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.

In-Vivo 130

In-Vivo In-Vitro Clinical Trials Clinical Trials 130

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 → (..)

Licensing 40

Licensing Licensing In-Vitro Development 40

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

In-Vitro 141

In-Vitro RNA Licensing Licensing 141

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.

Licensing 40

Licensing Licensing In-Vitro 40

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.

In-Vitro 98

In-Vitro Regulation Production Compliance 98

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.

Antibody 52

Antibody Licensing Licensing Development 52

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.

Gene Editing 105

Gene Editing In-Vivo DNA In-Vitro 105

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.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

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.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

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.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

Pharmaceutical Technology

AUGUST 26, 2008

” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy. .” ” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy. “Biotechnology has exploded across the industry. .

Antibody 100

Antibody Licensing Licensing Production 100

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.

Vaccine 111

Vaccine Vaccination Development In-Vitro 111

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). .

Bacteria 86

Bacteria Pharmacy Doctor Doctors 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.

In-Vitro 52

In-Vitro Containment Drugs Production 52

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., It is important to note that these studies are required by U.S.

Research 112

Research Vaccine Vaccination Drugs 112

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.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

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.

Development 104

Development Regulation Production Life Science 104

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.

Development 98

Development In-Vitro Manufacturing Compliance 98

Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

Drugs 110

Drugs Licensing Licensing Production 110

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 ).

In-Vitro 69

In-Vitro Regulation Production Development 69

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.

In-Vitro 52

In-Vitro FDA Approval Drugs Manufacturing 52

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.

Gene Therapy 52

Gene Therapy Gene Development In-Vivo 52

Delveinsight

FEBRUARY 23, 2021

BrainStorm Cell Therapeutics has received feedback from the USFDA on its Biologics License Application submitted for NurOwn therapy for amyotrophic lateral sclerosis (ALS). Earlier, the LightDeck had raised USD 11 M in a Series B funding to develop and commercialize its in vitro multiplex tests for several panels, including COVID-19.

In-Vitro 52

In-Vitro Vaccine Vaccination Licensing 52

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.

Development 105

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.

Pharmacy 98

Pharmacy Containment Production Sales 98

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).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

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

In-Vitro 52

In-Vitro Licensing Licensing FDA Approval 52

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.

Marketing 52

Marketing Protein In-Vitro Production 52

Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

Marketing 75

Marketing Production Drugs Licensing 75

Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. FDA Emergency Use Authorization Statement.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

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.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

Drugs 69

Drugs Licensing Licensing Containment 69

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

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.

Marketing 52

Marketing In-Vivo Protein In-Vitro 52

The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

Trials 52

Trials Antibody In-Vitro Medicine 52

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.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

The Pharma Data

MARCH 25, 2022

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.

Antibody 52

Antibody In-Vivo Medicine Vaccine 52