multiple sclerosis

Roche Collaborates with Temedica to Launch Brisa App for the Treatment of Multiple Sclerosis

Shots: The companies collaborated to launch a digital companion app i.e., Brisa to treat patients with MS. The app will be offered free of charge for users and motivates to change lifestyle in the long term The Brisa app is designed as an individual digital companion & will collect daily health data like activity, sleep, …

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Biogen reaches across globe and pays $125M to land its next new MS drug

By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the disease by targeting a particular enzyme highly expressed in the central nervous system. But Biogen still has some catching up to do.

Biogen builds MS pipeline via $125m deal with China’s InnoCare

Biogen has moved to shore up its besieged multiple sclerosis franchise by licensing a BTK inhibitor from Chinese biotech InnoCare currently in mid-stage clinical testing. InnoCare gets $125 million upfront in return for sharing rights to orelabrutinib, an orally-active BTK drug that is able to cross the blood-brain barrier and penetrate the central nervous system. …

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Biogen Signs a License Agreement with Innocare for Orelabrutinib to Treat Multiple Sclerosis

Shots: InnoCare to receive $125M as up front & is eligible to receive ~ $812.5M as development & commercial milestones, following the achievement of definite milestones along with royalties on sales of any product resulting from the collaboration Biogen to get exclusive rights for orelabrutinib to treat MS globally & other autoimmune diseases outside of …

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Foods, supplements, and medicine: the new frontier in chronic disease treatment

Chronic diseases are the biggest threat to our global socio-economic development. Lifestyle diseases including heart disease, neuro-degenerative disease, diabetes, and cancer collectively kill almost 50 million people per year.1 With 1 in 2 Americans diagnosed with pre-diabetes or type 2 diabetes, there is no doubt that the food we eat has implications not only for …

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ViewPoints Interview: Janssen’s Dr. Allitia DiBernardo Shares Insights on the Availability of Ponvory in the US

In an interview with PharmaShots, Dr. Allitia DiBernardo, Global Head of Medical Affairs for Neurology at the Janssen share her views on the availability of Ponvory in the US for MS patients. Shots: Ponvory offers patients superior efficacy in reducing annualized relapses and brain lesions over established oral therapy teriflunomide (Aubagio), with a safe and …

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NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis

NICE has issued a final “no” to Bristol-Myers Squibb’s oral MS drug Zeposia (ozanimod), in a decision that prevents access for patients in England and Wales. This ruling means that there will be a divide in access to Zeposia in the UK, after the Scottish Medicines Consortium allowed funding in February for the drug in …

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Repertoire Collaborates with Yale University to Identify Novel Antigen and T- Cell Receptor for Multiple Sclerosis

Shots: Repertoire and Yale University collaborated to understand the immunological causes of MS by identifying the specificity of various subsets of T cells The focus of the agreement is to determine the specificity of T cells obtained from the CSF of patients living with MS and determine the pathogenic T cells driving MS and the …

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ViewPoints Interview: Biogen’s Monica Mann Shares Insight on Plegridy to Treat Multiple Sclerosis

In an interview with PharmaShots, Monica Mann, Head of Global Medical, Multiple Sclerosis at Biogen shares her views on the Plegridy and how it works on MS patients. She also shed light on the approval of the therapy in the US and EU. Shots: The approval of Plegridy (IM) by the EC and the US …

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Genentech Presents New Data of Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Multiple Sclerosis at AAN2021

Shots: The interim analysis of open-label P- IIIb ENSEMBLE study of Ocrevus (ocrelizumab) showed 85% of patients achieved no evidence of disease activity in early-stage RRMS, low annualized relapse rate, improvement in EDSS score The post-hoc analysis of P-III ORATORIO study of Ocrevus vs PBO showed slow loss of brain tissue within T2 MRI lesions …

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Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue

A Helius Medical Technologies medical device that stimulates the brain by sending electrical stimulation to the tongue has received FDA clearance for multiple sclerosis patients. The company says its approach could also have applications in other disorders.

Helius Medical’s PoNS Receives the US FDA’s Approval to Improve Gait in Multiple Sclerosis Patients

Shots: The approval is based on two clinical studies and a retrospective analysis of RWD. The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients aged ⥸22yrs. The approval will help in improving the walking gait of people with MS in combination with a …

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Teva faces EU antitrust probe over MS drug Copaxone

The European Commission has formally opened an antitrust investigation into Teva, which will assess whether the pharma company illegally delayed launches and use of generic versions of its blockbuster multiple sclerosis drug Copaxone. Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing …

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COVID-19 increased demands on carers’ wellbeing, study finds

COVID-19 has increased demands on informal carers and severely increased demands on their mental, physical and financial wellbeing, according to a global study. Embracing Carers is a global initiative led by Germany’s Merck KGaA and is focused on recognising and raising awareness about the role of informal carers. It intends to develop solutions with global …

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Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

Shots: The multicenter survey involves assessing Kesimpta Sensoready autoinjector pen in 80 MS patients and 50 MS nurses, with RMS who received a disease modifying treatment through a subcutaneous/intramuscular injection via an autoinjector The result shows MS patients and nurses prefer the Kesimpta Sensoready autoinjector pen over other autoinjectors for current treatment (84% vs 16%). …

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BMS’ MS pill gets funding in Scotland after rejection in England by NICE

Scotland’s drugs cost-effectiveness body has recommended Bristol-Myers Squibb’s Zeposia multiple sclerosis pill, setting a potential north-south access divide following a draft rejection in England by NICE last month. There are a range of MS drugs on the market but Zeposia does not have the common unpleasant gastrointestinal side effects that can occur with Biogen’s Tecfidera. …

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CHMP clears way for EU approval of Novartis’ MS drug

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. Kesimpta (ofatumumab) started life as an oncology drug and was first developed by Genmab and licensed to GlaxoSmithKline who marketed under the brand name Arzerra to …

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From Analog to Digital Neurology: 3 Steps to Better Inform Patient Care

Dr. Nandor Pinter, Director of Neuroimaging Research, DENT Institute Dr. Murray Gillies, General Manager of Digital Cognitive Dx Venture, Philips The field of neurology is at an inflection point. With a growing aging population, neurologists are facing an increasing number of patients needing care, and the pent-up demand for services due to COVID-19 only exacerbates …

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NICE rejects BMS’ Zeposia MS pill in provisional guidance

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance. The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a). But in its first draft guidance NICE said …

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Clene goes public with gold-based neurology nanotechnology

Biotech Clene Nanomedicine has gone public with a mission to use nanotherapeutics that will use gold to treat devastating neurological diseases including Parkinson’s disease. Over the Christmas period Clene closed a reverse merger with Tottenham Acquisition I Limited, allowing shares to be publicly traded on the Nasdaq stock exchange. The US-based company says it aims …

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Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Shots: The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. …

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis Read More »

Bridging the gap between pharma and the NHS in MS

Janette Curlis is a Multiple Sclerosis Nurse Advisor (MSNA) at Biogen, helping to support the company’s Multiple Sclerosis (MS) field teams and developing patient and Healthcare Professional (HCP) materials. We spoke to her about being a bridge between pharma and the NHS and the challenges that are facing Multiple Sclerosis Nurses (MSNs) and patients today. …

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What About the Trans Fat in Animal Fat?

The years of healthy life lost due to our consumption of trans fats are comparable to the impact of conditions like meningitis, cervical cancer, and multiple sclerosis. But, if “food zealots” get their wish in banning added trans fats, what’s next? I explore this in my video Banning Trans Fat in Processed Foods but Not …

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Lilly to buy private biotech Disarm Therapeutics for up to $1.36bn

Eli Lilly is to buy the private biotech Disarm Therapeutics, which is working on a new class of disease-modifying drugs for neurological diseases, in a deal worth up to $1.36 billion. Massachusetts-based Disarm is focused on treatments for diseases caused by axonal degeneration, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm has discovered …

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NICE changes its mind on Novartis’ progressive MS drug Mayzent

UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance. The change of heart means Mayzent (siponimod) becomes the first oral disease-modifying therapy to be recommended for NHS use in SPMS patients with active disease, defined as relapses or evidence of …

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Cleveland Clinic Names Top 10 Medical Innovations For 2021

Cleveland Clinic’s top clinicians and researchers present the top 10 medical innovations transforming medical advancements and new awards to recognize healthcare innovation. The list of breakthrough technologies was selected by a committee of Cleveland Clinic subject matter experts, led by Will Morris, M.D., executive medical director for Cleveland Clinic Innovations, and Akhil Saklecha, M.D., managing …

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Mission successful for Novartis after FDA approves ofatumumab in MS

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. Kesimpta will have a list price of around $83,000 a year, which the …

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Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and …

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis Read More »

Teva shares slide as it faces illegal kickback charges from US government

Shares in Teva were down sharply this week after the US Department of Justice filed a complaint that the company paid illegal kickbacks to patient groups to boost sales of its multiple sclerosis drug Copaxone (glatiramer). The allegation is that Teva’s subsidiaries Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. illegally paid Medicare co-payment costs …

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Sanofi adds BTK inhibitors to pipeline with $3.68bn Principia Biopharma acquisition

Sanofi is to buy Principia Biopharma for up to $3.68 billion, adding a potential multiple sclerosis drug to its pipeline. The French pharma said it will pay $100 per share in cash for San Francisco-based Principia, which specialises in Bruton’s kinase (BTK) inhibitor drugs, after the deal was unanimously agreed by both boards of directors. …

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Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Shots: The real-world evidence partnership will allow the Roche to access PicnicHealth’s set of de-identified patient records to gain insights on certain diseases and treatments The collaboration will initially focus on MS and may be extended to support Huntington’s disease (HD), paroxysmal nocturnal hemoglobinuria (PNH), and hemophilia The companies signed a multi-year collaboration that combines …

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Roche, PicnicHealth start RWD partnership with multiple sclerosis focus

The companies will use a combination of more than seven years of medical record data with five years of prospective data on 5,000 MS patients, including real-world outcomes data and MRI images. Other disease areas to be explored include hematology and rare diseases.

One Way to Treat Asthma and Autoimmune Diseases with Diet

Cutting two teaspoons of salt’s worth of sodium from one’s daily diet can significantly improve lung function in asthmatics In the 1960s and 1970s, a mystery was emerging. Why were childhood asthma rates between 2 to 5 percent in the developed world but as low as 0.007 percent in the developing world? For example, in …

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