Pharmaceutical Technology

MAY 16, 2023

Nuvectis has licensed the exclusive global rights to NXP900 from the University of Edinburgh in Scotland, UK. NXP900 plus Osimertinib in vitro showed a possible ability to reverse acquired resistance to these drugs in non-small cell lung cancers. The approval also includes clearance for a Phase I clinical trial protocol of NXP900.

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BioTech 365

MARCH 9, 2021

Avacta Signs Diagnostic Licensing Deal with Biokit Avacta Signs Diagnostic Licensing Deal with Biokit Royalty bearing license agreement to develop and commercialise an Affimer-based in-vitro diagnostic test CAMBRIDGE, England & BARCELONA, Spain–(BUSINESS WIRE)–Avacta Group plc (AIM: AVCT), the developer of … Continue reading → (..)

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BioTech 365

OCTOBER 5, 2020

.–(BUSINESS WIRE)–Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced it has entered into a non-exclusive royalty-bearing license agreement with Abbott Laboratories (NYSE: ABT), the global healthcare company.

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pharmaphorum

FEBRUARY 19, 2021

The company, which has licensed the CRISPR-based technology from Philadelphia’s Temple University, says it has already produced a functional cure for HIV that works in animals and wants to develop the technology in humans. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

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Pharmaceutical Technology

FEBRUARY 28, 2023

Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma and Shenzhen Chipscreen Biosciences’ holding subsidiary Chipscreen NewWay Biosciences have entered an exclusive licensing agreement for YH008, a bispecific antibody. It also activated tumour-infiltrating DCs and T cells in vivo pharmacodynamic studies.

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pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

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FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

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pharmaphorum

JUNE 24, 2022

Fujifilm’s Irvine Scientific unit has licensed rights to an artificial intelligence-powered technology developed to improve the success rate of in vitro fertilisation (IVF) techniques. That could allow the best egg and sperm candidates to be chosen, further raising the chances of success. Terms of the deal were not disclosed.

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XTalks

MARCH 1, 2021

Sera from individuals will also be taken to evaluate neutralization of different SARS-CoV-2 strains in in vitro studies. The third booster will be given to participants from the Phase I study in the US. They will be given the opportunity to receive a third 30 µg booster six to 12 months after having received the initial two-dose schedule.

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Druggist

DECEMBER 2, 2020

Crystacide cream is licensed for the treatment of skin infections caused by a microorganism, which are sensitive to hydrogen peroxide. In today’s post, I will review over the counter antibiotic creams in the UK. Prescription-only antibiotic creams. Can you buy over the counter antibiotic cream? . Pankey & Sabath, 2004). .

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Bacteria Pharmacy Doctors Doctor 86

The Pharma Data

JANUARY 27, 2021

Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. FDA Investigational New Drug (“IND”)-enabling pharmacology studies. About BetterLife Pharma: BetterLife Pharma Inc.

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced. before expanding it into Europe.

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pharmaphorum

SEPTEMBER 29, 2022

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. When assessing mHealth technology, the FDA will determine whether an application is either: i.

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Development Regulation Production Life Science 104

FDA Law Blog

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. Within the collaboration, ViGeneron will optimize and validate in vitro therapeutic candidates for an undisclosed target to treat inherited eye disease. MUNICH, Germany, Jan.

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pharmaphorum

OCTOBER 4, 2022

Such non-device CDS are: (1) not intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (Criterion 1); (2) intended for the purpose of displaying, analysing, or printing medical information about a patient or other medical information (e.g.

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Development Regulation Cosmetics Life Science 105

Druggist

FEBRUARY 17, 2021

Hydrocortisone cream which is sold in pharmacies have few restrictions, which reflect the licensing of this medicine: Age restrictions: Adults and children above ten years of age. For many customers, ointment or cream for insect bites is the first line of rescue in stings management. What causes bite itchiness and redness? 822 Reviews.

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Druggist

OCTOBER 21, 2020

Additionally, oral antifungal tablets are not licensed for use in children. The main products used for toenail fungus treatment are available in most pharmacies, supermarkets and perhaps with the best range of products found online. I will review the best toenail fungus treatment options available over the counter in the UK.

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FDA Law Blog

FEBRUARY 2, 2023

The law defines this term to mean “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.” Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Roots Analysis

AUGUST 7, 2023

On the other hand, cell free system / cell free expression system are ­in-vitro platforms that harness the transcription and translation machinery of living cells, in the form of cell lysates, to synthesize various types of biologics, particularly proteins. Interestingly, most of these kits are used for cell-free protein expression.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

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XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Vaccination Vaccine Trials Clinical Trials 59

The Pharma Data

APRIL 4, 2022

today announced that the U.S. A decision on U.S. FDA approval is expected in the second half of this year. The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D.,

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XTalks

JUNE 12, 2023

As technology continues to revolutionize every sector of our lives, the medical device industry stands at the forefront of this innovation, playing a pivotal role in enhancing patient care, improving diagnostic accuracy and transforming treatment modalities. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

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The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 1,2 Vabysmo’s safety profile was consistent with previous trials. 1,2 Vabysmo’s safety profile was consistent with previous trials.

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FDA Law Blog

AUGUST 3, 2022

Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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pharmaphorum

JANUARY 22, 2021

The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses to remdesivir in vitro,” said Gilead in its statement. “We The UK strain – known as B.1.1.7

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XTalks

DECEMBER 13, 2024

XTALKS WEBINAR: Enhance Early Biomarker Discovery: Translating In Vitro and In Vivo Multi-Omics Oncology Data Live and On-Demand: Thursday, January 16, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how to harness the full potential of multi-omics data and advanced patient models to drive early biomarker discovery.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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Pharmaceutical Technology

MAY 26, 2023

Doggybone DNA is named for its bone-shaped schematic structure and produced using an in vitro enzymatic process over 50 days, which is more than five times quicker than the 270 days taken for plasmid DNA E.Coli fermentation process. One big pharma company has already given the seal of approval with a successful customer quality audit.

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The Pharma Data

DECEMBER 20, 2020

Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S. The data supported the potential benefits of the drug for OAB in patients with urge urinary incontinence (UUI), urgency, and urinary frequency. The drug is a once-daily, beta-3 adrenergic agonist.

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pharmaphorum

AUGUST 4, 2022

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. Harness technology.

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The Pharma Data

APRIL 26, 2022

— Approval is Supported by Phase 2/3 Data Demonstrating the Safety and Tolerability Profile and Clinical Improvement Outcome in Hospitalized Pediatric Patients Treated with Veklury — Gilead Sciences, Inc. Nasdaq: GILD) today announced that the U.S. Overall, 75% and 85% showed clinical improvement (?2

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The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

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Cloudbyz

AUGUST 19, 2024

European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare.

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The Pharma Data

DECEMBER 9, 2020

Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., Vigil’s $50 million Series A financing, completed this week, was powered by Atlas Ventures and Northpond Ventures, and includes participating investors Hatteras Partners and Alexandria Venture Investments. SciNeuro Pharmaceuticals.

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