The Pharma Data

DECEMBER 13, 2020

As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

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Pharmaceutical Technology

MAY 31, 2023

Sym-021 is under clinical development by Les Laboratoires Servier and currently in Phase I for Solid Tumor. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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XTalks

MAY 9, 2024

As we explore Genmab’s strategic vision, technological advancements and the next frontier in antibody research, we gain insights into the future of medicine — a future where Genmab’s cutting-edge therapies are poised to transform patient care and meet the complex challenges of the next generation of healthcare.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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XTalks

SEPTEMBER 21, 2023

“HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts,” said Carey Hwang, Vir’s Senior Vice President, Clinical Research, Head of Chronic Infection, in the company’s press release. mRNA, 2) BG505 MD39.3 gp151 mRNA and 3) BG505 MD39.3 gp151 CD4KO mRNA.

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The Pharma Data

DECEMBER 22, 2020

AVA6000 has been shown in animal models to significantly increase the amount of active drug in a tumour compared with the heart and should thereby improve tolerability and achieve better clinical outcomes for patients. Dosing of first patients will commence when we have responded to that feedback and received approval to proceed.

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Clinical Trials Clinical Trials Trials Development 52

XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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pharmaphorum

MAY 13, 2021

The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries. The trial is expected to enrol 99 ambulatory male patients, aged four to seven.

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Drug Discovery World

JANUARY 15, 2024

OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a key driver of foetal growth and development, and its binding protein, IGFBP-3. Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan.

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XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

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pharmaphorum

NOVEMBER 12, 2020

Regulators sitting on the European Medicines Agency’s CHMP scientific committee have already begun a rolling review of the vaccine, which will accelerate the process as they will be able to study trial results as they are made available. billion doses in 2021.

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The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. “Our minibinders sit on top of the spike protein like a tripod and block all three.

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Drug Discovery World

AUGUST 28, 2023

DS: Samsara’s autophagy inducing candidate SAM001 will be the first agent of its class to enter clinical trials. It is the method for removing unwanted debris, e.g., old proteins, and breaking them down so their constituent parts can be used again. What is autophagy? How does SAM001 work?

Genetics 52

Genetics Protein Genetic Disease Clinical Trials 52

Drug Discovery World

DECEMBER 27, 2023

Ng is working on critical challenges in clinical trials, specifically in planning and recruitment, and has been building innovative solutions designed to benefit patients and researchers – with a focus on efficiency, transparency and diversity in clinical development. Listen here. Listen here. Listen here.

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Clinical Trials Clinical Trials Drugs Development 69

Pfizer

AUGUST 3, 2022

Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. mitogen activated protein kinase pathway, which demonstrated improvement in functional capacity (6-minute walk test; 6MWT) in a 48-week, open-label, Phase 2 study among patients with symptomatic LMNA-related DCM.

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pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

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The Pharma Data

DECEMBER 10, 2020

“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.”. Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Safe Harbor Statement.

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Containment Clinical Development Development Protein 52

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. and Roche will develop, manufacture and distribute it outside of the U.S.

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The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

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The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Food and Drug Administration in 2017.

FDA Approval 52

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. Official comments .

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Delveinsight

AUGUST 13, 2020

Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an evaluation of Gilead’s remdesivir clinical trials, which found the studies that flunked to offer an equal representation of Black, Latinx, and Native Americans. F2G raises USD 60.8 F2G has raised USD 60.8

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Trials Research Drugs Protein 52

pharmaphorum

NOVEMBER 9, 2020

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier. It recommended that the study continues to collect additional safety and efficacy data as planned.

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pharmaphorum

NOVEMBER 9, 2022

for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed.

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In-Vitro Bioavailability Medicine Clinical Trials 52

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

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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

OCTOBER 19, 2020

Caris’ collaborative network focused on expanding the application of precision medicine in oncology supports Winship’s enterprising approach to research leading to transformative discoveries in cancer care and treatment. The NCTN serves as the NCI’s primary infrastructure to conduct phase II and III clinical trials.

Life Science 52

Life Science Clinical Trials Clinical Trials RNA 52

The Pharma Data

MARCH 23, 2021

The CDx approval is part of the global collaboration between Bayer and Foundation Medicine, Inc. FMI), for which Chugai is the local development partner of FMI. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. About Vitrakvi (Larotrectinib).

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Genome Genomics Gene Protein 52

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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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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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. that are fast progressing clinical trials. that are fast progressing clinical trials. SAN FRANCISCO and SUZHOU, China , Nov.

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Clinical Trials Clinical Trials Manufacturing Production 52

pharmaphorum

NOVEMBER 9, 2020

Swedish biotech Calliditas has announced plans to file its rare disease drug Nefecon with the FDA early next year following positive results from a phase 3 clinical trial. A filing for a conditional approval with the European Medicines Agency will follow in the second half of next year.

Drugs 52

Drugs Clinical Trials Clinical Trials Trials 52

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., The first patient is expected to be enrolled early in the second quarter of the 2023 calendar year.

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Trials Immune Response HR Clinical Development 52

The Pharma Data

AUGUST 15, 2021

The CRL requested an additional clinical trial on the safety of roxadustat in both the NDD and DD patient populations. Anaemia Anaemia can be a serious medical condition in which patients have insufficient red blood cells (RBCs) and low levels of haemoglobin, a protein in RBCs that carries oxygen to cells throughout the body.

Medicine 52

Medicine Clinical Trials Clinical Trials Production 52

The Pharma Data

OCTOBER 27, 2020

The company plans to tackle the existing challenges of precision medicine with a three-prong approach – developing better medicines for known cancer-driving mutations, developing drugs for targets previously thought to be undruggable, and finding new, untapped targets that could lead to even better drugs. Sirnaomics.

Gene 52

Gene Gene Therapy Medicine Genetics 52

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Oral therapy data presented at ASH. Professional reception of the findings.

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Development Drugs Clinical Development Antibody 52

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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