Chronic inflammatory demyelinating polyneuropathy

EQS-News: BB BIOTECH AG: Biotech equity markets in flux: the impact of rising bond yields and shifting healthcare policies

Retrieved on: 
Thursday, October 26, 2023

BB BIOTECH AG: Biotech equity markets in flux: the impact of rising bond yields and shifting healthcare policies

Key Points: 
  • BB BIOTECH AG: Biotech equity markets in flux: the impact of rising bond yields and shifting healthcare policies
    The issuer is solely responsible for the content of this announcement.
  • The rise in bond yields weighed heavily on biotech stocks as well as the stock market in general.
  • BB Biotech benefited from the dollar's appreciation, but it was also exposed to the sustained selling pressure on equity markets.
  • BB Biotech traded within a narrow range during the third quarter, closing slightly higher at CHF 41.35 per share.

Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China

Retrieved on: 
Monday, September 18, 2023

SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
  • “We have seen how efgartigimod SC can meaningfully improve and stabilize disease symptoms in these patients.
  • Existing treatment options are quite limited, and problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy.

We won't always have to use animals for medical research. Here's what we can do instead

Retrieved on: 
Wednesday, August 30, 2023

Animals have been used for medical research for thousands of years, dating back to ancient Greece where the first dissections were performed.

Key Points: 
  • Animals have been used for medical research for thousands of years, dating back to ancient Greece where the first dissections were performed.
  • These days, one of the main uses of animals is to ensure the safety of medical products before they’re trialled in humans.
  • But in addition to the important ethical reasons for minimising animal use, the reality is sometimes animals just aren’t that good at predicting human responses.

What are non-animal models?

    • In doing so, this can more accurately predict if a medical product is likely to fail, allowing reinvestment in products that are more likely to succeed.
    • These can be used across the medical product development process to complement – and in time potentially replace – other model types.
    • They can be used in drug studies to model a drug’s behaviour within the body, from cellular interactions to processes that involve multiple organs.


What can we use non-animal models for?


    In theory, we can use non-animal models for everything we use animal models for – and more. Simple non-animal models (human cells cultured over a flat surface) are already used to help identify drug targets due to their ability to test a large number of compounds and experimental conditions. In the future, non-animal models will reduce – and eventually replace – animal use across a range of applications:
    Outside of medical products designed for humans, non-animal models can also support innovation in veterinary and agricultural medicines, cosmetic testing and eco-toxicology.

An export opportunity for Australia

    • Non-animal models present an economic opportunity for Australia, where the models, their components, and surrounding services could be exported to the world.
    • Our novel economic analysis sized the potential Australian market for two non-animal models: organoids and organs-on-chips.
    • Another example is from Schott Minifab, an international biotech and medical device company with Australian roots, which has successfully established scaled production of non-animal model components in Australia for domestic and export markets.

Making it a reality

    • Non-animal models have already begun to complement and replace animal use in some areas, such as identifying drug targets.
    • However, accelerating their development and adoption across a wider range of applications will require further technical advances to lower cost and validate their performance as superior models.


    Governments, industry and research must collaborate to deliver against these actions. Success will only come from collective efforts.

    Read more:
    Is it time for Australia to be more open about research involving animals?

OmniAb Reports Second Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, August 10, 2023

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and six months ended June 30, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and six months ended June 30, 2023, and provided operating and partner program updates.
  • “Our business continued to grow and perform well during the second quarter with advancements in business development and progress across partner programs.
  • Revenue for the second quarter of 2023 was $6.9 million, compared with $7.2 million for the same period in 2022.
  • During the second quarter of 2023, OmniAb entered into four new license agreements including with Merck & Co., Inc., Neurocrine Biosciences Inc., Stanford University and Seattle Children’s Hospital.

Zai Lab and argenx Report Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
Monday, July 17, 2023

The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.

Key Points: 
  • The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.
  • Detailed data from ADHERE will be presented at an upcoming medical meeting.
  • “Currently, intravenous immunoglobulin (IVIg), plasma exchange (PLEX), and glucocorticoids are the main treatments used during the induction and maintenance phases.
  • Zai Lab has an exclusive license agreement with argenx for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China.

argenx Reports Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
Monday, July 17, 2023

The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.

Key Points: 
  • The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.
  • The positive ADHERE data show that VYVGART Hytrulo may represent a new patient-forward treatment option that can prevent symptom deterioration while minimizing side effects and treatment burden,” commented Jeffrey Allen, M.D., Associate Professor, Department of Neurology, University of Minnesota.
  • “With ADHERE, argenx has set a new standard for innovative CIDP studies that more broadly inform the neuromuscular community.
  • A webcast of the live call and replay may be accessed on the Investors section of the argenx website.

Takeda Presents Full Data Set from Phase 3 ADVANCE-CIDP 1 Clinical Trial Investigating HYQVIA® as a Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting

Retrieved on: 
Tuesday, June 20, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced full results from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial investigating HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced full results from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial investigating HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • The company also observed favorable data across other endpoints from the study and favorable tolerability.
  • These findings were presented at the 2023 Peripheral Nerve Society (PNS) Annual Meeting in Copenhagen, Denmark on June 20, 2023, and simultaneously published in the Journal of the Peripheral Nervous System (JPNS).
  • HYQVIA is currently under regulatory review in the U.S. and European Union for use as a maintenance therapy in adult patients with stable CIDP.

OmniAb Reports First Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, May 11, 2023

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three months ended March 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three months ended March 31, 2023, and provided operating and partner program updates.
  • On November 1, 2022, OmniAb completed a spin-off from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND), resulting in OmniAb becoming an independent publicly traded company.
  • Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company.
  • First quarter 2023 and recent partner highlights include the following:
    Immunovant announced that it expects to report initial results from its Phase 2 clinical trial in Graves’ disease in the second half of 2023.

Seismic Therapeutic Announces Presentation of Preclinical Data for Immunoglobin Sculpting Enzyme and Dual-Cell Bidirectional Antibody Programs at IMMUNOLOGY 2023

Retrieved on: 
Tuesday, May 9, 2023

Enzymes that specifically cleave antibodies may eliminate circulating and immune-complexed Ig, as well as cell surface B cell receptors, thereby modulating Ig-mediated autoimmunity and inflammation.

Key Points: 
  • Enzymes that specifically cleave antibodies may eliminate circulating and immune-complexed Ig, as well as cell surface B cell receptors, thereby modulating Ig-mediated autoimmunity and inflammation.
  • Seismic’s DcB antibody approach targets dysregulated cell-mediated immunity by optimally engaging both T cells and antigen presenting cells (APCs), such as B cells to restore homeostasis.
  • “Our lead Ig sculpting program, a pan-IgG protease, is suitable for the treatment of acute and chronic autoantibody mediated diseases.
  • We are also applying our insights to design additional Ig sculpting enzymes that are selective for IgG subclasses and other Ig isotypes.

Advanced Infusion Care (AIC) now offers Kedrion Biopharma infusion therapy GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified]

Retrieved on: 
Thursday, March 9, 2023

The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized in-home infusion services.

Key Points: 
  • The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized in-home infusion services.
  • This new therapy option, offered under a limited distribution contract with Kedrion, expands AIC’s ability to serve immunoglobulin (Ig) infusion patients.
  • “We’re proud to be able to add GAMMAKED™ to our growing list of Ig infusion therapies,” said Jud Hall, President at AIC.
  • AIS Healthcare is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers.