20.10.2020Wie Octapharma mitteilte, sind die aktualisierten Verschreibungsinformation (Prescribing Information - PI) für NUWIQ®, Octapharmas rekombinanten Faktor VIII (FVIII) aus menschlichen Zelllinien, durch die amerikanische Gesundheitsbehörde FDA (Food and Drug Administration) genehmigt worden. NUWIQ ® ist für die Prävention und Behandlung von Blutungen bei Menschen mit Hämophilie A zugelassen. Die aktualisierten Verschreibungsinformationen beinhalten Immunogenitätsdaten aus der NuProtect-Studie bei zuvor unbehandelten Patienten (PUPs).
20.10.2020AIDS Healthcare Foundation (AHF), the largest global AIDS organization, today sharply criticized Johnson & Johnson (J&J) and the United States Food and Drug Administration (FDA) for their refusal to release any information regarding a COVID-19 vaccination trial that J&J paused earlier this month, with the FDA citing federal regulations as its reason for its refusal to share any information. The refusal to share data or even basic information about the study and the pause comes on the heels of a recent and widely-touted joint pledge of prudence and caution on vaccine trial safety by nine drug companies, including J&J, working on COVID 19 vaccines.
20.10.2020AVEO Oncology today announced the appointment of David Crist as Vice President of Sales. In this role, Mr. Crist will be responsible for building out AVEO’s sales force in anticipation of the potential approval and launch of tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma.
20.10.2020Genesis Therapeutics, a privately-held company inventing and deploying state-of-the-art artificial intelligence (AI) techniques to augment drug discovery and development, today announced that it has entered into a multi-target collaboration agreement with Genentech, a member of the Roche Group. The collaboration leverages Genesis’ graph machine learning and drug discovery expertise to identify innovative drug candidates for therapeutic targets in multiple disease areas. Genesis will receive an upfront payment and is eligible to receive pre-clinical, clinical and regulatory milestone payments, as well as future royalties on Genentech’s sales of approved drugs resulting from the collaboration.
20.10.2020At the virtual 19th Human Proteome Organization World Congress (hupo2020.org), Bruker Corporation (Nasdaq: BRKR) today announced that Melvin A. Park and Oliver Raether were awarded the HUPO Science and Technology Award for the commercialization of Trapped Ion Mobility Spectrometry (TIMS) and the Parallel Accumulation Serial Fragmentation (PASEF®) method. This award recognizes innovation that changes the way scientists do proteomics, validating the role the timsTOF Pro has on enabling short gradients for large cohort deep 4D-Proteomics translational studies. Bruker also takes the opportunity to recognize the contributions of PASEF co-inventor Professor Matthias Mann.
20.10.2020Eurofins U.S. Clinical Diagnostics, announced that Clinical Enterprise Inc. has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their at Home COVID-19 Nasal PCR Test. The EUA authorized self-collection kit gives consumers a minimally invasive, convenient and quick option to test from the comfort of their home. Results are provided via email within 24 hours of sample receipt.
20.10.2020Untersuchung der Bocconi University hat Geschlechterunterschiede in acht Ländern festgestellt / Die erhöhte Einhaltung der Corona-Maßnahmen durch Frauen ist laut einer Studie der Bocconi University http://knowledge.unibocconi.eu ein Grund, warum diese im Vergleich zu Männern zu Beginn der Pandemie weniger anfällig dafür waren und auch seltener starben. Die Forscher haben Geschlechterunterschiede bei der Reaktion auf COVID-19 untersucht. Details wurden in "PNAS" veröffentlicht.
21.10.2020In April 2017, Rockford sued Mallinckrodt and Express Scripts for antitrust violations. Rockford’s lawsuit seeks to return more than $10 billion
20.10.2020Design Therapeutics, a biotechnology company developing a platform of gene targeted chimera (GeneTAC™) small molecules for the treatment of serious degenerative disorders caused by nucleotide repeat expansions, today announced that João Siffert, M.D., has been appointed as chief executive officer and will also join the Board of Directors.
20.10.2020Dr. Reddy’s Laboratories Ltd. today announced the re-launch of over-the-counter (OTC) Famotidine Tablets USP, 10 mg and 20 mg, the store-brand equivalents of Original Strength and Maximum Strength Pepcid AC®, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA). Dr. Reddy’s OTC Famotidine Tablets USP, 10 mg
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