Immunosuppressants

Biogen and Bio-Thera Announce Positive Results From Phase 3 Study of BAT1806, a Proposed Biosimilar Referencing Actemra® (Tocilizumab)

Retrieved on: 
Tuesday, June 1, 2021

and GUANGZHOU, China, June 01, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA/RoACTEMRA (tocilizumab).

Key Points: 
  • and GUANGZHOU, China, June 01, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA/RoACTEMRA (tocilizumab).
  • Biogen has exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).
  • We are pleased to report on our third proposed biosimilar with positive Phase 3 study results.
  • These results demonstrate the potential of our proposed tocilizumab biosimilar to be a safe and effective treatment, said Shengfeng Li, Ph.D., chief executive officer at Bio-Thera Solutions.

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis1

Retrieved on: 
Thursday, May 27, 2021

A Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active UC in the European Union is currently under review with the European Medicines Agency (EMA).

Key Points: 
  • A Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active UC in the European Union is currently under review with the European Medicines Agency (EMA).
  • Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis.
  • Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020.
  • The European Medicines Agency (EMA) validated Bristol Myers Squibbs Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.

Aurinia Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

Retrieved on: 
Thursday, May 27, 2021

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) today announced that members of the executive management team will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:30 a.m.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) today announced that members of the executive management team will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:30 a.m.
  • In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events through the Investors section of the Aurinia corporate website at www.auriniapharma.com .
  • Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need.
  • The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN).

Antares Pharma to Present at the Jefferies Virtual Healthcare Conference

Retrieved on: 
Wednesday, May 26, 2021

A live webcast of the presentation will be available under the For Investors section of the Antares Pharma website at www.antarespharma.com.

Key Points: 
  • A live webcast of the presentation will be available under the For Investors section of the Antares Pharma website at www.antarespharma.com.
  • Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology.
  • Antares Pharmas FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.
  • Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.

DGAP-News: Abivax reports excellent efficacy and safety of ABX464 in phase 2b clinical trial in ulcerative colitis and plans to proceed to phase 3

Retrieved on: 
Monday, May 24, 2021

254 patients with moderate to severe ulcerative colitis (UC) were treated with ABX464, a small molecule for once-daily administration with a first-in-class mechanism of action.

Key Points: 
  • 254 patients with moderate to severe ulcerative colitis (UC) were treated with ABX464, a small molecule for once-daily administration with a first-in-class mechanism of action.
  • The top-line data showed significant clinical efficacy in the overall patient population on primary and key secondary endpoints and a good safety profile of ABX464 during 8 weeks of induction treatment.
  • The phase 3 clinical program with ABX464 in UC is expected to start by year end.
  • I am looking forward to further support the planned phase 3 ulcerative colitis program as principal investigator."

European Commission approves PONVORYTM ▼ (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features

Retrieved on: 
Monday, May 24, 2021

Janssen Research & Development, LLC, and Johnson & Johnson Middle East FZ-LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Janssen Research & Development, LLC, and Johnson & Johnson Middle East FZ-LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 OPTIMUM study: a Randomized clinical trial.
  • Janssen Receives Positive CHMP Opinion for PONVORY (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features.
  • 11 DAmbrosio D, Feedman MS, Prinz J. Ponesimod, a selective S1P1 receptor modulator: a potential treatment for multiple sclerosis and other immune-mediated diseases.

Target RWE Research Presented at DDW 2021 Shows High Rates of Biologic Combination Therapy and Previous Biologic Exposure in IBD Population

Retrieved on: 
Sunday, May 23, 2021

b'DURHAM, N.C., May 23, 2021 /PRNewswire/ -- Research presented today at Digestive Disease Week (DDW) 2021 evaluated the prevalence and predictors of immunomodulator use as concomitant therapy with two commonly prescribed biologics, vedolizumab (Entyvio) or ustekinumab (Stelara), in patients with inflammatory bowel disease (IBD).

Key Points: 
  • b'DURHAM, N.C., May 23, 2021 /PRNewswire/ -- Research presented today at Digestive Disease Week (DDW) 2021 evaluated the prevalence and predictors of immunomodulator use as concomitant therapy with two commonly prescribed biologics, vedolizumab (Entyvio) or ustekinumab (Stelara), in patients with inflammatory bowel disease (IBD).
  • Data from Target RWE\'s TARGET-IBD large longitudinal cohort Immunomodulators are Commonly Used as Concomitant Therapy with Vedolizumab or Ustekinumab: TARGET-IBD Real World Cohort was selected for the Poster of Distinction Award.\nGlobal IBD prevalence has risen substantially over the past 30 years.
  • The addition of an immunomodulator in combination therapy may limit this potential benefit, especially in those over age 65, without reducing immunogenicity.\n"Immunogenicity occurs when a treatment provokes an immune response against itself.
  • Target RWE\'s novel NoviSci analytics platform enables the analysis and visualization of health data using state-of-the-science epidemiological methods and scientific principles, providing a highly adaptive environment to accelerate insights and reproducible research.

Meiji Seika Pharma: Promising Results of Phase I Clinical Trial of DMB-3115, a Proposed Ustekinumab Biosimilar, and Initiation of Phase III Clinical Trial in Patients With Plaque Psoriasis

Retrieved on: 
Friday, May 21, 2021

Meiji also announced the initiation of phase III multi-regional clinical trial in patients with plaque psoriasis.

Key Points: 
  • Meiji also announced the initiation of phase III multi-regional clinical trial in patients with plaque psoriasis.
  • Meiji and Dong-A are co-developing DMB-3115 under the strategic collaboration partnership agreement on biosimilars signed in September 2011.
  • As a result, bioequivalence of DMB-3115 compared to reference products was demonstrated in terms of several pharmacokinetic parameters.
  • There were no new unexpected adverse events.\nThe Phase III multi-regional clinical trials in patients with plaque psoriasis, with the target number of patient being 590, has been initiated in Europe and the United States.

Early use of anakinra reduces risk of mortality for patients with COVID-19 pneumonia, reduces ICU admission and increases likelihood of full recovery

Retrieved on: 
Thursday, May 20, 2021

Anakinra treatment also increased the number of patients discharged from hospital with no evidence of COVID-19 infection, with patients being 2.8 times more likely to fully recover than patients who received placebo and SOC.

Key Points: 
  • Anakinra treatment also increased the number of patients discharged from hospital with no evidence of COVID-19 infection, with patients being 2.8 times more likely to fully recover than patients who received placebo and SOC.
  • Anakinra isan anti-inflammatory drug that targets the cytokines IL-1/, which playan important role in COVID-19-induced hyperinflammation.
  • Blocking IL-1/ at an early stage of disease can have an important impact on COVID-19 disease progression.
  • 28-day mortality was also 55% lower among\npatients allocated to SoC and anakinra treatment.

Pyramid Biosciences Announces First Patients Dosed in Phase 1 Clinical Program for Dermatology

Retrieved on: 
Thursday, May 20, 2021

b'Pyramid Biosciences, Inc., a clinical-stage, biotechnology company developing novel precision therapies, announced that it has commenced a Phase 1 clinical study for its therapeutic candidate PBI-100, a first-in-class topical treatment targeting mild to moderate psoriasis in patients.

Key Points: 
  • b'Pyramid Biosciences, Inc., a clinical-stage, biotechnology company developing novel precision therapies, announced that it has commenced a Phase 1 clinical study for its therapeutic candidate PBI-100, a first-in-class topical treatment targeting mild to moderate psoriasis in patients.
  • People living with psoriasis report symptoms such as itching, burning and stinging.2\n\xe2\x80\x9cDosing our first patient is an important milestone for Pyramid Biosciences, physicians, and most importantly, patients suffering from psoriasis and other inflammatory skin disorders,\xe2\x80\x9d said Kollol Pal, PhD, co-founder, and CEO of Pyramid Biosciences.
  • Psoriasis affects approximately 125 million people globally3, and topical treatments remain one of the mainstays of current medical treatment.
  • Pyramid Biosciences plans to conduct further clinical testing of PBI-100 for use in additional indications.\nThe Phase 1 study is recruiting healthy volunteers to assess the safety and tolerability of multiple dose levels of PBI-100.