Isotretinoin

Timber Pharmaceuticals, Inc., a LEO Pharma Company, Presents Late-Breaking Preliminary Results of TMB-001 in Moderate-to-Severe Congenital Ichthyosis (CI) at the 2024 AAD Annual Meeting

Retrieved on: 
Sunday, March 10, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, LEO, Leo Pharma, Disease, Associate, Patient, Ageing, PKS, Knowledge, Research, American Academy, Acquisition, Tretinoin, Adolescence, Abstract, Yale School of Medicine, Clinical trial, Safety, AAD, Isotretinoin, ISO, FDA, Fissure, ASCEND, IGA, Food, Pharmaceutical industry

“With no specific treatment currently available, CI patients are currently having to deal with their condition with minimal support.

Key Points: 
  • “With no specific treatment currently available, CI patients are currently having to deal with their condition with minimal support.
  • I hope that the data and insights presented today can help provide new knowledge and support for this patient community.”
    In January 2024, LEO Pharma finalized the acquisition of Timber Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.
  • Upon completion, the Timber Pharmaceuticals lead investigational product candidate, TMB-001, was added to LEO Pharma’s pipeline.
  • TMB-001 is under investigation and has not been evaluated by any health authority.

EQS-News: CHEPLAPHARM acquires Roaccutane® from Roche

Retrieved on: 
Tuesday, January 30, 2024
Dermatology, Retinoid, Acne, Isotretinoin, Medicine, Intellectual property, Cheplapharm Arzneimittel, Fine chemical

The CHEPLAPHARM Group acquires the global rights to Roaccutane® from Roche, thereby strengthening its dermatological portfolio.

Key Points: 
  • The CHEPLAPHARM Group acquires the global rights to Roaccutane® from Roche, thereby strengthening its dermatological portfolio.
  • The medicine, which is based on the active ingredient isotretinoin, is used to treat severe acne.
  • CHEPLAPHARM, a leading purchaser of originator products from research-based pharmaceutical companies, has acquired the global rights to Roaccutane® from Roche, which include around 50 countries.
  • CHEPLAPHARM is already active in the therapeutic area of dermatology and owns medicines for the topical treatment of mild forms of acne and antibiotic-based products for mild to moderate forms of acne.

LEO Pharma Finalizes Acquisition of Key Assets From Timber Pharmaceuticals

Retrieved on: 
Tuesday, January 23, 2024
Health, Science, Pharmaceutical, Research, Clinical Trials, LEO, API, Skin, Acquisition, Leo Pharma, Isotretinoin, Bankruptcy, FDA, Pharmaceutical industry

LEO Pharma today announced that it has finalized the acquisition of the strategic asset TMB-001 as well as certain other assets from Timber Pharmaceuticals following its chapter 11 bankruptcy filing.

Key Points: 
  • LEO Pharma today announced that it has finalized the acquisition of the strategic asset TMB-001 as well as certain other assets from Timber Pharmaceuticals following its chapter 11 bankruptcy filing.
  • The TMB-001 project continues as planned and without changes within LEO Pharma.
  • All employees of Timber Pharmaceuticals will transition to LEO Pharma’s offices in New Jersey, US.
  • "We are excited to kick-off 2024 by adding TMB-001 to our pipeline and to welcome the employees of Timber Pharmaceuticals to LEO Pharma.

Orphan designation: isotretinoin Treatment of recessive X-linked ichthyosis, 15/02/2023 Positive

Retrieved on: 
Wednesday, January 24, 2024
COMP, Committee, European Commission, IRIS, Patient, Isotretinoin, EMA, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - isotretinoin
    - Intended use
    - Treatment of recessive X-linked ichthyosis
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2760
    - Date of designation
    - Sponsor
    Granzer Regulatory Consulting & Services
    Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

FDA Implements AADA's iPLEDGE Recommendations

Retrieved on: 
Tuesday, December 5, 2023
Workgroup, Isotretinoin, Dermatology, American Academy, Patient, REMS, Pregnancy, American Academy of Dermatology, FDA, Data collection, AAD, Hearing, Letter, AADA, FAAD, Pharmaceutical industry, Birth control, Medical device, MD

WASHINGTON, Dec. 5, 2023 /PRNewswire/ -- The FDA agreed to require important American Academy of Dermatology's (AAD) recommended changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists.

Key Points: 
  • "The FDA supported the AADA's critical recommendations that include allowing for continued use of at home and non-CLIA pregnancy tests."
  • In 2023, 300 AAD members sent about 600 messages to the FDA urging changes to iPLEDGE REMS Program.
  • These grassroots efforts, combined with AAD's strong advocacy led by its iPLEDGE Workgroup, including testifying during an FDA hearing in March, convinced the FDA to require modifications to the iPLEDGE REMS to minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin.
  • The AAD has been fighting for these changes since 2021, when the FDA transitioned to a new iPLEDGE platform that malfunctioned and disrupted treatment for many patients.

Sun Pharma Canada Launches (PR)ABSORICA LD® (isotretinoin capsules) for Treatment of Severe Acne

Retrieved on: 
Monday, December 4, 2023
Breakout, Reuters, Isotretinoin, Food, Patient, Sun Pharma, BSE, Pigment, Cyst, Skin, Quality of life, NSE, Face, Acne, Animal feed, Generic drug

BRAMPTON, ON, Dec. 4, 2023 /CNW/ - Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomb: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma") today announces that PRABSORICA LD (isotretinoin capsules) is now available in Canada.

Key Points: 
  • BRAMPTON, ON, Dec. 4, 2023 /CNW/ - Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomb: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma") today announces that PRABSORICA LD (isotretinoin capsules) is now available in Canada.
  • "Knowing the impact that severe acne has on the lives of patients, I look forward to seeing the potential results from this new treatment option."
  • Severe acne causes breakouts that often extend deep into the skin, including cysts and nodules that disfigure the face.
  • Even as severe acne clears, acne scars and pigmentation often appear.5
    "ABSORICA LD brings a novel, micronized formulation of isotretinoin to deal with severe nodular acne to Canadians," said Abhay Gandhi, North America CEO of Sun Pharma.

Accure Acne, Inc to Present at Canaccord Genuity Medtech, Diagnostics, and Digital Health & Services

Retrieved on: 
Monday, November 13, 2023
EST, Canaccord Genuity, Digital health, Isotretinoin, Diagnosis

BOULDER, Colo., Nov. 13, 2023 /PRNewswire/ -- Accure Acne, Inc.™ (www.accureacne.com), a global leader in AcneTech™ solely focused on curing acne and improving related skin conditions, announced today that members of its senior leadership team will present at the Canaccord Genuity Medtech, Diagnostics, and Digital Health & Services Forum on November 16, 2023 at 4:30 pm EST in New York City.

Key Points: 
  • BOULDER, Colo., Nov. 13, 2023 /PRNewswire/ -- Accure Acne, Inc.™ ( www.accureacne.com ), a global leader in AcneTech™ solely focused on curing acne and improving related skin conditions, announced today that members of its senior leadership team will present at the Canaccord Genuity Medtech, Diagnostics, and Digital Health & Services Forum on November 16, 2023 at 4:30 pm EST in New York City.
  • Management will also be available for one-on-one meetings with investors at the conference.
  • Investors who are interested in meeting with the Accure team are encouraged to reach out to their representative at Canaccord Genuity.
  • In addition, Canaccord Genuity has arranged for all presentations to be available via the conference portal for 14 days, exclusively on the conference portal to registered attendees.

A Novel Surgical Technique Brings New Hope to Folliculitis Decalvans Patients

Retrieved on: 
Monday, September 11, 2023
Athena, Harbor–UCLA Medical Center, Clinical, Cosmetic and Investigational Dermatology, Folliculitis decalvans, Quality of life, Head, Research, Pain, Patient, Itch, Isotretinoin, Recurrence, FD, Disease, Medical device

The study outcome was published under " Refractory folliculitis decalvans treatment success with a novel surgical excision approach using guarded high-tension sutures .

Key Points: 
  • The study outcome was published under " Refractory folliculitis decalvans treatment success with a novel surgical excision approach using guarded high-tension sutures .
  • Folliculitis decalvans (FD) causes chronic inflammation scarring with symptoms of pain, itch, discharge, and social debilitation, mainly in middle-aged individuals.
  • Dr. Umar highlights the remarkable success of combining this with second-intention healing, offering newfound relief for long-struggling folliculitis decalvans patients.
  • The team's enthusiasm for the potential of this technique to enhance the quality of life for individuals grappling with stubborn folliculitis decalvans lesions is palpable.

LEO Pharma Signs Agreement to Acquire Timber Pharmaceuticals

Retrieved on: 
Monday, August 21, 2023
Health, Pharmaceutical, Skin, Leo Pharma, API, Ichthyosis, Patient, CVR, LEO, Isotretinoin, FDA, NYSE, Pharmaceutical industry

LEO Pharma today announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. (NYSE American: TMBR.

Key Points: 
  • LEO Pharma today announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. (NYSE American: TMBR.
  • The deal is subject to certain closing conditions including, but not limited to, Timber Pharmaceuticals’ shareholder approval.
  • Christophe Bourdon, CEO of LEO Pharma commented:
    “Signing an agreement to acquire Timber Pharmaceuticals and TMB-001, which is still subject to certain closing conditions, is an additional step in delivering on our strategy.
  • Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.

UPSHER-SMITH LAUNCHES ISOTRETINOIN CAPSULES, USP

Retrieved on: 
Monday, July 24, 2023
REMS, Pregnancy, Central nervous system, Medication, Upsher-Smith Laboratories, Face, Marketing, Fetus, Senior counsel, Thymus, Cleft lip and cleft palate, IQ, Skull, Toxicity, Pharmacy, Capsule, Hydrocephalus, Food and Drug Administration, Gland, System, Patient, Birth defect, Risk, Microcephaly, Isotretinoin, FDA, Comparison of multi-paradigm programming languages, Death, Food, Microphthalmia, Birth control

Isotretinoin capsules must not be used by patients who are or may become pregnant.

Key Points: 
  • Isotretinoin capsules must not be used by patients who are or may become pregnant.
  • There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time.
  • If pregnancy does occur during treatment of a patient who is taking isotretinoin capsules, isotretinoin capsules must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
  • Because of isotretinoin teratogenicity and to minimize fetal exposure, isotretinoin capsules approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration.