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Monday, May 23, 2022

Learning about GAIT Issues in MS (Spasticity, Foot Drop, Walking & etc)

Supported by:  Sanofi, Biogen and Genentech


Video: Mental Wellness April Chat on Couples and MS - Recognizing when Counseling May Help

Click to watch 

Wednesday, May 18, 2022

The first decade of biosimilars – and beyond

Information showing is for meds released in recent years and for many still to come.

March 2017

Ahead of this year’s eyeforpharma conference in Barcelona, Richard Staines speaks to Sandoz’s CEO Richard Francis about the latest developments in biosimilars.

Richard Francis, CEO of Novartis’ generics and biosimilars division, Sandoz, says that 2016 was a key year for the company, which for the first time topped a billion dollars in total biopharmaceuticals sales.

It was also the 10th anniversary of the first biosimilar commercialization in Europe – Sandoz’s Omnitrope (somatropin) growth hormone.

Sandoz is now global leader by net sales in biosimilars, which are cheaper, follow-on versions of existing biologic drugs, approved on the basis that they have been shown to be equivalent in terms of safety and efficacy.

And biosimilars are playing an increasingly important role in the business, says Francis, who will be speaking at eyeforpharma Barcelona, which runs from 14-17 March.

Francis notes the Omnitrope approval preceded the first iPhone – quite an achievement – and at a time when the health systems of developed countries are under intense pressure to become more efficient, biosimilars could play a key role.

IMS Health estimates biosimilars could save up to $110 billion in health systems across Europe and the US, by providing cheaper competitors to well-established biologic drugs.

Sandoz was also the first company to get a biosimilar approved in the US, with Zarxio – a competitor to Amgen’s white blood cell booster, Neupogen (filgrastim) in 2015.

Francis states that Zarxio has passed $100 million in sales and has now overtaken the reference product in volume market share.

He explains: “This is not just a significant commercial milestone, reinforcing our position as the pioneer and global leader in biosimilars, with three marketed and four approved products – more than any other company.

“It also represents another step towards delivering on our purpose at Sandoz: to pioneer novel approaches to help people around the world access high-quality healthcare.”

Biosimilars play a key role in this – they generate cost savings and improve access by expanding the overall size of the market, according to Francis.

He notes that in the UK, biosimilar filgrastim is now well established and has increased use of the drug as a first-line treatment.

The challenge for biosimilars companies like Sandoz is to bring to market medicines based around larger, more complex proteins and monoclonal antibodies.

The FDA has also approved Sandoz’s biosimilar of Amgen’s Enbrel (etanercept) inflammatory diseases drug in all the indications of the reference product, which Francis cites as another important milestone.

Even more complicated than Enbrel are the monoclonal antibody-based drugs, which have revolutionized care of a diverse range of diseases over the last two decades.

It’s been a long journey for regulators to find ways of approving copies of these drugs, and billions of dollars in research by companies such as Sandoz to meet their stringent requirements.

The European Medicines Agency led the way with its ground-breaking work on how to ensure biosimilars are as close to the originator as possible, and as safe and effective.

But with Sandoz’s biosimilar of Enbrel approved in the US, a biosimilar of Johnson & Johnson’s Remicade (infliximab) approved and launched, and a biosimilar of AbbVie’s Humira (adalimumab) also approved, biosimilars could finally begin to shape the US market.

“We are proud to have developed two of the first four biosimilars to be approved in the US,” Francis adds.

In Europe, Sandoz’s biosimilar of Roche’s MabThera (rituximab) and its Enbrel biosimilar are both under review, and Francis said strong clinical data from the ASSIST-FL and EGALITY trials for rituximab and etanercept, respectively, has given confidence in filings.

Another key development last year was the Norwegian government’s NOR-SWITCH study – as an early adopter of biosimilar infliximab in Europe, Norway was an ideal test-bed for a study exploring whether it is safe to switch patients over to biosimilars.

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Tuesday, May 17, 2022

Exploring Diversity in the Multiple Sclerosis Community - (Part 2) - Are people of color being represented in Clinical Trials

Listen to the conversations with Sheila L. Thorne, President & CEO of Multicultural Healthcare Marketing Group, LLC and Mitzi Joi Williams, MD, FAAN  - an MS Neurologist 

in this second part of a two part series

Topics for this segment: 

• Minority participation in clinical trials

• Clinical trials in MS today - Are people of color being represented?

• COVID-19 and the MS Community 

• Q&A with presenters- An open conversation with the MS community

Supported by Biogen, Genentech and EMD Serono ___________________________________________

Exploring Diversity in the Multiple Sclerosis Community - part 1 - Good information for ALL to be watching, Learning and sharing

 Published: May 9, 2022

Listen to the presentations from:

 Sheila L.Thorne, President & CEO of Multicultural Healthcare Marketing Group, LLC 

and Mitzi Joi Williams, MD, FAAN  - MS Neurologist

-- as they have discussions on: 

 • Diversity and differences for People of Color living with MS

• Health disparities- The importance of representation of people of color in clinical trials

Listen with each presenter separately and then they speak together about the topics showing
This educational Program was supported by: Biogen, Genentech and EMD Serono

MS patients treated with rituximab may receive COVID-19 vaccine as soon as possible

 May 17, 2022

Rituximab-treated patients with MS may be vaccinated for COVID-19 as soon as possible, researchers reported in JAMA Network Open.

Andreas Tolf, MD, of the department of medical sciences at Uppsala University in Sweden, and colleagues conducted a prospective cohort study from Jan. 21 to Dec. 1, 2021, and analyzed data from 67 participants with planned or ongoing treatment with rituximab.

Source: Adobe Stock.
Source: Adobe Stock.

Researchers assessed serological vaccine responses by measuring quantitation of anti-spike IgG antibodies and anti-receptor-binding domain (RBD) IgG antibodies, as well as their neutralizing capacities.

Among the 60 patients currently receiving rituximab (49 women; mean age, 43 years), the median disease duration for MS was 9 years (range, 1-29 years), and the median drug dose was 2,750 mg (range, 500-10,000 mg). Vaccine responses were determined before vaccination with tozinameran and 6 weeks after.

Researchers established cutoff values for anti-spike IgG (264 binding antibody units/mL) and anti-RBD IgG (506 units/mL) to determine the proportion of patients who had a positive response, indicated by an increased number of B cells. A cutoff for B-cell count of at least 40/µL was associated with an optimal serological response.

Six months after the last rituximab infusion, data on B-cell counts were available for 48 patients, and 29 (60%) had a B-cell count of at least 10/µL. Of those 29 patients, 26 (90%) had positive results for anti-spike IgG antibodies, 21 (72%) for anti-RBD IgG antibodies, and 27 (93%) developed antibodies with greater than 90% inhibition of angiotensin-converting enzyme 2.

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Friday, May 13, 2022

Identification of four novel T cell autoantigens and personal autoreactive profiles in multiple sclerosis

 Published by: Science Advances - April 27, 2022


Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS), in which pathological T cells, likely autoimmune, play a key role. Despite its central importance, the autoantigen repertoire remains largely uncharacterized. Using a novel in vitro antigen delivery method combined with the Human Protein Atlas library, we screened for T cell autoreactivity against 63 CNS-expressed proteins. We identified four previously unreported autoantigens in MS: fatty acid–binding protein 7, prokineticin-2, reticulon-3, and synaptosomal-associated protein 91, which were verified to induce interferon-γ responses in MS in two cohorts. Autoreactive profiles were heterogeneous, and reactivity to several autoantigens was MS-selective. Autoreactive T cells were predominantly CD4+ and human leukocyte antigen–DR restricted. Mouse immunization induced antigen-specific responses and CNS leukocyte infiltration. This represents one of the largest systematic efforts to date in the search for MS autoantigens, demonstrates the heterogeneity of autoreactive profiles, and highlights promising targets for future diagnostic tools and immunomodulatory therapies in MS.

                                            Click this, to see full image


Multiple sclerosis (MS) is an organ-specific inflammatory, likely autoimmune, disease of the central nervous system (CNS) in which cells of the adaptive immune system cross the blood-brain barrier (BBB) and cause localized CNS inflammation, demyelination, and axonal damage (1). While more common in certain brain regions and the spinal cord, the inflammation can occur practically anywhere within the CNS and gives rise to a wide variety of neurological impairments. A definite trigger for the disease has not yet been identified but is believed to depend on an interplay of genetic, environmental, and lifestyle factors, which leads to pathological immune responses (2). The human leukocyte antigen (HLA) class II DRB1 locus with a DR15 haplotype, carrying the DRB1*15: 01 and DRB5*01:01 alleles, is the strongest genetic risk factor for MS, with an approximately threefold increased risk of disease, and implicates a central role for CD4+ T cells in disease development (3).
Much effort has been put into identifying MS-relevant T cell autoantigens. While myelin proteins such as myelin basic protein (MBP), proteolipid protein (PLP), and myelin oligodendrocyte glycoprotein (MOG) are currently considered T cell targets in MS, data remain inconsistent (411). Several other candidates have been reported in recent years, notably RAS guanyl-releasing protein 2 (12), GDP-L-fucose synthase (13), β-synuclein (14), αB-crystalline (15), and the autoantibody target anoctamin 2 (16), but the autoantigen repertoire known so far is likely to be incomplete (17).
With the emergence of antigen-specific immunotherapies, the interest in identifying novel autoantigens has intensified alongside their potential as future treatment targets (18). This treatment strategy is hypothesized to be effective while safer than currently available broadly acting immune-modulatory agents associated with risks for side effects such as infections and possibly cancer (1920). In animal models, where the autoantigens are both limited and defined, this strategy has shown promising results (2122), whereas in clinical trials in MS treatments targeting myelin antigens, they have been, if safe, of modest efficacy at best (2327). One explanation for the lack of efficacy is that effective tolerization therapy requires targeting of a greater number of autoantigens and preferably personalized according to each individual’s disease-driving autoantigens (17).

Monday, May 9, 2022

Exploring Diversity in the MS Community - part 1

 Listen to the presentations from Sheila L.Thorne, President & CEO of Multicultural Healthcare Marketing Group, LLC and Mitzi Joi Williams, MD, FAAN - MS Neurologist

• Discussions about diversity and differences for people of color living with MS

• Health disparities- The importance of representation of people of color in clinical trials

The Population of "white" people has declined dramatically in the USA while the numbers of People of Color has grown -- Listen to discussion to understand more.

The USA is now known as a Multicultural society. Removing disparities is needed...

Listen to this entire video to understand more.......

Multiple Sclerosis Vlog: DIET and MULTIPLE SCLEROSIS -- Wheelchair Weight Loss?

 LEARN how to lose weight if you have a slow metabolism due to being in a wheelchair or mobility scooter. 

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