The Pharma Data

APRIL 28, 2023

We strongly believe in the results of the PROpel trial, which demonstrated the clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” maturity, HR of 0.81, 95% CI 0.67-1.00; 0.43) and OS (HR of 0.29, 95% CI, 0.14-0.56). 0.81; p<0.001). months and 16.6

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pharmaphorum

OCTOBER 14, 2021

The approved treatment regime demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; 0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; 0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, where tumours expressed PD-L1 (CPS ?1).

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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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The Pharma Data

APRIL 28, 2023

We strongly believe in the results of the PROpel trial, which demonstrated a clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” In exploratory analyses of the BRCA m subgroup, patients in the LYNPARZA plus abi/pred arm had fewer rPFS (HR=0.23 [95% CI, 0.12-0.43])

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The Pharma Data

JANUARY 14, 2021

HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87). HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027. HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027.

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Trials HR Containment Development 52

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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HR Trials Clinical Development Clinical Research 52

The Pharma Data

JULY 22, 2021

“We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer.

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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). KEYTRUDA is currently approved in the U.S.,

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HR Trials Clinical Research Research 52

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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The Pharma Data

AUGUST 30, 2021

“We are pleased to offer two potential new treatment options with KEYTRUDA for patients in Japan based on compelling data from our clinical trial program,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. months (95% CI, 7.6-11.3)

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Hormones HR Trials Protein 52

The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation.

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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

NOVEMBER 18, 2021

The blessing is grounded on data from the vital Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant enhancement in complaint-free survival (DFS), reducing the threat of complaint rush or death by 32 (HR = 0.68 (95 CI,0.53-0.87); 0.87); p = 0.0010) compared to placebo. 0.87); p = 0.0010).

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FDA Approval HR Trials Drugs 52

The Pharma Data

JUNE 19, 2023

The findings bolster the idea, which is currently under investigation in at least three clinical trials, that when it comes to treating resistant breast cancer, two drugs may be better than one.

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The Pharma Data

DECEMBER 3, 2020

Previously, Wiedmann served as Head of Human Resources, overseeing a global team and developing HR management strategies for international companies, including Siemens and the US-based biotech company, Vertex Pharmaceuticals. BioAge – Paul Rubin was named CMO of BioAge and will lead the company’s clinical development efforts.

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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

MARCH 23, 2021

For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; 0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; for the placebo arm, with a HR of 0.62 (95% CI, 0.49-0.78; for the placebo arm, with a HR of 0.86 (95% CI, 0.68-1.10).

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The Pharma Data

APRIL 16, 2021

months, respectively; HR 0.51; 95% CI: 0.41 OS: The combination reduced the risk of death by 40% compared to sunitinib (HR: 0.60; 98.89% CI: 0.40 To date, the Opdivo clinical development program has treated more than 35,000 patients. With a minimum follow-up of 10.6 months vs. 8.3 vs. 27.1%).

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The Pharma Data

FEBRUARY 24, 2022

vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. vice president, Product Development, Lilly. In the trial, Jardiance demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79

FDA Approval 52

FDA Approval Medicine Trials HR 52

The Pharma Data

NOVEMBER 8, 2021

placebo donors (HR = 0.64; 95 CI0.41-0.995; The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development. ESKD passed in0.9 of finerenone versus1.3 0.995; p = 0.046).

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Clinical Trials Clinical Trials Trials HR 52

The Pharma Data

JUNE 7, 2023

Within the multivariate analysis, PFS was improved in patients with prior autoHCT compared to those without prior autoHCT (hazard ratio [HR] 0.56; 95% CI, 0.35–0.88).

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The Pharma Data

APRIL 26, 2022

The BLA for tremelimumab and sBLA for Imfinzi are based on final results from the HIMALAYA Phase III trial presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. 0.93; p=0.0035).4 4 Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.4.

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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

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Clinical Trials Clinical Trials Research Trials 52

The Pharma Data

JUNE 7, 2023

Rubin, senior vice president, global clinical development, Merck Research Laboratories. Patients with stage III and IV melanoma can be at high risk of having their cancer recur or metastasize to other sites,” said Dr. Eric H.

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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. .” COVID-19 continues to cause significant burden in the U.S.

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FDA Approval HR Vaccination Vaccine 40

Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). According to GlobalData, Phase III drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

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The Pharma Data

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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Trials Genetics Antibody HR 52

The Pharma Data

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; The Phase III clinical development programme for ENSPRYNG includes two studies: SAkuraStar and SAkuraSky.

Antibody 52

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The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) About the Enhertu Clinical Development Program.

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Medicine Trials Antibody HR 52

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

NOVEMBER 24, 2020

Together, the ILLUMINATE studies comprise a comprehensive clinical development program intended to demonstrate the safety and efficacy of Oxlumo across the full spectrum of patients diagnosed with PH1. 0.514 mmol/24 hr/1.73 0.514 mmol/24 hr/1.73 0.771 mmol/24 hr/1.73 IMPORTANT SAFETY INFORMATION.

FDA Approval 52

FDA Approval Production RNA Medicine 52

The Pharma Data

JANUARY 20, 2021

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; This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. 0.98; p=0.019).

FDA Approval 52

FDA Approval Production Trials Development 52

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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Antibody Trials Production Clinical Trials 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021. billion in 2022.

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XTalks

DECEMBER 4, 2020

Developed in 1999 2. Considered to be more accurate than 24 hr urine creatinine clearance or Cockcroft-Gault formula. As sponsors are building out their clinical development plan, it’s really beneficial to bring in that experienced medical and operational team to support early engagement with the regulatory agencies,” says Sheil.

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