European Medicines Agency

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.

Trodelvy® Continues to Show Durable Overall Survival Advantage in Pre-Treated HR+/HER2- Metastatic Breast Cancer

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Monday, June 5, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Neutropenia, European Medicines Agency, Senior, Diarrhea, HER2, Survival, Journal of the National Comprehensive Cancer Network, Breast, OS, Woman, ILD, Type, Doctor of Philosophy, Associate, PFS, Dana–Farber Cancer Institute, ASCO, Harvard Medical School, NCCN, American Society of Clinical Oncology, Progression-free survival, Patient, Division, Annual general meeting, TPC, Immunohistochemistry, Periodic breathing, Science, Clinical, MPH, Breast cancer, Sacituzumab govitecan, Abstract, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Thrombocytopenia, Food, Fatigue, Pharmaceutical industry, Dietary supplement, MD

These findings will be shared as an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1003).

Key Points: 
  • These findings will be shared as an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1003).
  • “These longer-term results show the durable overall survival benefit of sacituzumab govitecan over traditional chemotherapy in pre-treated HR+/HER2- metastatic breast cancer,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at the Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School.
  • The survival benefit demonstrated for patients with pre-treated metastatic HR+/HER2- and metastatic triple-negative breast cancer are just the beginning of our clinical development journey.
  • The European Medicines Agency has also validated a Type II Variation Marketing Authorization Application for Trodelvy in HR+/HER2- metastatic breast cancer.

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.

SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA

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Monday, June 5, 2023
Priority review, Prescription Drug User Fee Act, Plantar fibromatosis, The New England Journal of Medicine, University of Medicine 1, Yangon, European Medicines Agency, New Drug Application, NDA, Cancer, Marketing, Breakthrough therapy, Patient, PDUFA, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

The previously disclosed August 27, 2023 PDUFA date has been extended by the standard extension period of three months.

Key Points: 
  • The previously disclosed August 27, 2023 PDUFA date has been extended by the standard extension period of three months.
  • The FDA notified SpringWorks on June 2, 2023 that it required more time to review additional analyses of previously submitted data that had been provided by SpringWorks in response to the FDA’s information requests.
  • The submission of this additional information was determined by the FDA to constitute a Major Amendment to the NDA, thereby resulting in an extension of the PDUFA action date.
  • In addition, SpringWorks expects to file a Marketing Authorization Application for nirogacestat with the European Medicines Agency in 2024.

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

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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.

Billions is spent on cancer research globally – but is it money well spent?

Retrieved on: 
Friday, June 2, 2023
Vaccine, Gaps, US Food Sovereignty Alliance, Human, European Medicines Agency, Clinical trial, Cancer, Lung cancer, Quality of life, Hope, Cancer Research UK, Breast, Global health, Research, Medicine, COVID, Life expectancy, Lung, Leukemia, Death, Neoplasm, Patient, Diagnosis, Health, Thyroid cancer, Food, Disease, Pharmaceutical industry, Uranium mining, Medical imaging, Dietary supplement

Poorer countries will be especially hard hit, with an increasing number of cases and more deaths, compared with richer countries.

Key Points: 
  • Poorer countries will be especially hard hit, with an increasing number of cases and more deaths, compared with richer countries.
  • Cancer research is vital to helping ease this global burden, but where and how research money is spent doesn’t always match with where and how help is needed.
  • To get a clearer picture of where cancer research funding is spent, we collected and compiled data covering public and charitable cancer research investments, globally, between 2016 and 2020, inclusive.
  • By country, the US provided 57.3% of the total cancer research funding awarded, with the US National Institute of Health being by far the biggest funder.

Lung and thyroid cancers least funded

    • Our analysis compares the level of funding given to researching different types of cancers with the health burden of those types of cancer.
    • In terms of the type of research, preclinical research (typically laboratory studies) received US$18 billion (73.5%).
    • Our results suggest that lung cancer was particularly poorly funded.
    • Here, thyroid cancer came out as least-well funded.
    • Both lung and thyroid cancers were judged to be the least well-funded cancer conditions overall, compared to their global burdens.

Cancer funding fell 45%

    • This might have been a natural fluctuation – cancer funding levels were declining to some extent – but it’s possible the drop was caused by a diversion of funds into COVID research.
    • It’s also likely that these drops in funding will mean less new knowledge coming through the cancer research pipeline.
    • Our analysis showed the flow of funding into cancer research.
    • Ramsey Cutress receives grant funding from the NIHR, Prevent breast cancer, World Cancer Research Fund, Association of Breast Surgery, Astra Zeneca and institutional research support from seca.

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

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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.

Global Analgesics Market Report 2023: Sector is Expected to Reach $67.55 Billion by 2028 at a CAGR of 4.6% - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 1, 2023
Health, Pharmaceutical, Infection, Liver, Analgesic, Drug development, Prevalence, Diabetes, Drug overdose, Arthritis, Perception, European Medicines Agency, COVID-19, Stroke, Anesthetic, Cancer, Intelligence, Brain, Research, Kidney, Pain, Intravenous therapy, Administration, Incidence, Opioid, Haleon, Paracetamol, Nonsteroidal anti-inflammatory drug, Pain management, Oral, Drug, Growth, Ibuprofen, Chronic pain, Pharmaceutical industry, Diclofenac

The global analgesics market value is projected to grow at a CAGR of 4.6%, during the forecast period of 2023-2028.

Key Points: 
  • The global analgesics market value is projected to grow at a CAGR of 4.6%, during the forecast period of 2023-2028.
  • In 2022, the global analgesics market was valued at US$51.63 billion, and is probable to reach US$67.55 billion by 2028.
  • There are several different types of analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids, and local anesthetics.
  • Trends: A major trend gaining pace in analgesics market is use of artificial intelligence in analgesics.

Evaxion Announces Business Update and First Quarter 2023 Financial Results

Retrieved on: 
Wednesday, May 31, 2023
Vaccine, Exercise, DNA, AACR, European Medicines Agency, Survival, Infection, Cancer, CTA, CCL19, Immunotherapy, Messenger, Observational study, Erving Goffman, ASCO, Research and development, Development, Patient, Administration, Melanoma, Koala retrovirus, Research, Safety, Genome, Medical imaging, Pharmaceutical industry

“Evaxion continues to make significant progress towards our mission of advancing AI-powered immunotherapies to save lives,” said Per Norlén, Chief Executive Officer of Evaxion.

Key Points: 
  • “Evaxion continues to make significant progress towards our mission of advancing AI-powered immunotherapies to save lives,” said Per Norlén, Chief Executive Officer of Evaxion.
  • Operating spending for the first quarter of 2023 was offset by the proceeds from issue of shares and exercise of warrants.
  • Research and Development expenses were $3.9 million for the quarter ended March 31, 2023 as compared to $4.8 million for the quarter ended March 31, 2022.
  • General and Administrative expenses were $2.5 million for the quarter ended March 31, 2023 as compared to $1.6 million for the quarter ended March 31, 2022.

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.