Drug Discovery World

MARCH 24, 2023

Additionally, the trial design incorporates feedback from Scientific Advice meetings with the European Medicines Agency (EMA) to support a Marketing Authorisation Application (MAA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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The Pharma Data

JANUARY 4, 2021

During his time in this role, he oversaw the development and regulatory approval of 11 different oncology assets, including the combination of Xalkori and Lobrena for ALK+ non-small cell lung cancer (NSCLC); Xalkori for ROS1 positive NSCLC; kidney cancer drug Inlyta; Ibrance for HR+ breast cancer; Besponsa for acute lymphoblastic leukemia; and more.

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Drug Discovery World

JUNE 1, 2023

6 Also in May 2023, Shanghai-native LaNova Medicines entered into an exclusive license agreement with AstraZeneca for LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D).

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JUNE 7, 2023

Rubin, senior vice president, global clinical development, Merck Research Laboratories. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. Based on data from KEYNOTE-942/mRNA-4157-P201, the U.S.

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The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. Abstract title.

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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. HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87). HR (95% CI): 0.44 (0.25, 0.77).

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The Pharma Data

JUNE 25, 2021

41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; After a median follow-up of 24.1 months (14.9-41.5), 0.87]; p=0.0010). 0.96]; p=0.0164). It took several decades to achieve this milestone.

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The Pharma Data

APRIL 29, 2022

Available safety data for PAXLOVID has been generally consistent in more than 3,500 PAXLOVID-treated participants across the EPIC-HR, EPIC-SR and EPIC-PEP studies, as well as in reported post-market safety experience. In EPIC-PEP, this safety profile remained generally consistent when PAXLOVID was used for either five or ten days.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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The Pharma Data

MAY 26, 2023

4,5) The FDA approval of PAXLOVID is based on the totality of scientific evidence shared by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program. residents eligible for PAXLOVID will continue to receive the medicine at no charge.*

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The Pharma Data

NOVEMBER 8, 2021

In the FIGARO-DKD study, presented at ESC Congress 2021 and published in the New England Journal of Medicine, the prevalence of the first secondary endpoint, a compound of time to order failure, a sustained drop of estimated glomerular filtration rate (eGFR) ? placebo donors (HR = 0.64; 95 CI0.41-0.995; ESKD passed in0.9

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The Pharma Data

DECEMBER 3, 2020

Barnett joined Array in 2000, two years after the company was founded, and played an invaluable role in successfully bringing Mektovi and Braftovi, two precision oncology medicines, to market while serving in a range of roles including research, business development and technical operations.

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JANUARY 15, 2021

This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population.”. 4.3] (HR=0.47; 95% CI 0.31-0.71)

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SEPTEMBER 9, 2020

In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; Roche’s Chief Medical Officer and Head of Global Product Development. 0.79; p=0.002) compared to those originally in the placebo group.

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The Pharma Data

MARCH 17, 2022

The study found that adjuvant treatment with KEYTRUDA significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo (hazard ratio [HR]=0.76 [95% CI, 0.63-0.91]; 0.91]; p=0.0014) in patients with stage IB (?4 About Merck.

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The Pharma Data

JUNE 7, 2023

Trodelvy® Continues to Show Durable Overall Survival Advantage in Pre-Treated HR+/HER2- Metastatic Breast Cancer Gilead Sciences, Inc. In this exploratory analysis, Trodelvy demonstrated a clinically meaningful improvement in median OS benefit compared to TPC (median OS: 14.5 months; hazard ratio (HR): 0.79; [95% CI: 0.65-0.95];

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The Pharma Data

DECEMBER 29, 2020

one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). Senior Vice President and Head of Global Clinical Development at Regeneron. The results passed the futility analysis (p<0.3 log 10 copies/mL for combined doses).

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The Pharma Data

JANUARY 20, 2021

Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. Verquvo met the primary efficacy objective based on a time-to-event analysis (hazard ratio [HR]: 0.90, 95% confidence interval [CI], 0.82-0.98; 0.98; p=0.019).

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The Pharma Data

MARCH 17, 2021

percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). Accepted as ePoster – Adjuvant Systemic Therapy. Available on-demand on March 10, 2021. Selected for one of the three St.

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The Pharma Data

JULY 15, 2021

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]; 0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. 1.02]; p=0.03214). 10) as determined by an FDA-approved test.

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Drug Discovery World

OCTOBER 7, 2022

HR : We have some great assets at CRUK – access to world-leading cancer biology, strong, proven drug discovery capabilities and access to a network of life-science organisations – Cancer Research Horizons was set up to expand on these assets and make them accessible to researchers, investors and industry through collaboration. Hamish Ryder.

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XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

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FEBRUARY 24, 2022

with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine”[i],[ii]. chairman, Department of Medicine, University of Mississippi. vice president, Product Development, Lilly. with more than 8 million cases expected by 2030.

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The Pharma Data

APRIL 16, 2021

The combination of Opdivo and Cabometyx was well tolerated, with safety reflective of the known profiles of both medicines and a low rate of treatment-related adverse events (TRAEs) leading to discontinuation. vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. With a minimum follow-up of 10.6

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MARCH 31, 2023

months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 32%, demonstrating a landmark three-year event-free survival (EFS) rate of 57% with Opdivo with chemotherapy compared to 43% with chemotherapy alone (Hazard Ratio [HR], 0.68; 95% Confidence Interval [CI], 0.49 With median follow up of 41.4

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The Pharma Data

NOVEMBER 24, 2020

Results from the ILLUMINATE-A and ILLUMINATE-B studies demonstrate that Oxlumo addresses the underlying pathophysiology of PH1 in adults, children and infants, and we believe this newly approved medicine has the potential to change the course of this progressive disease,” said Akshay Vaishnaw, M.D., 0.514 mmol/24 hr/1.73

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The Pharma Data

APRIL 26, 2022

In this trial, patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 96.02% confidence interval [CI] 0.65-0.93; Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). Keytruda is under development as an adjuvant treatment for patients with stage IB (≥4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection.

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JUNE 26, 2021

In the overall study population, Libtayo significantly reduced the risk of death by 32% and extended median overall survival (OS) by 8 months compared to chemotherapy, even with 74% of patients crossing over to Libtayo following disease progression on chemotherapy (hazard ratio HR: 0.68; 95% confidence interval CI: 0.53-0.87; 0.87; p=0.0022).

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The Pharma Data

AUGUST 9, 2021

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. 1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.

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The Pharma Data

APRIL 11, 2021

Patients treated with this combination had a decrease in risk of disease progression or death by 48% (HR=0.52, p=0.000002) compared to patients treated with placebo and rituximab, with a median PFS of 21.5 months versus 13.8

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