Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Sponsors need to carefully consider how they will prove safety and efficacy in a manner sufficient to satisfy the regulators.

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The Pharma Data

DECEMBER 14, 2020

“Filing an IND with the FDA is an important step in the clinical development of Rabeximod. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinical development to the United States.

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The Pharma Data

OCTOBER 18, 2020

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. Tremfya (R) is a registered trademark of Janssen Biotech, Inc.

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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. The FcRn extends the half-life and hence the availability of pathogenic immunoglobulin G (IgG) antibodies.

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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. Food and Drug Administration (“FDA”) approval.

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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. About Tiziana Life Sciences.

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The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests.

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The Pharma Data

OCTOBER 26, 2020

This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure. Enquiries: Hemogenyx Pharmaceuticals plc. [link]. . .

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The Pharma Data

JANUARY 25, 2021

“The technology has a unique pharmacological profile, which is very different from other products in preclinical and clinical development in that it focuses on restoring function. All clinical development plans are subject to additional funding. for the latest news on the Company.

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XTalks

NOVEMBER 9, 2023

XTALKS WEBINAR: The Evolution of the Cardiovascular Clinical Development Landscape and Potential Role of GLP-1 RAs Live and On-Demand: Wednesday, December 6, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to learn about successful study outcomes in developing GLP1s to new therapeutic areas within cardiovascular medicine and more.

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The Pharma Data

JULY 21, 2021

the product label for VERQUVO contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. Food and Drug Administration (FDA) approved VERQUVO in the U.S. In the U.S., For more information, see “Selected Safety Information” below.

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The Pharma Data

DECEMBER 30, 2020

Ensysce will use the funds to progress the clinical development of PF614, a first in class Trypsin Activated Abuse Protection (TAAP TM ) extended-release opioid prodrug, and its Multi-Pill Abuse Resistance (MPAR TM ) overdose protected counterpart, PF614-MPAR TM. www.ensysce.com. Forward-Looking Statements.

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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.

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The Pharma Data

JANUARY 24, 2021

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures. For more information, please visit www.citiuspharma.com. .

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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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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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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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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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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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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

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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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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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The Pharma Data

JANUARY 20, 2021

mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. Verquvo (vericiguat) 2.5 For more information, see “Selected Safety Information” below.

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FDA Law Blog

SEPTEMBER 20, 2021

Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

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Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not. Quitting smoking is an arduous, exhausting process. However, it is possible.

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The Pharma Data

JANUARY 18, 2021

His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the discovery that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. Enquiries: OKYO Pharma Limited. Gary S. Jacob, Chief Executive Officer.

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The Pharma Data

JANUARY 4, 2021

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. This press release contains forward-looking statements that involve substantial risks and uncertainties. “We believe Prof.

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FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”

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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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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. Forward Looking Statement.

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The Pharma Data

NOVEMBER 10, 2020

We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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Drug Discovery World

AUGUST 2, 2023

Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1. Those results led to further clinical development in ongoing larger studies in patients with advanced hepatocellular carcinoma and cholangiocarcinoma.

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. About the Sotrovimab Clinical Development Program.

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The Pharma Data

OCTOBER 14, 2020

About VBL’s VB-600 Platform VBL is conducting two parallel drug development programs that are exploring the potential of MOSPD2 (motile sperm domain-containing protein 2), a protein that VBL has identified as a key regulator of cell motility, as a therapeutic target for inflammatory diseases and cancer.

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The Pharma Data

SEPTEMBER 20, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen.

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