pharmaphorum

DECEMBER 1, 2021

The panel met shortly after updated results from the phase 3 MOVE-OUT trial of the drug showed it was less effective than previously thought, reducing the risk of hospitalisation or death in high-risk patients by around 30%. On the other hand, there were also more older people later on, which should have benefited the active drug.

Drugs 52

Drugs HR Protein Development 52

The Pharma Data

JUNE 26, 2021

Basel, June 23, 2021 — VISION data published today in The New England Journal of Medicine (NEJM) shows that 177 Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52?0.74]; months) and imaging-based progression-free survival (HR = 0.40 [99.2% 0.74]; P<0.001; median 15.3

Medicine 52

Medicine HR Hormones Protein 52

pharmaphorum

JUNE 17, 2022

At the time of authorisation, the United States federal government had already purchased 10 million doses of the drug. Developed by Pfizer, Paxlovid was granted emergency use authorization (EUA) to treat COVID-19 patients based on the EPIC-HR study which showed it reduced the risk of hospitalization or death by almost 90 percent.

Drugs 105

Drugs Clinical Trials Clinical Trials HR 105

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 101

FDA Approval Drugs Sales Development 101

Pfizer

AUGUST 15, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. AUTHORIZED USE. anti-infectives).

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

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.

Trials 52

Trials Immune Response HR Clinical Development 52

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.

Trials 52

Trials HR Containment Development 52

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

SEPTEMBER 16, 2020

Food and Drug Administration, about four months earlier than anticipated, for the treatment of early and metastatic HER2-positive breast cancer. HR-positive breast cancer. PI3K pathway biomarkers and clinical response in a phase I/Ib study of GDC-0077 in hormone receptor-positive/HER2-negative breast cancer (HR+/HER2– BC).

HR 52

HR Medicine Hormones Trials 52

Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Sufficient information is not available to assess for a potential drug interaction. Modification of other medications is needed due to a potential drug interaction.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

SEPTEMBER 19, 2020

The safety profile was consistent with the established profile of the individual drugs and no new safety concerns were identified. months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). pCR was observed in 57.6% (95% CI: 49.7–65.2)

HR 52

HR Medicine In-Vitro Development 52

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

Drugs 69

Drugs Licensing Licensing Containment 69

XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). DRUG INTERACTIONS. ERLEADA ® received U.S.

HR 52

HR Hormones Development Production 52

The Pharma Data

SEPTEMBER 18, 2020

The recommendation from the CHMP is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79; 0.76; p<0.0001), compared with sorafenib. The most frequent serious adverse reactions (?2%)

Medicine 52

Medicine HR In-Vitro Protein 52

The Pharma Data

SEPTEMBER 28, 2021

In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) Data from the IMpower010 trial were published simultaneously within the Lancet. 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%,

Clinical Trials 52

Clinical Trials Clinical Trials Trials HR 52

The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?

HR 52

HR Antibody FDA Approval Licensing 52

Drug Discovery World

APRIL 11, 2024

On the final day of AACR, the plenary session of the Annual Meeting put artificial intelligence at the forefront and featured a stellar lineup of AI and data science experts who discussed AI and topics such as imaging, precision medicine, and drug development.

HR 52

HR Antibody In-Vitro DNA 52

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

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) Regular approval by the U.S. months [95% CI 9.6-14.3]

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

APRIL 23, 2021

Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). Venclyxto blocks the BCL-2 protein and works to help restore the process of apoptosis. The median OS was 14.7 months (95% CI: 11.9,

Medicine 40

Medicine In-Vitro Antibody Branding 40

Drug Discovery World

FEBRUARY 21, 2023

The FDA has granted expanded approval for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) for patients with HR-positive/HER2-negative metastatic breast cancer who have received hormonal therapy and at least two additional therapies in the metastatic setting. GlobalData’s forecasts project sales to reach 2.8

HR 52

HR Hormones Sales Antibody 52

Drug Discovery World

APRIL 18, 2023

Impairments in homologous recombination (HR), a type of DNA repair, can sensitise cells to drugs called PARP inhibitors. Need to apply drugs more creatively Gatz explained that paediatric cancers are often driven by complex mechanisms, making it difficult to identify an effective treatment regimen.

DNA 52

DNA Genome Genomics HR 52

The Pharma Data

JUNE 18, 2021

months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]); with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. Drug Interactions. 0.45]); results are descriptive.

Medicine 40

Medicine HR Trials Production 40

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).

Research 112

Research Vaccination Vaccine Drugs 112

Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

Drugs 110

Drugs Licensing Licensing Production 110

XTalks

DECEMBER 4, 2020

Imaging techniques such as ultrasound and computerized tomography (CT) are used to visualize structural changes or abnormalities resulting from kidney damage or congenital causes, while urinalysis can be used to detect blood or protein in the urine — another indication of kidney damage. Developed in 1999 2. Expressed in mL/min/1.73m 2.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 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). Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The results passed the futility analysis (p<0.3

Antibody 52

Antibody Trials Production Clinical Trials 52

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

NOVEMBER 23, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

The Pharma Data

APRIL 7, 2021

Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. months (HR: 0.51; 95% CI: 0.41-0.62;

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

APRIL 26, 2022

The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for their regulatory decision, is during the fourth quarter of 2022 following the use of a priority review voucher. Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020.

Immune Response 52

Immune Response Trials Protein Antibody 52

The Pharma Data

FEBRUARY 8, 2021

months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). DRUG INTERACTIONS. 0.83]; p<0.0001).

HR 52

HR In-Vitro Development Clinical Trials 52

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).

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). receptors. .

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

NOVEMBER 24, 2020

Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. 0.514 mmol/24 hr/1.73 0.771 mmol/24 hr/1.73 CAMBRIDGE, Mass.–(BUSINESS

FDA Approval 52

FDA Approval Production RNA Medicine 52

The Pharma Data

APRIL 14, 2021

The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Premedicate with a two or three drug combination regimen (e.g., DRUG INTERACTIONS. FOSTER CITY, Calif.–(BUSINESS About Trodelvy.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52