EMA

Global Allogeneic Cell Therapy Market Report 2023: Sector is Expected to Reach $1.72 billion by 2030 at a CAGR of 27.4% - ResearchAndMarkets.com

Retrieved on: 
Monday, June 5, 2023
Biotechnology, Genetics, Health, Lymphoma, Charles River Laboratories, Hematologic disease, European Medicines Agency, Bone marrow, Cancer, Research, EMA, MSC, Patient, Investment, Blood, Medicine, Conditional sentence, Growth, Leukemia, FDA, Vaccine, Pharmaceutical industry

Allogeneic cell therapy involves transferring cells from healthy donors to patients to treat chronic diseases such as cancer and cardiovascular diseases.

Key Points: 
  • Allogeneic cell therapy involves transferring cells from healthy donors to patients to treat chronic diseases such as cancer and cardiovascular diseases.
  • Allogeneic cell therapies offer several benefits over autologous therapies, including being less expensive and their availability as a scalable off-the-shelf product.
  • The rising number of regulatory approvals for allogeneic cell-based therapies is expected to boost market growth over the forecast period.
  • Moreover, in August 2022, Charles River Laboratories received approval from the European Medicines Agency (EMA) for its Memphis cell therapy manufacturing facility, which will enable the commercial production of allogeneic cell therapy.

The Netherlands is Europe's Connected Life Sciences & Health Metropolis

Retrieved on: 
Monday, June 5, 2023
MSD, International, Biotechnology, European Medicines Agency, University, Health, Research, Multimedia, Netherlands Foreign Investment Agency, Science, EMA, Huntingdon, Patient, European, Alnylam Pharmaceuticals, Kite Pharma, NFIA, Pharmaceutical industry, Fine chemical

WASHINGTON, June 5, 2023 /PRNewswire/ -- The Netherlands is a prime location for biotech companies that bring forth an open-minded, innovative and inclusive approach to novel challenges in life sciences and health. Companies that invest in Holland are innovating for the benefit of patients and society at large. This dynamic Dutch life sciences and health ecosystem will be on full display during the BIO International Convention in Boston on June 5-8, 2023.

Key Points: 
  • This dynamic Dutch life sciences and health ecosystem will be on full display during the BIO International Convention in Boston on June 5-8, 2023.
  • "International companies that have operations in the Netherlands work alongside Dutch life sciences and health partners to build a healthier world together.
  • The Netherlands' central European location and vibrant life sciences & health ecosystem helps drive solutions for the future of biotech and healthcare."
  • Life Sciences & Health companies can connect with Europe and the world from the Netherlands.

AGC Biologics Introduces AGCellerate, Offering Fast Timelines, Fixed Pricing and Guaranteed Product Quantity

Retrieved on: 
Monday, June 5, 2023
Health, Genetics, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, Immortalised cell line, GMP, Plasmid, Hook effect, Food and Drug Administration, AGC, EMA, CDMO, Patient, European Medicines Agency, FDA, Zenith Contract Services, Food, Fine chemical, Vaccine, Pharmaceutical industry

AGCellerate offers guaranteed amounts at fixed timelines and costs – accelerating projects through development and into clinical phases.

Key Points: 
  • AGCellerate offers guaranteed amounts at fixed timelines and costs – accelerating projects through development and into clinical phases.
  • The new program offers support to biologics projects using monoclonal antibodies (mAbs), lentiviral vectors, adeno-associated vectors and Plasmid DNA (pDNA) material.
  • Drawing on 30 years of scientific expertise, the AGCellerate program offers a templated approach to maximize speed and product deliverables.
  • That is at the center of everything we strive to do at AGC Biologics,” said JB Agnus, Chief Business Officer, AGC Biologics.

BC Platforms Acquires 4Pharma, a Leading International Provider of Medical Research Data and Analytics Services for Global Clinical Trials and Real World Data

Retrieved on: 
Thursday, June 1, 2023
Real, Data management, Heart, Drug development, Jolt, Q2, Biotechnology, Clinical trial, Intelligence, Infection, Research, RWD, Real world data, BCP, Gynaecology, Science, EMA, HQ, Acquisition, Patient, Machine learning, Ophthalmology, Medicine, Data, Biostatistics, FDA, Neurology, Pharmaceutical industry, Central Europe, PMDA

In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.

Key Points: 
  • In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.
  • Tero Silvola, CEO at BC Platforms, said, “This exciting acquisition of the excellent 4Pharma brings impressive healthcare data intelligence expertise.
  • We combine omics and clinical data assets around the world, without compromising data privacy and security.
  • The company’s focus is on incorporating machine learning and artificial intelligence into generating useable clinical, and drug development, insights from Real World Data.

AB Science announces issuance of a Canadian patent for masitinib in the treatment of ALS with protection until 2037

Retrieved on: 
Thursday, June 1, 2023
Science, US Foods, SG, JP, European Medicines Agency, Policy, Calendar, KOREA, IP, EMA, US, NOA, Patent, FDA, Health Canada, ALS, Masitinib, Food, AU, Pharmaceutical industry, EUROPE

A NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability.

Key Points: 
  • A NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability.
  • In addition to patent protection, masitinib is also eligible for regulatory data protection in Canada, preventing generic competition for a period of 8 years following initial approval.
  • As a reminder, Health Canada had granted authorization to file a new drug submission for masitinib in the treatment of ALS under the notice of compliance with conditions (NOC/c) policy.
  • On May 9, 2023, AB Science announced that Health Canada had resumed its review of the application of masitinib in the treatment of ALS.

Can-Fite Reports First Quarter 2023 Financial Results & Provides Clinical Update

Retrieved on: 
Thursday, June 1, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acumen, Survival rate, Travel, Hepatocellular carcinoma, Pancreatic cancer, Liver cancer, Safety, Survival, American Society of Clinical Oncology, Rabin Medical Center, Journal, Hepatorenal syndrome, Patent, Patient, Liver failure, NYSE, HCC, A3, Disease, Therapy, NASH, Institutional review board, Food, EMA, Pancreas, Ascites, Liver, Cancer, Cirrhosis, FDA, Soroka Medical Center, Hepatic encephalopathy, Liver transplantation, Psoriasis, Fibrosis, Jaundice, CANF, Kidwai Memorial Institute of Oncology, TASE, Decompensation, American Journal of Clinical Oncology, Hepatology, Progression-free survival, Microsoft Access, WNT, ASCO, Green Light, Pivotal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Pharmaceutical industry, Medical imaging, Cryptocurrency

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.
  • Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored.
  • The mechanism of action entails de-regulation of the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.
  • The Company's consolidated financial results for the three months ended March 31, 2023 are presented in accordance with US GAAP Reporting Standards.

MediWound Reports First Quarter 2023 Financial Results and Provides a Company Update

Retrieved on: 
Tuesday, May 30, 2023
Operating cost, Biomedical Advanced Research and Development Authority, Table, VLU, Event, European Operations Management Association, Conference call, Bank statement, Eastern Time Zone, Bromelain (pharmacology), European Medicines Agency, Tax, Deep Insight, HERE, Forecasting, EMA, Development, Incidence, EBITDA, Patient, Investment, NEXT, Depreciation, Mouth ulcer, Growth, Research, Phase, FDA, Adjustment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Conference, Food, Safety, Corporate development, Pharmaceutical industry, Management, Renewable energy, Video game, Bookkeeping, Vericel

YAVNE, Israel, May 30, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • Importantly, MediWound is now in a strong financial position, with over $57 million in cash.
  • This provides the company with ample resources to effectively execute its corporate initiatives and drive continuous innovation," stated Ofer Gonen, Chief Executive Officer of MediWound.
  • First Quarter 2023 Highlights and Recent Developments:
    The Company’s global Phase III clinical study for EscharEx is expected to begin in the fourth quarter of 2023.
  • The Company utilized $1.8 million to fund its operating activities in the first quarter of 2023.

Valneva Files for Chikungunya Vaccine Authorization with Health Canada

Retrieved on: 
Tuesday, May 30, 2023
Epidemic, Biologics license application, Pan American Health Organization, Saint-Herblain, Vaccination, Priority, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, PDUFA, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine

Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.

Key Points: 
  • Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.
  • If accepted, Health Canada will provide additional information on the potential approval timeline.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.

Rocket Pharmaceuticals Receives European Medicines Agency (EMA) Priority Medicines (PRIME) Designation for RP-A501 Gene Therapy for Danon Disease

Retrieved on: 
Wednesday, May 31, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Regenerative Medicine Advanced Therapy, Marketing, Pharming, European Medicines Agency, Quality of life, Risk assessment, Fast Track, MBA, Cardiology, AAV, RP, Disorder, PRIME, Medication, EMA, Troponin I, New York Heart Association Functional Classification, Patient, BNP, Danon disease, Pharmaceutical industry

PRIME designation offers the benefits of early and enhanced support from the EMA for the development of medicines that target unmet medical needs, as well as the opportunity for an accelerated review of the marketing application.

Key Points: 
  • PRIME designation offers the benefits of early and enhanced support from the EMA for the development of medicines that target unmet medical needs, as well as the opportunity for an accelerated review of the marketing application.
  • Rocket was also recently granted Regenerative Medicine Advanced Therapy (RMAT) designation for its RP-A501 program, which also holds Fast Track , Orphan Drug (U.S.) and Rare Pediatric designations.
  • “PRIME designation from the EMA further highlights the positive benefit/risk profile of RP-A501 in addressing the critical unmet need of patients facing Danon Disease,” said Kinnari Patel, Pharm.D., MBA, President and Chief Operating Officer, Rocket Pharma.
  • The results demonstrated improvements and/or normalization across multiple quantifiable parameters that cardiologists use in clinical practice to enable risk assessment and treatment decisions.

Acticor Biotech: Progress in Discussions with EU and US Regulatory Agencies

Retrieved on: 
Tuesday, May 30, 2023
Biotechnology, Pharmaceutical, Health, Intracerebral hemorrhage, Splenic infarction, IDMC, Clinical trial, AIS, PRIME, EMA, Thrombectomy, Patient, ISIN, Mortality, FDA, BLA, Safety, Pharmaceutical industry, Medical device, EU

In the US, Acticor Biotech was granted FDA Type C consultation on its non-clinical and clinical developments for its first-in-class drug candidate, glenzocimab.

Key Points: 
  • In the US, Acticor Biotech was granted FDA Type C consultation on its non-clinical and clinical developments for its first-in-class drug candidate, glenzocimab.
  • Written responses were received by the end of May 2023 on a list of questions regarding potential future marketing authorization (BLA) of glenzocimab in AIS indication.
  • The FDA provided valuable feedback to reinforce the proposed development plan and to best address US requirements on the expected design of a pivotal study.
  • In Europe, Acticor continues to discuss the clinical and pharmaceutical developments for registration with the EMA as part of the PRIME designation program.