USFDA

Dr. Reddy's Laboratories Announces the Launch of Doxycycline Capsules, 40 mg* in the U.S.

Retrieved on: 
金曜日, 5月 3, 2024
FDA, Health, General Health, Research, Pharmaceutical, Science, Laboratory, USP, Capsule, Doxycycline, USFDA, RDY, Food

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced its launch of Doxycycline Capsules, 40 mg* in the U.S. market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced its launch of Doxycycline Capsules, 40 mg* in the U.S. market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the U.S. Food and Drug Administration (USFDA).
  • Dr. Reddy’s Doxycycline Capsules, 40 mg*, are supplied in bottle counts of 30.
  • *Each capsule contains: 26 mg immediate-release pellets and 14 mg delayed-release pellets equivalent to 40 mg of anhydrous doxycycline, USP.
  • ORACEA® is a trademark of Galderma Holdings, S.A.

Novotech Publishes Research Report on Acute Myeloid Leukaemia Clinical Trial Landscape for Clinical Stage Biotechs

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木曜日, 4月 11, 2024
Contract research organization, IDH2, FDA, Mutation, Acute myeloid leukemia, SWOT, Risk, Research, Prognosis, AML, USFDA, Leukemia, Pharmacotherapy, Therapy, Smoking, Incidence, Azacitidine, Protein, ROW, FLT3, Standard of care, Acute promyelocytic leukemia, Drug development, Biomarker, Clinical trial, IDH1, Growth, Pharmaceutical industry

BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.

Key Points: 
  • BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.
  • Importantly it also includes an in-depth SWOT analysis to guide strategic decision-making, prioritize research areas, and identify challenges for clinical stage biotechs.
  • The Acute Myeloid Leukaemia (AML) - Global Clinical Trial Landscape report notes that since 2019, the global biotech and biopharmaceutical industry initiated over 1,000 clinical trials for AML.
  • These reports offer current insights into global clinical trial activity, revealing which regions experience the highest trial volumes and the unique factors behind these trends.

Novotech Publishes Analyst Report on Cystic Fibrosis Clinical Trial Landscape to Inform Biotech Research Planning 

Retrieved on: 
木曜日, 4月 11, 2024
Contract research organization, Mutation, Epithelium, Pancreas, Investment, SWOT, Cystic fibrosis, CFTR, USFDA, Growth, Therapy, Patient, Research report, Medicine, ROW, Life expectancy, Standard of care, Clinical trial, Quality of life, Longevity, Prevalence, Pharmaceutical industry

BOSTON, April 10, 2024 (GLOBE NEWSWIRE) --  Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released a comprehensive research report entitled Cystic Fibrosis - Global Clinical Trial Landscape.

Key Points: 
  • BOSTON, April 10, 2024 (GLOBE NEWSWIRE) --  Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released a comprehensive research report entitled Cystic Fibrosis - Global Clinical Trial Landscape.
  • The report presents a data-backed review of the Cystic Fibrosis (CF) funding landscape, trial density and patient recruitment data across geographies, standard of care and emerging therapies, recent USFDA approvals, and regulatory trends.
  • Importantly it also includes an in-depth SWOT analysis, to guide biotech firms on strategic decision-making, and research opportunities, and challenges.
  • The Novotech research analyst team provides these expert reports on a monthly basis, completely free of charge.

Global Weight Loss Drugs Markets Report 2023-2024 & 2029 - The Emergence of GLP-1 and GIP, Unmet Market Needs and Emerging Product Pipeline - ResearchAndMarkets.com

Retrieved on: 
金曜日, 4月 26, 2024
Health, Fitness & Nutrition, Other Science, General Health, Science, Pharmaceutical, Biotechnology, Online, Conditional sentence, Market, Semaglutide, Sale, Investment, Social media, Injection, Weight gain, Huadong Medicine, Safety, Risk, Plasma protein binding, CDC, Underweight, Alli, OTC, Overweight, Eli Lilly, GSK plc, Diabetes, Weight loss, Research, Liraglutide, USFDA, Appetite, Success, Roche, Obesity, Culture, Novo Nordisk, Distribution, Patient, Powder, Metabolism, Marketing, GIP, Cancer, COVID-19, Pharmacy, Growth, Prevalence, Pharmaceutical industry

The global weight loss drugs market was valued at US$3.83 billion in 2023, and is expected to be worth US$44.12 billion in 2029.

Key Points: 
  • The global weight loss drugs market was valued at US$3.83 billion in 2023, and is expected to be worth US$44.12 billion in 2029.
  • The global weight loss drugs market is expected to grow at a CAGR of 49.85% over the years 2024-2029.
  • The weight loss drugs market in the Asia Pacific is expected to grow significantly during the forecasted period.
  • Offline distribution channels, comprising brick-and-mortar pharmacies, clinics, and healthcare facilities, dominated the global weight loss drugs market in 2023.

Zydus launches Mirabegron Extended-Release Tablets in the US

Retrieved on: 
月曜日, 4月 22, 2024
Biotechnology, General Health, Pharmaceutical, Health, Zydus Lifesciences, USP, Patient, Overactive bladder, USFDA, Mirabegron, Urinary incontinence, OAB, Generic drug

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.

Key Points: 
  • Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.
  • The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets).
  • Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
  • Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Rett syndrome - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report 2023 To 2033

Retrieved on: 
火曜日, 4月 9, 2024
Knowledge, Neurology, Acadia Pharmaceuticals, Pediatrics, CDKL5, Communication, RTT, Patient, FOXG1, Research, Disorder, Competitive landscape, Rett syndrome, Drug development, USFDA

HARTFORD, Conn., April 9, 2024 /PRNewswire/ -- Thelansis Knowledge Partners, specialized in pharmaceutical and biopharmaceutical business research and consulting Company that provides data driven research and consulting support released highly valued Market Outlook Report Title: Rett syndrome - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report 2023 To 2033

Key Points: 
  • HARTFORD, Conn., April 9, 2024 /PRNewswire/ -- Thelansis Knowledge Partners, specialized in pharmaceutical and biopharmaceutical business research and consulting Company that provides data driven research and consulting support released highly valued Market Outlook Report Title: Rett syndrome - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report 2023 To 2033
    Rett Syndrome (RTT) is an orphan neurodevelopmental disorder for which no cure exists.
  • The condition is clinically heterogenous; key patient types include typical or classical RTT and atypical RTT.
  • Although the disorder is rare, it causes life-long impairment and severe symptoms requiring treatments such as antiepileptics and supportive therapies.
  • Only one drug is USFDA approved for the treatment of RTT: Daybue (trofinetide), which is marketed by Acadia Pharmaceuticals.

Rett syndrome - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report 2023 To 2033

Retrieved on: 
火曜日, 4月 9, 2024
Knowledge, Neurology, Acadia Pharmaceuticals, Pediatrics, CDKL5, Communication, RTT, Patient, FOXG1, Research, Disorder, Competitive landscape, Rett syndrome, Drug development, USFDA

HARTFORD, Conn., April 9, 2024 /PRNewswire/ -- Thelansis Knowledge Partners, specialized in pharmaceutical and biopharmaceutical business research and consulting Company that provides data driven research and consulting support released highly valued Market Outlook Report Title: Rett syndrome - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report 2023 To 2033

Key Points: 
  • HARTFORD, Conn., April 9, 2024 /PRNewswire/ -- Thelansis Knowledge Partners, specialized in pharmaceutical and biopharmaceutical business research and consulting Company that provides data driven research and consulting support released highly valued Market Outlook Report Title: Rett syndrome - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report 2023 To 2033
    Rett Syndrome (RTT) is an orphan neurodevelopmental disorder for which no cure exists.
  • The condition is clinically heterogenous; key patient types include typical or classical RTT and atypical RTT.
  • Although the disorder is rare, it causes life-long impairment and severe symptoms requiring treatments such as antiepileptics and supportive therapies.
  • Only one drug is USFDA approved for the treatment of RTT: Daybue (trofinetide), which is marketed by Acadia Pharmaceuticals.

Koel USA Inc. Selects Univar Solutions to Represent Specialty Pigment and Dyes Portfolio

Retrieved on: 
月曜日, 4月 1, 2024
CARE, Skin care, Partnership, Beauty, Univar Solutions, Food and Drug Administration, Accreditation, Transport, Laboratory, Cosmetics, Marketing, USFDA, Food, Individual

DOWNERS GROVE, Ill., April 1, 2024 /PRNewswire/ -- Univar Solutions, LLC (Univar Solutions" or "the Company"), a leading global solutions provider to users of specialty ingredients and chemicals, today announced Koel USA Inc., a subsidiary of Koel Colours Private Ltd. ("Koel Colours"), has chosen Univar Solutions to exclusively distribute its pigments and colorants used in cosmetics and personal care formulations. Koel Colours is a leading global cosmetic pigment manufacturer for the beauty and personal care industry with a full range of colorant solutions, including organic, effect, and specialty pigments, water-based pigment dispersions, water soluble dyes, and oil soluble and natural colorants.

Key Points: 
  • With the increased demand for beauty and personal care products, Univar Solutions strengthens its portfolio of cosmetic pigments to offer even more innovative color solutions for customers in the United States
    DOWNERS GROVE, Ill., April 1, 2024 /PRNewswire/ -- Univar Solutions, LLC (Univar Solutions" or "the Company"), a leading global solutions provider to users of specialty ingredients and chemicals, today announced Koel USA Inc., a subsidiary of Koel Colours Private Ltd. ("Koel Colours"), has chosen Univar Solutions to exclusively distribute its pigments and colorants used in cosmetics and personal care formulations.
  • Koel Colours is a leading global cosmetic pigment manufacturer for the beauty and personal care industry with a full range of colorant solutions, including organic, effect, and specialty pigments, water-based pigment dispersions, water soluble dyes, and oil soluble and natural colorants.
  • "As a leading global distributor of specialty ingredients, we recognize the growing worldwide need for high quality sustainable color cosmetic products.
  • With dyes, pigments, and specialty color solutions that also impact performance, Univar Solutions' beauty expertise knows no bounds.

Psychedelics set to be the revolutionary treatments in pscyhiatry- Thelansis Knowledge Partners

Retrieved on: 
木曜日, 2月 22, 2024
Knowledge, DSM-IV codes, Esketamine, TRD, Major depressive disorder, Drug development, TAS, USFDA, Psilocybin, MDMA, Psychiatry, CNS, Patient, Acute stress disorder, PTSD, Polypharmacy, Psychotherapy, MDD, KOL, Research, Central nervous system disease, Pharmaceutical industry

Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."

Key Points: 
  • Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."
  • According to an interviewed U.S.-based neurologist by Thelansis – "We desperately need disease-modifying treatments for many neurodegenerative conditions.
  • As psychedelics would be beneficial for treatment-nonresponders or severe patients, the commercial opportunities are multiple for in-pipeline psychedelic therapies.
  • What is the probable opportunity for Psychedelics (e.g., psilocybin, MDMA) to address the unmet needs of other TAs?

Psychedelics set to be the revolutionary treatments in pscyhiatry - Thelansis Knowledge Partners

Retrieved on: 
木曜日, 2月 22, 2024
Knowledge, DSM-IV codes, Esketamine, TRD, Major depressive disorder, Drug development, TAS, USFDA, Psilocybin, MDMA, Psychiatry, CNS, Patient, Acute stress disorder, PTSD, Polypharmacy, Psychotherapy, MDD, KOL, Research, Central nervous system disease, Pharmaceutical industry

Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."

Key Points: 
  • Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."
  • According to an interviewed U.S.-based neurologist by Thelansis – "We desperately need disease-modifying treatments for many neurodegenerative conditions.
  • As psychedelics would be beneficial for treatment-nonresponders or severe patients, the commercial opportunities are multiple for in-pipeline psychedelic therapies.
  • What is the probable opportunity for Psychedelics (e.g., psilocybin, MDMA) to address the unmet needs of other TAs?