Top Selling Monoclonal Antibodies 2014
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Top Selling Monoclonal Antibodies 2014
Top Selling Monoclonal Antibodies 2014
Abstract A review of the best selling monoclonal antibodies in 2014 and 2013 is provided. Humira with sales of over $12.7 billion ($9.3 bn in 2012, $11bn 2013) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2014 and since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table.  Remicade (9.8 Bn), Rituxan (7.6 Bn) , Avastin (7.0 Bn) and Herceptin (6.8 Bn)  were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2014 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $68 billion in 2014. The global sales of all the approved therapeutic monoclonal antibodies were $78 billion in 2014. Besides the top 5 mabs, there was two monoclonal antibody with sales of over $3 billions, three with sales over $ 2 billion and 6 with sales of over $ 1 billion in 2014. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 36 monoclonal antibodies are marketed in the US and Europe (January 2015).  FDA approved 6 new monoclonal antibodies in 2014. Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.2 billion in 2014.
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Best Selling Blockbuster Monoclonal Antibodies 2015

Best Selling Blockbuster Monoclonal Antibodies 2015 | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Abstract 

 A review of the best selling monoclonal antibodies in 2015 and previous years is provided. Humira with sales of over $14.5 billion ($9.3 bn in 2012, $11bn 2013, $12.7 billion in 2014) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2015. Humira has remained the top selling global brand since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table. Remicade (8.8 Bn), Rituxan (7.7 Bn) , Avastin (7.5 Bn) and Herceptin (7.3 Bn) were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2015 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $72 billion in 2015. The global sales of all the approved therapeutic monoclonal antibodies were $80 billion in 2015. Besides the top 5 mabs, there was one monoclonal antibody with sales of over $4 billions, six with sales over $ 2 billion and 5 with sales of over $ 1 billion in 2015. There were 17 blockbuster mabs in 2015. At least 3 new recently launched mabs are likely to cross sales of $ 1 billion in 2016.
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No public access as the article is in preparation and not completed


Best Selling Monoclonal Antibodies 2015 by Krishan Maggon

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Novel prostate cancer immunotherapy with a DNA-encoded anti-prostate-specific membrane antigen monoclonal antibody

Novel prostate cancer immunotherapy with a DNA-encoded anti-prostate-specific membrane antigen monoclonal antibody | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Prostate-specific membrane antigen (PSMA) is expressed at high levels on malignant prostate cells and is likely an important therapeutic target for the treatment of prostate carcinoma. Current immunot
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 Dr. Melissa Snyder's AACC Short Course on Monoclonal Antibody Therapeutics

 Dr. Melissa Snyder's AACC Short Course on Monoclonal Antibody Therapeutics | Top Selling Monoclonal Antibodies 2014 | Scoop.it
At the recent American Association for Clinical Chemistry (AACC) annual scientific meeting in San Diego, Melissa Snyder, Ph.D., Consultant in the Division [...]
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Neutralizing Antibody Responses to Viral Infections Are Linked to the Non-classical MHC Class II Gene H2-Ob

Neutralizing Antibody Responses to Viral Infections Are Linked to the Non-classical MHC Class II Gene H2-Ob | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Genetics affect sensitivity of animals and humans to viral infections. Denzin et al.
show that mice from the I/LnJ strain produce neutralizing antibodies against retroviruses
due to inactivation of beta subunit of non-classical major histocompatibility complex
(MHC) protein H2-O. Mutations found in human orthologous HLA-DO genes may explain
resistance or sensitivity to hepatitis B and C viruses.
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Preclinical immunoPET/CT imaging using Zr-89-labeled anti-PD-L1 monoclonal antibody for assessing radiation-induced PD-L1 upregulation in head and ... - PubMed - NCBI

Preclinical immunoPET/CT imaging using Zr-89-labeled anti-PD-L1 monoclonal antibody for assessing radiation-induced PD-L1 upregulation in head and ... - PubMed - NCBI | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Oncoimmunology. 2017 May 19;6(7):e1329071. doi: 10.1080/2162402X.2017.1329071. eCollection 2017.
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Pfizer Receives U.S. FDA Approval for BESPONSA® (inotuzumab ozogamicin) for ALL

Pfizer Receives U.S. FDA Approval for BESPONSA® (inotuzumab ozogamicin) for ALL | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® . . 


Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 


The approval was based on results from the Phase 3 INO-VATE ALL trial, a randomized, open-label, international, multicenter study evaluating the safety and efficacy of BESPONSA compared with Investigator’s choice of chemotherapy in 326 adult patients with relapsed or refractory B-cell ALL.1


The complete remission rate (CR/CRi)* for patients treated with BESPONSA was 81 percent [95% CI: 72%-88%] compared to 29 percent with chemotherapy [95% CI: 21%-39%]. Among patients achieving CR/CRi, those treated with BESPONSA also demonstrated a higher rate of minimal residual disease (MRD) negativity (78% [95% CI: 68%-87%]) compared to those treated with chemotherapy (28% [95% CI: 14%-47%]). Forty-eight percent of patients treated with BESPONSA proceeded to hematopoietic stem cell transplantation (HSCT) compared to 22 percent treated with chemotherapy. The median overall survival (OS) for patients treated with BESPONSA was 7.7 months [95% CI: 6.0, 9.2] and 6.2 months [95% CI: 4.7, 8.3] for patients treated with chemotherapy. The analysis of OS for patients treated with BESPONSA compared to chemotherapy did not meet the pre-specified boundary for statistical significance (HR: 0.75 [97.5% CI: 0.57-0.99]).1


The U.S. labeling for BESPONSA includes a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), and increased risk of post-HSCT non-relapse mortality. Veno-occlusive disease, including fatal and life-threating VOD, occurred in 14 percent of patients treated with BESPONSA. A higher post-HSCT non-relapse mortality rate occurred in patients treated with BESPONSA (39%) than chemotherapy (23%).1 In patients treated with BESPONSA, the most common (≥20%) adverse reactions were thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.1

Krishan Maggon 's insight:
BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs..
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Krishan Maggon 's curator insight, August 18, 2:47 AM
BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs..
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European Medicines Agency - Find medicine - Empliciti

European Medicines Agency - Find medicine - Empliciti | Top Selling Monoclonal Antibodies 2014 | Scoop.it
European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
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The DNA Methylcytosine Dioxygenase Tet2 Sustains Immunosuppressive Function of Tumor-Infiltrating Myeloid Cells to Promote Melanoma Progression

The DNA Methylcytosine Dioxygenase Tet2 Sustains Immunosuppressive Function of Tumor-Infiltrating Myeloid Cells to Promote Melanoma Progression | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The DNA methylcytosine dioxygenase Tet2 functions as a tumor suppressor in multiple
contexts, including hematopoietic malignancies. Pan et al. now reveal a tumor-promoting
role for Tet2, whereby Tet2 functions to sustain an immunosuppressive program in myeloid
cells that in turn dampens the anti-tumor T cell response.
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FDA Advisory Committee Recommends Approval of Our Avastin® (bevacizumab) Biosimilar Candidate ABP 215

FDA Advisory Committee Recommends Approval of Our Avastin® (bevacizumab) Biosimilar Candidate ABP 215 | Top Selling Monoclonal Antibodies 2014 | Scoop.it
​The Oncologic Drug Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recommended approval of ABP 215, a biosimilar candidate
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Biotecnol - Tribody™ Technology Immunotherapies 

Biotecnol - Tribody™ Technology Immunotherapies  | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Biotecnol is working in the field of cancer immunotherapy using proprietary antibody-based technologies to engineer and develop therapeutic products which utilize a patient’s own immune system to fight cancer. These powerful approaches are based on T-Cells and NK-Cell activation and on modulation strategies of key immune checkpoint regulators.


The Tribody ™ technology enables the generation of multi-specific antibody products. This unique technology overcomes the key shortcomings of conventional mono- as well as of currently developed bi-specific antibody formats. With the Tribody™ technology, Biotecnol can engineer and assemble recombinant antibodies in a rational manner in order to design a chosen mechanism of action to address the killing of a specific tumour type. An anti-CD3 antibody which binds the T-cells is engineered in the Tribody™ "scaffold" where additional tumour antigens are also engineered. The Tribody™ then crosslinks tumour antigens and T-cells to initiate the tumour-cell killing process.

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Trials and tribulations: Herceptin development relied on many parallel developments in many labs.

Trials and tribulations: Herceptin development relied on many parallel developments in many labs. | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Executives at Genentech were nervous. The company had already tested other cancer drugs, including TNF, that had failed and using antibodies to treat cancer was a new idea. Another failed drug could bankrupt the company.

In the early 1990s researchers at biotech company Genentech in San Francisco started trialling a trailblazing drug for an aggressive form of breast cancer that affects about one in five women with the disease. At the time, treatment options for these women were highly toxic chemotherapies with harsh side effects that rarely brought the disease under control. The survival rate for this form of cancer, now known as HER2-positive, was also lower than other types of breast tumours.

The drug has been used to treat around two million people since it first appeared in clinical trials. Beyond breast cancer, Herceptin “created a new paradigm for how to look for treatments in cancer,” says Shepard.

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Sujata Gupta 
Nature 548, S28–S31 (10 August 2017) doi:10.1038/548S28a Published online 09 August 2017
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Monoclonal Antibody to TLR4 (Clone: HTA125) | PD1, PD-L1, Recombinant Antibodies, Immuno Check Point Reagents, Reporter Cell lines: ABEOMICS

Monoclonal Antibody to TLR4 (Clone: HTA125) | PD1, PD-L1, Recombinant Antibodies, Immuno Check Point Reagents, Reporter Cell lines: ABEOMICS | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Monoclonal Antibody to TLR4 (Clone: HTA125)
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nSMOL Antibody BA Kit : SHIMADZU LC/MS/MS Sample Prep Kit for Quantitative Analysis of Monoclonal Antibodies

nSMOL Antibody BA Kit : SHIMADZU LC/MS/MS Sample Prep Kit for Quantitative Analysis of Monoclonal Antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it

nSMOL Antibody BA Kit LC/MS/MS Sample Prep Kit for Quantitative Analysis of Monoclonal Antibodies


Shimadzu Scientific Instruments (SSI) announces the release of the nSMOL (nano-surface and molecular orientation limited proteolysis) Antibody Bio-Analysis Kit. Applicable to a variety of pharmaceutical antibodies, this proprietary technique enables selective proteolysis of the Fab region of monoclonal antibodies to dramatically improve the productivity and robustness of LCMS mAB bioanalysis.

Krishan Maggon 's insight:
nSMOL (nano-surface and molecular orientation limited proteolysis) is Shimadzu’s proprietary, innovative technique that enables selective proteolysis of the Fab region of monoclonal antibodies. The nSMOL Antibody BA Kit is a ready-to-use reagent kit for collecting monoclonal antibodies from blood or other biological samples using immunoglobulin collection resin, and then performing selective proteolysis of the Fab region of these antibodies via trypsin-immobilized nanoparticles. Variable region-derived peptides produced by limited proteolysis can then be quantified via MRM measurements utilizing a high-performance LCMS-8050/8060 triple quadrupole liquid chromatograph mass spectrometer. An unparalleled convenient and rapid workflow provided by the nSMOL Antibody BA Kit dramatically improves the productivity and robustness of LCMS mAb bioanalysis.
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Takeda Submits a New Drug Application for Vedolizumab for the Treatment of Moderately to Severely Ulcerative Colitis in Japan

Takeda Submits a New Drug Application for Vedolizumab  for the Treatment of Moderately to Severely Ulcerative Colitis in Japan | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Takeda Submits a New Drug Application for Vedolizumab for the Treatment of Moderately to Severely Ulcerative Colitis in Japan
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Hematopoietic stem cell involvement in BCR-ABL1-positive ALL as potential mechanism of resistance to blinatumomab therapy

Hematopoietic stem cell involvement in BCR-ABL1-positive ALL as potential mechanism of resistance to blinatumomab therapy | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The bispecific T-cell engager blinatumomab targeting CD19 can induce complete remission in relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). However, some patients ultimately relapse with loss of CD19-antigen on leukemic cells which has been established as a novel escape mechanism to CD19-specific immunotherapies. Here, we provide evidence that CD19-negative relapse after CD19-directed therapy in BCP-ALL may be due to selection of preexisting CD19-negative malignant progenitor cells. We present two BCR-ABL1-fusion-positive BCP-ALL patients with CD19-negative myeloid lineage relapse after blinatumomab therapy and show BCR-ABL1-positivity in their hematopoietic stem cell (HSC)/progenitor/myeloid compartments at initial diagnosis by fluorescence in situ hybridization after cell sorting. Using the same approach in 25 additional diagnostic samples of patients with BCR-ABL1-positive BCP-ALL, HSC involvement was identified in 40% of the patients. Patients with major-BCR-ABL1 transcript encoding P210BCR-ABL1 mainly showed HSC involvement (6/8), whereas in most of the patients with minor-BCR-ABL1 transcript encoding P190BCR-ABL1 only the CD19-positive leukemia compartments were BCR-ABL1-positive (9/12) (p=0.02). Our data are of clinical importance, because they indicate that not only CD19-positive cells, but also CD19-negative precursors should be targeted to avoid CD19-negative relapses in patients with BCR-ABL1-positive ALL.
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CK17 Monoclonal Antibody review – Biotech Advisers

CK17 Monoclonal Antibody review – Biotech Advisers | Top Selling Monoclonal Antibodies 2014 | Scoop.it
CK17 plays a role in the formation and maintenance of various skin appendages, specifically in determining shape and orientation of hair. It may be a marker of basal cell differentiation in complex epithelia and therefore indicative of a certain type of epithelial “stem cells”.
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FDA Approves Nivolumab for Colorectal Cancer - National Cancer Institute

FDA Approves Nivolumab for Colorectal Cancer - National Cancer Institute | Top Selling Monoclonal Antibodies 2014 | Scoop.it
FDA Approves Nivolumab for Colorectal Cancer - National Cancer Institute FDA Approves Nivolumab for Some Metastatic Colorectal Cancer
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Lymphocyte antigens targetable by monoclonal antibodies in non-systemic vasculitic neuropathy

Lymphocyte antigens targetable by monoclonal antibodies in non-systemic vasculitic neuropathy | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Objective To identify the most relevant antigens for monoclonal antibodies in lymphocytic infiltrates in non-systemic vasculitic neuropathy (NSVN).

Background Current immunosuppressive treatment for NSVN is insufficient. Monoclonal antibodies might be a treatment option, but the expression profile for targetable antigens on lymphocytic infiltrates in NSVN is unknown.

Methods Sural nerve biopsies from a cohort of patients with NSVN were immunohistochemically studied for the expression of potential candidate antigens in perivascular and intramural lymphocytic infiltrates and correlated with neurological and electrophysiological parameters. 20 patients with treatment naïve NSVN and 5 patients with idiopathic axonal neuropathy were included.

Results The CD52, BAFF and CD49d antigens were expressed in epineurial, perivascular or intramural lymphocytes of all (20/20) patients. CD52 was most prominently expressed in 21.49% of all inflammatory infiltrates. BAFF and CD49d were detected in 11.25% and 10.99% of these lymphocytes, respectively. The CD20, CD25 and CD126 antigens were found less frequently and at low levels only (CD20: 10/20 patients, 5.84% of lymphocytes; CD25: 17/20 patients, 5.22% of lymphocytes; CD126: 3/20 patients, 0.15% of lymphocytes).

Conclusion This is the first study in NSVN that identifies antigens expressed by pathogenic lymphocytes, which are potential targets for future monoclonal antibody treatment. Our data suggest that NSVN is amenable to monoclonal antibodies and, moreover, that targeting CD52 may be particularly promising. Our results strongly warrant future clinical trials in NSVN with monoclonal antibodies.
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Clinical Evaluation of Ebola Virus Disease Therapeutics

Clinical Evaluation of Ebola Virus Disease Therapeutics | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Ebola virus disease (EVD) was first described over 40 years ago, but no treatment
has been approved for humans. The 2013–2016 EVD outbreak in West Africa has expedited
the clinical evaluation of several candidate therapeutics that act through different
mechanisms, but with mixed results. Nevertheless, these studies are important because
the accumulation of clinical data and valuable experience in conducting efficacy trials
under emergency circumstances will lead to better implementation of similar studies
in the future.
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European Medicines Agency - Find medicine - Humira

European Medicines Agency - Find medicine - Humira | Top Selling Monoclonal Antibodies 2014 | Scoop.it
European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
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Regeneron Suptavumab fails Phase III trial in Respiratory Syncytial Virus, ends Development. 

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), did not meet its primary endpoint of preventing medically-attended RSV infections in infants. Suptavumab did show signs of efficacy in a subgroup of patients. Adverse events were generally balanced between suptavumab and placebo. Regeneron plans to discontinue further clinical development of this antibody.
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Monoclonal Antibodies: A Review. - PubMed - NCBI

Monoclonal Antibodies: A Review. - PubMed - NCBI | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Curr Clin Pharmacol. 2017 Aug 9. doi: 10.2174/1574884712666170809124728. [Epub ahead of print]


Abstract Over the last three decades, monoclonal antibodies (MAbs) have made a striking transformation from scientific tools to powerful human therapeutics. Muromonab CD3 a murine MAb, was first FDA approved therapeutic MAb for prevention of kidney transplant rejection. Since its approval in 1986, there has been decline in the further application and approvals until the late 1990s when the first chimeric Mab, Rituximab was approved for the treatment of low grade B cell lymphoma in 1997. With the approval by licensing authorities of chimeric, followed by humanized and then fully human monoclonal antibodies, rate of approval and monoclonal antibodies available in the market for the treatment of various diseases has increased dramatically. As of March 2017, FDA has approved approximately 60 therapeutic MAbs with much more currently under evaluation in various phases of clinical trials. MAbs are approved for the treatment of a diseases belonging to various system like cardiovascular, respiratory, hematology, kidney, immunology and oncology. Mab are approved for the treatment of orphan diseases or indications such as paroxysmal nocturnal hemoglobinuria as well as cancers and multiple sclerosis where hundreds of patients are treated and even diseases such as breast cancer, asthma and rheumatoid arthritis where millions are being treated. This review focuses briefly on types, molecular targets, mechanism of actions and therapeutic indications of FDA approved MAb products that are currently on the market. 


Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Krishan Maggon 's insight:
Curr Clin Pharmacol. 2017 Aug 9. 
doi: 10.2174/1574884712666170809124728. [Epub ahead of print] 
Monoclonal Antibodies: A Review. 

 Singh S1, Kumar N2, Dwiwedi P3, Charan J3, Kaur R4, Sidhu P5, Chugh VK6.
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Monoclonal antibodies: technologies for early discovery and engineering. - PubMed - NCBI

Monoclonal antibodies: technologies for early discovery and engineering. - PubMed - NCBI | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Crit Rev Biotechnol. 2017 Aug 8:1-15. doi: 10.1080/07388551.2017.1357002. [Epub ahead of print]
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PPARγ-RXRα alterations promote immune evasion

PPARγ-RXRα alterations promote immune evasion | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The introduction and subsequent FDA approval of antibodies that inhibit immune checkpoints or their endogenous ligand, such as the anti-PD1-antibodies nivolumab and pembrolizumab, or the anti-PD-L1 antibodies atezolizumab, avelumab and durvalumab, has dramatically improved the outcomes of a subset of patients with metastatic urothelial carcinoma. However, despite these improvements, the majority of…
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Nature Reviews Urology (2017) doi:10.1038/nrurol.2017.133 Published online 08 August 2017 Article tools
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Trellis selects CMC Biologics to make mAb therapies

Trellis selects CMC Biologics to make mAb therapies | Top Selling Monoclonal Antibodies 2014 | Scoop.it
CMC Biologics and Trellis Bioscience are teaming up to make monoclonal antibody (mAb)-based therapies.
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New monoclonal antibody presentations efficacy in continual migraine sufferers with medicine overuse | Medicalnewser.com

New monoclonal antibody presentations efficacy in continual migraine sufferers with medicine overuse | Medicalnewser.com | Top Selling Monoclonal Antibodies 2014 | Scoop.it
June 27, 2017 A brand new human antibody might quickly turn out to be to be had as a particular medicine for combating common migraine assaults. As showed
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