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FDA clearance for HealthLytix for breakthrough prostate imaging solution, RSI-MRI+

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FDA clearance for HealthLytix for breakthrough prostate imaging solution, RSI-MRI+

Nov 26, 2019:  HealthLytix, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its breakthrough prostate imaging software, RSI-MRI+ which utilizes a patented advanced diffusion MRI technique called Restriction Spectrum Imaging (RSI) in order to improve early detection and diagnosis of prostate cancer by clinicians.

This software  uses artificial intelligence and an innovative tissue microstructure modelin order to increase the visibility of constrained water in the body’s tissue. All types of cancer including prostate cancer restrict or trap water.

Conventional diffusion MRI has its limitation that it does not measure restricted water directly, instead of that it relies on a simpler measure known as the apparent diffusion coefficient (ADC).ADC is an important biomarker affected by a number of impenetrable factors that can negatively impact its sensitivity and specificity to cancer, which can result in missed or inaccurate diagnoses. https://fda.einnews.com/article__detail/503400363-healthlytix-receives-fda-clearance-for-breakthrough-prostate-imaging-solution-rsi-mri?vcode=XIbw

USFDA Approved Silodosin Capsules, 4 mg and 8 mg for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

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USFDA Approved Silodosin Capsules, 4 mg and 8 mg for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

Nov 25, 2019: Alembic Pharmaceuticals  Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg approved by US Food & Drug Administration (USFDA).

This approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC. Silodosin capsule, (a selective alpha1 adrenergic receptor antagonist) used for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). 

Estimated market size of  Silodosin Capsules is  US$ 114 million for twelve months ending June 2019 according to IQVIA. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/11/Press-Release-USFDA-Approval-Silodosin-Capsules-4-mg-and-8-mg-November-2019-1.pdf

Healx commits $20M to launch Rare Treatment Accelerator programme that focus on finding new treatments for rare diseases

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Healx commits $20M to launch Rare Treatment Accelerator programme that focus on finding new treatments for rare diseases

Nov 26, 2019: Healx’s Applications are now being accepted for its Rare Treatment Accelerator (RTA), new programme that focus on finding new treatments for rare diseases.

The AI-powered and patient-inspired technology company sponsors the project with a total of $20m funding injection, contemplate to invest up to $1m of that in AI and drug discovery resources per disease project.

The collaboration offers rare disease patient groups and clinicians the prospect to work with Healx to reveal new treatments for rare disease, combining their data, AI capabilities and disease proficiency to discover new treatments and move them towards the clinic within 24 months.
https://healx.io/news/

KEYTRUDA, Merck’s anti-PD-1 therapy Now Approved by the National Medical Products Administration in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

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KEYTRUDA, Merck’s anti-PD-1 therapy Now Approved by the National Medical Products Administration in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

Nov 26, 2019: Merck announced that KEYTRUDA (Merck’s anti-PD-1 therapy) in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration (NMPA) in China.

This new indication was granted full approval based on pivotal Phase 3 KEYNOTE-407 trial and data from the global study in Chinese patients. In china death rate increase every year due to lung cancer, this approval represents an important milestone for the patients facing such difficulties for the treatment.

KEYTRUDA (pembrolizumab Inj) is an humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, in that way activating T lymphocytes which may affect both tumor cells and healthy cells. https://www.mrknewsroom.com/news-release/oncology-newsroom/mercks-keytruda-pembrolizumab-now-approved-china-first-line-treatment

Tonix Pharmaceuticals Announces Tonmya® (cyclobenzaprine) as a Potential New Treatment for posttraumatic stress disorder (PTSD)

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Tonix Pharmaceuticals Announces Tonmya® (cyclobenzaprine) as a Potential New Treatment for posttraumatic stress disorder (PTSD)

Nov 26, 2019: Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company announced that from the Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA)  it received the official minutes from the Breakthrough Therapy Type B for Tonmya®* (or TNX-102 SL, cyclobenzaprine sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD).

The minutes from our Breakthrough Therapy Clinical Guidance meeting are consistent with the agreement that we previously announced. the primary endpoint of the RECOVERY Phase 3 trial will be at Week 12, and the Company plans to add an unblinded interim analysis that allows for a potential sample size adjustment, With more than 50 percent of the current target number of participants enrolled, results of the  report of the interim analysis will be in the first quarter of 2020. https://fda.einnews.com/pr_news/503308754/tonix-pharmaceuticals-announces-receipt-of-fda-official-minutes-from-breakthrough-therapy-type-b-clinical-guidance-meeting-for-tonmya-as-a-potential

California-based food manufacturer agrees to stop production after repeated food safety violations

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California-based food manufacturer agrees to stop production after repeated food safety violations

Nov 26, 2019: After several inspections conducted by the FDA, Golden Gate Soy Products, a California-based food manufacturer agreed to stop the progress of selling food products until the company complies with federal regulations and other requirements.

Listeria monocytogenes was found (L. mono) in the company’s food preparation area, also company was holding food for distribution in insanitary conditions. Golden Gate Soy Products specializes in manufacturing a variety of tofu and soy-based products, including soy milk.

This practice of Golden Gate Soy Products not only violated the law, but also put customers in harm. food contaminated with L. mono may develop a disease called listeriosis that will  effect women who are or may become pregnant, the elderly and people with weakened immune systems.

Defendants are restricted from receiving, preparing, processing, packing, holding, labeling and/or distributing foods at or from their facility until certain requirements are met, If they choose to restart operations, the consent decree requires them to notify the FDA and take corrective actions before resuming operations. https://fda.einnews.com/pr_news/503311206/california-based-food-manufacturer-agrees-to-stop-production-after-repeated-food-safety-violations

U.S. Food and Drug Administration issued warning letters to 15 companies Including Several In California for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act

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U.S. Food and Drug Administration issued warning letters to 15 companies Including Several In California for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act

Nov 25, 2019: 15 companies Including Several In California received warning letters by  the U.S. Food and Drug Administration for illegally selling products containing cannabidiol (CBD) in ways that disobey the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA continues to explore potential pathways for various types of CBD products to be legally marketed, includes ongoing work to obtain and evaluate information to address terrific questions allied to the safety of CBD products, while maintaining the agency’s rigorous public health standards.

In the coming weeks FDA plans to provide an update on its improvement regarding the agency’s approach to these products.

There are so many market preparations of CBD such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams that can impact on susceptible populations such as children and pregnant or breastfeeding women. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

15 Companies received warning letter by U.S. Food and Drug Administration for illegally selling products containing cannabidiol as agency details safety concerns

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15 Companies received warning letter by U.S. Food and Drug Administration for illegally selling products containing cannabidiol as agency details safety concerns

Nov 25, 2019: 15 Companies received warning letter by U.S. Food and Drug Administration the for illegally selling products containing cannabidiol that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA published a revised Consumer Update detailing safety concerns about CBD products.The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed related to the safety of CBD products.

Some of the available data raise serious concerns about potential harm from CBD including potential liver injury, interactions with other drugs, drowsiness, diarrhea, changes in mood, and decrease testosterone levels and impair sexual behavior in males.

CBD preparations are  oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. https://fda.einnews.com/pr_news/503206803/fda-warns-15-companies-for-illegally-selling-various-products-containing cannabidiol-as-agency-details-safety-concerns

Oxbryta (voxelotor) approved by U.S. Food and Drug Administration for the treatment of sickle cell disease (SCD)

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Oxbryta (voxelotor) approved by U.S. Food and Drug Administration for the treatment of sickle cell disease (SCD)

Nov 25, 2019 Oxbryta (voxelotor)approved by  the U.S. Food and Drug Administration  for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.

More than 100,000 people in the U.S., and the more than 20 million globally sufferd with this blood disorder.Sickle cell disease is a lifelong, hereditary blood disorder in which red blood cells are peculiarly shaped (sickle  shape), which restricts the flow in blood vessels that limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage.

Oxbryta inhibits red blood cell sickling, and improves red blood cell deformability (ability of a red blood cell to change shape)also  improves the ability of bloods flow. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-treatment-target-abnormality-sickle-cell-disease

The first oral small molecule targeting splicing Risdiplam approved by US FDA for the treatment of spinal muscular atrophy

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The first oral small molecule targeting splicing Risdiplam approved by US FDA for the treatment of spinal muscular atrophy

Nov 25, 2019: PTC Therapeutics, Inc announced that the United States Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for risdiplam (RG7916) for the treatment of spinal muscular atrophy (SMA).

It gives improvements in the safety or efficiency of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The SMA program is a collaboration between PTC, the SMA Foundation and Roche.

It is designed to supply sustained increase in SMN protein centrally and peripherally through daily dosing and is being evaluated for its potential aptitude to help the SMN2 gene produce more functional SMN protein to all over the body.

Risdiplam is being studied in a clinical trial for patients with type 1 SMA, called FIREFISH, in pre-symptomatic babies, RAINBOWFISH, in patients who have been in previous clinical trials for SMA, JEWELFISH and in SUNFISH, a placebo-controlled study in people aged 2-25 years with type 2 or 3 SMA.
http://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-announces-fda-grants-priority-review-risdiplam

Vaccitech announces successful recruitment and vaccination for two phase 2 Universal influenza studies FLU009 and FLU010 for the treatment and prevention of cancer and infectious diseases

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Vaccitech announces successful recruitment and vaccination for two phase 2 Universal influenza studies FLU009 and FLU010 for the treatment and prevention of cancer and infectious diseases

Nov 25, 2019: Vaccitech Ltd, a clinical-stage T cell immunotherapy company develop the products for the treatment and prevention of  cancer and infectious diseases, reports victorious recruitment and vaccination for its Universal influenza A vaccine MVA-NP+M1 (VTP-100), across two Phase 2 clinical studies, FLU009 and FLU010. Final data of FLU010 is expected in early 2020, the Phase 2 studies are part of a dual development pathway for VTP-100 that will deal with both pandemic and seasonal influenza vaccine markets.

FLU010 (randomised, double-blind, placebo controlled, influenza challenge) study conducted in Antwerp, Belgium, and co-funded by BARDA for $8.6M, 145 participants vaccinated, out of which 108 were challenged with the A/Belgium/4217/2015 (H3N2) influenza virus. Another group is programmed to be challenged by the end of this year. https://www.vaccitech.co.uk/vaccitech-provides-update-phase-2-influenza/

FDA approves new system for the delivery of tympanostomy tubes under local anesthesia to treat ear infection

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FDA approves new system for the delivery of tympanostomy tubes under local anesthesia to treat ear infection

Nov 25, 2019 :Tusker Medical recievied approval from The U.S. Food and Drug Administration for the delivery of tympanostomy tubes (ear tubes)  that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).

These are the first Tubes Under Local Anesthesia (Tula) System that can be performed in young children using local anesthesi.

The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices essential for the delivery of the ear tubes and the anesthetic into the ear drum for the treatment of recurrent ear infections that does not require general anesthesia.

In a physician’s office setting, this System enables the delivery of an ear tube to patients under local anesthesia.

Small electrical current used to deliver a local anesthetic into the ear drum preceding to tube insertion. It is approved for use in both adults and children (more than six months). https://fda.einnews.com/pr_news/503206800/fda-approves-system-for-the-delivery-of-ear-tubes-under-local-anesthesia-to-treat-ear-infection

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