The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. You should not place undue reliance on these statements.

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The Pharma Data

JULY 15, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase 3 study KEYNOTE-522. After a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82];

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The Pharma Data

NOVEMBER 30, 2020

Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. to determine efficacy and safety of NVX-CoV2373.

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Drug Discovery World

DECEMBER 13, 2023

In the FIRsT Phase I/II clinical trial, seven patients completed one-year treatment with FR104/VEL-101 and one is ongoing (Month 4). Adverse events were those conventionally observed in kidney transplantation. At this interim analysis, no safety alert was detected for FR104/VEL-101.

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) announced today that Gökhan Batur, Chief Executive Officer, will take part in a panel discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on Thursday, January 7 from 8:00AM Eastern Standard Time. Investors can pre-register for the event here.

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Drug Discovery World

AUGUST 22, 2023

Bloom Science has announced positive topline data from a Phase I clinical trial of BL-001 , a potential first-in-class therapeutic the company is developing for Dravet syndrome and amyotrophic lateral sclerosis (ALS). BL-001 shows promise as a novel treatment option that can change lives.

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The Pharma Data

FEBRUARY 24, 2022

“Despite treatment with standard of care, the residual risk for cardiorenal events remains high in patients living with chronic kidney disease and type 2 diabetes. Up to 40% of all patients with type 2 diabetes (T2D) develop CKD. It is estimated that CKD affects more than 160 million people with T2D worldwide.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Drug Discovery World

APRIL 25, 2023

“We have reached an important milestone with the dosing of the second participant in our clinical trial evaluating a potentially groundbreaking CAR-T cell therapy to cure HIV,” said Mehrdad Abedi, Professor of Internal Medicine, Hematology and Oncology and co-investigator of the study. “So

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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Drug Discovery World

JUNE 21, 2023

Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study. The company has stated its intention to schedule an end of Phase II meeting with the US Food and Drug Administration (FDA) to begin planning the next steps in the regulatory and clinical development programme for CITI-002.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

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The Pharma Data

NOVEMBER 8, 2021

Bristol Myers Squibb moment blazoned the Phase 3 CheckMate-816 trial met the primary endpoint of bettered event-free survival (EFS) in cases with resectable stage IB to IIIAnon-small cell lung cancer (NSCLC). vice chairman, thoracic cancers development lead, Bristol Myers Squibb. “ About Lung Cancer.

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Drug Discovery World

NOVEMBER 10, 2023

KIO-301 was safe and well tolerated with no ocular and non-ocular serious adverse events, nor any signs of retinal inflammation. The mechanism of action and trial data firmly support KIO-301’s continued development, potentially filling a major unmet need in the search for treatments for these patients,” said Dr Van Gelder.

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Drug Discovery World

MAY 3, 2023

Official comments “Measuring endothelial dysfunction with the EndoPAT technology in drug trials is a cost-effective and robust method for early documentation of proof-of-concept in pulmonary, renal and vascular diseases” says Elin Rosendahl, VP Clinical Operations, Vicore Pharma.

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Drug Discovery World

FEBRUARY 22, 2023

The multi-year clinical development of Hemgenix was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialise the treatment. The HOPE-B study 24-month analysis continued to show a sustained and durable effect of Hemgenix.

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Drug Discovery World

AUGUST 10, 2023

Consistent with the previously reported Phase III ORCA-2 study, ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events. MT: What do these results mean for escalating levels of vaping? JB: Nicotine dependency continues to be a prominent health issue worldwide.

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Drug Discovery World

JULY 3, 2023

This was centred around pre-clinical models (in vitro and in vivo) to support discovery and development, re-entering the fray with costimulatory agonists, and clinical development strategies for combinations with immune cell engagers​.

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The Pharma Data

JUNE 30, 2021

With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. This press release features multimedia.

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Drug Discovery World

JUNE 15, 2023

Two is the science – the drug discovery and development I have been able to do. Finally, three is that I have been lucky enough to work on three drugs from early non-clinical development all the way through to the clinic that have been approved. That’s very satisfying. You take that with you.

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Drug Discovery World

OCTOBER 24, 2023

One of the key presentations will be given by Dr Qasim Ahmad, Chief Medical Officer of IO Biotech, a Clinical Oncologist with two decades of strategic clinical development, medical affairs, and marketing authorisation expertise.

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The Pharma Data

NOVEMBER 11, 2021

The primary efficacity endpoint is the time to first event of cardiovascular death or hospitalization for heart failure (NCT05093933). Joerg Koglin, vice chairman, Global Clinical Development and Therapeutic Area Head, Cardiovascular for Merck Research Laboratories. Reclamation for the VICTOR trial has begun. each time,” saidDr.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

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Drug Discovery World

SEPTEMBER 12, 2022

Chaired by Karin Blumer, Director of Global Patient Engagement at Novartis, the first event in this track, called ‘Patient Engagement: Driving Patient Advocacy to Inform Patient Centric Development’, looked into the multi-layered importance of involving patients in the drug development process, particularly in this case for gene therapy.

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Drug Discovery World

MARCH 13, 2024

of patients experienced adverse events (AEs), with no evidence of dose-dependent increase in AEs, including gastrointestinal disorders. The most frequently reported AEs were nasopharyngitis (18.1%), upper respiratory tract infection (9.7%) and Covid-19 (5.3%). Across JNJ-2113 treatment groups, 58.6%

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Alta Sciences

AUGUST 18, 2023

Don’t miss out: [link] Event End Date Thu, 10/26/2023 - 12:00 Event Start Date Thu, 10/26/2023 - 12:00 Weight 1

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Drug Discovery World

JUNE 5, 2023

DDW’s Megan Thomas comments on the event. New approaches to partnering In this event in the Biotech track, Clive Cookson, Science Editor at the Financial Times, interviewed John McDonald, Corporate Vice President, Global R&D Business Development, Novo Nordisk.

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Drug Discovery World

NOVEMBER 30, 2023

Lonza’s integrated CMC strategy and timeline was presented, as well as case studies highlighting key approaches and technologies, including: vector design & integration, cell line selection, downstream process, analytical method and formulation development.

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The Open Targets Blog

JUNE 26, 2023

Gene essentiality Core essential genes are unlikely to tolerate inhibition, and are therefore susceptible to cause adverse events if modulated. This is crucial safety information for drug discovery scientists looking to develop inhibition strategies. Users can view a specific list of adverse events, mapped to EFO terms.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024. CEST / 8 a.m.

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Drug Discovery World

APRIL 3, 2024

million from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.

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Conversations in Drug Development Trends

APRIL 5, 2024

Each day throughout the month of February, we heard what was on the minds and hearts of patients and patient advocacy organizations, clinical developers driving treatments, and family members supporting people with rare diseases. We were overwhelmed by how excited the community was to participate!

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Drug Discovery World

JANUARY 12, 2023

DDW shared a global data analysis from Phesi, which showed the extent of the impact from the war in Ukraine on clinical development. Additionally, DDW’s Diana Spencer examined clinical trial data from Phesi and spoke to Dr Olena Karpenko, Clinical Research Director at Medical Center Ok!Clinic+,

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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The Pharma Data

MARCH 28, 2022

Further, Ozempic ® is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease. The most common adverse events were gastrointestinal. mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg and 2.0 Ozempic ® 2.0

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The Pharma Data

APRIL 24, 2023

“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

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