US FDA

Emerging Therapeutics for Rare Neuromuscular Diseases: Pipeline Analysis

Retrieved on: 
Thursday, December 1, 2022

Muscle weakness, cramps, and impaired musculoskeletal functions that occur due to rare defects in nerve and muscle cells characterize neuromuscular disorders (NMDs).

Key Points: 
  • Muscle weakness, cramps, and impaired musculoskeletal functions that occur due to rare defects in nerve and muscle cells characterize neuromuscular disorders (NMDs).
  • The disorders are largely classified as motor neuron diseases, hereditary ataxias, peripheral nerve disorders, neuromuscular junction transmission disorders, and myopathies.
  • Frost & Sullivans research, Emerging Therapeutics for Rare Neuromuscular Diseases: A Pipeline Analysis explores emerging biologics across these six NMDs.Key biologics emerging for these rare NMDs include stem cell therapies, other cell-based treatments, gene therapies, RNA therapeutics, immunotherapies, and other protein/peptide-based treatments.
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GE Healthcare’s AIR Recon DL Technology Recognized by Popular Science Magazine in the ‘Best of What’s New’ Awards

Retrieved on: 
Wednesday, November 30, 2022

GE Healthcare announced today that it was recognized in the annual Best of Whats New awards by Popular Science Magazine.

Key Points: 
  • GE Healthcare announced today that it was recognized in the annual Best of Whats New awards by Popular Science Magazine.
  • The award highlights GE Healthcares AIR Recon DL technology and the benefits it brings to the healthcare industry.
  • GE Healthcare recently announced US FDA 510(k) clearance of its AIR Recon DL 3D and motion-insensitive PROPELLER imaging sequences.
  • The illustration above breaks down GE Healthcares advanced AIR Recon DL technology in an easy-to-understand fashion that connects non-engineers/people of all ages to this exciting, industry-leading innovation.

CIPLA ANNOUNCES LAUNCH OF LEUPROLIDE ACETATE INJECTION DEPOT (22.5Mg)

Retrieved on: 
Wednesday, November 30, 2022

MUMBAI, India and WARREN, N.J., Nov. 29, 2022 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and its wholly owned subsidiary Cipla USA Inc. (hereafter referred to as 'Cipla'), today announced the launch of Leuprolide Acetate Injection Depot 22.5mg.

Key Points: 
  • MUMBAI, India and WARREN, N.J., Nov. 29, 2022 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and its wholly owned subsidiary Cipla USA Inc. (hereafter referred to as 'Cipla'), today announced the launch of Leuprolide Acetate Injection Depot 22.5mg.
  • Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3-month administration given as a single dose injection.
  • Arunesh Verma, CEO Cipla North America, said, "The launch of Leuprolide Acetate Injection Depot reinforces our commitment as an organization to bring high quality and affordable treatments to patients in the US.
  • The active ingredient, route of administration, dosage form and strength are the same as LUPRON DEPOT 22.5 mg strength, from Abbvie.

RadioMedix and Vect-Horus announce first dosing of Glioblastoma Multiforme and Pancreatic ductal adenocarcinoma patients with 68Ga-RMX-VH

Retrieved on: 
Tuesday, November 15, 2022

PDAC is one of the most chemo-resistant and radio-resistant types of cancers due to the dense pancreatic connective tissue and the diversity of genetic mutations.

Key Points: 
  • PDAC is one of the most chemo-resistant and radio-resistant types of cancers due to the dense pancreatic connective tissue and the diversity of genetic mutations.
  • Our current therapeutic approaches for these cancers are invasive and fail meaningful results while adversely effects on the quality of life of our patients.
  • RadioMedix is serving as a Sponsor and manufacturer of the clinical doses of 68Ga-RMX-VH., said Dr. Izabela Tworowska, CSO of RadioMedix.
  • In addressing other unmet needs in oncology, RadioMedix is developing theranostic agents to treat brain tumors, and pancreatic ductal adenocarcinoma (PDAC).

Global Insulin Market Forecast to 2028 - Insufficient Competition from Biosimilars Presents Opportunities - ResearchAndMarkets.com

Retrieved on: 
Friday, November 25, 2022

The "Insulin Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type and Geography" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Insulin Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type and Geography" report has been added to ResearchAndMarkets.com's offering.
  • The insulin market is projected to grow from US$ 54,611.42 million in 2021 to US$ 111,213.73 million by 2028.
  • The increase in the incidence of diabetes and rapid technological developments in insulin delivery devices by major players is expected to bolster the insulin market in the years to come.
  • Additionally, the regeneration of the diabetic pancreas with advanced transplants is likely to emerge as a significant future trend in the insulin market from 2022 to 2028.

Reunion Neuroscience Inc. Provides Business Update and Reports Fiscal Second Quarter 2023 Financial Results

Retrieved on: 
Monday, November 14, 2022

TORONTO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN), a biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, today reported its business update and fiscal second quarter ended September 30, 2022 results.

Key Points: 
  • TORONTO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN), a biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, today reported its business update and fiscal second quarter ended September 30, 2022 results.
  • We are well positioned to round out the year in preparation for what promises to be an exciting 2023.
  • The study aims to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of RE104 over a range of dosage levels.
  • Per the Phase 1 protocol, up to two additional dosing cohorts may be evaluated based on pharmacokinetics, pharmacodynamics and safety.

Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory: A 2 Day US FDA, US EPA and OSHA Focus Course (December 8-9, 2022) - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 24, 2022

The "2 Day Seminar on Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus) Course" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "2 Day Seminar on Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus) Course" training has been added to ResearchAndMarkets.com's offering.
  • Any action in the laboratory must be done by following an SOP, no matter how common or seemingly trivial the action might be.
  • Know the roles within the laboratory of each individual in creating, implementing, monitoring, training, documenting, and updating an SOP.
  • The reasons why will be described, as will the steps needed to convert a standard method into a compliant SOP.

CANbridge Pharmaceuticals Granted Orphan Drug Designation for CAN 106 for the Treatment of Myasthenia Gravis

Retrieved on: 
Wednesday, November 16, 2022

Orphan Drug Designation for CAN106 in MG is both a validation of CANbridge innovation and a major milestone as our first US FDA regulatory designation, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.

Key Points: 
  • Orphan Drug Designation for CAN106 in MG is both a validation of CANbridge innovation and a major milestone as our first US FDA regulatory designation, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.
  • We continue to advance our global development strategy for CAN106 and look forward to developing CAN106 for myasthenia gravis and other complement-mediated diseases.
  • CAN106 is a clinical-stage investigational novel, long-acting recombinant humanized monoclonal antibody that binds to and neutralizes C5, a key component of the complement system.
  • CAN106 acts downstream of C3 in the complement pathway, preserving the generation of C3a and C3b, which are important for innate immunity.

Piramal Critical Care (PCC) commits to reduce its environmental footprint and growing responsibly through sustainable operations

Retrieved on: 
Thursday, November 17, 2022

MUMBAI, India, Nov. 17, 2022 /PRNewswire/ -- Piramal Critical Care (PCC) has integrated its sustainability framework with its strategy as well as daily business practices. As part of the endeavour, PCC's Environment, Social and Governance (ESG) policy covers sustainable and environment-friendly practices across energy and waste management, climate change management, greenhouse gas (GHG) reduction, water stewardship, supplier assessment, and integration of sustainability into our operations to ensure continual improvement in our performance and employee engagement. PCC is the complex hospital generics business under Piramal Pharma Limited (PPL). PCC's commitment towards sustainability dovetails into the overall objective of integrating sustainable practices across all businesses under PPL, as articulated in PPL's Sustainability Report FY 21–22.

Key Points: 
  • Under the ESG strategy, one of the key focus areas for Piramal is sustainability initiatives.
  • Energy management is one of our primary focus areas because of its direct influence on emissions and costs associated with our operations.
  • Piramal Critical Care (PCC) is a global leader in anesthesia, pain management, and intrathecal therapy.
  • PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business, and the India Consumer Healthcare business selling over-the-counter products.

Piramal Critical Care (PCC) commits to reduce its environmental footprint and growing responsibly through sustainable operations

Retrieved on: 
Thursday, November 17, 2022

MUMBAI, India, Nov. 17, 2022 /PRNewswire/ -- Piramal Critical Care (PCC) has integrated its sustainability framework with its strategy as well as daily business practices. As part of the endeavour, PCC's Environment, Social and Governance (ESG) policy covers sustainable and environment-friendly practices across energy and waste management, climate change management, greenhouse gas (GHG) reduction, water stewardship, supplier assessment, and integration of sustainability into our operations to ensure continual improvement in our performance and employee engagement. PCC is the complex hospital generics business under Piramal Pharma Limited (PPL). PCC's commitment towards sustainability dovetails into the overall objective of integrating sustainable practices across all businesses under PPL, as articulated in PPL's Sustainability Report FY 21–22.

Key Points: 
  • Under the ESG strategy, one of the key focus areas for Piramal is sustainability initiatives.
  • Energy management is one of our primary focus areas because of its direct influence on emissions and costs associated with our operations.
  • Piramal Critical Care (PCC) is a global leader in anesthesia, pain management, and intrathecal therapy.
  • PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business, and the India Consumer Healthcare business selling over-the-counter products.