Pharmaceutical Technology

APRIL 14, 2023

This will suppress the effector characteristics in multiple immune cell subsets. The effect was observed in patients with Covid-19 and multiple sclerosis, and also in healthy participants. After refining our clinical protocols, we need to discuss this approach with the FDA and plan to file an IND in 4Q 2023.”

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Immunization FDA 98

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).

FDA 40

FDA 40

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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FDA 98

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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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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Drug Store News

MARCH 22, 2023

Generic Aubagio treats relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults.

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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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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

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Generic Medicine Pharmaceutical Companies Pharmaceutical Companies Vaccines 93

Drug Store News

JANUARY 30, 2023

Briumvi is used to treat relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults.

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FDA 52

The Checkup by Singlecare

DECEMBER 29, 2022

Overview: What does multiple sclerosis (MS) feel like? Multiple sclerosis is an autoimmune disease that affects nerves in the brain and spinal cord. You may be at risk for developing MS symptoms if you have family members diagnosed with multiple sclerosis. MS symptoms , National Multiple Sclerosis Society.

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People Management Immunization 52

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.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

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.

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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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FDA 100

The Checkup by Singlecare

JANUARY 23, 2024

One placebo-controlled clinical study compared typical daily doses of either 600 mg or 1200 mg of guaifenesin twice daily to placebo in patients experiencing acute pain and muscle spasms in their back, neck, or shoulders. The results suggest there may be some clinically relevant use for guaifenesin as a muscle relaxer.

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FDA Labelling 105

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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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

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Labelling FDA 84

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.

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Labelling 88

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.

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Hospitals Documentation 110

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.

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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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FDA 75

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).

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Vaccines 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

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Compounding Vaccines FDA 98

The Checkup by Singlecare

JANUARY 11, 2024

Tolebrutinib for multiple sclerosis Tolebrutinib has shown promise as a novel oral treatment for multiple sclerosis (MS), and it could receive the FDA green light in 2024. It works by inhibiting Factor D, which may help reduce the overactive immune response that causes the destruction of red blood cells in PNH.

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FDA Immunization Patient Care Packaging 52

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.

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Pharmaceutical Companies Pharmaceutical Companies 98

Roots Analysis

FEBRUARY 6, 2023

Presently, several industry and non-industry stakeholders are evaluating SARM1 inhibitors as potential therapeutic agents for the treatment of neurological disorders across various preclinical studies and early stages of clinical development, worldwide. The market is characterized by a mix of well-established and small firms.

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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%

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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

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.

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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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FDA 98

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

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Labelling Immunization FDA 58

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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FDA 52

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 (..)

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FDA Immunization 53

PQA

SEPTEMBER 25, 2023

also highlight our members' perspectives on diversity and accessibility in clinical trials, improving adherence, and adherence to multiple sclerosis medications. Learn more about these opportunities and accomplishments below.We The data can also show short term results.

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Specialty Pharmacies Documentation Patient Care Immunization 52

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. The post Liver injuries prompt clinical hold on Sanofi BTK drug appeared first on. One of the main assets of Sanofi’s $3.7

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FDA 98

Pharmaceutical Technology

MAY 31, 2023

BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is administered through oral and rectal route.

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pharmaphorum

JUNE 7, 2022

Biogen and Alectos will collaborate on the remaining preclinical work on AL01811, with Biogen taking responsibility for the project if it reaches the clinical testing stage. It’s not the first time that Biogen has licensed rights to a drug targeting lysosomal function in Parkinson’s disease.

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Compounding 79