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

pharmaphorum

FEBRUARY 19, 2021

Snipping out this viral code with powerful CRISPR gene editing technology, which last year won Drs Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize for chemistry, would in theory prevent the need for drugs to suppress the virus and the development of AIDS. The post Could CRISPR cure HIV?

Gene Editing 105

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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.

In-Vivo 130

In-Vivo Antibody In-Vitro Licensing 130

pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. . About ViGeneron.

Gene Therapy 52

Gene Therapy Gene Development In-Vivo 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.

In-Vitro 52

In-Vitro Licensing Licensing Genetics 52

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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The Pharma Data

JANUARY 27, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, announces it has entered into an agreement with Eurofins Discovery for TD-0148A’s U.S. VANCOUVER, Jan.

In-Vitro 52

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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.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

FDA Law Blog

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

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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In-Vitro Regulation Production Development 69

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.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

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

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

XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. 1) Medtronic 2022 Revenue: Medtronic reported an annual revenue of $31.69

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FDA Approval Production Sales In-Vitro 98

The Pharma Data

APRIL 4, 2022

Chief Medical Officer and Head of Global Product Development, Roche. today announced that the U.S. FDA approval is expected in the second half of this year. The sBLA submission is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials In-Vitro 52

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). Roche’s Chief Medical Officer and Head of Global Product Development. “If In BALATON, vision gains were +16.9

Antibody 40

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FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. As with any “child” they’ve matured and developed as they’ve grown into adulthood. By Jeffrey N.

In-Vitro 98

In-Vitro Regulation Production Compliance 98

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

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

pharmaphorum

AUGUST 4, 2022

Training and development. Staff development and training programmes were largely on pause during the pandemic. Businesses need to ensure they prioritise the recruitment and development of staff to help ensure longevity and survival. Harness technology.

Development 98

Development In-Vitro Manufacturing 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

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.

DNA 130

DNA Manufacturing Gene Gene Therapy 130

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. Klisyri is a home-grown product discovered and characterized by Athenex scientists and developed from pre-IND to NDA by the Athenex team. and Europe, including Russia.

In-Vitro 52

In-Vitro FDA Approval Drugs Manufacturing 52

The Pharma Data

DECEMBER 9, 2020

Uniquely positioned in the rapidly evolving local biotech ecosystem in China in addition to an expansive global presence, Overland will strategically partner to jointly develop innovative, novel therapeutics. We look forward to developing and advancing our differentiated pipeline of novel therapeutics in carefully selected disease areas.”.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Compliance 52

Compliance Manufacturing Regulation Marketing 52

The Pharma Data

DECEMBER 9, 2020

Liebisch , Vigil Neuroscience is developing a pipeline of precision-based therapies to combat both rare and common neurodegenerative diseases by restoring the vigilance of microglia. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., Vigil Neuroscience. SciNeuro Pharmaceuticals.

Marketing 52

Marketing In-Vivo Protein In-Vitro 52

The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Delveinsight

FEBRUARY 23, 2021

The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases. BrainStorm Cell Therapeutics has received feedback from the USFDA on its Biologics License Application submitted for NurOwn therapy for amyotrophic lateral sclerosis (ALS).

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

The Pharma Data

JUNE 25, 2021

In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% (95% confidence interval (CI): -26, 65) compared to placebo, which was not statistically significant (Table 1). The trial did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo.

Trials 52

Trials Antibody In-Vitro Medicine 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial. Christoph D.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

Pfizer

JANUARY 27, 2023

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

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Marketing Production Drugs Licensing 75

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. BeiGene, Novartis partner to develop cancer drug Tislelizumab, an Anti-PD-1 Antibody.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

The Pharma Data

MARCH 25, 2022

” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing COVID-19. .”

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. NEW YORK, December 20, 2022 -- Pfizer Inc.

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Drugs Licensing Licensing Containment 69

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. .

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Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1,

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Drugs Licensing Licensing Production 110