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FluMist QIV
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FluMist QIV (AstraZeneca/Daiichi Sankyo) is a quadrivalent live-attenuated influenza vaccine containing antigens from two A strains and two B strains specified by the World Health Organization seasonally for influenza vaccination.
January 10, 2019
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Fluad QIV
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Fluad QIV (CSL) is a subunit, surface antigen-containing seasonal quadrivalent influenza vaccine adjuvanted with MF-59, an oil-in-water emulsion. It contains antigens from two A strains and two B strains specified by the World Health Organization seasonally for influenza vaccination.
January 10, 2019
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PF-06482077
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Pfizer’s PF-06482077 is a 20-valent pneumococcal conjugate vaccine, which is currently in Phase II development in the US and EU. PF-06482077 contains the 13 serotypes included in Prevnar 13 (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A), as well as seven additional serotypes.
December 21, 2018
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ralinepag
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Ralinepag (Arena Pharmaceuticals/Everest Medicines) is a selective prostaglandin I2 receptor agonist. PGI2 agonists are potent vasodilators and platelet aggregation inhibitors, which also help relax smooth muscle cells by counteracting the effect of vasoconstrictive mediators.
October 29, 2018
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esuberaprost
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Esuberaprost (United Therapeutics) is an oral chemically stable prostacyclin analog targeting the prostaglandin I2 (PGI2) receptor. PGI2 agonists are potent vasodilators and platelet aggregation inhibitors, and also help relax smooth muscle cells by counteracting the effect of vasoconstrictive mediators.
October 29, 2018
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bardoxolone methyl
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Bardoxolone methyl (AbbVie/Kyowa Hakko Kirin), under development by the research-stage company Reata Pharmaceuticals, is a Phase III candidate in clinical trials for the treatment of pulmonary arterial hypertension.
October 29, 2018
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INOpulse
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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
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Aurora-GT
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United Therapeutics is developing a gene therapy product called Aurora-GT (endothelial nitric oxide-synthase-enhanced endothelial progenitor cells)
October 29, 2018
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Tyvaso
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United Therapeutics developed Tyvaso (treprostinil) as a follow-on product to Remodulin. As an inhaled formulation of treprostinil
October 29, 2018
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Adcirca
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Launching after Revatio, Adcirca became the second-to-market PDE5 inhibitor upon its approval in major markets in 2009. Inhibiting the PDE5 enzyme enhances the effect of the endogenous vasodilator, nitric oxide (NO).
October 29, 2018
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lisocabtagene maraleucel
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Lisocabtagene maraleucel (also known as JCAR017; Celgene) will be the third autologous chimeric antigen receptor T-cell (CAR-T) therapy to reach the diffuse large B-cell lymphoma (DLBCL) market following the launches of approved CAR-T drugs Kymriah (tisagenlecleucel; Novartis) and Yescarta (axicabtagene ciloleucel; Gilead).
January 30, 2019
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polatuzumab vedotin
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Polatuzumab vedotin (Roche) is an antibody-drug conjugate (ADC) that combines a humanized immunoglobulin (Ig)-G1 monoclonal antibody (MAb) targeting human B-cell surface antigen cluster of differentiation (CD)79b and antimitotic agent monomethyl auristatin E (MMAE).
October 9, 2018
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MOR208
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MorphoSys is positioning its cluster of differentiation (CD)19-targeted monoclonal antibody MOR208 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant.
October 9, 2018
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umbralisib
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Umbralisib (TG Therapeutics/Rhizen) is a novel phosphoinositide 3-kinase (PI3K) delta inhibitor that also selectively inhibits casein kinase-1 (CK1) epsilon. Expression of the PI3K delta isoform plays a role in B-cell development and function, and is often overactivated in B-cell malignancies.
January 30, 2019
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Kinenza
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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
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Yescarta
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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
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Kymriah
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Kymriah (tisagenlecleucel; Novartis) is a cluster of differentiation (CD)19-targeted genetically modified autologous T-cell immunotherapy, comprised of a murine single-chain antibody fragment that binds CD19 and is linked to intracellular signaling domains from 4-1BB (CD137) and CD3 zeta.
January 31, 2019
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MEDI8897
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MEDI8897 is a human immunoglobulin G1 MAb derived from human B cells intended to provide protection against RSV infection.
October 5, 2018
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RSV preF vaccine
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Pfizer’s RSV preF vaccine is based on the prefusion form of the RSV fusion protein, aided by the discovery of the crystal structure of key viral proteins by the National Institutes of Health.
October 5, 2018
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Symdeko
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Vertex’s Symdeko ([tezacaftor + ivacaftor]) is a cystic fibrosis transmembrane conductance regulator (CFTR) corrector compound
September 3, 2018
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Seribantumab
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Seribantumab (Merrimack Pharmaceuticals) is a monoclonal antibody directed against human epidermal growth factor receptor 3 (HER3).
August 30, 2018
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Lorlatinib
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Lorlatinib (Pfizer) is an orally administered anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinase inhibitor (TKI) with potential antineoplastic activity
August 30, 2018
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Entrectinib
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Entrectinib (Roche/Chugai/Nerviano) is a selective tyrosine kinase inhibitor (TKI) of the tropomyosin receptor kinases (Trk) A, B, and C; ROS1; and anaplastic lymphoma kinase (ALK) proteins. Under normal conditions, these oncogenes regulate the flow of cellular growth signaling.
August 30, 2018
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Cemiplimab
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Cemiplimab (Regeneron/Sanofi) is a programmed death-1 (PD-1)-targeted monoclonal antibody
August 30, 2018
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Capmatinib
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Capmatinib (Incyte/Novartis) is an orally bioavailable inhibitor of the proto-oncogene c-MET, also called hepatocyte growth factor receptor (HGFR).
August 30, 2018
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Alunbrig
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Alunbrig (brigatinib; Takeda) is a dual anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) inhibitor.
September 8, 2018
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Ygalo
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Ygalo (melphalan-flufenamide; Oncopeptides) is a cytotoxic alkylating agent that consists of melphalan conjugated to phenylalanine
August 9, 2018
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Isatuximab
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Isatuximab (Sanofi/ImmunoGen) is a humanized monoclonal antibody which targets cancer cells expressing the transmembrane glycoprotein CD38, which is highly expressed on malignant multiple myeloma (MM) cells, but at low levels in other tissues.
August 9, 2018
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bb2121
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Pipeline product bb2121 (Celgene/bluebird bio) is a second-generation chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA), a promising target for immunotherapy which is found in 60–70% of multiple myeloma (MM) patients.
August 9, 2018
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Alofisel
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Alofisel (darvadstrocel; TiGenix/Takeda) is a suspension of allogeneic expanded adipose-derived stem cells via intralesional injection.
August 2, 2018
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Risankizumab
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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. It is being developed in psoriasis and Crohn’s disease.
August 2, 2018
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Utibron Neohaler
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Novartis, under license from Vectura and Sosei, developed Utibron, a once-daily long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination product containing indacaterol and glycopyrrolate.
July 31, 2018
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Trimbow
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Trimbow ([beclomethasone + formoterol + glycopyrrolate]; Chiesi Farmaceutici) is a fixed triple-combination product consisting of glycopyrrolate (a LAMA), formoterol (a LABA), and beclometasone (an ICS), used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
July 31, 2018
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Revefenacin
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Revefenacin (Theravance Biopharma/Mylan) is a long-acting muscarinic antagonist (LAMA) that will join a very crowded COPD market.
July 31, 2018
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Aspirin
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Aspirin (acetylsalicylic acid) is a non-steroidal anti-inflammatory drug (NSAID) and antiplatelet that is taken orally and commonly used for the treatment of pain. It is highly genericized and has been available in its present form since 1899, when it was first marketed by Bayer.
July 2, 2018
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Evinacumab
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Evinacumab (Regeneron) is a monoclonal antibody (MAb) that inhibits angiopoietin-like 3 inhibitor (ANGPTL3). ANGPTL3 is secreted naturally by the liver and acts as a partial inhibitor of lipoprotein lipase and endothelial lipase.
November 20, 2018
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Ongentys
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Ongentys (Neurocrine/Bial/Ono Pharmaceutical) is a once-daily formulation of the catechol-O-methyltransferase (COMT) inhibitor opicapone, approved as an add-on therapy to levodopa for the treatment of Parkinson’s disease patients with end-of-dose motor fluctuations.
June 21, 2018
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Inbrija
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Inbrija (Acorda Therapeutics) is an inhaled formulation of levodopa, in development as an adjunct to existing oral levodopa formulations in patients experiencing motor fluctuations.
June 21, 2018
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APL-130277
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APL-130277 (Dainippon Sumitomo/Sunovion) is a sublingual film formulation of apomorphine, a non-ergoline dopamine receptor agonist.
June 21, 2018
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ND0612
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The ND0612 (Mitsubishi Tanabe) product line comprises two subcutaneous, continuously delivered carbidopa/levodopa liquid formulations: the lower-dose ND0612L, and the higher-dose ND0612H.
June 21, 2018
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Gocovri
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Gocovri (Adamas Pharmaceuticals) is an extended-release formulation of amantadine, uniquely indicated for the treatment of levodopa-induced dyskinesia (LID) in Parkinson’s disease.
June 21, 2018
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Raxatrigine
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Raxatrigine (Biogen) is a peripherally and centrally acting agent that inhibits sodium channels in a state-dependent fashion. Raxatrigine shows selectivity for the Nav1.7 subtype over the other subtypes.
May 31, 2018
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Nucynta
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Nucynta (tapentadol; Collegium Pharmaceutical) first gained US Food and Drug Administration (FDA) approval in November 2008 as an immediate-release formulation, for the relief of acute pain, and was the first novel opioid to be launched for pain in more than 25 years.
May 31, 2018
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Mirogabalin
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Mirogabalin (Daiichi Sankyo) is an oral therapy that preferentially and selectively binds to the α2δ-1 (alpha-2 delta-1) subunit of calcium channels widely found in the nervous system in areas that mediate pain transmission and processing.
May 31, 2018
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Lidoderm
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Lidoderm is a medicated plaster containing 5% lidocaine, and was developed by Endo Pharmaceuticals. Lidocaine is an amide-type local anesthetic agent that acts by stabilizing neuronal membranes.
May 31, 2018
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