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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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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XTalks

DECEMBER 5, 2023

Augtyro, a tyrosine kinase inhibitor (TKI), is available as oral capsules, each containing 40 mg of repotrectinib. New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” said Jessica J.

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The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). Hong , M.D.,

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. About Lexicon Pharmaceuticals. Safe Harbor Statement.

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The Pharma Data

OCTOBER 26, 2020

Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. , 27, 2020 /PRNewswire/ — Synlogic, Inc.

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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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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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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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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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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

DECEMBER 12, 2020

We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.” ” Ludwig Hantson , Ph.D., Strategic rationale.

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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

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

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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Pfizer

JULY 26, 2022

is immunocompromised or are on a medicine that affects the immune system. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of July 27, 2022.

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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 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 27, 2021

Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S. We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

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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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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

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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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

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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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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Pfizer

JULY 8, 2022

The adverse event profile was generally consistent with other clinical data for the vaccine, with a favorable safety profile observed across 6 months of safety follow-up data after the second dose. . Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

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Delveinsight

JULY 27, 2021

This globalized COVID-19 vaccine supply chain and manufacturing network, incorporates 3 continents and will contain around 20 manufacturing facilities. As suggested by analysts, the most rapid, cost-effective and easiest way of vaccine development is regional partnership with prominent vaccines developers.

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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.

Antibody 52

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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 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

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. 28, 2021 11:00 UTC. About MultiStem ®.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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Clinical Trials Clinical Trials Development Trials 52

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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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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Pfizer

JULY 8, 2022

is immunocompromised or is on a medicine that affects the immune system. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of July 8, 2022.

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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 31, 2021

In addition to Metrion, these collaborations with Captor Therapeutics in targeted protein degradation and with PharmEnable to access proprietary artificial intelligence-enabled and medicinal chemistry technologies are a key factor to drive our future growth ambitions.”

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