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CUV, CLINUVEL PHARMACEUTICALS LIMITED
rabbitrun
post Posted: Oct 9 2019, 01:55 AM
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In Reply To: Johnny H's post @ Oct 9 2019, 01:52 AM

Wolgen is circling his kitchen rug, chain-smoking Gitanes, waiting for the call.

It's interesting. Based on Drugs@FDA, some days the agency approves a boatload of drugs...other days, just a handful. Doesn't seem like it's shaping up to be a marathon day today.


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Johnny H
post Posted: Oct 9 2019, 01:52 AM
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In Reply To: FarmaZutical's post @ Oct 9 2019, 12:27 AM

If I understand that correctly, Clinuvel is notified first, and Clinuvel has to confirm that they received the notification. Only then is the press office notified, completing step 2 of the process.

If that's how this works, I don't see why Clinuvel wouldn't issue a press release at the time they confirm that they have received the notification.

It sounds like we're going to hear from Clinuvel first, but that's not going to stop me from refreshing the FDA page in the meantime.



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Clinuvel until my bowels release for the last time.

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investek
post Posted: Oct 9 2019, 01:37 AM
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Some rare disease news on the FDA announcement page...

FDA awards two grants for natural history studies in rare diseases

October 08, 2019
FDA News Release

For Immediate Release:
The U.S. Food and Drug Administration today announced it has awarded two new research grants for natural history studies in rare diseases. The FDA is providing over $4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test future treatments.

Natural history studies closely look at how specific diseases progress over time. The natural history of a disease is the course a disease takes from its onset, through the presymptomatic and clinical stages, to a final outcome in the absence of treatment.

“The FDA is committed to funding these important studies in order to define how rare diseases develop and progress,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Further, these studies provide important roadmaps for how to conduct subsequent studies. With the natural history of many rare diseases remaining relatively unknown, efficiently developing diagnostics and therapies for patients poses unique challenges. Promoting and conducting work in this area is critical.”

The FDA received 31 grant applications that were reviewed and evaluated for scientific and technical merit by more than 45 rare disease, natural history, regulatory and statistical experts, that included representatives from academia, patient groups, the National Institutes of Health and the FDA. The grants were awarded to:

University of Texas MD Anderson Cancer Center (Houston, Texas), Elizabeth Grubbs, prospective study in medullary thyroid carcinoma, approximately $1.7 million over four years

The study seeks to leverage a multi-institutional registry to characterize disease variables and patient perspectives that inform decisions regarding initiation of and adherence to chemotherapy in medullary thyroid cancer. Such critical knowledge can be incorporated into the design of clinical trials of emerging therapies for this disease.

Vanderbilt University Medical Center (Nashville, Tennessee), Jonathan Soslow, prospective study in cardiac disease in Duchenne muscular dystrophy, approximately $2.4 million over four years.

This study aims to focus on cardiomyopathy (heart muscle disease), which is the leading cause of death in Duchenne muscular dystrophy. The study will combine genetic differences with imaging and blood biomarkers to identify surrogate biomarkers that predict the risk of cardiac dysfunction in Duchenne muscular dystrophy and other related diseases. This information has the potential to improve future clinical trial efficiency in these diseases by decreasing their size and cost.
Congress appropriates funding to the FDA for the study of rare diseases. The FDA uses these funds for the Orphan Products Grants Program to support these natural history studies as well as clinical trials for rare diseases.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/news-events/press-annou...s-rare-diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

October 08, 2019
FDA News Release

For Immediate Release:
The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $15 million over the next four years to enhance the development of medical products for patients with rare diseases. The grants were awarded to principal investigators from academia and industry across the country.

The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program, funded by Congress to encourage clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases. The grants are intended to substantially contribute to marketing approval of products to treat rare diseases or provide essential data needed for development of such products.

“For more than 35 years, the FDA has been providing much-needed financial support for clinical trials of potentially life-changing treatments for patients with rare diseases. To date, the Orphan Products Clinical Trials Grants Program’s grants have supported research that led to the marketing approval of more than 60 treatments for rare diseases,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We are encouraged by the amount of interest we continue to have in the grants program and are committed to working with researchers and industry to facilitate and support the study and development of treatments for patients with rare diseases.”

The FDA received 89 clinical trial grant applications that were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, including members of academia.

The grants awarded are focused on supporting product development to meet the needs of patients impacted by a variety of rare diseases, mainly those affecting children and cancers. The recipients, principal investigators and approximate funding amounts, listed alphabetically, are:

Chemocentryx, Inc. (Mountain View, California), Peter Staehr, phase 2 study of avacopan for the treatment of complement 3 glomerulopathy – $1 million over two years
Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Maryam Fouladi, phase 1 study of PTC596 for the treatment of diffuse intrinsic pontine glioma & high-grade gliomas -- $750,000 over three years
Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Parinda Mehta, phase 2 study of quercetin chemoprevention for the treatment of squamous cell carcinoma in patients with Fanconi Anemia – $1.7 million over four years
Columbia University Health Sciences (New York, New York), Gary Brittenham, phase 2 study of daily vitamin D for the treatment of sickle-cell respiratory complications – $2 million over four years
Cumberland Pharmaceuticals, Inc. (Nashville, Tennessee), Ines Macias-Perez, phase 2 study for oral ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy – $1 million over three years
Massachusetts General Hospital (Boston, Massachusetts), Sara Pai, phase 2 study of anti-PD1 therapy for the treatment of HPV-associated recurrent respiratory papillomatosis – $1 million over three years
New York Medical College (Valhalla, New York), Mitchell Cairo, phase 2 study of viral specific cytotoxic T-lymphocytes for the treatment of refractory viral infections and T-cell immunodeficiency – $1.7 million over four years
Privo Technologies, LLC. (Peabody, Massachusetts), Manijeh Goldberg, phase 1/2 study of cisplatin patch (PRV111) for the treatment of oral cancer – $2 million over four years
Targeted Therapy Technologies, LLC (Somerset, New Jersey), Ricardo Carvalho, phase 1 study of episcleral topotecan for the treatment of retinoblastoma – $660,000 over three years
University of Alabama at Birmingham (Birmingham, Alabama), Gregory Friedman, phase 1 study of oncolytic engineered herpes simplex virus therapy for the treatment of pediatric malignant cerebellar brain tumors – $750,000 over three years
University of California San Diego (La Jolla, California), Jason Sicklick, phase 2 study of temozolomide for the treatment of gastrointestinal stromal tumor – $1.5 million over three years
University of Texas MD Anderson Cancer Center (Houston, Texas), Michael Andreeff, phase 1/2 study of the imipridone (ONC201) for treatment of acute myeloid leukemia – $1 million over four years
“The majority of rare diseases still do not have approved therapies and the FDA is committed to fostering product development in areas of unmet need. The Orphan Products Grants Program is one of several ways that the FDA supports the development of products for rare diseases. Since its creation in 1983, the program has provided more than $400 million to fund more than 600 new clinical studies,” said Janet Maynard, M.D., director of the FDA’s Office of Orphan Products Development. “We are pleased to continue to support research for a variety of rare diseases that have little, or no, treatment options for patients. By helping to spark research, we hope to speed the development of products for rare diseases, and ultimately, make needed treatments available to those patients who need them most.”

Three-quarters (75%) of the new awards fund studies enrolling children, including children as young as one month. These studies target a variety of rare diseases affecting children and have the potential to advance treatments for these diseases. Some of these diseases include Duchenne Muscular Dystrophy, a genetic disorder characterized by progressive muscle loss and weakness; sickle cell disease, a group of inherited red blood disorders which can cause anemia, infections and stroke; and Fanconi Anemia, a rare inherited condition that can result in bone marrow failure and has a high risk for squamous cell cancers.

Two-thirds (67%) of the new awards fund clinical studies of products for use in various rare cancers. For example, one of the new awards aims to advance research in brain cancers affecting children. This study enrolls affected children as young as 36 months and tests an innovative treatment approach to treat brain cancers using an engineered virus therapy designed to target and kill tumor cells while sparing normal brain cells. Another newly funded study evaluates a novel drug delivery system that delivers chemotherapy on a sustained basis directly to the eye to treat retinoblastoma, a rare cancer in the eye most commonly affecting young children. This delivery system may help address current barriers to drug delivery that patients face.

Past studies funded by this program that have resulted in or contributed to recent product approvals, include: fish oil triglycerides, a first FDA-approved lipid emulsion made from fish oil, approved as a source of calories and fatty acids in children with parenteral nutrition-associated cholestasis; and the first treatment (tafamidis meglumine and tafamidis) for heart disease caused by transthyretin mediated amyloidosis.

In addition to the FDA Orphan Products Clinical Trials Grants Program, the agency also supports natural history studies for rare diseases to further advance the FDA’s mission of bringing new therapies to approval and patients.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/news-events/press-annou...reatment-rare-0

 
KRD
post Posted: Oct 9 2019, 01:16 AM
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Now that Clinuvel has requested and received a trading halt, including in the US, there is no reason for the FDA to wait until the markets close before making the announcement; in effect the market is already closed.

The announcement with their decision could come at any time now.







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PortugueseMan
post Posted: Oct 9 2019, 12:58 AM
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2nd approval today out graduated.gif
Dilaudid
NDA #019892
Hydromorphone Hydrochloride Tablet; Oral SUPPL-35 Rhodes Pharms Labeling Approved


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LevelHeaded2000
post Posted: Oct 9 2019, 12:52 AM
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If the decision gets delayed a couple days there will be a lot of pissed off people on this forum who are staying up late. The trade halt was up to October 11th. I wonder if they suspected it could be delayed.

 

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Artkatansclean
post Posted: Oct 9 2019, 12:48 AM
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In Reply To: rabbitrun's post @ Oct 9 2019, 12:47 AM

nice...F5ing the wrong page...

 
rabbitrun
post Posted: Oct 9 2019, 12:47 AM
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In Reply To: Artkatansclean's post @ Oct 9 2019, 12:46 AM

https://www.accessdata.fda.gov/scripts/cder...ent=report.page


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Artkatansclean
post Posted: Oct 9 2019, 12:46 AM
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In Reply To: CUV88's post @ Oct 9 2019, 12:45 AM

where can you see that?

 
CUV88
post Posted: Oct 9 2019, 12:45 AM
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First approval today out

Fiorinal W/Codeine
NDA #019429 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral



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CLINUVEL's SCENESSE Potential: 1.)EPP 2.)Vitiligo 3.)SUN Protection and skin cancer prevention

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