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MedaSystems Secures Seed Financing to Modernize Global Access to Investigational Medicine

Retrieved on: 
木曜日, 10月 12, 2023
Health Technology, Technology, Pharmaceutical, Practice Management, Managed Care, Professional Services, General Health, Artificial Intelligence, Clinical Trials, Science, Biotechnology, Software, Data Analytics, Health, Research, Expanded access, Workload, Physician, Machine learning, User-Managed Access, Automation, Veeva Systems, Software as a service, Clinical trial, Pharmacist, Patient, Microsoft Access, Pharmaceutical industry, Medical device, Nursing

MedaSystems, developer of the only purpose-built pharma-physician network to provide patients with access to pre-approval medicine*, today announced the completion of a seed funding round.

Key Points: 
  • MedaSystems, developer of the only purpose-built pharma-physician network to provide patients with access to pre-approval medicine*, today announced the completion of a seed funding round.
  • The MedaSystems SaaS platform streamlines collaboration between medical affairs, clinical operations, regulatory and shipping teams internally, and physicians and their staff, externally, enabling the rapid processing of treatment inquiries and capture of real-world data.
  • The platform provides significant benefits to various stakeholders:
    Sponsors (pharmaceutical manufacturers) gain significant processing speed and efficiency.
  • The platform enables the capture of real-world data which speeds drug discovery, expedites regulatory submission and informs the design of more effective clinical trials.

Matinas BioPharma to Feature MAT2203 in a Pipeline Presentation at IDWeek

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水曜日, 9月 27, 2023
Infection, AMB, Fungal infection, IV, Toxicity, Patient, Access, Microsoft Access, Pharmaceutical industry, Vaccine

"We are delighted to participate in this important scientific conference and to highlight additional clinical evidence from our Expanded Access Program supporting the ability of MAT2203 to safely and effectively improve outcomes for patients suffering from potentially deadly fungal infections," said Dr. Matkovits.

Key Points: 
  • "We are delighted to participate in this important scientific conference and to highlight additional clinical evidence from our Expanded Access Program supporting the ability of MAT2203 to safely and effectively improve outcomes for patients suffering from potentially deadly fungal infections," said Dr. Matkovits.
  • "The efficacy of AMB is well established, but use of this potent fungicidal drug is typically administered selectively and only to patients with severe disease because of its toxicity.
  • MAT2203 reduces the systemic toxicity associated with IV AMB by delivering drug directly to targeted cells at the sites of infection, supporting a favorable safety profile with the additional benefit of oral administration.
  • "The compelling compassionate use data we will be presenting at IDWeek as part of our pipeline overview support our strategy to develop an ideal antifungal agent for the treatment of a variety of invasive fungal infections while potentially having a dramatic impact on the cost of treating these deadly diseases," she added.

Clene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls

Retrieved on: 
月曜日, 9月 25, 2023
ACT, Database, Medicine, CNM, Survival, Clinical trial, Meta-analysis, Multiple sclerosis, SALT, Ventilation, MS, Open-label trial, Microsoft Access, Patient, Data, Risk, Common-pool resource, Principal, Massachusetts General Hospital, Death, ALS, Safety, OLE, Pharmaceutical industry

The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled clinical trial program designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS.

Key Points: 
  • The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled clinical trial program designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS.
  • Participants received CNM-Au8 in addition to ALS standard-of-care and were randomized to the drug or placebo during the 24-week double-blind period.
  • The PRO-ACT dataset is derived from pooled ALS clinical trial data from 29 completed Phase 2 and Phase 3 ALS clinical trials.
  • This database provides a useful and validated surrogate for survival status of past participants in ALS clinical trials with long-term follow-up.

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

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火曜日, 8月 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.

Matinas BioPharma Reports Second Quarter 2023 Financial Results and Provides a Business Update

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水曜日, 8月 9, 2023
BioNTech, CT, Nephrotoxicity, IV, Diabetes, Hospital, Mucor, Conference call, Clinical trial, Women's Hospital International and Fertility Centre, Infection, Brain, LNC, Research, Biomedical Research, European Congress of Ethnic Religions, Messenger, Lung, Acute myeloid leukemia, Development, MRI, Kidney, National Resilience Institute, ECCMID, MD, Patient, Standard of care, Azole, Microsoft Access, RNA interference, Fungal infection, FDA, Nationwide, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Conference, NYSE, Food, Female, Pharmaceutical industry, Medical imaging, Antifungal

BEDMINSTER, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) --  Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports financial results for the three and six months ended June 30, 2023 and provides a business update.

Key Points: 
  • Matinas’ collaboration with National Resilience continues to focus on in vitro and in vivo delivery of mRNA and expects initial data later in 2023.
  • The Company reported no revenue for the second quarter of 2023 compared with $1.1 million of revenue for the second quarter of 2022, which was generated from the Company’s research collaborations with BioNTech SE.
  • Total costs and expenses for the second quarter of 2023 were $6.2 million compared with $7.0 million for the second quarter of 2022.
  • The net loss for the second quarter of 2023 was $6.1 million, or $0.03 per share, compared with a net loss for the second quarter of 2022 of $5.9 million, or $0.03 per share.

TFF Pharmaceuticals Inc. and Uniphar Durbin Ireland Ltd. Announce the Opening of an Expanded Access Program for Voriconazole Inhalation Powder (TFF VORI) for the Treatment of Pulmonary Aspergillosis and Other Voriconazole Responsive Fungal Pulmonary Infec

Retrieved on: 
月曜日, 7月 31, 2023
Partnership, EAP, TFF, Expanded access, Aspergillus, Clinical trial, Voriconazole, Allergic bronchopulmonary aspergillosis, Chronic pulmonary aspergillosis, IPA, Patient, Microsoft Access, Special access program, Pharmaceutical industry

The Expanded Access Program covers pulmonary aspergillosis including invasive pulmonary aspergillosis, chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis, and aspergillus bronchoanastomotic infections as well as other voriconazole responsive fungal pulmonary infections.

Key Points: 
  • The Expanded Access Program covers pulmonary aspergillosis including invasive pulmonary aspergillosis, chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis, and aspergillus bronchoanastomotic infections as well as other voriconazole responsive fungal pulmonary infections.
  • Uniphar Durbin Ireland Limited has been appointed to implement TFF Pharmaceutical’s Expanded Access Program in the United States, Australia, United Kingdom, Canada, and within select countries in Europe.
  • “We are pleased to be working with Durbin to offer the Expanded Access Program for TFF VORI,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.
  • The EAP comes after positive clinical outcomes in two patients with pulmonary fungal infection treated with TFF VORI on a compassionate use basis.

Secondary publishing rights can improve public access to academic research

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火曜日, 7月 25, 2023
Review, Adoption, Tri-Agency Open Access Policy on Publications, Copyright, Culture, Policy, University, Taverne, Social science, Canadian Association of Research Libraries, Research, Publication, History, Canadian Federation of Library Associations, Government, Science, APC, Humanities, Publishing, Social Sciences and Humanities Research Council, Association, Engineering, Global North and Global South, European, Compliance, Microsoft Access, Pharmaceutical industry, Medical device, Cryptocurrency

To meet this requirement, the Canadian government should empower academic authors through the adoption of secondary publishing rights.

Key Points: 
  • To meet this requirement, the Canadian government should empower academic authors through the adoption of secondary publishing rights.
  • Tweaking the Copyright Act to include such rights would give academic authors the ability to make taxpayer-funded journal articles available to the public through open access upon publication.

Open access policy review

    • In the past, most research papers would only be accessible to individuals who pay to access research papers or who work or study at universities willing to pay for access.
    • However, authors are increasingly required to pay publishers in order to be published open access.
    • In the European Union and the United States, governments have committed to immediate open access for publicly funded research.

Article processing charges

    • For example, the Tri-Agency suffers from low rates of compliance with their open access policy when compared to other jurisdictions.
    • It might be that they misunderstand their obligations or that they simply cannot afford the high article processing charges (APCs) that they might need to pay to publish in their journal of choice.
    • Estimates indicate Canadian academic authors spent at least US$27.6 million on processing charges from 2015 to 2018, despite the preponderance of free-to-publish open access journals.

Secondary publishing rights

    • While academic journal publishing is extremely profitable for publishing companies, the authors, editors and reviewers that form the backbone of the system are rarely compensated for their labour and face challenges negotiating fair publication agreements.
    • The Canadian Federation of Library Associations has recently proposed one partial solution: to provide secondary publishing rights to academic authors in Canada.
    • Secondary publishing rights have already been implemented in multiple European countries, with perhaps the most notable example being the Taverne Amendment in the Netherlands, which has seen the rate of open access top 80 per cent.

EQS-News: Heidelberg Pharma Reports on First Half-Year 2023 and the Course of Business

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木曜日, 7月 13, 2023
State University of New York, AACR, EAP, GCC, Half-life, HPHA, ATAC, SRC, Binghamton University, Multiple myeloma, Clinical trial, State university system, Bone marrow, Cancer, American Association for Cancer Research, FSE, Magenta, Research, ATACS, Sale, Spanish mythology, Amanitin, Data analysis, CAIX, Patient, Antibody-drug conjugate, Microsoft Access, Marketing, CFO, Management, Ethics, ADC, Eli Lilly and Company, Depreciation, Spacecraft, Phase, FDA, Therapy, Market Access Program, Safety, Disease, Pharmaceutical industry, Vaccine, Fine chemical, Generic drug, Cryptocurrency, Telix, Emergence

Ladenburg, Germany, 13 July 2023 - Heidelberg Pharma AG (FSE: HPHA) published today its financial report on the first six months of 2023 (1 December 2022 - 31 May 2023).

Key Points: 
  • Ladenburg, Germany, 13 July 2023 - Heidelberg Pharma AG (FSE: HPHA) published today its financial report on the first six months of 2023 (1 December 2022 - 31 May 2023).
  • HDP-101 (BCMA-ATAC) program: Heidelberg Pharma presented preliminary safety data from the clinical trial with HDP-101.
  • The Heidelberg Pharma Group (Heidelberg Pharma) – comprising Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures.
  • The full-year financial guidance issued on 24 March 2023 for the Heidelberg Pharma Group is confirmed at this time.

AI Therapeutics Announces Appointment of Biotechnology Industry Leader David Scheer as Chairman of the Board of Directors

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水曜日, 7月 12, 2023
Yale University, National Medal of Technology and Innovation, DNA, Bioethics, Therapy, Esperion Therapeutics, Harvard T.H. Chan School of Public Health, NORD, Biotechnology, Johnson & Johnson, NYU, Microsoft Access, National Medal, Innovation, National Organization for Rare Disorders, Harvard College, Harvard University, Esperies, Developmental Biology (journal), Public health, Investment, Patient, Initial public offering, AI, Rare, Global Virus Network, Pharmaceutical industry, Medical device, Cell, ViroPharma

GUILFORD, Conn., July 12, 2023 (GLOBE NEWSWIRE) -- AI Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, announced today the appointment of David Scheer as Chairman of the Board of Directors.

Key Points: 
  • GUILFORD, Conn., July 12, 2023 (GLOBE NEWSWIRE) -- AI Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, announced today the appointment of David Scheer as Chairman of the Board of Directors.
  • Since 1981, Mr. Scheer has provided corporate strategic and transactional advisory services to the life sciences industry as founder and President of Scheer & Company.
  • “It is with great pleasure that I welcome David Scheer as Chairman of AI Therapeutics.
  • Dr. Rothberg is a true visionary, and we are grateful for his continued involvement as a Director of the Company.”
    “It is a privilege to join the AI Therapeutics Board of Directors as Chairman,” said Mr. Scheer.

Geron Announces U.S. Expanded Access Protocol for Imetelstat in Lower Risk MDS

Retrieved on: 
木曜日, 6月 29, 2023
FDA, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, EAP, Red blood cell, Majesty of the Seas, Lenalidomide, NDA, MDS, Imetelstat, Corporation, Geron Corporation, Microsoft Access, Patient, Physician, Risk, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor.
  • In that trial, the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (P
  • Mean hemoglobin levels in imetelstat-treated patients increased significantly (P
  • Further, statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.