XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. Acromegaly. Prevalence: 50 to 70 people per 1 million.

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Trials Gene Hormones Clinical Trials 98

XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDA approved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.

Insulin 98

Insulin Hormones FDA Approval Sales 98

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

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. It was also given FDA priority review. billion to $1.28

HR 98

HR FDA Approval Gene Trials 98

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

Drug Discovery World

MAY 9, 2024

RA: Tell us how OXE103 works? MW: OXE103 (ghrelin) is a 28 amino acid neuro-peptide hormone that crosses the blood brain barrier and is responsible for maintaining brain energy homeostasis and neuroprotection related to neuronal cell preservation, axonal connectivity and decreased inflammation.

Development 72

Development Hormones Drugs Trials 72

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Sales Manufacturing FDA Approval Life Science 98

Drug Discovery World

AUGUST 21, 2023

However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited. The regulator had already approved the combination treatment in advanced cancers the previous year.

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Protein Trials Clinical Trials Clinical Trials 52

Intouch Solutions

AUGUST 5, 2021

This then leads many of those same people to online forums like the TransDIY subreddit that’s dedicated to do-it-yourself hormone replacement therapy, or DIY HRT. DIY HRT is a combination of non-prescribed, often unregulated, hormone medicines and self-performed surgeries that are administered without the supervision of an HCP.

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Marketing Doctors Doctor Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. v] ERLEADA ® is being studied in five Phase 3 clinical trials. The safety profile was consistent with prior studies of ERLEADA ® , with no new safety signals observed.

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

JUNE 18, 2021

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. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

Medicine 40

Medicine Production FDA Approval Trials 40

The Pharma Data

JUNE 18, 2021

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. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

Drugs 317

Drugs Gene Hormones Clinical Trials 317

XTalks

MAY 20, 2022

Eli Lilly’s diabetes and weight loss shot tirzepatide, known by its trade name Mounjaro, received a much-anticipated nod from the US Food and Drug Administration (FDA) last week for the treatment of diabetes. The injection is intended to regulate blood sugar, in conjunction with diet and exercise, in adults with type 2 diabetes.

Insulin 52

Insulin Life Science Drugs Sales 52