Paliperidone

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on:

Wednesday, February 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on:

Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points:

— Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
"Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on:

Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points:

— Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
"Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Saladax Biomedical and HLS Therapeutics Strengthen Partnership With an Exclusive Distribution Agreement for Canada

Retrieved on:

Thursday, November 18, 2021

Saladax Biomedical, Inc (Saladax) is pleased to announce an exclusive distribution agreement with HLS Therapeutics Inc. (HLS) (TSX:HLS) to distribute five MyCare Psychiatry Laboratory Assays used to measure the six most commonly prescribed antipsychotic drugs in Canada.

Key Points:

Saladax Biomedical, Inc (Saladax) is pleased to announce an exclusive distribution agreement with HLS Therapeutics Inc. (HLS) (TSX:HLS) to distribute five MyCare Psychiatry Laboratory Assays used to measure the six most commonly prescribed antipsychotic drugs in Canada.
The MyCare Psychiatry Laboratory Assays are essential diagnostic tools to monitor a patients antipsychotic drug blood level.
Unfortunately, these medications can have adverse effects if the drug level is too high.
Conversely, if the drug level is too low, the patient's condition may not be treated effectively.

Saladax Biomedical Announces Health Canada Approval of Five MyCare™ Psychiatry Laboratory Diagnostic Assay

Retrieved on:

Tuesday, February 16, 2021

Biotechnology, Mental health, Other Health, Health, Pharmaceutical, Receptor antagonists, Serotonin antagonists, Drugs, Atypical antipsychotics, Mood stabilizers, Olanzapine, Antipsychotic, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Psychiatry

Saladax Biomedical, Inc. (Saladax) is pleased to announce the approval of five MyCare Psychiatry Laboratory Assays by Health Canada for use in measuring drug levels in patients prescribed any of the six most common antipsychotic drugs.

Key Points:

Saladax Biomedical, Inc. (Saladax) is pleased to announce the approval of five MyCare Psychiatry Laboratory Assays by Health Canada for use in measuring drug levels in patients prescribed any of the six most common antipsychotic drugs.
The MyCare Psychiatry Laboratory Assays are essential diagnostic tools used by psychiatrists to monitor the patient's blood concentration level of these prescribed drugs.
The approved MyCare Psychiatry Laboratory Assays provide blood drug concentration levels for clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and quetiapine.
These assays are available in Canada through HLS Therapeutics Inc., the exclusive Canadian distributor of Saladax's MyCare Psychiatry Laboratory Assays.

Intra-Cellular Therapies Announces the Initiation of Clinical Trials for ITI-LLAI, a Long-Acting Injectable Formulation of Lumateperone for the Treatment of Schizophrenia and for ITI-333, a Novel Treatment for Opioid Use Disorder

Retrieved on:

Tuesday, December 29, 2020

Drugs, Psychiatry, Organic compounds, Prolactin releasers, Appetite stimulants, Diketones, Pregnanes, Progestogens, Schizophrenia, Medroxyprogesterone acetate, Management of schizophrenia, Paliperidone

This study will evaluate the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia.

Key Points:

This study will evaluate the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia.
Oral lumateperone has demonstrated efficacy in treating schizophrenia symptoms with a favorable safety and tolerability profile.
A long-acting formulation of lumateperone if successfully developed and approved will provide an additional option for patients.
The Company is developing a long-acting injectable formulation of lumateperone (LLAI) that is designed for once monthly administration by subcutaneous injection for the treatment of schizophrenia.

Janssen Submits Marketing Authorisation Extension to the European Medicines Agency to Register Paliperidone Palmitate 6-Monthly (PP6M) for Treatment of Schizophrenia in Adults

Retrieved on:

Friday, December 4, 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Marketing Authorisation Extension Application to the European Medicines Agency (EMA) to register paliperidone palmitate 6-monthly (PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on paliperidone palmitate 1monthly (PP1M)1 or 3-monthly (PP3M)2 injectable products.

Key Points:

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Marketing Authorisation Extension Application to the European Medicines Agency (EMA) to register paliperidone palmitate 6-monthly (PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on paliperidone palmitate 1monthly (PP1M)1 or 3-monthly (PP3M)2 injectable products.
We look forward to working with the European Medicines Agency to add a 6-month formulation to our family of paliperidone palmitate products.
Addressing this challenging aspect of treatment has been the catalyst for our research and development of long-acting injectable medications for people living with schizophrenia.
Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial.

Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults

Retrieved on:

Monday, November 2, 2020

Chemical compounds, Organic compounds, Heterocyclic compounds, Atypical antipsychotics, Lactams, Piperidines, Prolactin releasers, Mood stabilizers, Paliperidone, Palmitic acid, Risperidone

We look forward to working with the FDA to add a 6-month formulation to our family of paliperidone palmitate products."

Key Points:

We look forward to working with the FDA to add a 6-month formulation to our family of paliperidone palmitate products."
INVEGA TRINZA is used in people who have been treated with INVEGA SUSTENNA (1-month paliperidone palmitate) for at least 4 months.
INVEGA SUSTENNA (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional.
Do not receive INVEGA TRINZA or INVEGA SUSTENNA if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA or INVEGA SUSTENNA.

CA Appellate Court Rules Risperdal Not Federally Preempted | Sanders Phillips Grossman, LLC

Retrieved on:

Monday, May 11, 2020

Chemical compounds, Organic compounds, Heterocyclic compounds, Atypical antipsychotics, Lactams, Piperidines, Prolactin releasers, RTT, Risperidone, Johnson & Johnson, Paliperidone, Lawsuit

The decision allows affected Risperdal cases to proceed in the California coordinated proceeding after years of motion practice.

Key Points:

The decision allows affected Risperdal cases to proceed in the California coordinated proceeding after years of motion practice.
J&J is defending more than 13,000 lawsuits alleging that Risperdal (risperidone) and Invega (paliperidone) cause gynecomastia , a condition where boys grow female breasts.
However, the decision by the California 2nd District Court of Appeal reversed the summary judgment and said that plaintiffs' claims are not preempted.
Sanders Phillips Grossman represents approximately 10,000 Risperdal claimants.

ANI Announces Launch of Paliperidone Extended-Release Tablets

Retrieved on:

Tuesday, January 14, 2020

Psychiatry, Chemical compounds, Psychoactive drugs, Mood stabilizers, Atypical antipsychotics, Piperidines, Lactams, Paliperidone, Antipsychotic, Schizoaffective disorder, Alkermes

BAUDETTE, Minn., Jan. 14, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg and 9 mg.

Key Points:

BAUDETTE, Minn., Jan. 14, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg and 9 mg.
The product was developed by Inventia Healthcare Limited as part of a two drug development, manufacturing and commercialization partnership.The launch expands our commercial generic portfolio to 47 drugs."
Paliperidone Extended-Release Tablets is an atypical antipsychotic agent indicated for the treatment of schizophrenia, the treatment of schizoaffective disorder as monotherapy, and as an adjunct to mood stabilizers and/or antidepressants.
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.