XTalks

MARCH 1, 2021

Pfizer/BioNTech are executing the three-dose study to also determine the effectiveness of a third dose against evolving variants as part of their clinical development strategy. Our proactive clinical development strategy aims to create the foundation today, that will enable us to address the challenges of tomorrow.

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pharmaphorum

JULY 5, 2021

Parexel has been a champion of the concept for years, but while adoption was fairly slow pre-COVID, it has accelerated at a fast pace since the crisis, aided by the increasing willingness of regulators to accept decentralised trial data in marketing applications.

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Clinical Trials Clinical Trials Regulation Trials 64

pharmaphorum

FEBRUARY 19, 2021

billion cumulative doses of its NVX-CoV2373 recombinant protein-based vaccine candidate, which is yet to be approved by regulators. Novavax licensed its NVX-CoV2373 technology to SII with no upfront, milestone or technology transfer payments so that the vaccine can be manufactured and supplied cheaply to poorer countries.

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Vaccination Vaccine Manufacturing RNA 74

pharmaphorum

JUNE 27, 2022

The safety of Astellas’ gene therapy portfolio has been thrust into the spotlight once again, after the FDA placed a clinical hold on a trial of its Pompe disease candidate AT845.

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Gene Therapy Gene Gene Expression Trials 52

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. Genentech, a member of the Roche group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. indications.

FDA Approval 52

FDA Approval Clinical Development Allergies Medicine 52

XTalks

APRIL 24, 2023

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. Early and ongoing engagement with regulators greatly helps clinical development planning.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

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pharmaphorum

DECEMBER 21, 2021

BeiGene was also the developer of Novartis’ PD-1 inhibitor tislelizumab , which was filed for FDA approval in September as a second-line treatment for oesophageal cancer. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55

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Drugs Antibody Pharma Companies Development 96

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. View source version on accesswire.com: [link].

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Containment Clinical Development Antibody Development 52

Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America.

Drugs 59

Drugs Vaccination Vaccine Medicine 59

pharmaphorum

JUNE 14, 2021

GlaxoSmithKline has staked a claim to the fast-moving category of cancer therapies targeting the TIGIT immune checkpoint, agreeing a $2 billion plus licensing agreement with iTeos Therapeutics for an antibody candidate in early clinical development.

Antibody 52

Antibody Trials Drugs Development 52

The Pharma Data

MARCH 1, 2022

It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well positioned to move into later stages of clinical development.” The company has also benefited from support from the Walloon Region. Source link: [link].

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Protein Licensing Licensing Development 52

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. About Tiziana Life Sciences.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

pharmaphorum

MAY 14, 2021

Merck KGaA had been developing the drug with partner Avillion and van Amstel’s team got in touch as soon as they heard the German pharma was considering selling it as part of a pipeline rethink. Licensed in from Ablynx in 2013 five years before a merger with Sanofi, German Merck recognised its potential.

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Licensing Licensing Drugs Marketing 60

The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

Life Science 52

Life Science Manufacturing Production Development 52

Drug Discovery World

MAY 6, 2024

Professor Dr Carla van Gils, Director of KWF, comments: “Many of academia’s most innovative agents can be difficult to bring into clinical development. Partnering with the Centre for Drug Development enables us to jump into the bench-to-bedside gap and fast track academic findings into clinical trials.

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Drugs Life Science Gene Editing Gene 59

FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14.

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Reagent Manufacturing Production Gene Therapy 59

The Pharma Data

JANUARY 25, 2021

“ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing.

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Production Clinical Development Licensing Licensing 40

The Pharma Data

AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. 7,8,9,10,11. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009.

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Trials Clinical Development Antibody Dermatology 52

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Persons”, as such term is defined in Regulations under the U.S. PharmaDrug Inc.

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Drugs Containment Development Sales 52

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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Drugs Medicine Regulation Licensing 94

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. ” About Ascentage Pharma.

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Clinical Development Development Licensing Licensing 40

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Any failure to comply with this restriction may constitute a violation of such laws or regulations.

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Development Regulation Medicine Containment 75

pharmaphorum

APRIL 29, 2021

The major European countries will likely be among the first to reimburse the technology at scale but in terms of geographical distribution Mehl is looking at “pretty much everything” There’s the possibility of a license in Japan and countries like the UK, France, and the Nordics are likely to launch reimbursement codes soon, according to Mehl.

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Production Doctors Doctor Clinical Trials 67

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

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Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. ; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc. Tonix Pharmaceuticals Holding Corp.

Antibody 52

Antibody Development Protein Vaccination 52

The Pharma Data

DECEMBER 9, 2020

This work has led to the identification of molecular components regulating crucial processes impaired in depression. announced a research collaboration to develop hormone receptor antagonist (GHRA) peptides as potential treatments for acromegaly, a rare but serious endocrine disorder with significant unmet medical need.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. LONDON and BOSTON, Jan. Gary S.

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Life Science Development Sales Drugs 40

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. “We believe Prof.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

NOVEMBER 5, 2020

Background and reason Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation. CET on November 6, 2020.

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Marketing Production Regulation Containment 40

pharmaphorum

AUGUST 4, 2020

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. AstraZeneca has bought an exclusive global licence to develop and market RXC006, a porcupine inhibitor for fibrotic diseases including idiopathic pulmonary fibrosis (IPF).

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Drugs Clinical Trials Clinical Trials Pharma Companies 92

The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.

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Development Clinical Development Clinical Trials Clinical Trials 40

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX.

FDA Approval 52

FDA Approval Hormones Production Drugs 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52