Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

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.

In-Vitro 52

In-Vitro Licensing Licensing Genetics 52

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 140

In-Vitro RNA Licensing Licensing 140

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

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 104

Gene Editing In-Vivo DNA In-Vitro 104

Drug Discovery World

JULY 10, 2023

Yet when seeking to obtain an existing model, researchers often encounter obstacles related to intellectual property, availability, or licensing. As a result, model generation is an attractive option often considered in parallel. As a result, model generation is an attractive option often considered in parallel. An example project (Fig.

Genetics 52

Genetics Gene Editing Genetic Engineering In-Vitro 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

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 Manufacturing Licensing 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 Vaccination Vaccine Licensing 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

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.

Vaccination 111

Vaccination Vaccine Development In-Vitro 111

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 Vaccination Vaccine Drugs 112

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 94

Development Manufacturing In-Vitro Compliance 94

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

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 91

Development Regulation Production Life Science 91

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

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

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 Vaccination 52

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.,

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials In-Vitro 52

The Pharma Data

MARCH 29, 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, 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,

Antibody 52

Antibody In-Vivo Vaccination Vaccine 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

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

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

In-Vitro 52

In-Vitro Contract Manufacturing Manufacturing Production 52

Pharmaceutical Technology

MAY 31, 2023

C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. Betta will be responsible for the development, manufacture and commercialisation of CFT8919 in the licensed territories.

Bioavailability 130

Bioavailability In-Vivo In-Vitro Licensing 130

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

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.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

XTalks

NOVEMBER 20, 2020

A new type of test based on detection of activated T cells may prove to have greater utility in determining whether someone has had a COVID-19 infection compared to a traditional antibody test. The cell-based tests are designed to identify specific T cells that are activated in response to a pathogen — which in this case would be SARS-CoV-2.

Antibody 98

Antibody Immune Response Protein In-Vitro 98

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing 40

Licensing Licensing Drugs Manufacturing 40

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

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

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.

Antibody 40

Antibody In-Vitro Clinical Development Medicine 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 Compliance Production 98

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.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

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.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

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.

Production 98

Production Containment In-Vitro Sales 98

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 130

Antibody Licensing Licensing Production 130

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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81