Drug Discovery World

OCTOBER 20, 2023

GenomeFrontier will use their virus-free cell and gene engineering platforms and Quantum Engine cell-engineering system to manufacture the CAR-T therapy for use in a Phase I clinical trial. With this merger, we pool our expertise, resources, and commitment to pushing the boundaries of what’s possible in microbiome research.

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Delveinsight

AUGUST 27, 2021

The company further plans for EU approval of the drug; however, the Phase III trial for the EU locations is still recruiting, and the approval might depend on the further data readouts. It is a major competitor for Viltepso (viltolarsen) approved in 2020 in the US and Japan. Viltepso is being developed and marketed by NS Pharma.

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XTalks

OCTOBER 5, 2022

The efficacy of Relyvrio was investigated in the CENTAUR trial , a multi-center, randomized, placebo-controlled Phase II clinical trial. The study also included an open-label extension long-term follow-up phase to observe longer term effects of Relyvrio. Investigation of Relyvrio in the CENTAUR Clinical Trial.

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The Pharma Data

JANUARY 19, 2021

Now, a Phase I/IIa dose escalation study is underway in patients with relapsed and/or refractory AML. Once the dose is established, we will move to Phase II to determine safety, tolerability and anti-tumor activity,” Wilson said. Animals showed complete, durable remissions in multiple models of AML. Morgan week.

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Drug Discovery World

JUNE 1, 2023

Seagen is a major player in ADC technology, with four of the 12 FDA-approved and marketed ADCs using its technology industry-wide 3. “Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr Albert Bourla, Pfizer Chairman and CEO.

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VirTrial

JANUARY 2, 2024

Emerging biopharma can utilize our Unified Platform for any trial and any phase. They also often rely on CROs to recommend eClinical solutions that can help meet critical milestones on time.

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WCG Clinical

MAY 31, 2023

They must do this throughout the research process of designing studies, assembling teams, managing resources, and continuously learning from their acquired data. Involving patients in the planning phase not only respects patient perspectives but also enhances safety and data quality. Put yourself in the participant’s shoes.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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The Pharma Data

OCTOBER 1, 2021

The approval of CIBINQO in Japan was based on the results from 1,513 patients across four Phase 3 studies, ranging from 12 to 16 weeks of treatment, and a long-term extension study from a robust clinical trial program. Our priority will now be to ensure CIBINQO is routinely accessible to as many patients as possible.”.

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XTalks

OCTOBER 12, 2022

Early phase clinical trials in oncology of vascular-targeting agents and anti-angiogenic drugs that used data from DCE-MRI perfusion imaging techniques were quite common between 2002 and 2012. The example above from the Phase I study of AG-013736 shows that DCE-MRI-based perfusion imaging can be a good predictive biomarker.

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Drug Discovery World

JUNE 5, 2023

I consider one of my responsibilities to advocate the advent of a new era for 3D genomics. By utilising genetic information, we can make a big difference to patients.” When it comes to the challenges Enhanc3D is facing, Lucarelli says there are slightly different ones depending on the phase.

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The Pharma Data

APRIL 29, 2022

NYSE: PFE) today shared top-line results from the Phase 2/3 EPIC-PEP ( E valuation of P rotease I nhibition for C OVID-19 in P ost- E xposure P rophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use. Pfizer Inc.

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The Pharma Data

MAY 12, 2021

New data and analyses to be presented from the pivotal Phase 3 CADENZA and CARDINAL studies of sutimlimab, a first-in-class investigational C1s inhibitor that has the potential to be the first approved treatment for hemolysis in adults with cold agglutinin disease (CAD), a serious and chronic autoimmune hemolytic anemia. Oral Presentation.

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The Pharma Data

JANUARY 15, 2021

4] I believe this approval will increase awareness of and education around this life-threatening disease and offer new hope for people with AL amyloidosis and their caregivers.”. Serious cardiac disorders occurred in 16 percent of patients (8 percent of patients with Mayo Cardiac Stage I and II and 28 percent of patients with Stage III).

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The Pharma Data

NOVEMBER 5, 2020

We look forward to multiple Phase 3 and Phase 2 clinical data readouts in 2021.”. Ocuphire held its end of phase 2 (EOP2) meeting with the FDA in May 2020 to discuss the regulatory pathway for Nyxol in multiple chronic and acute refractive indications.

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The Pharma Data

DECEMBER 14, 2020

As was the case at biotech companies globally, there was internal debate on how many resources to place on the vaccine. I was so focused on the program, and I would leave the office at 10 o’clock at night. I would come back by 7 a.m. They had also been partnered with the NIH on bringing mRNA vaccines to market.

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Drug Discovery World

MAY 16, 2023

Skills gap Bruce Levine, International Society for Cell & Gene Therapy (ISCT) Immediate Past President and Chair, Strategic Advisory Council, says a critical challenge that has become apparent for the CGT sector is the need for workforce development and training resources. The solution?

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The Pharma Data

APRIL 28, 2021

Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001). million cases of invasive fungal infections occur worldwide each year, with mortality rates as high as 30-80% across infection types i. i Bongomin F et al J. ii Center for Disease Control and Prevention.

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The Pharma Data

JANUARY 20, 2021

CytomX expects to use any remaining net proceeds from this offering for capital expenditures, working capital and other general corporate purposes.

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Drug Discovery World

APRIL 14, 2023

She is also the Scientific Director at the Abramson Family Cancer Research Institute and Associate Director, Shared Resources, at the Abramson Cancer Center. He is also being recognised for his steadfast commitment to leading research dedicated to understanding how to eliminate cancer and health disparities. Doctors said not to worry.

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Pharmaceutical Technology

JANUARY 20, 2023

Nevertheless, the potential for mAb therapies in treating medical conditions that have limited options means that biopharma companies are investing considerable resources in development. Process intensification is essentially producing more product with fewer resources.

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Drug Discovery World

OCTOBER 25, 2022

The acquisition adds ELE-101, a next-generation, short-duration psychedelic ready for Phase I clinical trials, to Beckley Psytech’s pipeline. . Beckley Psytech will continue the analysis of existing data from the Phase Ib clinical study and apply the learnings from this programme to current and future pipeline candidates.

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XTalks

FEBRUARY 10, 2023

The rapidly expanding landscape of cell therapy trials has put an operational strain on many clinical sites due to limited resources and infrastructure. “In Requirements for Phase I trials may not be as stringent as Phase III trials. The number and experience of the vendors involved in the cell tracking system.

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The Pharma Data

JANUARY 25, 2021

The encouraging survival data from the Phase I study of MTX110 in DIPG announced on 19 October 2020 combined with a significant increase in budgeted costs by the proposed Phase II clinical site at Kinderspital, Zurich have prompted a re-evaluation of the MTX110 programme.

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XTalks

FEBRUARY 4, 2021

Bernard, executive vice president for research and chief research officer at Vanderbilt University Medical Center, shared his experience in helping set up a DNA and clinical data resource called BioVU. He says, “this generated an environment in which it was very easy, shall I say, to recruit subjects into studies.”.

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pharmaphorum

DECEMBER 13, 2021

The Covid-19 pandemic showed what could be done with resources and collaboration to accelerate the development of vaccines. Meanwhile, Moderna started phase I/II trials of its mRNA-based influenza vaccine and announced plans to develop a combination mRNA vaccine targeting flu, covid and respiratory syncytial virus (RSV) in a single shot.

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The Pharma Data

OCTOBER 27, 2020

“I expect these three launches will set us on the path to revenue growth in the near term.” our initial phase 1 study of OreniPro , which has since been completed. Ralinepag phase 3 development program — ADVANCE CAPACITY and ADVANCE OUTCOMES. Chairman and Chief Executive Officer of United Therapeutics.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration gave it the green light to initiate a Phase III study of tesamorelin for the treatment of adults with Nonalcoholic Steatohepatitis (NASH) with liver fibrosis. The proposed Phase III trial design will enroll participants with liver-biopsy confirmed NASH and stage 2 or 3 fibrosis.

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Drug Discovery World

AUGUST 24, 2023

Despite psilocybin’s presence in many mushrooms, by and large they are considered ‘controlled substances’, or a Schedule I drug, and as such a drug or chemical whose manufacture, possession and use is illegal. Psilocybin is a naturally occurring psychedelic compound that is produced by more than 200 species of fungi.

Medicine 52

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Drug Discovery World

FEBRUARY 2, 2023

Accordingly, RRx-001 is currently in a phase III trial called REPLATINUM 2 for the treatment of third line or beyond SCLC, a disease mainly of heavy smokers, in combination with the chemotherapy agents, carboplatin and etoposide. Rockets, radiosensitizers, and RRx-001: an origin story part I. Future Oncol. 2019 Oct;15(30):3427-3433.

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The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. The company and Pfizer Inc.

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The Pharma Data

MAY 9, 2022

i In the U.S., ii,iii,iv It can take between four and eleven years to get an endometriosis diagnosis v,vi,vii,viii and for some women, current treatment options do not provide relief. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis.

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The Pharma Data

JUNE 2, 2022

The sNDA proposes updates to MYFEMBREE’s United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years. An estimated five million women in the U.S.

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The Pharma Data

FEBRUARY 8, 2021

Sanofi Chief Executive Officer, Paul Hudson, commented: “ While last year was an extraordinarily challenging year for all, I am incredibly proud of the measurable progress we made within the backdrop of a global pandemic. Total Multiple Sclerosis/ Neurology/Other I&I. Lemtrada ®. In 2020, the franchise’s sales were up 3.9%

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The Pharma Data

FEBRUARY 4, 2021

Sanofi Chief Executive Officer, Paul Hudson, commented: “ While last year was an extraordinarily challenging year for all, I am incredibly proud of the measurable progress we made within the backdrop of a global pandemic. Total Multiple Sclerosis/ Neurology/Other I&I. Lemtrada ®. In 2020, the franchise’s sales were up 3.9%

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The Pharma Data

NOVEMBER 26, 2020

The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. About Pegunigalsidase Alfa.

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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. About the Phase 1 Study . Wed, 11/02/2022 - 15:44.

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