Genovac Becomes the First Contract Research Organization (CRO) to Leverage the Beacon System for Both Antibody Discovery and Cell Line Development Genovac Becomes the First Contract Research Organization (CRO) to Leverage the Beacon System for Both Antibody Discovery and Cell Line Development

Here is the original post:
Genovac Purchases Third Beacon® Optofluidic System and Expands its Capabilities into Cell Line Development

Global News Feed Comments Off on Genovac Purchases Third Beacon® Optofluidic System and Expands its Capabilities into Cell Line Development | October 5th, 2021

BOSTON, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease company developing novel bile acid modulators, joins the PFIC Advocacy and Resource Network (PFIC Network) in recognition of PFIC Awareness Day 2021, a global effort to support patients and families affected by progressive familial intrahepatic cholestasis (PFIC). Established in 2019, PFIC Awareness Day aims to highlight the impact of this disease on patients and families, and to call for new levels of support, including research, advocacy, education and opportunities to connect and share information.

See the original post here:
Albireo Recognizes PFIC Awareness Day 2021

Global News Feed Comments Off on Albireo Recognizes PFIC Awareness Day 2021 | October 5th, 2021

Scopus to present on the recent launch of Duet Therapeutics, its wholly-owned subsidiary focused on immuno-oncology

Read more:
Scopus BioPharma to Present at the LD Micro Main Event

Global News Feed Comments Off on Scopus BioPharma to Present at the LD Micro Main Event | October 5th, 2021

LAWRENCEVILLE, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, announces the strengthening of its management team with a new hire and a promotion in its vaccine development program, and the hiring of a veteran clinical trial project manager for its Phase II GEN-1 immunotherapy study in advanced ovarian cancer. These changes all are effective immediately and are as follows:

See the original post:
Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities

Global News Feed Comments Off on Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities | October 5th, 2021

MENLO PARK, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, announced today that its Chief Executive Officer, Dr. Joseph Sarret, will present a company overview at the H.C. Wainwright 5th Annual NASH Investor Conference, being held virtually on October 12, 2021.

Read more:
CohBar to Present at H.C. Wainwright 5th Annual NASH Investor Conference

Global News Feed Comments Off on CohBar to Present at H.C. Wainwright 5th Annual NASH Investor Conference | October 5th, 2021

CAMBRIDGE, Mass., Oct. 05, 2021 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced the e-poster presentation of new preclinical data at the American Association for Cancer Research (AACR) Virtual Special Conference on Tumor Immunology and Immunotherapy, taking place October 5-6, 2021. The e-poster titled “Expression of an IL-15 Receptor Fusion Protein Enhances the Persistence of TRuC-T Cells” highlights preclinical data on the Company’s proprietary mesothelin-directed T Cell Receptor Fusion Construct (TRuC®) T cells that express IL-15-based enhancements as a strategy for improving T cell persistence. The co-expression of these IL-15 enhancements enriched for naïve and central memory T cells, upregulated the stemness-associated transcription factor TCF-1 and increased TRuC-T cell proliferation upon repeated stimulation with mesothelin-expressing cancer cell lines. In addition, IL-15 promoted the survival of TRuC-T cells in the absence of T cell receptor (TCR) or exogenous cytokine stimulation. In a mesothelioma xenograft mouse model, IL-15 co-expression resulted in a higher number of TRuC-T cells in the tumor and significantly increased their persistence in peripheral blood. The administration of a single dose of IL-15 enhanced TRuC-T cells cleared tumors in all mice and fully protected them from tumor rechallenge.

See more here:
TCR² Therapeutics Presents Preclinical Data on IL-15 Enhanced TRuCs at AACR Virtual Special Conference on Tumor Immunology & Immunotherapy

Global News Feed Comments Off on TCR² Therapeutics Presents Preclinical Data on IL-15 Enhanced TRuCs at AACR Virtual Special Conference on Tumor Immunology & Immunotherapy | October 5th, 2021

Dr. Periman Joins Chairman Joseph Tauber as Advisory Board’s Second Member Dr. Periman Joins Chairman Joseph Tauber as Advisory Board’s Second Member

More here:
AXIM® Biotechnologies Appoints Senior DED Expert Dr. Laura Periman to its Medical Advisory Board

Global News Feed Comments Off on AXIM® Biotechnologies Appoints Senior DED Expert Dr. Laura Periman to its Medical Advisory Board | October 5th, 2021

VANCOUVER, British Columbia, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Levitee Labs Inc. (the "Company" or "Levitee Labs”) (CSE: LVT), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to publish revenue figures for the month of August 2021. On a consolidated basis, the Company has recorded (unaudited) revenue of $893,863 for the month of August.

Go here to see the original:
Levitee Labs Publishes First Revenue Figures for August 2021

Global News Feed Comments Off on Levitee Labs Publishes First Revenue Figures for August 2021 | October 5th, 2021

KEEGO HARBOR, Mich., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Zivo Bioscience, Inc. (NASDAQ: ZIVO, ZIVOW) (“ZIVO” and the “Company”), a biotech/agtech R&D company engaged in the development and commercialization of therapeutic, medicinal and nutritional product candidates originally derived from proprietary algal cultures, today issues a notice to its shareholders concerning the annual shareholder meeting.

Continued here:
Weblink Instructions for the Annual Meeting of Shareholders of Zivo Bioscience, Inc.

Global News Feed Comments Off on Weblink Instructions for the Annual Meeting of Shareholders of Zivo Bioscience, Inc. | October 5th, 2021

Prospective joint venture will accelerate precision medicine in Europe by harnessing innovations in high-throughput drug testing, 3D tumor cell culture, and AI analytics established at SEngine Precision Medicine to identify the best personalized therapeutic matches for patients Prospective joint venture will accelerate precision medicine in Europe by harnessing innovations in high-throughput drug testing, 3D tumor cell culture, and AI analytics established at SEngine Precision Medicine to identify the best personalized therapeutic matches for patients

Here is the original post:
SEngine Precision Medicine and Gustave Roussy Announce Plan to Launch PARIS® Test in Europe

Global News Feed Comments Off on SEngine Precision Medicine and Gustave Roussy Announce Plan to Launch PARIS® Test in Europe | October 5th, 2021

DUBLIN, Ireland and TREVOSE, Pa., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (NASDAQ: SBBP) (the “Company” or “Strongbridge”) today announced that the High Court of Ireland (the "Court") has approved the previously announced proposed acquisition of Strongbridge by Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) (“Xeris”) by means of a scheme of arrangement (the "Scheme") under Chapter 1 of Part 9 of the Irish Companies Act 2014 (the "Act").

More here:
Strongbridge Biopharma plc Announces Completion of Acquisition by Xeris Pharmaceuticals, Inc.

Global News Feed Comments Off on Strongbridge Biopharma plc Announces Completion of Acquisition by Xeris Pharmaceuticals, Inc. | October 5th, 2021

SANTA CLARA, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced it will report financial results for the third quarter 2021 after market close on Monday, November 8, 2021. Company management will host a corresponding conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time.

Read the original post:
Shockwave Medical to Report Third Quarter 2021 Financial Results on November 8, 2021

Global News Feed Comments Off on Shockwave Medical to Report Third Quarter 2021 Financial Results on November 8, 2021 | October 5th, 2021

-Management to host conference call and webcast on October 12th at 4:30 p.m. ET-

Read more:
CRISPR Therapeutics to Host Virtual Event Highlighting CTX110™ Clinical Data

Global News Feed Comments Off on CRISPR Therapeutics to Host Virtual Event Highlighting CTX110™ Clinical Data | October 5th, 2021

FOSTER CITY, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the H.C. Wainwright 5th Annual NASH Investor Conference on Tuesday, October 12 at 2:30 p.m. ET.

Read more from the original source:
Terns Pharmaceuticals to Present at H.C. Wainwright 5th Annual NASH Investor Conference

Global News Feed Comments Off on Terns Pharmaceuticals to Present at H.C. Wainwright 5th Annual NASH Investor Conference | October 5th, 2021

SAN DIEGO, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced pre-clinical data from ONCT-534, an androgen receptor N-terminal-domain-binding small molecule degrader, was accepted for virtual poster presentation at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics on October 7-10, 2021. Oncternal has conducted a series of preclinical studies in collaboration with the Center for Cancer Research at the University of Tennessee Health Science Center.

Read more here:
Oncternal Therapeutics Announced Pre-Clinical Data from ONCT-534, an Androgen Receptor N-Terminal-Domain-Binding Small Molecule Degrader, Was Accepted...

Global News Feed Comments Off on Oncternal Therapeutics Announced Pre-Clinical Data from ONCT-534, an Androgen Receptor N-Terminal-Domain-Binding Small Molecule Degrader, Was Accepted… | October 5th, 2021

MALVERN, Pa., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial-stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, today announced a commercial agreement with Success TMS in which Success TMS will exclusively utilize Neuronetics’ platform, NeuroStar Advanced Therapy for Mental Health, for the treatment of patients suffering from treatment-resistant major depressive disorder (MDD). In connection with the commercial agreement, the Company has made a strategic investment in Success TMS in the form of a $10 million term loan to further accelerate the growth of Success TMS’ business.

Excerpt from:
Neuronetics Announces Commercial Agreement with Success TMS

Global News Feed Comments Off on Neuronetics Announces Commercial Agreement with Success TMS | October 5th, 2021

IRVINE, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), announced an upcoming presentation on AT-1501, its lead clinical candidate, at the International Pancreas and Islet Transplantation Association (IPITA) Congress, which is being held virtually from October 20-23, 2021.  An oral presentation on the use of AT -1501, and pre-clinical data showing the effectiveness of AT-1501 in preventing islet allograft rejection in nonhuman primate models, will be featured.

Read the original here:
Eledon Pharmaceuticals Announces Upcoming Presentation on AT-1501 at the Virtual 2021 International Pancreas and Islet Transplantation Association...

Global News Feed Comments Off on Eledon Pharmaceuticals Announces Upcoming Presentation on AT-1501 at the Virtual 2021 International Pancreas and Islet Transplantation Association… | October 5th, 2021

Encouraging preclinical data support continued advancement of SZN-1326 towards first in human clinical studies in 2022 Encouraging preclinical data support continued advancement of SZN-1326 towards first in human clinical studies in 2022

More:
Surrozen Presented Data Supporting Potential of SZN-1326 at the 2021 United European Gastroenterology Week

Global News Feed Comments Off on Surrozen Presented Data Supporting Potential of SZN-1326 at the 2021 United European Gastroenterology Week | October 5th, 2021

DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced the publication of a post-hoc analysis from the N-MOmentum phase 2/3 pivotal trial of UPLIZNA, which highlights a sustained effect on attack risk with no new safety signals in people with NMOSD who received the treatment for four or more years. These data are published in the Multiple Sclerosis Journal.

NMOSD is a rare, severe autoimmune disease that attacks the optic nerve, spinal cord and brain stem. The attacks are often recurrent and can cause irreversible damage to the nerves, leading to cumulative visual and motor disabilities over time. UPLIZNA is the first and only FDA-approved anti-CD19 B-cell-depleting humanized monoclonal antibody for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.

This long-term study is important because NMOSD is a chronic disease that requires lifelong management. Physicians need to understand the implications of prolonged treatment, said Bruce Cree, M.D., Ph.D., MAS, professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences and primary study investigator. It is highly encouraging to see that most patients in this study were attack-free after the first year of UPLIZNA treatment and that new safety concerns were not observed. The data demonstrate that long-term UPLIZNA use is associated with a reduced risk of NMOSD attacks possibly due to the depth and extent of B-cell depletion with repeated doses.

The post-hoc analysis represents the experience of 75 people with AQP4 antibody positive NMOSD who were treated with UPLIZNA for four or more years during the open-label extension period of the N-MOmentum trial.

Key study findings include the following:

NMOSD is a complex and often unpredictable B-cell-mediated disease that presents significant challenges to both patients and physicians, said Kristina Patterson, M.D., Ph.D., medical director, neuroimmunology, Horizon. With recent treatment advancements, the NMOSD community now has more options than ever before including UPLIZNA, which is engineered for broad, deep and durable B-cell depletion. We are fully committed to increasing our understanding of this disease so we can continue to improve patient care.

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.1,2 Approximately 80 percent of all patients with NMOSD test positive for anti-AQP4 antibodies.3 AQP4-IgG binds primarily to astrocytes in the central nervous system and triggers an escalating immune response that results in lesion formation and astrocyte death.4

Anti-AQP4 autoantibodies are produced by plasmablasts and plasma cells. These B-cell populations are central to NMOSD disease pathogenesis, and a large proportion of these cells express CD19.5 Depletion of these CD19+ B cells is thought to remove an important contributor to inflammation, lesion formation and astrocyte damage. Clinically, this damage presents as an NMOSD attack, which can involve the optic nerve, spinal cord and brain.4,6 Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease.7 Each NMOSD attack can lead to further cumulative damage and disability.8,9 NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.10,11

About UPLIZNA

INDICATION

UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%) and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of hepatitis B virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

For additional information on UPLIZNA, please see Prescribing Information at http://www.UPLIZNA.com.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit http://www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential benefits of UPLIZNA and Horizons research and development plans. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether future results of clinical trials will be consistent with preliminary results or results of prior trials or other data or Horizons expectations, the risks associated with clinical development and adoption of novel medicines and risks related to competition or other factors that may change physician treatment strategies. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizons filings with the United States Securities and Exchange Commission, including those factors discussed under the caption Risk Factors in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

References

Go here to read the rest:
New Analysis Published in Multiple Sclerosis Journal Assesses Long-Term Use of UPLIZNA (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica...

Spinal Cord Stem Cells Comments Off on New Analysis Published in Multiple Sclerosis Journal Assesses Long-Term Use of UPLIZNA (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica… | October 5th, 2021

DUBLIN - Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of a post-hoc analysis from the N-MOmentum phase 2/3 pivotal trial of UPLIZNA, which highlights a sustained effect on attack risk with no new safety signals in people with NMOSD who received the treatment for four or more years. These data are published in the Multiple Sclerosis Journal.

NMOSD is a rare, severe autoimmune disease that attacks the optic nerve, spinal cord and brain stem. The attacks are often recurrent and can cause irreversible damage to the nerves, leading to cumulative visual and motor disabilities over time. UPLIZNA is the first and only FDA-approved anti-CD19 B-cell-depleting humanized monoclonal antibody for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.

'This long-term study is important because NMOSD is a chronic disease that requires lifelong management. Physicians need to understand the implications of prolonged treatment,' said Bruce Cree, M.D., Ph.D., MAS, professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences and primary study investigator. 'It is highly encouraging to see that most patients in this study were attack-free after the first year of UPLIZNA treatment and that new safety concerns were not observed. The data demonstrate that long-term UPLIZNA use is associated with a reduced risk of NMOSD attacks - possibly due to the depth and extent of B-cell depletion with repeated doses.'

The post-hoc analysis represents the experience of 75 people with AQP4 antibody positive NMOSD who were treated with UPLIZNA for four or more years during the open-label extension period of the N-MOmentum trial.

Key study findings include the following:

A total of 18 attacks occurred in 13 people, with an annualized attack rate of 0.052 attacks per person year.

The small number of total attacks decreased significantly after the first year of treatment with UPLIZNA.

67% of attacks occurred within the first year (12 attacks).

92% of patients were attack-free in subsequent years (two attacks each during years two to four).

The infection rate did not increase over time on treatment with UPLIZNA.

UPLIZNA was generally well tolerated, with few treatment-related dose interruptions and no treatment discontinuations.

'NMOSD is a complex and often unpredictable B-cell-mediated disease that presents significant challenges to both patients and physicians,' said Kristina Patterson, M.D., Ph.D., medical director, neuroimmunology, Horizon. 'With recent treatment advancements, the NMOSD community now has more options than ever before - including UPLIZNA, which is engineered for broad, deep and durable B-cell depletion. We are fully committed to increasing our understanding of this disease so we can continue to improve patient care.'

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.1,2 Approximately 80 percent of all patients with NMOSD test positive for anti-AQP4 antibodies.3 AQP4-IgG binds primarily to astrocytes in the central nervous system and triggers an escalating immune response that results in lesion formation and astrocyte death.4

Anti-AQP4 autoantibodies are produced by plasmablasts and plasma cells. These B-cell populations are central to NMOSD disease pathogenesis, and a large proportion of these cells express CD19.5 Depletion of these CD19+ B cells is thought to remove an important contributor to inflammation, lesion formation and astrocyte damage. Clinically, this damage presents as an NMOSD attack, which can involve the optic nerve, spinal cord and brain.4,6 Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease.7 Each NMOSD attack can lead to further cumulative damage and disability.8,9 NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.10,11

About UPLIZNA

INDICATION

UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

A history of life-threatening infusion reaction to UPLIZNA

Active hepatitis B infection

Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%) and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of hepatitis B virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

For additional information on UPLIZNA, please see Prescribing Information at http://www.UPLIZNA.com.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit http://www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential benefits of UPLIZNA and Horizon's research and development plans. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether future results of clinical trials will be consistent with preliminary results or results of prior trials or other data or Horizon's expectations, the risks associated with clinical development and adoption of novel medicines and risks related to competition or other factors that may change physician treatment strategies. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption 'Risk Factors' in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

Contact:

Rachel Vann

Director

Product Communications

E: media@horizontherapeutics.com

Original post:
Horizon Therapeutics Public : plc - New Analysis Published in Multiple Sclerosis Journal Assesses Long-Term Use of UPLIZNA (inebilizumab-cdon) for the...

Spinal Cord Stem Cells Comments Off on Horizon Therapeutics Public : plc – New Analysis Published in Multiple Sclerosis Journal Assesses Long-Term Use of UPLIZNA (inebilizumab-cdon) for the… | October 5th, 2021