Italian Medicines Agency

Hansa Biopharma announces positive reimbursement decision in Italy for Idefirix® (imlifidase) as desensitization treatment for highly sensitized patients in kidney transplantation

Retrieved on: 
Thursday, December 8, 2022
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The decision by the Italian Medicine Agency (AIFA) provides highly sensitized patients in Italy with the opportunity to receive Idefirix to enable kidney transplantation.

Key Points: 
  • The decision by the Italian Medicine Agency (AIFA) provides highly sensitized patients in Italy with the opportunity to receive Idefirix to enable kidney transplantation.
  • By the time the body starts to synthesize new IgG, the patient will be receiving post transplant immunosuppressive therapy to reduce the risk of organ rejection.
  • Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions.
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

NUROSENE BUSINESS UPDATE

Retrieved on: 
Thursday, December 1, 2022
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TORONTO, Dec. 1, 2022 /PRNewswire/ - Nurosene Health Inc. ("Nurosene" or the "Company") (CSE: MEND) (Frankfurt: 8TV) (OTC: MNNDF), a company that is focused on being a leader in the development of Artificial Intelligence (AI) / Machine Learning (ML) solutions targeted at the pharmaceutical industry, is pleased to share the following business update.

Key Points: 
  • TORONTO, Dec. 1, 2022 /PRNewswire/ - Nurosene Health Inc. ("Nurosene" or the "Company") (CSE: MEND) (Frankfurt: 8TV) (OTC: MNNDF), a company that is focused on being a leader in the development of Artificial Intelligence (AI) / Machine Learning (ML) solutions targeted at the pharmaceutical industry, is pleased to share the following business update.
  • The opportunity At Nurosene, we believe there is a significant opportunity to address the very low rate of success in the clinical trial process, by using the NetraAI technology.
  • Any forward-looking information speaks only as of the date on which it is made, and, except as required by law, Nurosene does not undertake any obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
  • New factors emerge from time to time, and it is not possible for Nurosene to predict all such factors.

NeuroSense Receives Regulatory Approval to Commence Patient Enrollment in Italy for its Phase 2b Trial in ALS

Retrieved on: 
Wednesday, November 16, 2022
Quality of life, Celecoxib, RNA, ALS, EMA, European Medicines Agency, Massachusetts General Hospital, Forward-looking statement, Ciprofloxacin, Safety, Neurodegeneration, FDA, Paralysis, Hope, Company, Italian Medicines Agency, Therapy, Patent, Death, Patient, Parkinson's disease, NASDAQ, Amyotrophic lateral sclerosis, Inflammation, Nature, SOC, Alzheimer's disease, Diagnosis, NDE, Food, Biomarker, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, EU

The Phase 2b ( NCT05357950 ) double-blind, placebo-controlled, multinational clinical trial aims to assess PrimeC's efficacy, as well as safety and tolerability, in people living with ALS.

Key Points: 
  • The Phase 2b ( NCT05357950 ) double-blind, placebo-controlled, multinational clinical trial aims to assess PrimeC's efficacy, as well as safety and tolerability, in people living with ALS.
  • The study is enrolling and randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively.
  • Primary endpoints of the study include assessment of ALS-biomarkers, evaluation of clinical efficacy, and improvement in quality of life.
  • Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate.

ReiThera expands large-scale viral vector production capabilities with opening of new manufacturing facility

Retrieved on: 
Thursday, November 3, 2022
GMP, D, Vaccine, CGMP, HSV, Engineering, Italian Medicines Agency, R, Infection, COVID-19, MVA, Malaria, AAV, Lentivirus, Laboratory, European Medicines Agency, Therapy, HIV, Hepatitis C, Fine chemical, Adenoviridae

ROME, Nov. 3, 2022 /PRNewswire/ -- ReiThera, a biotech company dedicated to the development of new technologies, GMP production and the clinical translation of genetic vaccines and products for advanced therapies, today announces that it has received operational authorization from the Italian Medicines Agency (AIFA) to open the new production area at its pharmaceutical facility at the Castel Romano Technopole, for the large-scale production of viral vectors for vaccines and gene therapy.  

Key Points: 
  • The facility will serve ReiThera's client base, which ranges from small biotechnology companies to large multinational pharma groups.
  • The construction of the new production facility, which covers an area of 1500 sq.m., began in May 2020 with investment of over 15 million euros by ReiThera.
  • ReiThera is actively working in the setting up scalable processes applicable to different viral vectors: AAV, LV, MVA, HSV.
  • Today ReiThera offers a wide range of services that include both process development and GMP production of viral vectors and analytical activities including immunological characterization of biological therapeutics.

ReiThera expands large-scale viral vector production capabilities with opening of new manufacturing facility

Retrieved on: 
Thursday, November 3, 2022
GMP, D, Vaccine, CGMP, HSV, Engineering, Italian Medicines Agency, R, Infection, COVID-19, MVA, Malaria, AAV, Lentivirus, Laboratory, European Medicines Agency, Therapy, HIV, Hepatitis C, Fine chemical, Adenoviridae

ROME, Nov. 3, 2022 /PRNewswire/ -- ReiThera, a biotech company dedicated to the development of new technologies, GMP production and the clinical translation of genetic vaccines and products for advanced therapies, today announces that it has received operational authorization from the Italian Medicines Agency (AIFA) to open the new production area at its pharmaceutical facility at the Castel Romano Technopole, for the large-scale production of viral vectors for vaccines and gene therapy. 

Key Points: 
  • The facility will serve ReiThera's client base, which ranges from small biotechnology companies to large multinational pharma groups.
  • The construction of the new production facility, which covers an area of 1500 sq.m., began in May 2020 with investment of over 15 million euros by ReiThera.
  • ReiThera is actively working in the setting up scalable processes applicable to different viral vectors: AAV, LV, MVA, HSV.
  • Today ReiThera offers a wide range of services that include both process development and GMP production of viral vectors and analytical activities including immunological characterization of biological therapeutics.

Dipharma Receives Regulatory Authorization for the New Line at Its cGMP Pilot Plant

Retrieved on: 
Thursday, October 6, 2022
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(Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today that the Italian Medicines Agency (AIFA) approved the brand-new production line at the cGMP pilot plant suite, located in its facility of Mereto di Tomba (Italy).

Key Points: 
  • (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today that the Italian Medicines Agency (AIFA) approved the brand-new production line at the cGMP pilot plant suite, located in its facility of Mereto di Tomba (Italy).
  • View the full release here: https://www.businesswire.com/news/home/20221005005738/en/
    New Dipharma cGMP pilot plant line, located in the Italian facility of Mereto di Tomba (UD).
  • With this state-of-the-art investment Dipharma doubles its capacity to process projects for customers, both in the generics and CDMO arena, while enhancing operational safety and isolation technologies.
  • We have experienced an unprecedented increase in demand for our services said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l.

Alimera Announces Approval and Pricing Granted for ILUVIEN® for Uveitis in Italy

Retrieved on: 
Friday, July 8, 2022
Weight gain, Patient, GLOBE, Retina, Cancer, AIFA, Osteoporosis, Uveitis, Recurrence, Injection, Alimera Sciences, Analysis, SIFI, Organization, Financial condition report, SEC, Result, Associate, Eye, Lists of countries and territories, Inflammation, Lists of diseases, DME, Severe cognitive impairment, Infection, Private Securities Litigation Reform Act, Sleep, Italian Medicines Agency, Hypertension, Mutual, Diabetic retinopathy, News, Acne, Annual report, Vita-Salute San Raffaele University, Disease, Compte rendu, Risk, Fluocinolone acetonide, Intraocular pressure, Physician, European Medicines Agency, Pharmaceutical industry, Trosia

Alimera will launch ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant behind its new uveitis indication in Italy, through its distribution partner, SIFI.

Key Points: 
  • Alimera will launch ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant behind its new uveitis indication in Italy, through its distribution partner, SIFI.
  • The Companys primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye.
  • In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.
  • Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf.

Orchard Therapeutics Announces Reimbursement Agreement Making Libmeldy Available for All Eligible MLD Patients in Italy

Retrieved on: 
Monday, April 11, 2022
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The news marks the second reimbursement agreement to cover all eligible MLD patients that Orchard has reached with a European market this year.

Key Points: 
  • The news marks the second reimbursement agreement to cover all eligible MLD patients that Orchard has reached with a European market this year.
  • Earlier this month, an MLD patient from the Middle East also received Libmeldy through reimbursed international treatment abroad at Ospedale San Raffaele, in Milan, Italy.
  • Patients with MLD gradually lose the ability to move, talk, swallow, eat and see.
  • Libmeldy is the first therapy approved for eligible patients with early-onset MLD.

RAMM Provides Update on European Operations

Retrieved on: 
Tuesday, February 22, 2022
GLOBE, Ownership, Pharmacology, CSE, CBD, Population, Growth, International, Overalls, Cannabis, API, AIFA, Company, Sale, Italian Medicines Agency, Acquisition, RAMM, Food, Biomass, Marketing, Engineering, Patient, KPD, Goal, Contract, European Medicines Agency, Certification, Fine chemical, Risk management, European, EU

TORONTO, Feb. 22, 2022 (GLOBE NEWSWIRE) -- RAMM Pharma Corp. (including its wholly owned subsidiaries, the Company or "RAMM") (CSE: RAMM), a leader in plant-derived cannabinoid pharmaceutical products, is pleased to provide an update on their European operations as well as the recent positive regulatory developments in Europe.

Key Points: 
  • TORONTO, Feb. 22, 2022 (GLOBE NEWSWIRE) -- RAMM Pharma Corp. (including its wholly owned subsidiaries, the Company or "RAMM") (CSE: RAMM), a leader in plant-derived cannabinoid pharmaceutical products, is pleased to provide an update on their European operations as well as the recent positive regulatory developments in Europe.
  • In October 2021, RAMM engaged a local engineering firm to complete commissioning activities on the Companys KPD Industrial Unit.
  • Key European countries including Germany and France have announced regulatory developments that will directly improve RAMMs ability to expand European operations and bring its products to market.
  • RAMM Pharma includes wholly owned subsidiaries Canapar Corp., Medic Plast SA, Yurelan SA, Glediser SA and RAMM Pharma Holdings Corp.

Theratechnologies Announces Reimbursement Agreement in Italy for Trogarzo® for Eligible Patients With Multi-Drug Resistant HIV-1

Retrieved on: 
Tuesday, October 26, 2021
Immunoglobulin G, Research, Mission statement, Subtypes of HIV, EDGAR, EMA, Patient, General manager, NASDAQ, SEDAR, FDA, Forward-looking statement, Food, TSX, AIFA, Regulation of tobacco by the U.S. Food and Drug Administration, Company, European Medicines Agency, COVID-19, HIV-1, Health, CD4, GLOBE, MDR, Italian Medicines Agency, Pharmaceutical industry, Vaccine, Public relations, Risk management

This agreement is an important milestone for Trogarzo and for HIV-1 patients in Italy, said Conor Walshe, General Manager, Europe.

Key Points: 
  • This agreement is an important milestone for Trogarzo and for HIV-1 patients in Italy, said Conor Walshe, General Manager, Europe.
  • Italy is the first country with a universal healthcare plan that has approved the formal reimbursement of Trogarzo for all patients in need.
  • We expect to launch Trogarzo in Italy during the current quarter and look forward to its wider commercial availability in Europe over the coming months.
  • Theratechnologies plans to launch Trogarzo on a country-by-country basis across Europe as it gains reimbursement in each individual country.