Anti-acne preparations

Sol-Gel Technologies Announces FDA Approval of TWYNEO®

Retrieved on:

Tuesday, July 27, 2021

Health, Anti-acne preparations, Medicine, Skin care, Benzoyl peroxide, Galderma, Food and Drug Administration

The FDA approval of TWYNEO underscores our ability to deliver innovative, proprietary drugs to the market, stated Dr. Alon Seri-Levy, Co-Founder and Chief Executive Officer of Sol-Gel.

Key Points:

The FDA approval of TWYNEO underscores our ability to deliver innovative, proprietary drugs to the market, stated Dr. Alon Seri-Levy, Co-Founder and Chief Executive Officer of Sol-Gel.
With market leader, Galderma, handling the product launch of TWYNEO, we are excited that TWYNEO will soon be available to patients in the U.S., continued Dr. Seri-Levy.
We remain focused on obtaining FDA approval of EPSOLAY (benzoyl peroxide), our other Galderma-partnered product the approval of which has been delayed due to FDAs COVID-19-related restrictions.
The approval of TWYNEO offers patients efficacy with these two products in a single convenient application.

VYNE Therapeutics Announces Initiation of Investigator Initiated Trial Evaluating AMZEEQ® (Minocycline) with Oral Isotretinoin in Patients with Moderate to Severe Acne

Retrieved on:

Monday, July 19, 2021

Clinical medicine, Medicine, Organ systems, Anti-acne preparations, Acneiform eruptions, Retinoids, Acne, Puberty, Isotretinoin, Minocycline, Tretinoin, Scar

BRIDGEWATER, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (VYNE or the Company) today announced the initiation of an investigator initiated trial (IIT or study) evaluating the safety and efficacy of AMZEEQ (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne.

Key Points:

BRIDGEWATER, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (VYNE or the Company) today announced the initiation of an investigator initiated trial (IIT or study) evaluating the safety and efficacy of AMZEEQ (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne.
Isotretinoin has been widely used forthe management of severe or scarring acne since its introduction as Accutane in the 1980s.
Dr. Lain also served as an investigator in the clinical trials for AMZEEQ and is a consultant to VYNE.
AMZEEQ is a valuable topical treatment option for moderate to severe acne.

Sol-Gel Technologies and Galderma Announce Exclusive Licenses for the Commercialization of EPSOLAY® and TWYNEO® in the United States

Retrieved on:

Monday, June 28, 2021

Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical trials, Other Health, Anti-acne preparations, Health, Drugs, Clinical medicine, Skin care, Galderma, Health care, L'Oréal, Nestlé, Benzoyl peroxide, Adapalene/benzoyl peroxide

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, and Galderma, the worlds largest independent dermatology company, today announced they have signed two exclusive 5-year license agreements for the commercialization of EPSOLAY and TWYNEO in the United States.

Key Points:

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, and Galderma, the worlds largest independent dermatology company, today announced they have signed two exclusive 5-year license agreements for the commercialization of EPSOLAY and TWYNEO in the United States.
Innovation is at the heart of our commitment to advancing dermatology, said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma.
EPSOLAY utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin.
If approved, EPSOLAY has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product.

Upsher-Smith Launches Isotretinoin Capsules

Retrieved on:

Friday, June 25, 2021

Anti-acne preparations, Chemical compounds, Retinoids, Organic compounds, Clinical medicine, Enones, Isotretinoin, Polyenes, iPLEDGE program, Pregnancy, Tretinoin, Acne

Isotretinoin capsules can cause lifethreatening birth defects and is contraindicated in pregnancy.

Key Points:

Isotretinoin capsules can cause lifethreatening birth defects and is contraindicated in pregnancy.
There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time.
Isotretinoin capsules are available only through a restricted program called the iPLEDGE REMS.
Please refer to the full Prescribing Information, including Boxed Warning for Isotretinoin Capsules here .

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on:

Tuesday, June 1, 2021

Tetracycline antibiotics, Hepatotoxins, Medicine, Chemistry, Chemical elements, Omadacycline, Antacid, Antidiarrhoeals, Anti-acne preparations, Food and Drug Administration, Bismuth subsalicylate, Bismuth

Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

Key Points:

Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Sol-Gel Technologies Reports First Quarter 2021 Financial Results and Corporate Update

Retrieved on:

Thursday, May 13, 2021

Anti-acne preparations, Communication, Forward-looking statement, Food and Drug Administration, Benzoyl peroxide, Chemistry, Medicine, Health care

In the most recent written communication with the FDA regarding EPSOLAY, Sol-Gel and the FDA discussed and agreed to the final content of the labeling of the product.

Key Points:

In the most recent written communication with the FDA regarding EPSOLAY, Sol-Gel and the FDA discussed and agreed to the final content of the labeling of the product.
The silica-based shell is designed to release benzoyl peroxide slowly over time to provide a favorable efficacy and safety profile.
These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives.
Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.\n"

Teva Announces the Launch of the First Generic Version of Absorica® (isotretinoin) Capsules, for the Treatment of Severe Recalcitrant Nodular Acne in Patients 12 Years of Age and Older, in the United States

Retrieved on:

Thursday, April 29, 2021

See \xe2\x80\x9cBefore taking isotretinoin capsules\xe2\x80\x9d\nDo not drive at night until you know if isotretinoin capsules have affected your vision.

Key Points:

See \xe2\x80\x9cBefore taking isotretinoin capsules\xe2\x80\x9d\nDo not drive at night until you know if isotretinoin capsules have affected your vision.
Isotretinoin capsules may make your skin more sensitive to light.\nDo not share isotretinoin capsules with other people.
Your healthcare provider will do tests to check your liver before and during treatment with isotretinoin capsules.
Tell your healthcare provider if you are very thirsty or urinate more than usual.\nThe most common side effects of isotretinoin capsules include:\n'

VYNE Therapeutics to Report First Quarter 2021 Financial Results on May 6, 2021

Retrieved on:

Wednesday, April 28, 2021

Hepatotoxins, Anti-acne preparations, Tetracycline antibiotics, Minocycline, Triketones, XC2, Medication package insert, Drugs, Health sciences, Health

b'A replay of the call will be archived on the Company\xe2\x80\x99s website at www.vynetherapeutics.com after the conference call.\nVYNE\xe2\x80\x99s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.\nWith expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST\xe2\x84\xa2), and has received FDA approval for AMZEEQ\xc2\xae (minocycline) topical foam, 4%, the world\xe2\x80\x99s first topical minocycline, and for ZILXI\xc2\xae (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.\xc2\xa0For more information about our approved products, please see AMZEEQ\xe2\x80\x99s Full Prescribing Information at AMZEEQ.com and ZILXI\xe2\x80\x99s Full Prescribing Information at ZILXI.com .\nFor more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter.

Key Points:

b'A replay of the call will be archived on the Company\xe2\x80\x99s website at www.vynetherapeutics.com after the conference call.\nVYNE\xe2\x80\x99s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.\nWith expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST\xe2\x84\xa2), and has received FDA approval for AMZEEQ\xc2\xae (minocycline) topical foam, 4%, the world\xe2\x80\x99s first topical minocycline, and for ZILXI\xc2\xae (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.\xc2\xa0For more information about our approved products, please see AMZEEQ\xe2\x80\x99s Full Prescribing Information at AMZEEQ.com and ZILXI\xe2\x80\x99s Full Prescribing Information at ZILXI.com .\nFor more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter.
VYNE may use its website to comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor VYNE\xe2\x80\x99s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.\n'

Daré Bioscience Announces the Presentation of DARE-BVFREE Phase 3 Clinical Trial Results at the 2021 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists

Retrieved on:

Monday, April 26, 2021

Anti-acne preparations, Sexually transmitted diseases and infections, Probiotics, Clindamycin, Organochlorides, Thioethers, Bacterial vaginosis, Organ systems, Chemistry, Drugs

DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis.

Key Points:

DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis.
Patients were evaluated during three clinic visits: Day 1 (screening and randomization visit), Day 7-14 (assessment visit), and Day 21-30 (test-of-cure visit).
\xe2\x80\x9cIn the DARE-BVFREE trial, DARE-BV1 was well-tolerated and demonstrated clinical cure efficacy rates superior to those shown by current branded prescription products for treatment of bacterial vaginosis.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made.

World Acne Market Spotlight Report 2021: Treatment, Epidemiology, Marketed Drugs, Pipeline Drugs, Recent Events, Regulatory Events, Revenue Opportunity, Clinical Trial Landscape

Retrieved on:

Wednesday, April 14, 2021

Acneiform eruptions, Organ systems, Health sciences, Anti-acne preparations, Health, Acne, Puberty, Clinical trial

These drugs are administered via the oral and topical routes.\nThe majority of industry-sponsored drugs in active clinical development for acne are in Phase II, with just a single product in the NDA/BLA stage.\nTherapies in development for acne focus on a wide variety of targets.

Key Points:

These drugs are administered via the oral and topical routes.\nThe majority of industry-sponsored drugs in active clinical development for acne are in Phase II, with just a single product in the NDA/BLA stage.\nTherapies in development for acne focus on a wide variety of targets.
The overall likelihood of approval of a Phase I dermatology-general asset is 20.2%, and the average probability a drug advances from Phase III is 68%.
Germany leads the major European markets, while Japan has the top spot in Asia.\nClinical trial activity in the acne space is dominated by completed trials.
GlaxoSmithKline has the highest number of completed clinical trials for acne, with 35 trials.\nGlaxoSmithKline leads industry sponsors with by far the highest overall number of clinical trials for acne, followed by AbbVie.\n'