Delveinsight

DECEMBER 7, 2020

Development in the technology has made it possible for solutions to surface, primarily related to R&D, clinical trials, and diagnostics and treatment, as well as patient management, leading to even more significant innovative potential and promise for AI in the industry.

Protein 56

Protein Insulin Hormones FDA Approval 56

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

MARCH 15, 2023

FDA-approved ADHD-specific non-stimulants are a relatively newer class of medication designed to treat ADHD that have much fewer side effects than stimulants. Strattera’s active ingredient is the SNRI atomoxetine hydrochloride while Qelbree contains viloxazine hydrochloride, a serotonin-norepinephrine modulating agent (also a SNRI).

Drugs 98

Drugs Sales Trials Marketing 98

XTalks

NOVEMBER 9, 2022

Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. Lilly is also working towards an obesity treatment form of tirzepatide, with trials currently underway to evaluate its weight loss effects. The obesity drug market is currently valued at $2.82 billion in 2021 to $61.6

Insulin 98

Insulin Hormones FDA Approval Sales 98

XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

FEBRUARY 8, 2021

Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials.

HR 52

HR Hormones Development Production 52

Pharmaceutical Technology

MARCH 2, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

FDA Approval 100

FDA Approval Containment Development Genome 100

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. 1 TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.

Medicine 40

Medicine In-Vitro Antibody Development 40

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. in these patients.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

Pfizer

JANUARY 27, 2023

In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JULY 23, 2021

Opdivo was first granted this indication in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Trials 52

Trials Hormones Genome Genomics 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. chief medical officer and head of Global Product Development. “We

Immune Response 52

Immune Response Medicine Protein Gene 52

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] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. All rights reserved.

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

APRIL 7, 2021

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study. About the ASCENT Study.

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

Additionally, there are other ongoing company-sponsored and investigator-initiated trials exploring the potential of ibrutinib and venetoclax in combination for CLL treatment, including the Phase 3 GLOW study. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. For more information, visit www.IMBRUVICA.com .

Medicine 40

Medicine Production FDA Approval Trials 40

The Pharma Data

JUNE 18, 2021

The GLOW study is a randomized, open label Phase 3 trial comparing progression-free survival in patients treated with either I+V or C+O as assessed by an Independent Review Committee. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Venetoclax is approved in more than 80 countries, including the U.S.

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

SEPTEMBER 10, 2021

The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. For endometriosis-associated pain, per current guidelines, initial treatment options include hormonal contraceptives and over-the-counter pain medications. In the U.S., An estimated six million women in the U.S.

Hormones 52

Hormones FDA Approval Drugs Development 52

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Results from the study are expected to be available in the second half of 2021.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

MAY 11, 2023

This joint committee decision came from Nonprescription Drugs, and the Obstetrics, Reproductive and Urologic Drugs FDA divisions was based on meetings conducted on 9 – 10 May, was based on data presented from the Phase III ACCESS trial (NCT04112095) that assessed adherence to a dosing regimen for Opill, an oral contraceptive.

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FDA Approval Hormones Drugs Containment 130