LAI

Indivior Enters an Exclusive Licensing Agreement with Alar Pharmaceuticals

Retrieved on: 
Wednesday, October 11, 2023
LAI, Drug development, Opioid use disorder, Central nervous system, Buprenorphine, Safety, Conditional sentence, OUD, CNS, Justice, Patient, Pharmaceutical industry, Daminozide, Indivior

RICHMOND, Va., Oct. 11, 2023 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV), a leading addiction treatment company, today announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable ("LAI") candidate, ALA-1000.

Key Points: 
  • Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights (except in China, Hong Kong, Taiwan and Macau) to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates.
  • The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in Q1.
  • Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved.
  • Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039.

Teva to Present Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023

Retrieved on: 
Wednesday, September 6, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Teva Pharmaceuticals, HD, Abstract (summary), LAI, Risk, Different Stages, TEVA, Global R&D management, Olanzapine, Teva, De novo, TD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lais, Doctor of Philosophy, Medication, Depression, Risperidone, Poster, Migraine, MD, Treatment, TASE, Post hoc analysis, Chorea, Reactions on surfaces, FDA, Mental health, NYSE, Tardive dyskinesia, Food, Pharmaceutical industry, Patient, Schizophrenia

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.
  • Abstracts include data for AUSTEDO, once-daily AUSTEDO XR, UZEDY, TV-44749 and AJOVY.
  • Once-daily AUSTEDO XR, a new formulation of twice-daily AUSTEDO was approved by the U.S. Food and Drug administration (FDA) in February 2023 for adults with TD and chorea associated with Huntington’s disease (HD), and UZEDY, a long-acting formulation of risperidone for subcutaneous use, was approved by the FDA in April 2023 for adults with schizophrenia.1,2 TV-44749 is an investigational formulation of olanzapine currently being studied in adults with schizophrenia.3
    “Because of the immense impact that mental health and neurological conditions like schizophrenia, TD and HD pose for patients, we are constantly striving to advance research that can enhance available treatment options,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
  • “Following this year’s FDA approval of once-daily AUSTEDO XR and UZEDY and the excitement they have received from the medical community, we are thrilled to continue to share research showcasing their potential for patients living with these debilitating conditions.”
    In addition to these data presentations, Teva will also be hosting a symposium to discuss results of the DECIDE study, highlighting perspectives from U.S. psychiatric clinicians on selecting and initiating LAI antipsychotics as well as the real-world barriers that cause LAIs to remain underutilized in clinical practice.

Xtalks Announces its Life Science Webinar Calendar for September 2023

Retrieved on: 
Friday, September 1, 2023
LAI, Food, Health care, Impact, Health, History, UAT, Biomarker, Development, Clinical trial, Universal language, Visibility, Data, Clinical study design, Drug discovery, Site, Physics, Research, Dynamic method, FDA, Integration, Success, Pharmaceutical industry, Medical device, Fine chemical, Birth control, Radiobiology, Xtalk

TORONTO, Sept. 1, 2023 /PRNewswire-PRWeb/ -- Stay on top of current hot topics through free webinars presented by leading experts in the pharma, biotech, medical device and food industries. Access to all webinars is free, so be sure to register today to save your place! Participate in the discussion and stay relevant in your field!

Key Points: 
  • Upcoming free, educational webinars from Xtalks will feature topics on biomarkers, clinical trials, commercialization & HEOR, drug discovery & development, food, healthcare, laboratory technology, medical device, patient recruitment & retention, pharmaceutical and pharma manufacturing & supply chain.
  • TORONTO, Sept. 1, 2023 /PRNewswire-PRWeb/ -- Stay on top of current hot topics through free webinars presented by leading experts in the pharma, biotech, medical device and food industries.
  • Access to all webinars is free, so be sure to register today to save your place!
  • Participate in the discussion and stay relevant in your field!

UPS TEAMSTERS CONTRACT TAKES EFFECT AS FINAL SUPPLEMENT RATIFIED

Retrieved on: 
Friday, August 25, 2023
LAI, Teamsters Local 1932, Chess title, International Brotherhood of Teamsters, Local, 2021 Teamsters Union Election, Air conditioning, UPS, Pension fund

WASHINGTON, Aug. 25, 2023 /PRNewswire/ -- The Teamsters' new National Master Agreement with UPS has officially gone into effect, protecting more than 340,000 full- and part-time workers, after an outstanding supplemental contract was resolved and ratified in Florida.

Key Points: 
  • The LAI supplement for 174 members of Teamsters Local 769 was voted and successfully passed by affected workers Friday afternoon.
  • Discussions between the Teamsters' supplemental committee and UPS representatives cleared up questions from Local 769 members about benefits.
  • The local supplement was overwhelmingly ratified 80-8 following the historic approval of the UPS Teamsters national agreement on Tuesday.
  • Rank-and-file Teamsters ratified the five-year contract by a record 86.3 percent, tallying an unprecedented 58.1 percent voter turnout.

TEAMSTERS RATIFY HISTORIC UPS CONTRACT

Retrieved on: 
Tuesday, August 22, 2023
LAI, Safety, History, San Francisco UPS shooting, Amazon, Chess title, The Devil Is a Part-Timer!, Local, Teamster, 2021 Teamsters Union Election, Air conditioning, UPS, Longevity, Clothing, Pension fund, Food delivery, Ridesharing, International Brotherhood of Teamsters

WASHINGTON, Aug. 22, 2023 /PRNewswire/ -- Today, Teamsters voted by an overwhelming 86.3 percent to ratify the most historic collective bargaining agreement in the history of UPS. The five-year contract protects and rewards more than 340,000 UPS Teamsters nationwide, raising wages for full- and part-time workers, creating more full-time jobs, and securing important workplace protections, including air conditioning.

Key Points: 
  • The agreement passed by the highest vote for a contract in the history of the Teamsters at UPS.
  • The UPS Teamsters National Negotiating Committee will immediately meet with the company to work to resolve any outstanding issues with the supplement.
  • "This is the richest national contract I've seen in my more than 40 years of representing Teamsters at UPS," said Teamsters General Secretary-Treasurer Fred Zuckerman.
  • Last month, the UPS Teamsters National Negotiating Committee, as well as representatives of UPS Teamster locals in the U.S. and Puerto Rico, unanimously endorsed the agreement.

Ivanhoe Mines Announces MOU to Commence Exports of Concentrate from Kamoa-Kakula Copper Complex via Lobito Atlantic Rail Corridor

Retrieved on: 
Wednesday, August 16, 2023
Ivanhoe Mines, LAI, Mota-Engil, Kipushi, Transport, U.S. International Development Finance Corporation, CITIC, Consortium, RTNC, TSX, Safety, Pressure, Robert L. Sumwalt (U.S. government official), Carbon, Climate change, MOU, Tehsil Municipal Administration, Multilateralism, Metal, GHG, Movement, Republic, DFC, Democratic republic, Economic development, Excellency, Copper, Copperbelt, Rail freight transport, Rail transport, Rare-earth element, Mining, Typesetting, Trafigura, DRC, Atlantic Ocean

The rail line linking the DRC Copperbelt to the port of Lobito, Angola is known as the "Lobito Atlantic Railway Corridor" or "Lobito Corridor".

Key Points: 
  • The rail line linking the DRC Copperbelt to the port of Lobito, Angola is known as the "Lobito Atlantic Railway Corridor" or "Lobito Corridor".
  • There is also potential for additional investment in the future as the opportunity is explored to further extend the Lobito Corridor into Zambia.
  • Up to 10,000 tonnes of copper concentrate from Kamoa-Kakula to be exported from the port in Q4 2023.
  • The MOU is the first commercial agreement under the new concession for exporting metals from the DRC using the Lobito Atlantic Rail Corridor.

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

Retrieved on: 
Saturday, April 29, 2023
Mental Health, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Teva Pharmaceuticals, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, LAI, TEVA, Clinical trial, Lais, Brain, DSM-IV codes, Medication, Risperidone, WAC, MD, Patient, Risk, Physician, Nursing, TASE, Wholesale acquisition cost, RISE, FDA, Maintenance, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Psychiatry, NYSE, Mitsubishi Q2M, Food, Pharmaceutical industry, Teva, Euronext, Schizophrenia

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone.

Key Points: 
  • UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone.
  • “The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market.
  • "The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit,” said Christophe Douat, CEO of MedinCell.
  • It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY.

ReKlame Health Extends BIPOC Addiction Medicine Care into the Home

Retrieved on: 
Wednesday, April 12, 2023
Psychiatry, Insurance, LAI, Anxiety, Health, Loneliness, African Americans, Telepsychiatry, Cigna, Binge drinking, Death, AUD, CQD, Patient, RN, BIPOC, Mental health, UnitedHealth Group, Pharmaceutical industry, Nursing, Naltrexone, Seidels Reklame

Delivered as part of a comprehensive mental health treatment plan and inclusive of virtual care, the program treats alcohol use disorder (AUD) within the BIPOC community in New York City.

Key Points: 
  • Delivered as part of a comprehensive mental health treatment plan and inclusive of virtual care, the program treats alcohol use disorder (AUD) within the BIPOC community in New York City.
  • Naltrexone LAI is an injection administered monthly by a health provider that historically followed an "in-person first, virtual second" standard of care pre-pandemic at health clinics and offices.
  • The patient is assessed during their tele-psychiatric appointments with their ReKlame care provider, who can assess medication tolerance.
  • "Engagement is critical when treating substance use disorders," said Evans Rochaste, founder and CEO of ReKlame Health.

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

Retrieved on: 
Tuesday, March 7, 2023
Growth, FDA, MBI, Simulation, SVP, Pharmacokinetics, Trial of the century, QSP, LAI, PBPK, Lactation, Doctor of Philosophy, Drug development, Pregnancy, Excipient, Metabolism, Patient, Quantitative systems pharmacology, PD, Generic drug, Pharmaceutical industry, Simcyp, Pharmacodynamics, Certara

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.

Key Points: 
  • The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.
  • The Simcyp Simulator has proven use cases across drug development, including first-in-human dosing, extrapolation to special populations, bioequivalence testing, optimizing clinical study design and predicting drug-drug interactions (DDIs).
  • “We are excited to expand and improve upon the Simcyp Simulator capabilities to advance modern drug development with the launch of our latest version,” said Masoud Jamei, Ph.
  • For more information about the Simcyp PBPK Simulator and Simcyp Designer, please visit: https://www.certara.com/software/simcyp-pbpk/

Initiation of the Phase 3 study for the second long-acting injectable antipsychotic using MedinCell’s technology (program mdc-TJK)

Retrieved on: 
Tuesday, January 24, 2023
Pharmaceutical, Health, Clinical Trials, LAI, FDA, Safety, Risperidone, Patient, Olanzapine, Schizophrenia, Pharmaceutical industry

The Phase 3 study conducted in the U.S. will assess the efficacy and safety of the first subcutaneous long-acting Injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia.

Key Points: 
  • The Phase 3 study conducted in the U.S. will assess the efficacy and safety of the first subcutaneous long-acting Injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia.
  • Enrollment of the first patients is expected in the coming days.
  • mdc-TJK follows mdc-IRM (LAI risperidone), the first subcutaneous antipsychotic based on MedinCell’s technology currently under regulatory review by the U.S. FDA, with a launch target set for H1 2023.