Scienmag

SEPTEMBER 29, 2020

20-year research breakthrough offers new hope for high risk patients with HR+ breast cancer A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25%, according to a study led by The Royal Marsden NHS […].

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The Pharma Data

APRIL 27, 2022

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.

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pharmaphorum

SEPTEMBER 23, 2022

The cost-effectiveness agency has said that Ibrance (palbociclib) plus fulvestrant can be used routinely on the NHS as a second-line therapy for patients with advanced hormone receptor-positive, HER2-negative breast cancer who have already been treated with hormonal drugs. months in the trial, median overall survival was 6.8

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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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Drug Discovery World

JANUARY 9, 2024

Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year’s Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes.” The 2024 Drugs to Watch, are: 1.

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The Pharma Data

AUGUST 30, 2021

New Kisqali ® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2? Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. 19, 2:10 PM CEST].

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The Pharma Data

SEPTEMBER 16, 2020

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. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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The Pharma Data

SEPTEMBER 6, 2021

Over 70% of breast cancer cases are hormone receptor (HR)-positive, and there is a need for more effective and tolerable treatments, since up to 30% of patients develop resistance to standard of care treatments and in the adjuvant setting half of patients stop treatment due to the toll of side effects. Abstract title. Breast cancer.

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The Pharma Data

DECEMBER 2, 2020

Abemaciclib is a cyclin dependent kinase (CDK) 4 & 6 inhibitor used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. . PLYMOUTH MEETING, Pa. ,

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The Pharma Data

MARCH 7, 2022

(Nasdaq: GILD) today announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Its safety and efficacy have not been established for this indication.

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XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.

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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). About Metastatic Castration-Sensitive Prostate Cancer.

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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

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Pfizer

JANUARY 27, 2023

Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. No dosage adjustment is needed in patients with mild renal impairment.

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The Pharma Data

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; Data Supporting the Approval.

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Pfizer

AUGUST 15, 2022

Contraception : Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1

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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. And thanks to the city of San Diego for its hospitality.”

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XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

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XTalks

AUGUST 10, 2022

Approximately 80 to 85 percent of these cases were previously considered to be the HER2-negative subtype (which includes hormone receptor positive and triple negative breast cancer), which means the tumors do not make higher than normal amounts of the HER2 protein. Enhertu Trial Data. Of the trial participants, females made up 99.6

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The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints.

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XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

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Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. In the U.S.,

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Pfizer

DECEMBER 13, 2022

Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. No dosage adjustment is needed in patients with mild renal impairment.

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Pfizer

NOVEMBER 23, 2022

Expanding Access to Patent-Protected Medicines in Lower-Income Countries : Launched An Accord for a Healthier World , a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S.

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Pfizer

JANUARY 27, 2023

Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. No dosage adjustment is needed in patients with mild renal impairment.

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The Pharma Data

MARCH 3, 2021

LORBRENA has been a transformative medicine for people with ALK-positive advanced NSCLC, and this FDA approval in the first-line setting means that we can now extend hope to even more people.”. Detailed results from the CROWN study were published in the November 2020 issue of the New England Journal of Medicine. About the CROWN Trial.

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The Pharma Data

APRIL 7, 2021

months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months (HR: 0.51; 95% CI: 0.41-0.62; The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. Medicines targeting these receptors therefore are not typically effective in treating TNBC. months from 1.7

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The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. This marks the 37th BTD for Genentech’s portfolio of medicines. months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61).

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The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001).

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Pharmaceutical Technology

MARCH 2, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It was also under development for the treatment of nasopharyngeal cancer and homologous-recombination deficient (HRD) metastatic hormone refractory prostate cancer.

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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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The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

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The Pharma Data

APRIL 14, 2021

Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial. Tagawa, MD, MS, FACP, Professor of Medicine and Urology at Weill Cornell Medicine, an oncologist at New York-Presbyterian/Weill Cornell Medical Center and principal investigator of the TROPHY study. About Trodelvy.

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The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA ® was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

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The Pharma Data

MAY 4, 2021

Internal Medicine. In March 2021, Pfizer announced the publication of complete results from the JADE COMPARE study of its investigational oral, once-daily, Janus kinase 1 (JAK1) inhibitor in The New England Journal of Medicine (NEJM). REVENUES. . . . . . ($ in millions). First-Quarter. . 1,611. . *. *. Rare Disease.

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