USFDA

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

Retrieved on: 
Tuesday, April 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: 
Tuesday, April 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: 
Monday, April 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: 
Thursday, February 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: 
Thursday, February 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?

QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) Receives USFDA 510(k) Clearance

Retrieved on: 
Friday, January 5, 2024
IDAC, ICRP, USFDA, Multimedia, Physician, Radiology, Software, FDA, Physics, Multi, Nuclear medicine, Tissue, MIRD, European, Radiopharmaceutical, Algorithm, Radiation, Medical imaging

KALAMAZOO, Mich., Jan. 5, 2024 /PRNewswire/ -- QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) received USFDA 510(k) clearance in August 2023.

Key Points: 
  • KALAMAZOO, Mich., Jan. 5, 2024 /PRNewswire/ -- QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) received USFDA 510(k) clearance in August 2023.
  • QDOSE® features fully automated organ segmentation, single time-point dosimetry, and one-click hybrid dosimetry capabilities, supported by algorithms for fast data processing and an extensive radionuclide database.
  • Versant Medical Physics , the US distributor for QDOSE® Multi-purpose Voxel Dosimetry Software, reflects the software's reliability and efficacy in radiation dose assessment.
  • With both FDA clearance and the European CE Mark, QDOSE® stands out as a comprehensive tool for diagnostic and therapeutic radiopharmaceutical dosimetry."

PharmAla Files Audited Financials for Year Ending August 31, 2023

Retrieved on: 
Friday, December 29, 2023
Psilocybin, MDXX, Patient, USFDA, Research, MDMA, Clinical trial, Bank statement, GMP, PTSD, OTC, Authorization, Pharmaceutical industry

- PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.

Key Points: 
  • - PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.
  • “This has been an exciting year for PharmAla, and for MDMA more broadly,” said Nick Kadysh, CEO, PharmAla Biotech.
  • We are excited to continue to build off of the milestones we achieved at PharmAla in 2023.
  • The recent filing of the MAPS New Drug Application for MDMA-Assisted Therapy for PTSD provides a favourable industry tailwind.

Carbapenem Market Research Report 2023-2030: Analysis by Drug Class (Meropenem, Imipenem, Ertapenem), and Application (UTI, Blood Stream Infections, Pneumonia) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 28, 2023
General Health, Pharmaceutical, Health, USFDA, Fungal infection, Research, Urinary tract infection, Prevalence, Market, Developed country, Infection, ICU, Meropenem, Patient, Carbapenem, Death, USD, UTI, COVID-19, Bacteria, AMR, American Lung Association, Growth, MEM, Pfizer, Pharmaceutical industry, Antibiotics, Ertapenem, Application, Pneumonia, Imipenem

The "Carbapenem Market Size, Share & Trends Analysis Report By Drug Class (Meropenem, Imipenem, Ertapenem), By Application (UTI, Blood Stream Infections, Pneumonia), By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Carbapenem Market Size, Share & Trends Analysis Report By Drug Class (Meropenem, Imipenem, Ertapenem), By Application (UTI, Blood Stream Infections, Pneumonia), By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global carbapenem market size is expected to reach USD 5.24 billion by 2030., exhibiting a CAGR of 4.78% from 2023 to 2030.
  • In May 2023, Antabio initiated its Phase I trial by administering the initial dose of antibiotic therapy to healthy volunteers for hospital-acquired infections.
  • Based on drug class, the meropenem segment dominated the market in 2022, owing to their broad-spectrum activity against various bacteria, including multidrug-resistant strains.

FDA Approves Bio-Thera Solutions' Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®

Retrieved on: 
Thursday, December 7, 2023
USFDA, Lung, Safety, Patient, FDA, Lung cancer, Pharmacokinetics, Novartis, Biosimilar, Generic drug, Bevacizumab

Avzivi® is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.

Key Points: 
  • Avzivi® is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.
  • The FDA approval of Avzivi® was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA.
  • Extensive analytical characterization between BAT1706 and US and EU Avastin® was conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706.
  • The approval of Avzivi® by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.

Aurisco sets Goals and Plans for Carbon Neutrality by 2027 and Zero Emissions by 2030

Retrieved on: 
Monday, November 20, 2023
USFDA, Targets, Sustainable development, Classification, Carbon, Climate change, Organization, Recycling, Science, Peptide, Solar energy, Medication, Social media, Science Based Targets initiative, CGMP, Oligonucleotide, API, Walking, Renewable energy, Oil

SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- Aurisco Pharmaceutical Co., Ltd (Aurisco), a science-based, USFDA inspected cGMP generic API manufacturer and CRDMO for modified amidites, oligonucleotides and peptides, announced today its sustainability goals and plans in alignment with global efforts to address climate change, reflecting the company's strong commitment to reduce the environmental impact of its operations.

Key Points: 
  • It has set Sustainable Development goals, is Ecovadis ranked and has joined the Science Based Targets initiative (SBTi).
  • To achieve carbon neutrality by 2027 and zero emissions by 2030.
  • To increase to more than 95% of total energy consumption to be from renewable energy sources by 2030.
  • Establish partnerships with domestic and overseas enterprises and organizations to jointly promote achieving the carbon neutrality targets.