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.”

FDA 98

FDA Patients Healthcare Healthcare 98

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.

Food and Drug Administration 98

Food and Drug Administration Engineering Food Patients 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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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

Medicine 91

Medicine Patients Marketing Pharmaceutical 91

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.

Side effects 115

Side effects Patients Marketing Safety 115

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.

Side effects 100

Side effects Patients Leads Safety 100

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.

Recruitment 52

Recruitment FDA Medical Pharmaceutical 52

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.

Patients 20

Patients Management 20

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.

Patients 83

Patients 83

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.

Physicians 85

Physicians Patients Safety Pharmaceutical 85

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.

Patients 98

Patients Side effects Safety Pharmaceutical 98

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.

FDA 66

FDA Side effects Biopharma Prospecting 66

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.

Pharmaceutical 40

Pharmaceutical Patients 40

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).

Food and Drug Administration 52

Food and Drug Administration Food FDA Patients 52

Medgadget

NOVEMBER 16, 2022

Muscle atrophy, where muscles progressively waste away, can be caused by a variety of factors, from immobility because of injury, to neurological disorders, such as amyotrophic lateral sclerosis and multiple sclerosis.

Engineering 113

Engineering Medicine 113

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.

Medical 52

Medical 52

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

Marketing 52

Marketing Side effects Safety Specialization 52

European Pharmaceutical Review

OCTOBER 20, 2022

In this article, Sangamo Therapeutics’ Chief Scientific Officer, Jason Fortenot, explains why CAR Tregs may become transformational therapeutics for immune-mediated diseases, highlighting the challenges his company has overcome to get the first ever engineered Treg therapy into clinical trials. Supporting evidence.

Engineering 125

Engineering Side effects Manufacturing Patients 125

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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Side effects Safety Biopharma Recruitment 79

European Pharmaceutical Review

MAY 16, 2023

1 Since the first therapy using stem cells was developed in 1957, only few stem cell-based therapies have entered the clinic 1 as advanced therapy medicinal products (ATMPs). in a 2023 paper published in the Journal of Clinical Microbiology. Scaling up human mesenchymal stem cell manufacturing using bioreactors for clinical uses.

Manufacturing 86

Manufacturing Medicine Marketing Medical 86

pharmaphorum

JANUARY 15, 2023

Neurological conditions like Multiple Sclerosis (MS) are an incredibly important area of research when it comes to drug discovery, but under that (sometimes mistaken) umbrella diagnosis occur other, rarer diseases, such as Neuromyelitis Optica Spectrum Disorder (NMOSD). I had several dozen patients […] in my clinic.

Patients 87

Patients Medicine Physicians Medical 87

European Pharmaceutical Review

AUGUST 9, 2023

In REMIX-2, the clinical trial enrolled 455 participants with CSU. There were 470 participants in the REMIX-1 study.

Safety 72

Safety Medical Patients Pharmaceutical 72

pharmaphorum

JULY 15, 2022

Akili looks like it could bring another digital therapeutic (DTx) to market after a clinical trial backed the efficacy of its AKL-T01 in patients with the autoimmune disorder systemic lupus erythematosus (SLE). million people in the US are living with SLE.

Patients 102

Patients Engineering Marketing Medical 102

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.” The sarcopenia study met both of its primary endpoints.

Food and Drug Administration 107

Food and Drug Administration Side effects Pharmaceutical Leads 107

European Pharmaceutical Review

FEBRUARY 21, 2023

Notably Wakeley explained: “new R&D is opening up the potential of these medicines in new indications, eg, epilepsy and multiple sclerosis (MS).” Arthur Wakeley What data can you share about clinical trials for cannabis-based medicines? James Short What were the key challenges for Celadon during the GMP registration process?

Medicine 130

Medicine Manufacturing Specialization Pharmaceutical 130

pharmaphorum

JANUARY 26, 2023

Roche and Boehringer Ingelheim have both formed partnerships with tech companies this week to develop and deploy wearable biosensor technology for use in clinical trials and patient monitoring.

Patients 68

Patients Healthcare Healthcare Pharma 68

European Pharmaceutical Review

APRIL 3, 2023

The committee adopted a positive opinion for Briumvi (ublituximab) for relapsing multiple sclerosis (MS). It relies partly on results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data. It is the eighth vaccine recommended in the European Union (EU) for COVID-19.

Medicine 85

Medicine Pharmaceutical Marketing Patients 85

European Pharmaceutical Review

FEBRUARY 29, 2024

We have access to multiple modalities such as biologics, gene therapies, antisense oligonucleotides. A key challenge in treating rare diseases is that “patient populations are so small that patients struggle to find a diagnosis and in turn it is difficult to recruit clinical trials.

Medicine 72

Medicine Patients Recruitment Training 72

Pharmaceutical Technology

FEBRUARY 20, 2023

ABN-401 is under clinical development by Abion and currently in Phase II for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Abion is headquartered in Seoul City, Seoul, South Korea.

Pharmaceutical 40

Pharmaceutical 40

pharmaphorum

DECEMBER 22, 2022

If approved, etrasimod will mount a direct challenge to Bristol-Myers Squibb’s S1P drug Zeposia (ozanimod), which was approved for UC last year and also for a green light to treat multiple sclerosis in 2020.

Pharmacology 52

Pharmacology Safety Patients Marketing 52

Pharmaceutical Technology

JANUARY 30, 2023

In June 2021, the FDA granted accelerated approval of Biogen’s (Cambridge, MA, US) Aduhelm (aducanumab-avwa) for Alzheimer’s disease, despite there being questionable evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug’s approval. months longer on the treatment.

Manufacturing 52

Manufacturing FDA Side effects Marketing 52

Pharmaceutical Technology

NOVEMBER 4, 2022

Scottish projects are already showing significant potential in diagnosing and treating conditions such as liver fibrosis, dementia, multiple sclerosis, cancer, and diabetes. Treating multiple sclerosis and other brain health conditions. Multiple sclerosis is one condition undergoing research in this field.

Medicine 52

Medicine Medical Patients Side effects 52

pharmaphorum

JULY 4, 2022

Hughes – currently Vertex’s head of clinical development and translational medicine – will make the move to his new employer on 1 August, less than a year after taking on the role. Eric A Hughes.

Medicine 52

Medicine Specialization Competition Medical 52

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Merck overview Merck, a subsidiary of E. Merck KG, is a science and technology company.

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Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Merck overview Merck, a subsidiary of E.

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