PharmaShots

APRIL 13, 2023

Shots: The US FDA has placed a partial clinical hold on the initiation of evobrutinib (BTK) inhibitor in new patients and those with less than 70 days of exposure The decision was based on the response of laboratory results which suggested drug-induced liver injury during the P-III studies (EVOLUTION RMS 1 & 2).

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Express Pharma

APRIL 1, 2024

The efficacy of Usnoflast (ZYIL1) has been established in several validated pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS). ZYIL1 was found distributed in the brain and CSF of various nonclinical species including mice, rats and non-human primates.

Clinical Pharmacology 64

Clinical Pharmacology Drug Development 64

Pharmaceutical Technology

JUNE 2, 2023

The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients. Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features.

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Pharmaceutical Technology

FEBRUARY 7, 2024

IMS-001 is under clinical development by Imstem Biotechnology and currently in Phase II for Secondary Progressive Multiple Sclerosis (SPMS).

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Express Pharma

OCTOBER 24, 2023

Zydus Life Sciences has received permission from CDSCO, India, to initiate the Phase II clinical study of NLRP3 inhibitor ‘ZYIL1’ in patients with amyotrophic lateral sclerosis (ALS). ALS results in loss of motor neurons in the brain and spinal cord which controls voluntary muscle movement.

Clinical Pharmacology 87

Clinical Pharmacology Drug Development 87

Pharmaceutical Technology

FEBRUARY 7, 2024

IMS-001 is under clinical development by Imstem Biotechnology and currently in Phase II for Primary Progressive Multiple Sclerosis (PPMS).

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Pharmaceutical Technology

NOVEMBER 17, 2023

(Atorvastatin + fluconazole + minocycline) is under clinical development by GlobeStar Therapeutics and currently in Phase I for Relapsing Multiple Sclerosis (RMS).

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Big Molecule Watch

SEPTEMBER 12, 2023

Tyruko ® injection is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). The post Sandoz Receives FDA Approval for Tyruko® (natalizumab-sztn), the First and Only FDA-Approved Biosimilar for Relapsing Forms of Multiple Sclerosis appeared first on Big Molecule Watch. Sarah Yim, M.D.,

Biosimilars 62

Biosimilars 62

Pharmaceutical Business Review

JANUARY 4, 2024

This therapy is designed for the treatment of multiple sclerosis (MS), a chronic neurodegenerative autoimmune disease. “This is a clear paradigm shift for autoimmune diseases, and a testament to our commitment to expand potentially life-changing therapeutic benefits to multiple indications.”

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Pharmaceutical Business Review

MAY 5, 2023

Under the collaboration, Neogap will provide its EpiTCer technology for Cellerys’ upcoming Phase II study of an innovative cell therapy to fight multiple sclerosis. The RED4MS therapy is being studied for the induction of antigen-specific immune tolerance in multiple sclerosis patients.

Immunity 52

Immunity Immunization 52

European Pharmaceutical Review

FEBRUARY 26, 2024

A new treatment for ALS A marketing authorisation for the new treatment Qalsody* (tofersen) was recommended by the CHMP for exceptional circumstances in adults with the rare disease amyotrophic lateral sclerosis (ALS). After 12 weeks, patients treated with danicopan had a clinically-relevant increase in haemoglobin (an average of 2.35

Generic Medicine 92

Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies 92

Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Pharmaceutical Technology

MAY 30, 2023

The formulation is intended for indications, including systemic sclerosis, graft versus host disease, systemic lupus erythematosus 151, central nervous system inflammatory diseases associated with multiple sclerosis and infectious diseases linked to Covid-19.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Business Review

OCTOBER 24, 2023

FT011 is a first-in-class oral therapy designed to treat chronic fibrosis in multiple organs. It is currently progressing through clinical development for the treatment of scleroderma. indicating the highest likelihood of clinical improvement. In the pooled FT011 groups, three patients reached a maximum CRISS score of 1.0,

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pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

Hospitals 116

Hospitals 116

Pharmaceutical Technology

MARCH 7, 2023

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy.

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pharmaphorum

NOVEMBER 11, 2021

MSCopilot, a smartphone-based app that is used by patients with multiple sclerosis to gauge how their symptoms are developing, has been shown to correlate closely with measures used by neurologists in a clinical trial. The post MSCopilot app tracks MS symptoms as well as standard tests; study appeared first on.

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Pharmacy Times

MARCH 28, 2024

The manager of clinical pharmacy at UPMC Health Plan describes the significance of the pharmacist’s role in multiple sclerosis care and when collaborating with other health care providers.

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pharmaphorum

SEPTEMBER 11, 2020

Roche has hit back at Novartis’ newly-approved multiple sclerosis drug Kesimpta, with new data from its already-marketed blockbuster Ocrevus. Ocrevus (ocrelizumab) was approved in 2017 for relapsing and primary progressive forms of MS and is seen as one of the most successful drug launches in pharma history, generating sales of $3.79

Labelling 86

Labelling 86

Pharmaceutical Business Review

MARCH 13, 2024

These measures include day-to-day function, cognition, motor and clinical progression in people living with HD. In January 2024, Prilenia revealed successful discussions with global regulatory agencies concerning pridopidine’s development for amyotrophic lateral sclerosis (ALS), with a pivotal Phase III study in the pipeline.

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Big Molecule Watch

MARCH 27, 2023

Reddy’s proposed abatacept biosimilar and obtain exclusive rights to develop and commercialize COYA 302 across multiple neurodegenerative diseases in multiple territories, including in North and South America, the EU, United Kingdom, and Japan. Dr. Reddy’s will have exclusive rights to the same in areas outside of these territories.

Biosimilars 70

Biosimilars Labelling 70

European Pharmaceutical Review

FEBRUARY 6, 2023

In a recent Phase II study , FT011, a novel, first-in-class oral therapy for chronic fibrosis in multiple organs showed meaningful improvements in over 60 percent of scleroderma patients after 12 weeks. Evidence demonstrates the role this GPCR has on multiple downstream pathways causing inflammation and fibrosis.

Labelling 86

Labelling 86

pharmaphorum

NOVEMBER 17, 2022

The community should be included in important decisions about their health, particularly in the early stages of clinical trial design to ensure research is designed to address unmet needs and in a way that encourages participation. The post The future of clinical research in neurology must be driven by community voices appeared first on.

Drug Development 83

Drug Development 83

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . While it requires a clinic visit, Ocrevus only has to be administered twice a year. billion in sales in 2028.

Hospitals 111

Hospitals Documentation 111

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. InnoCare says it will also introduce the restrictions on studies ongoing outside the US.

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PharmaShots

MAY 31, 2023

Smriti: Give our readers a comparative view between matching analysis of VUMERITY (diroximel fumarate) to Ponvory (ponesimod) and Aubagio (teriflunomide) for the treatment of Multiple Sclerosis. Smriti: Shed some light on the details (MOA, ROA, formulation, etc.) of TECFIDERA (dimethyl fumarate).

Vaccines 40

Vaccines Drug Development 40

pharmaphorum

DECEMBER 14, 2021

It also adds various other clinical-stage cardiovascular projects including temanogrel – in phase 2 for microvascular obstruction and Raynaud’s phenomenon secondary to systemic sclerosis – and acute heart failure candidate APD418. Analysts at Wells Fargo have said they think etrasimod could become a $2.5

Compounding 98

Compounding Vaccines 98

PharmaShots

APRIL 5, 2023

maintenance phase results showed a dose-linear increase in clinical remission, 10 & 30mg, qd of vidofludimus calcium showed clinical remission rate (42.3% & 61.5% vs 27.8%); steroid-free clinical remission rate (38.5% & 61.5% vs 27.8%); steroid-free clinical remission rate (38.5% & 61.5%

Immunity 40

Immunity Immunization 40

PharmaShots

JUNE 2, 2023

Shots: The EC has approved Briumvi for adult patients with RMS with active disease defined by clinical or imaging features. Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

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Pharmaceutical Technology

NOVEMBER 30, 2022

Multiple sclerosis (MS) is an autoimmune disease causing chronic inflammation and demyelination of the nerves, affecting around 2.5 million people worldwide. Currently, only Roche’s Ocrevus (ocrelizumab) is available for this patient population and its efficacy is limited.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies 98

RX Note

JANUARY 29, 2024

External Links UpToDate - Management of restless legs syndrome and periodic limb movement disorder in adults Mayo Clinic - Restless legs syndrome Therapeutic effects of magnesium and vitamin B6 in alleviating the symptoms of restless legs syndrome: a randomized controlled clinical trial, 2022 mirtazapine and SSRIs).

Mayo Clinic 52

Mayo Clinic Diabetes 52

Pharmaceutical Technology

FEBRUARY 19, 2023

Annexuzlimab is under clinical development by MedAnnex and currently in Phase I for Kidney Cancer (Renal Cell Cancer). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also provides non-clinical testing programs.

Drug Development 40

Drug Development 40

pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

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pharmaphorum

OCTOBER 14, 2021

Multiple sclerosis drug Kesimpta has shown promising safety data for patients who are exposed to it for extended periods. Meanwhile, a Phase 3 open-label extension (OLE) of Roche’s Ocrevus (ocrelizumab) reveals a 35% reduction in the risk of patients needing a walking aid in relapsing multiple sclerosis (RMS) after 7.5

Labelling 59

Labelling Immunity Immunization 59

Pharmaceutical Technology

APRIL 18, 2023

PIPE-307 has already been evaluated in two Phase I clinical trials in healthy patients, and has also received Food and Drug Administration (FDA) clearance as an investigational new drug (IND) to commence its clinical development in patients with relapsing-remitting multiple sclerosis (RRMS).

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European Pharmaceutical Review

MAY 2, 2024

Recent developments in the biologic therapies sector include the authorisation of Pyzchiva ® (biosimilar ustekinumab) by the European Commission, and promising 12-month data for Roche’s subcutaneous injection of OCREVUS ® (ocrelizumab) for relapsing or primary progressive multiple sclerosis.

Biosimilars 100

Biosimilars Drug Development 100

PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

Biosimilars 53

Biosimilars Immunity Immunization 53