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CUV, CLINUVEL PHARMACEUTICALS LIMITED
sharelooker
post Posted: Today, 02:44 AM
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Things are getting closer! SC is now listed on the front page of https://www.drugs.com/ under the category 'Drugs in Development (Not yet approved)'.

 
investek
post Posted: Today, 12:35 AM
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BioMarin and NICE had a rocky start with Batten disease therapy Brineura, but the two have now come to an agreement
The positive recommendation of Brineura was agreed by NICE’s Highly Specialised Technology committee. The disease, known as neuronal ceroid lipfuscinosis type 2 (CLN2), is a very rare inherited condition. According to NICE, it is thought to affect between one and six babies every year in the UK.
Although Brineura does not does not cure the disease, NICE agreed that it is an important development in the treatment of the condition. There is currently no cure or life-extending treatments for CLN2, so the approval is likely to be met with elation from patient groups.
Boysen
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE
“This treatment shows great promise in slowing the progression of this devastating condition to allow children to enjoy normal childhood activities for longer which is so important,” said Meindert Boysen (pictured above).
The initial decision to reject the therapy was down to the cost of the therapy. Despite the disease affecting up to six infants each year (with up to 50 children in the UK living with the condition), the £500,000 ($651,100) per patient per year price tag was considered to not be value for money in the absence of long-term effectiveness data.
However, the therapy has now been approved in the context of a managed access agreement between BioMarin and the cost-effectiveness watchdog. BioMarin have said that the two have “agreed a fair price”, but as the financial details of the deal are confidential, the exact amount is unknown. However, it is likely that BioMarin will have had to make a concession on price to reach an agreement.
The announcement coincides with an ongoing judicial review, which would have looked at new evidence supporting the therapy. NICE seems to have jumped the gun, approving the therapy before the review of the new data.
Health Secretary Matt Hancock also commented on the approval: “I’m absolutely delighted this new treatment will be funded by the NHS, giving families dealing with the devastating impact of Batten disease renewed hope for a better quality of life for their child.”
NICE is due to provide a further update on the expected publication date of the Final Evaluation Document soon, which will reveal the full details of the committee discussion and recommendation.
Article by
Lucy Parsons
12th September 2019
https://www.pmlive.com/pharma_news/nice_app...IGN_NAME=2&

And an earlier article
Brineura hit with NICE rejection
http://www.pharmatimes.com/news/brineura_h...jection_1279019

Brineura
https://www.nice.org.uk/guidance/indevelopment/gid-hst10008
NICE appeal - 1st May 2019
And a total of 5 committee meetings...

Afamelanotide
https://www.nice.org.uk/guidance/indevelopment/gid-hst10009
NICE appeal - 20th June 2018
3 committee meetings so far...

 
KRD
post Posted: Today, 12:32 AM
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Maybe we'll see something similar in the next few weeks:

Shares of the online merchant Overstock.com are on a tear, up 60% in two weeks. The rally coincides with a flurry of short covering that comes a week before the record date for an exotic dividend the company unveiled to much fanfare and confusion last month. (insert FDA approval)






 
investek
post Posted: Yesterday, 10:31 PM
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Total amounts reimbursed (* € 1,000), number of insured persons and average reimbursement per insured person (* € 1,000) per product per year

https://www.zorginstituutnederland.nl/binar...aktijk+2019.pdf

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NewToCli
post Posted: Yesterday, 09:52 PM
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In Reply To: PunkassDerm's post @ Yesterday, 09:29 PM

... and 5 years after the article has been published nothing has been accomplished on the business side.. is there any company actually with IP on aMSH? Ah yea... Clinuvel ...


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PunkassDerm
post Posted: Yesterday, 09:29 PM
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In Reply To: investek's post @ Yesterday, 04:30 PM

ANTI-INFLAMMATORY
ANTI-MICROBIAL
ANTI-FUNGAL
NON-TOXIC

PSORIASIS POTENTIAL



https://www.hindawi.com/journals/bmri/2014/874610/


Alpha-Melanocyte Stimulating Hormone: An Emerging Anti-Inflammatory Antimicrobial Peptide
Madhuri Singh1,2 and Kasturi Mukhopadhyay1
BioMed Research International
Volume 2014, Article ID 874610, 10 pages
2014


Conclusions

In this postantibiotic era, AMPs have already created huge hopes for their host defense mechanism and several of these peptides find ways into medical practice although the numbers are less than expected. The development of AMPs as therapeutic alternatives to combat the resistant pathogenic microbes is facing problems, majorly due to the enhanced inflammatory reactions associated with them and their potential for toxicity. -MSH overcomes both of these issues being anti-inflammatory and nontoxic. This endogenous neuropeptide was initially characterized as a pigment producing peptide and later received serious attention due to its potent protective and anti-inflammatory activity. -MSH performs these actions by binding to centrally expressed melanocortin receptors, which subsequently coordinate numerous anti-inflammatory pathways leading to shutting down all the downstream effector proinflammatory mechanisms. Besides anti-inflammation, it also exhibited immunosuppression in case of skin-inflammatory diseases like psoriasis. The striking resemblance of this anti-inflammatory neuropeptide with cationic AMPs compelled the scientists to further explore its antimicrobial efficacy. Indeed, -MSH appeared to possess potent antimicrobial activity against pathogens from different classes like C. albicans, S. aureus, E. coli, and more. It also adopts variable approaches to kill different microbes. For instance, it kills fungal cells through the induction of cAMP and bacterial cells by damaging the membrane [14, 18]. The C-terminal region (KPV) of -MSH demands special attention for several reasons. It exhibits in vitro and in vivo anti-inflammatory activity similar to that of parent peptide without melanotropic effect. This observation removes the main obstacle in developing -MSH based peptides as therapeutics, which is nothing, but its pigmentary effects and KPV are devoid of that. Moreover, this essential anti-inflammatory sequence, that is, C-terminal tripeptide (KPV) of -MSH, is also essential for its direct antimicrobial efficacy. Therefore, this short molecule KPV appears to have tremendous potential to be developed as therapeutic agent as it is more suitable for clinical use and demands further research. The dimer of this short peptide, that is, (CKPV)2 being both anti-inflammatory and antimicrobial, is already in clinical trial and will definitely make its way to enter into medical practice in near future.

The pleiotropic effects of -MSH and its C-terminal peptides, including their anti-inflammatory, immunosuppressive, antipyretic, and antimicrobial activities, are unique. These endogenous properties make them the most promising antimicrobial host defense peptides. More work is however needed to bring these peptides from the lab to clinic. First, a deeper corelation is required to be established between its anti-inflammatory and anti-infective reactions through the in vivo models of infections. Second, further biophysical studies are required to design a potent -MSH based AMP with enhanced killing and immunomodulatory activities. Third, the possibility of resistance developing against this peptide needs to be ruled out. Fourth, overall safety profile of these peptides particularly with -MSH fragments requires to be vigorously examined.

In conclusion, -MSH, its analogues, and related C-terminal tripeptide with broad-spectrum antimicrobial activity combined with immunomodulating effects and no cytotoxicity could emerge as excellent therapeutic agents against resistant pathogens.


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Dr Wally
post Posted: Yesterday, 08:31 PM
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In Reply To: royco's post @ Yesterday, 06:10 PM


Good on ya Royco, I feel your pain. Hopefully you’ll be back no later than 10th October. 👍🏽



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50+ on or before PDUFA... GLTA that have seen the future and kept the faith. 😎 Scenesse 100% will be approved. Too safe, too beneficial to the health of millions. Logic and community pressure will eventually prevail over regulator ignorance.
.A wise sharescene poster once posted here many years ago a short statement and it seems to hold true to this very day: “no one here knows sh1t about what’s really happening, is going to happen or has actually happened in regards to Clinuvel and Scenesse ”.😬

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royco
post Posted: Yesterday, 06:10 PM
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Im going in black out comms mode until approval.
See you all on the other side!
glta



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Ἀρτεμίσιον

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investek
post Posted: Yesterday, 04:30 PM
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AD treatment advances on psoriasis research
ILYA PETROU, M.D. | Staff Correspondent
Continued research and development in psoriasis has led to a translational revolution — the lessons from which can now be observed in other common inflammatory diseases, such as atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa, acne, and rosacea. According to one expert, the journey has been arduous but, due to the years-long work on psoriasis, the future is bright for patients with inflammatory skin diseases.
Atopic dermatitis and psoriasis are characterized by immune-mediated inflammation and abnormal keratinocyte differentiation and, although their T-cell infiltration characterizes both diseases, T-cell polarization differs. Because of their similarities however, the therapeutics for atopic dermatitis, in particular, have benefit- ted from continued psoriasis research.
“It took decades for us to get from relatively primitive treatments of psoriasis to the very advanced perfected treatments that we currently have available, and we can clear almost everybody with these therapies. The advent of the biologics around the turn of the century has changed the treatment and management of inflammatory skin diseases forever,” says Mark Lebwohl M.D., FAAD, Sol and Clara Kest professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York, New York.
Cyclosporine worked well but it basically knocked out the whole immune system, Dr. Lebwohl says, making patients more susceptible to cancers, opportunistic infec- tions, as well as a host of other side effects. Current advanced treat- ment approaches include therapies that target individual molecules in the immune system and lead to the clearing of inflammatory skin diseases that are immunologically mediated, without disrupting the immune system as a whole.
“The first biologics, like alefacept, were only modestly effective, and they targeted the activation of lymphocytes. These agents were designed to target just a tiny frac- tion of the immune system, which ultimately allowed us to treat psoriasis much more effectively, Dr. Lebwohl says.
The TNF (tumor necrosis factor) blockers also proved to be effective and although TNF is a much smaller target in the immune system compared to what cyclosporine targets, these agents still block a fair amount of the immune system, leading to an increase in opportunistic infections and a slight increase in skin cancers.
It was the realization of the critical importance of the IL-17 and IL-23 pathways that led to the development of numerous therapies that target and block only a very small part of the immune system, Dr. Lebwhohl says. And this has resulted in extraordinary clinical outcomes with very few side effects.
“IL-12 has once been likened to the master switch of psoriasis. Today, we know that blocking IL-12 also blocks IL-23. They share p40, a common molecule, and the antibodies to IL-12 are the same ones to IL-23,” Dr. Leb- wohl says.
As the only biologic currently approved by the U.S. Food and Drug Administration for atopic dermati- tis, dupilumab (Dupixent, Sanofi Regeneron Pharmaceuticals) is the first and only IL-4 and IL -13 anti- body used for patients with atopic dermatitis. Early results show that it can achieve dramatic clinical out- comes at the lowest dose. Follow- ing the success with dupilumab, a host of other biologic agents includ- ing tralokinumab (Leo Pharma) and lebrikizumab (Dermira) were devel- oped to target IL-13, and are achiev- ing positive clinical outcomes in tri- als with minimal side effects.
It was the realization of the critical importance of the IL-17 and IL-23 pathways that led to the development of numerous therapies that target and block only a very small part of the immune system, Dr. Lebwhohl says. And this has resulted in extraordinary clinical outcomes with very few side effects.
The role of IL-31 has also been well established in patients with pru- ritus and atopic dermatitis. Levels of
IL-31 are elevated in atopic dermatitis and corre- late with disease severity.
Other promising systemic agents for the treat- ment of atopic dermatitis are those that target this pathway, according to Dr. Lebwohl, including nemolizumab (Galderma), several JAK inhibi- tors: baricitinib (Olumiant, Eli Lilly), upadacitinib (ABT-494, AbbVie Inc.), Pfizer’s PF04965842, and the JAK-SYK inhibitor ASN002 from Asana.
Developed by Kiniksa Pharmaceuticals Corp., KPL-716 is a fully-human monoclonal antibody that, in addition to blocking oncostatin M (OSM), also inhibits IL-31, which, according to Dr. Leb- wohl, has also achieved remarkable results in pre- liminary clinical trials, particularly in the reduc- tion of pruritus.
The topical JAK inhibitor crisaborole (Eucrisa, Pfizer) is the first phosphodiesterase 4 (PDE4) inhibitor on the market that has demonstrated effi- cacy in controlling inflammation in atopic skin, according to Dr. Lebwohl.
“After almost a century of relatively primitive treatment options including systemic steroids, cyclosporine and a number of other immunosup- pressant drugs all associated with sometimes sig- nificant side effects, we now have a whole host of innovative therapies that, due to their smaller tar- get, can improve the symptoms of atopic dermati- tis with minimal side effects,” Dr. Lebwohl says. “The future is very bright for atopic dermatitis patients, as these new and exciting agents have been shown to help clear patients, particularly when recalcitrant to other tried therapies.”

https://www.dermatologytimes.com/sites/defa...t0919_ezine.pdf

Dr Lebwohl has previously received grants/research funding from CUV.






 
Dr Wally
post Posted: Yesterday, 01:29 PM
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In Reply To: endymion96's post @ Yesterday, 12:37 PM

If you factored in even the tiniest sliver of logic to the situation you could only ever come up with one sensible answer here
but logic has rarely played a roll in Scenesses journey to FDA acceptance (so far) so I
won’t bother. 😡



--------------------
50+ on or before PDUFA... GLTA that have seen the future and kept the faith. 😎 Scenesse 100% will be approved. Too safe, too beneficial to the health of millions. Logic and community pressure will eventually prevail over regulator ignorance.
.A wise sharescene poster once posted here many years ago a short statement and it seems to hold true to this very day: “no one here knows sh1t about what’s really happening, is going to happen or has actually happened in regards to Clinuvel and Scenesse ”.😬

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