to Keppra (levetiracetam; UCB/Otsuka), acting as an anticonvulsant by binding to the synaptic vesicle glycoprotein 2A (SV2A), directly causing…
June 7, 2016
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Lebrikizumab
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Lebrikizumab (Roche/Chugai) is a humanized monoclonal antibody that binds to interleukin (IL)-13. IL-13 induces bronchial epithelial cells to secrete periostin, a matricellular protein.
May 12, 2016
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Brintellix
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Brintellix (vortioxetine; Lundbeck/Takeda) is the latest antidepressant to be approved in the US for major depressive disorder. The drug follows a successful line of antidepressants developed by Lundbeck, which includes Cipralex (escitalopram) and Cipramil (citalopram).
May 5, 2016
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Buparlisibi
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Buparlisib is a pan-PI3K inhibitor that attempts to counteract the dysregulation of the PI3K/protein kinase B (AKT) pathway in cancerous tissues…
May 2, 2016
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Sofosbuvir/Velpatasvir
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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. Sofosbuvir/velpatasvir/GS-9857 will face fierce competition from

AbbVie’s glecaprevir/pibrentasvir (ABT-493/ABT-530), which is also expected to be approved as an

eight-week regimen in non-cirrhotic patients, but will retain greater patient share in cirrhotic

patients, where glecaprevir/pibrentasvir is being investigated in a longer 12-week course.
April 22, 2016
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Sofosbuvir/Velpatasvir/GS-9857
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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
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Glembatumumab Vedotin
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Glembatumumab vedotin (Celldex) is an antibody–drug conjugate that targets cancer cells expressing glycoprotein non-metastatic B.
April 15, 2016
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Pyridorin
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Pyridorin’s (pyridoxamine; NephroGenex) trial program has been put on hold due to company finances

and lack of investor/partner interest, so could well be suspended.
April 15, 2016
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Brilinta
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Brilinta (ticagrelor; AstraZeneca/The Medicines Company) is an antiplatelet agent designed to inhibit blood clot formation. It works by reversibly binding to the blood platelets’ adenosine diphosphate (ADP) P2Y12 receptor…
April 14, 2016
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Kengreal
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Kengreal (cangrelor; AstraZeneca) targets a previously unmet need in the acute treatment of

myocardial infarction (MI) patients receiving percutaneous coronary intervention (PCI) on account of

its intravenous formulation and quick onset of action.
April 14, 2016
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Zontivity
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Zontivity (vorapaxar; Merck & Co) gained US and EU approval for the reduction of thromboembolic

events in secondary-prevention patients with a history of myocardial infarction (MI).
April 14, 2016
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Effient
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An oral antiplatelet agent, Effient is a pro-drug which is converted to its active metabolite after
metabolism by cytochrome P450 enzymes.
April 14, 2016
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Angiomax
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Angiomax is a direct thrombin inhibitor which prevents the formation of fibrin from fibrinogen and the activation of coagulation factor XII.
April 14, 2016
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Temodar
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Temodar is an orally available cytotoxic drug indicated for the treatment of GBM. It is an alkylating
agent that triggers cell death by alkylating guanine residues, inhibiting DNA replication and
subsequent cancer cell proliferation (Friedman et al., 2000).
April 13, 2016
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VB-111
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VB-111 (VBL Therapeutics) will be able to succeed in the US as an add-on therapy to Avastin

(bevacizumab; Genentech/Roche/Chugai) in the second-line of therapy, should it present positive data

from the Phase III GLOBE study.
April 13, 2016
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ICT-107
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ICT-107 (ImmunoCellular Therapeutics) is an autologous dendritic cell immunotherapy that targets six different antigens associated with glioblastoma multiforme (GBM).
April 13, 2016
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DCVax-L
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DCVax-L (Northwest Biotherapeutics) is a dendritic cell vaccine in development for the treatment of glioblastoma multiforme (GBM). It is a personalized immunotherapy that utilizes patients’ own dendritic cells to stimulate…
April 13, 2016
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Toca 511/FC
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Toca 511 (vocimagene amiretrorepvec) and Toca FC (5-fluorocytosine) are under investigation as a
combination therapy for use in recurrent high-grade gliomas, including GBM. Toca 511 is an
injectable retroviral replicating vector that encodes the prodrug activator enzyme cytosine deaminase
(CD), which is derived from yeast and not found in the human genome
April 13, 2016
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Ultibro
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Ultibro’s (indacaterol/glycopyrrolate bromide; Novartis/Pfizer) extensive clinical trial program for

chronic obstructive pulmonary disease (COPD) and its first-in-class status in Japan and select EU

markets boost its overall clinical and commercial attractiveness.
April 11, 2016
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FF/UMEC/VI
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FF/UMEC/VI (fluticasone/umeclidinium/vilanterol; GlaxoSmithKline) is a fixed triple combination product consisting of a long-acting muscarinic antagonist (umeclidinium), a long-acting beta 2 agonist (vilanterol), and an inhaled corticosteroid (fluticasone).
April 8, 2016
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CHF 5993
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While CHF 5993 has the potential to be the first-to-market triple combination therapy in Europe, Datamonitor Healthcare believes that its commercial prospects largely depend on Chiesi Farmaceutici partnering with a more experienced player in the respiratory market.
April 8, 2016
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PT003
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While PT003 (formoterol/glycopyrrolate; AstraZeneca) demonstrated statistically significant

improvements in trough forced expiratory volume in one second (FEV1) compared to its individual

components and placebo in its Phase III PINNACLE program, pulmonologists are unconvinced about its

role in symptom improvement.
April 8, 2016
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