The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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Drug Discovery World

SEPTEMBER 14, 2023

Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

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WCG Clinical

JULY 12, 2023

For more than 20 years, Avoca has surveyed industry stakeholders to gain an understanding of key trends affecting outsourced clinical development,” explains Christine Albano, general manager, WCG Benchmarking & Analytics. Avoca joined the WCG family of companies in April 2021. For more information, visit www.theavocagroup.com.

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The Pharma Data

OCTOBER 21, 2020

Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it will present a poster on SYNB8802, an investigational Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria (HOX), during the American Society of Nephrology (ASN) Kidney Week, Oct.

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pharmaphorum

MAY 4, 2022

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. An organoid system approach takes self-organising clusters of cells that grow in three dimensions, closely resembling real tissue and organs.

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The Pharma Data

OCTOBER 28, 2020

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., .–( BUSINESS WIRE )– Moderna, Inc.

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XTalks

APRIL 24, 2023

According to Dr. Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Niraparib is also sold by GSK under the name Zejula in other indications.

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pharmaphorum

OCTOBER 30, 2019

Pathways have not held up to their promise for containing cost. Personalized medicine approaches such as biomarkers serve an important role in targeting therapy to the most appropriate patients, thereby reigning in cost. However, there are limitations in the breadth and utility of these tools.

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The Pharma Data

OCTOBER 18, 2020

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / October 19, 2020 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC. European Medicines Agency. emc/medicine/34321. Tremfya (R) is a registered trademark of Janssen Biotech, Inc.

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The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. About Synlogic Synlogic is bringing the transformative potential of synthetic biology to medicine.

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Drug Discovery World

MARCH 29, 2023

An example of the current disparity, drawn from data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), can be seen in Romania, Poland or Bulgaria, where a recently approved medicine will take more than 800 days on average before it becomes publicly available compared with Germany, where that figure is 133 days 3.

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pharmaphorum

OCTOBER 14, 2021

Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system. Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said the data showing a 36% reduction in the risk of death “are compelling”.

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 19, 2022.

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Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

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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. About PharmaDrug Inc.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. The European Medicines Agency has also granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency. Food and Drug Administration cleared Investigational New Drug Application.

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The Pharma Data

NOVEMBER 3, 2020

Nasdaq:LOGC) (LogicBio), a company dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms, announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LEXINGTON, Mass.,

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The Pharma Data

JANUARY 10, 2021

Morgan Healthcare Conference, including preclinical data showing tumor regressions in MTAP-deleted PDX models and proposed Phase 1 clinical plan. IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.

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The Pharma Data

DECEMBER 9, 2020

NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. All forward-looking statements contained in this press release speak only as of the date on which they were made.

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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. NEW YORK and LONDON, Jan.

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The Pharma Data

JANUARY 3, 2021

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

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The Pharma Data

JANUARY 20, 2021

Statistician: Dr. George Wells – Professor, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa and Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute. Dr. Bennett is a board-certified cardiologist and board-eligible in critical care medicine.

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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. About SQI Diagnostics. SQI Diagnostics, Inc. FORWARD-LOOKING INFORMATION.

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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. In June, the medicine was approved by the Ministry of Health, Labour, and Welfare (MHLW) in Japan. The companies share equally the costs of the development of vericiguat.

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The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

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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

JANUARY 4, 2021

BOSTON–( BUSINESS WIRE )– PureTech Health plc (LSE: PRTC, NASDAQ: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced that George Farmer, Ph.D.,

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The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. See below forU.S. Important Safety Information. Gilead Sciences, Inc.

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The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. This release contains forward-looking statements. SINGAPORE, Oct. Forward l ooking s tatements.

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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

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. Cautionary Note Regarding Forward-Looking Statements.

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The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. This vision is what defines us and guides our research, clinical development and partnerships. Wainberg, M.D., Wainberg, M.D.,

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