Interferon beta-1a

Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

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星期一, 二月 1, 2021

The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.

Key Points: 
  • The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.
  • This approval expands Biogens industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of PLEGRIDY, and follows the European Commissions marketing authorization for the IM administration in December 2020.
  • A phase 1, open-label, crossover study to evaluate the bioequivalence of intramuscular and subcutaneous peginterferon beta-1a in healthy volunteers.
  • Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis - 2020 Forum; 2020 Feb 27-29; West Palm Beach, Florida, USA.

Synairgen announces completion of recruitment into its Phase II Home-Based COVID-19 study of inhaled interferon beta

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星期三, 一月 20, 2021

Professor Nick Francis, Professor of General Practice at the University of Southampton, commented:"We are delighted to announce completion of recruitment into the SG016 Home trial.

Key Points: 
  • Professor Nick Francis, Professor of General Practice at the University of Southampton, commented:"We are delighted to announce completion of recruitment into the SG016 Home trial.
  • We have shown that inhaled therapies can be safely delivered at home, without the need for the patients, nurses or doctors to travel.
  • The Lancet Respiratory Medicine:"Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial".
  • For more information about Synairgen, please see www.synairgen.com
    Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses.

Synairgen announces completion of recruitment into its Phase II Home-Based COVID-19 study of inhaled interferon beta

Retrieved on: 
星期三, 一月 20, 2021

Professor Nick Francis, Professor of General Practice at the University of Southampton, commented:"We are delighted to announce completion of recruitment into the SG016 Home trial.

Key Points: 
  • Professor Nick Francis, Professor of General Practice at the University of Southampton, commented:"We are delighted to announce completion of recruitment into the SG016 Home trial.
  • We have shown that inhaled therapies can be safely delivered at home, without the need for the patients, nurses or doctors to travel.
  • The Lancet Respiratory Medicine:"Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial".
  • For more information about Synairgen, please see www.synairgen.com
    Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses.

The European Commission Grants Marketing Authorization for PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Relapsing-Remitting Multiple Sclerosis

Retrieved on: 
星期一, 十二月 21, 2020

The new IM administration of PLEGRIDY provides the well-characterized efficacy and safety of the platform injectable along with the potential for reduction in injection site reactions.

Key Points: 
  • The new IM administration of PLEGRIDY provides the well-characterized efficacy and safety of the platform injectable along with the potential for reduction in injection site reactions.
  • The ECs approval of PLEGRIDY for IM administration is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers.
  • A phase 1, open-label, crossover study to evaluate the bioequivalence of intramuscular and subcutaneous peginterferon beta-1a in healthy volunteers.
  • Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis - 2020 Forum; 2020 Feb 27-29; West Palm Beach, Florida, USA.

UPDATE: BetterLife CEO Highlights Crucial Difference Between the Company’s Interferon Alpha 2b and Synairgen PLC’s Interferon Beta

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星期三, 十月 28, 2020

NEW YORK CITY, Oct. 28, 2020 (GLOBE NEWSWIRE) -- UPDATE: BetterLife CEO Highlights Crucial Difference Between the Companys Interferon Alpha 2b and Synairgen PLCs Interferon Beta

Key Points: 
  • NEW YORK CITY, Oct. 28, 2020 (GLOBE NEWSWIRE) -- UPDATE: BetterLife CEO Highlights Crucial Difference Between the Companys Interferon Alpha 2b and Synairgen PLCs Interferon Beta
    The Chief Executive Officer for BetterLife Pharma Inc. (OTCQB:BETRF) (CSE:BETR), an emerging biotechnology company currently preparing for clinical trials of AP-003, its interferon alpha 2b COVID-19 treatment, joined investor portalProactiveto discuss the key differences between the interferon inhalation formula used by BetterLife against that used successfully by Synairgen PLC.
  • The Synairgen trials caused much excitement, strongly demonstrating that treatments using an interferon beta inhalation in COVID-19 patients significantly improved their condition and sped up recovery.
  • BetterLife is due to start its clinical trials later this fall in Australia for AP-003, BetterLifes inhaled human interferon alpha 2b, in patients with mild to moderate symptoms of COVID-19.
  • While both AP-003 and interferon beta are hypothesized to bypass the COVID-19 induced interferon production blockade, BetterLife believe that their proprietary inhaled alpha 2b (exclusively owned and developed by the Company) could be much more effective against the severity and duration of COVID-19 than interferon beta.

BetterLife CEO Highlights Crucial Difference Between the Company’s Interferon Alpha 2b and Other Treatements

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星期二, 十月 27, 2020

BetterLife is due to start its clinical trials later this fall in Australia for AP-003, BetterLifes inhaled human interferon alpha 2b, in patients with mild to moderate symptoms of COVID-19.

Key Points: 
  • BetterLife is due to start its clinical trials later this fall in Australia for AP-003, BetterLifes inhaled human interferon alpha 2b, in patients with mild to moderate symptoms of COVID-19.
  • However, interferon production is inhibited by the virus responsible for COVID-19.
  • While both AP-003 and interferon beta are hypothesized to bypass the COVID-19 induced interferon production blockade, BetterLife believe that their proprietary inhaled alpha 2b (exclusively owned and developed by the Company) could be much more effective against the severity and duration of COVID-19 than interferon beta.
  • In the interview with Proactive, Dr. Doroudian, BetterLife CEO explains why the AP-003 formulation potentially represents a superior mode of treatment over interferon beta due to its proven anti-viral therapeutic.

Cipla receives final approval for generic version of Biogen IDEC Inc.'s Tecfidera® (Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pack)

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星期一, 九月 28, 2020

Cipla's Dimethyl Fumarate DR Caps 120mg, 240mg and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.'s Tecfidera.

Key Points: 
  • Cipla's Dimethyl Fumarate DR Caps 120mg, 240mg and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.'s Tecfidera.
  • It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • According to IQVIA (IMS Health), Tecfiderahad US sales of approximately $3.8 Billion for the 12-month period ending July 2020.
  • Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.

Interferon Biosimilar Landscape Report, 2020 Featuring Zydus Cadila, Reliance Life Sciences, Profarma, Harvest Moon Pharmaceuticals, Dong-A ST, CinnaGen, BioPartners, Biocad, Amega Biotech - ResearchAndMarkets.com

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星期二, 九月 8, 2020

This Interferon-Biosimilar Insight, 2020 report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Interferon Biosimilars landscape.

Key Points: 
  • This Interferon-Biosimilar Insight, 2020 report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Interferon Biosimilars landscape.
  • It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type.
  • Harvest Moon Pharmaceuticals is developing Interferon beta-1b biosimilar for the treatment of Multiple sclerosis.
  • Interferon pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Rebif® U.S. Label Now Includes Pregnancy Outcomes and Lactation Information to Help Inform Treatment Decisions for Women with MS

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星期三, 五月 27, 2020

"Today's update provides physicians critical information to help inform women with MS in managing this chronic disease during a very important time in their lives."

Key Points: 
  • "Today's update provides physicians critical information to help inform women with MS in managing this chronic disease during a very important time in their lives."
  • "The inclusion of pregnancy outcomes and lactation data in the Rebif label provides valuable insights.
  • I believe it will encourage discussions between physicians and their patients about MS treatment options when considering pregnancy."
  • Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif.

New 6-year Data for Genentech’s Ocrevus (ocrelizumab) Show Earlier Treatment Initiation Nearly Halves Risk of Needing Walking Aid in Relapsing Multiple Sclerosis

Retrieved on: 
星期二, 四月 28, 2020

These new analyses add additional evidence to the benefit-risk profile of Ocrevus, including the impact of MS on peoples daily lives.

Key Points: 
  • These new analyses add additional evidence to the benefit-risk profile of Ocrevus, including the impact of MS on peoples daily lives.
  • Slowing MS progression earlier in the disease course not just treating relapses may bring additional clinically meaningful outcomes to people living with this disease.
  • People treated with Ocrevus had a 49% reduction in the risk of needing a walking aid compared to those that received interferon beta-1a over 6 years of study (4.3% vs. 7.2%*; p=0.0042).
  • Ocrevus can cause serious side effects, including:
    Infusion reactions: Ocrevus can cause infusion reactions that can be serious and require you to be hospitalized.