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Vivoryon is de naam. Daarom nieuw draadje

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Alzheimers News today 11/4 over Biogen. Deels goed nieuws: patiënten krijgen kosten vergoed als ze deel uitmaken van een onderzoek, maar niet als er alleen maar zicht is op enig resultaat.

News
Medicare Coverage of Aduhelm Will Be Limited to Patients in Trials

by Marisa Wexler MS | April 11, 2022




The Centers for Medicare and Medicaid Services (CMS), in a final national policy decision, is allowing Medicare to cover the cost of Aduhelm (aducanumab) and other medicines in its class given accelerated approval only for Alzheimer’s disease patients enrolled in qualifying clinical trials.

Should Adulhelm or future amyloid-targeting monoclonal antibodies be given standard or full — rather than accelerated — FDA approval, CMS will broaden Medicare’s coverage to include people on those treatments enrolled in real-life studies “with comparators,” like large patient registry studies.

Standard approval for Adulhelm, however, could be years away.

“This final National Coverage Determination reflects CMS’ commitment to provide the American public with a transparent, trusted, evidence-based decision — without regard to cost — that is made only after a thorough analysis of public feedback,” Chiquita Brooks-LaSure, CMS administrator, said in a press release.

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“Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants,” Brooks-LaSure added.

The decision met with disappointment from the Alzheimer’s Association, which called the policy “broad overreach” by the CMS. It “essentially reject[s]” the FDA’s accelerated approval pathway for monoclonal antibody disease treatments, the group argued.

“CMS has created unnecessary barriers for individuals with Alzheimer’s disease. Patients with Alzheimer’s, a fatal disease, should have FDA-approved treatments covered by Medicare just as those facing other diseases do,” Harry Johns, the association’s CEO, said in a separate release.

Aduhelm, developed by Biogen and Eisai, is a monoclonal antibody that is designed to clear amyloid plaques — irregular clumps of protein in the brain that are characteristic of Alzheimer’s, and are thought to drive the disease. Clinical trial data have demonstrated that Aduhelm can lower amyloid levels, but the therapy’s effect on cognitive outcomes remains unclear, as two large Phase 3 trials found conflicting results.

In a controversial decision, the U.S. Food and Drug Administration (FDA) last year approved Aduhelm to treat early Alzheimer’s through its accelerated approval pathway. Essentially, this decision allowed Aduhelm to be sold in the U.S. based on the early data of amyloid clearance, while requiring the therapy’s developers to conduct additional studies to test its efficacy for cognition.

Biogen is planning to launch a Phase 4 clinical trial called ENVISION in the coming months to further test the therapy.

The CMS issued a draft National Coverage Determination (NCD) in January, stating that Medicare (the government-funded health insurance program for the elderly) would only pay for the cost of Aduhelm for people enrolled in clinical trials. This proposal was met with outrage by the Alzheimer’s Association and other patient organizations, and also drew harsh criticism from Biogen and health experts.

The final NCD decision stipulates that Medicare will cover the cost of Aduhelm and other amyloid-targeting monoclonal antibodies given accelerated approval only for people taking part in FDA- or National Institutes of Health (NIH)-approved clinical trials.

“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” said Lee Fleisher, CMS chief medical officer and director of its Center for Clinical Standards and Quality.

“In arriving at this final decision, we looked at the very unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” Fleisher added.

For amyloid-targeting antibodies given full FDA approval at a future date, Medicare will cover their cost for patients in a wider range of studies, including large registries collecting data on a therapy’s use in real-world settings.

“If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry … We structured this decision to provide flexibility and assurance that CMS can respond quickly to providing coverage for any new drugs in this class when a clinical benefit is determined,” Fleisher said.

This decision, which differs from the original draft, was commended by the Alzheimer’s Association, which noted that similar registries have been implemented with success for heart disease and cancer treatments. The association, working with other institutes, also announced plans to open a large registry — the National Treatment and Diagnostic Alzheimer’s Registry — in November.

Still, the association maintains that the CMS, in its final decision, “has essentially ignored the needs” of Alzheimer’s patients and their families.

“People living with MCI [mild cognitive impairment], Alzheimer’s disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS. They deserve the opportunity to assess if a FDA-approved treatment is right for them,” said Joanne Pike, the association’s president. “Drugs that treat people in the early stages of Alzheimer’s could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer.”

The association also expressed concerns that the CMS policy may make drug developers hesitant to invest in potential Alzheimer’s treatments that may not be covered even if they are approved by the FDA.

“The decision by CMS is a step backward for families facing Alzheimer’s disease,” said Maria Carrillo, PhD, chief science officer at the Alzheimer’s Association. “Years of increased research funding has led to more progress and innovation than ever before, but today’s decision may halt this progress as developers question if there is a pathway forward to coverage.”
DeZwarteRidder
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quote:

Klladejon schreef op 12 april 2022 11:39:

Hoe denken jullie over de stand van zaken qua goedkeuringen?
Daar denken wij niet goed over.
Melkkoe C1INH
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quote:

DeZwarteRidder schreef op 12 april 2022 12:00:

[...]

Daar denken wij niet goed over.
Dit moet je onderbouwen graag.
K. Wiebes
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Je hoeft je over goedkeuringen niet al teveel hoofdbrekens te maken: tegen de tijd dat dié
aan de orde zouden zijn, zijn we al lang en breed overgenomen ;)
DeZwarteRidder
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quote:

lucas D schreef op 14 april 2022 09:18:

Verwacht nieuws (derden) nu de financiën op orde gebracht zijn.
Ik verwacht helemaal niks.
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bron Alzheimer News Today:

STAR Molecule Shows Promise in Cell Model of Alzheimer’s Disease

by Patricia Inacio PhD | April 18, 2022



Gain Therapeutics‘ investigational STAR (small-molecule structurally targeted allosteric regulators) candidate lowered toxic amyloid-beta and tau protein levels, both hallmarks of Alzheimer’s disease, in a cellular model of the disease.

Treatment with the STAR molecule enhanced the survival and boosted communication between nerve cells, the company announced.

The results support the potential of STARs molecules for Alzheimer’s disease, after initial findings showed promise in Gain’s Parkinson’s disease program.

“The new data corroborate similar results we have recently published in our PD [Parkinson’s disease] program, and represent the first data showing a beneficial effect of our STAR compounds in an AD [Alzheimer’s disease] model,” Manolo Bellotto, PhD, president and general manager of Gain, said.

“We are excited to present this data that provides further evidence of the significant therapeutic potential of our STAR small molecules in neurodegenerative diseases, including Parkinson’s and Alzheimer’s Disease,” Eric Richman, Gain’s CEO, said.

The results were presented in the poster, “Brain-penetrant Structurally targeted Allosteric Regulators for Glucocerebrosidase (GCase) Show Promising Pharmacological Activity in Models of Parkinson Disease” at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022).

The enzyme beta-glucocerebrosidase (GCase) is an important component of cells’ recycling factories, called lysosomes.

Mutations in the GBA1 gene, which gives rise to GCase, are the most common genetic risk factor for Parkinson’s and result in a lack of or faulty activity of this enzyme. This leads to toxic substances accumulating inside cells, such as the alpha-synuclein protein, which is linked with the neurodegeneration seen in people with alpha-synucleinopathies, including Parkinson’s disease.

Despite not being much studied, reduced levels and activity of GCase are also involved in the accumulation of abnormal aggregates of amyloid-beta and tau proteins characteristic of Alzheimer’s disease.

Specifically, brain nerve cells of people with Alzheimer’s disease are enriched in a toxic form of amyloid beta, called amyloid beta 42, and hyperphosphorylated tau (pTau). These abnormal proteins are more prone to form toxic aggregates that cause the typical amyloid plaques and tangled tau fibers.

Gain Therapeutic’s STARs were designed using Gain’s Site-directed Enzyme Enhancement Therapy (SEE-Tx) system. The platform uses the 3D structure of proteins to identify and predict the affinity of potential drug-binding sites.

This platform “is uniquely suited to identify novel allosteric binding sites and small molecule that regulate protein function,” Richman said.

Administered orally, STARs were designed to stabilize and increase GCase protein levels and their transport to lysosomes, raising the levels of GCase enzymatic activity.

Results revealed that treatment with the company’s STARs in a cellular model of Alzheimer’s decreased the neurotoxicity and inflammation that results when toxic species of amyloid-beta and tau accumulate. Treatment also promoted the survival of nerve cells and neurites, cell body extensions that nerve cells normally use to communicate with each other.

In a mouse model of Parkinson’s disease, treatment resulted in decreased neuroinflammation, lower levels of toxic alpha-synuclein and reduced motor deficits.

The new data “show that our STARs molecules, which stabilize wild-type GCase protein in a dose dependent-manner, promote depletion of [alpha]-synuclein toxic forms as well as … tau protein, thus improving key pathophysiological features in [Parkinson’s] and [Alzheimer’s], respectively,” Bellotto said.
lucas D
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De koers heeft nu lang genoeg gebivakkeerd rond de € 10,00, tijd om weer naar koersen boven de € 20,00 te gaan.
Waarom?

De onderzoeken van bedrijven als Vivoryon zijn weer een jaar dichterbij (deel) oplossingen voor Werelds meest bedreigende ziektebeeld gekomen. A;zheimer.

Alleen al door het aandeel te steunen door een paar honderd aandelen gewoon vast te zetten draag je als belegger al bij om daar aan bij te dragen.

Verlies lijd je er niet op, wat let je nog?
lucas D
1
Daarbuiten bestaat de kans dat het Vivoryon als eerste in de Wereld echt lukt, vooral omdat ze het totaal anders benaderen als de grootste farma bedrijven tot heden die miljarden omzet hebben maar desalnietemin ondanks grote investeringen af moesten haken, ze zaten tot heden allemaal op het verkeerde spoor.

Wat gaan die bedrijven doen denk je wanneer Vivoryon wel vorderingen maakt in de zoektocht naar de ontwikkeling van een procedure tegen Alzheimer.

Die zullen er alles aan doen om samen met Vivoryon te gaan werken. Overname is geen optie en slechts mogelijk bij toestemming grootaandeelhouders en die zullen het bereikte nooit helemaal uit handen geven. Dan blijft sterke samenwerking over. Dat betekend grote investeringen om de onderzoek capaciteit te vergroten, niet te versnellen maar de mogelijkheden te vergroten.
Als dat allemaal werkelijkheid word en waarom zou dat niet kunnen, dan worden we er allemaal beter van, al is het maar dat je er van gevrijwaard blijft die ziekte te krijgen.
lucas D
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Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. rapporteert financiële resultaten en operationele voortgang voor het volledige jaar 2021 op 28 april 2022
DGAP-Nieuws: Vivoryon Therapeutics N.V. / Trefwoord(en): Jaarresultaten
Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. rapporteert financiële resultaten en operationele voortgang over het volledige jaar 2021 op 28 april 2022
21.04.2022 / 07:00
De emittent is als enige verantwoordelijk voor de inhoud van deze aankondiging.

Vivoryon Therapeutics N.V. rapporteert financiële resultaten en operationele voortgang over het volledige jaar 2021 op 28 april 2022

Halle (Saale) / München, Duitsland, 21 april 2022 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), een bedrijf in de klinische fase dat zich richt op de ontdekking en ontwikkeling van geneesmiddelen met kleine moleculen om de activiteit en stabiliteit van pathologisch veranderde eiwitten te moduleren, heeft vandaag aangekondigd dat het zijn financiële resultaten voor het volledige jaar 2021 zal publiceren en op donderdag 28 april 2022 een bedrijfsupdate zal geven. Het bedrijf zal een conference call en webcast organiseren die open is voor het publiek. Het rapport zal beschikbaar zijn om te downloaden op de website van het bedrijf (https://www.vivoryon.com/investors-news/financial-information/).

Details conference call
Datum: 28 april 2022
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Zijsprong: aan de hash........bron Alzheimer News Today

CogniCann, Potential Cannabinoid Therapy, Being Prepared for Europe
Lindsey Shapiro PhD avatar
by Lindsey Shapiro PhD | April 19, 2022
CogniCann | Alzheimer's News Today | illustration of medical cannabinoid treatments



Sciensus Rare, a Dutch healthcare group, was given rights to distribute CogniCann, MGC Pharmaceutical’s cannabinoid-based investigative treatment for people with dementia and Alzheimer’s disease in Europe, should it be approved for commercial use or use in select early access programs.

The agreement stipulates that Sciensus Rare will have four years of exclusive distribution rights for CogniCann in the U.K., Denmark, France, Italy, Spain, and Luxembourg. It also covers distribution rights for CannEpil, MGC Pharma’s potential treatment for drug-resistant epilepsy.

Both treatments are currently in Phase 2 trials. The CogniCann study, taking place at a single Australian site in up to 50 patients, expects to finish by the close of June.

“We are extremely pleased to be working in partnership with MGC Pharmaceuticals within the exciting global medical cannabis market and look forward to supporting clinicians with access to both CannEpil and CogniCann,” Gareth Williams, president of Sciensus Rare, said in a press release.

Under the agreement’s terms, Sciensus will need to meet a purchase order minimum over the first year to maintain exclusive distribution rights.

MGC Pharma will handle requests for both treatments’ regulatory approval in those countries, while Sciensus Rare will work to make them available to select patients through early access or named patient programs.

“Sciensus Rare is an excellent pharmaceutical service company, with the experience and expertise necessary to increase clinical access for both CannEpil and CogniCann to those patients who are most in need,” said Roby Zomer, managing director and CEO of MGC Pharma.

This agreement, Zomer added, “puts in place a long term plan to build the distribution networks required in Western Europe.”

Alzheimer’s is the most common type of dementia, a group of disorders marked by cognitive symptoms, such as memory loss, confusion, and declining reasoning skills, that interfere with daily life.

Both potential therapies are phytocannabinoids, plant-based chemicals derived from cannabis. Due to their ability to cross the blood-brain barrier and influence the central nervous system (CNS, the brain and spinal cord), these compounds are being considered to treat several neurological disorders.

The blood-brain barrier, a semipermeable membrane that protects the CNS from viruses and other insults that can be carried in the bloodstream, can be a major barrier for the efficient delivery of treatments needing to reach the central nervous system.

Evidence from early studies suggest that phytocannabinoids may be able to ease the behavioral and psychological symptoms of dementia in Alzheimer’s patients, and possibly help to break down the abnormal clumps of the amyloid protein that are associated with disease progression.

Few large, well-controlled clinical trials, however, have evaluated the effects of cannabis or its components on dementia symptoms.

CogniCann is an oral spray that combines two of the most abundant phytocannabinoids in the cannabis plant — tetrahydrocannabinol (THC) and cannabidiol (CBD). The specific ratio of THC to CBD in the blend is designed to improve behavior and cognition in dementia patients, MGC Pharma reported.

The Phase 2 trial of CogniCann, taking place at the University of Notre Dame in Perth, is reported to be a randomized and placebo-controlled, crossover trial in up to 50 people with mild dementia, including that due to Alzheimer’s, ages 65 and over and living in residential care facilities. Its main goals are to evaluate changes in patients’ behavior, quality of life, and pain with treatment.

The COVID-19 pandemic affected this trial, which was reported to have officially opened in 2020 and was initially set to conclude by December 2021.
lucas D
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Het heeft weinig zin lappen tekst te plaatsen die geen enkele toegevoegde waarde hebben.
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quote:

lucas D schreef op 21 april 2022 17:29:

Het heeft weinig zin lappen tekst te plaatsen die geen enkele toegevoegde waarde hebben.
stimulerend!!
lucas D
0
Vivoryon is een witte raaf onder de onderzoekers naar Alzheimer.
Waarom? Omdat ze het als mini bedrijfje aandurfde een totaal andere benadering van de ziekte te introduceren dan alle andere Pharma bedrijven die duizend keer meer te besteden hebben per onderzoek dan Vivoryon.
Dat bijna al die bedrijven er na jaren geld met scheepsladingen aan geld de onderzoeken stopzette bij gebrek aan vooruitgang, boekte het kleine Vivoryon wel vooruitgang.

Voorwaar een Wereld prestatie gezien het verschil in beschikbare middelen.
Het laat zien dat kleine bedrijven inventiever omgaan met kiezen van strategie en voor een andere benadering kozen daar de oude al jaren geen resultaten opleverde.

Waarom de grote Pharma's daar toch mee door wilde gaan is het kwijtraken en de teloorgang aan innovatieve kwaliteit waardoor ze groot zijn geworden. En ze kunnen het lijden.

Dat is bij Vivoryon niet het geval, elke cent moet goed besteed worden en alle zeilen bijgezet om het succes wat gloort werkelijkheid te laten worden.
De grootaandeelhouders zijn standvastig.
Ook al zit je op het goed spoor, de onderzoeken verlopen net zo traag als het verloop van Alzheimer.

Ze zullen de steun van alle beleggers nodig hebben.
Pjotr
0
quote:

lucas D schreef op 20 april 2022 14:04:

Daarbuiten bestaat de kans dat het Vivoryon als eerste in de Wereld echt lukt, vooral omdat ze het totaal anders benaderen als de grootste farma bedrijven tot heden die miljarden omzet hebben maar desalnietemin ondanks grote investeringen af moesten haken, ze zaten tot heden allemaal op het verkeerde spoor.

Wat gaan die bedrijven doen denk je wanneer Vivoryon wel vorderingen maakt in de zoektocht naar de ontwikkeling van een procedure tegen Alzheimer.

Die zullen er alles aan doen om samen met Vivoryon te gaan werken. Overname is geen optie en slechts mogelijk bij toestemming grootaandeelhouders en die zullen het bereikte nooit helemaal uit handen geven. Dan blijft sterke samenwerking over. Dat betekend grote investeringen om de onderzoek capaciteit te vergroten, niet te versnellen maar de mogelijkheden te vergroten.
Als dat allemaal werkelijkheid word en waarom zou dat niet kunnen, dan worden we er allemaal beter van, al is het maar dat je er van gevrijwaard blijft die ziekte te krijgen.
Ik hoop het voor je maar die kans is ontzettend klein!
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