STAT News

DECEMBER 5, 2022

Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK, Roche, and others to remake plans for their drugs or pull them from the market , The Wall Street Journal notes.  Pluvicto is already cleared in the U.S.

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Insulin Manufacturing Medicine Drugs 52

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study.

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FDA Approval Antibody DNA Hormones 52

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.

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Protein Insulin Hormones FDA Approval 56

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. dependent insulin secretion and suppression of glucagon release. billion by 2030.

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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

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

The Pharma Data

APRIL 4, 2023

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S. confirmatory trial for the accelerated approval.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

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.

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Trials Hormones Genome Genomics 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.

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Hormones Trials Genome Genomics 52

The Pharma Data

JUNE 28, 2021

Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. SURPASS-2 was a 40-week, randomized, open-label trial comparing the efficacy and safety of tirzepatide to semaglutide as an add-on to metformin in adults with type 2 diabetes.

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Insulin Clinical Trials Clinical Trials Hormones 52

XTalks

MAY 20, 2022

Related: Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial. Like Mounjaro, Novo Nordisk’s Ozempic is also a GLP-1 receptor agonist and in a head-to-head trial last year, Lilly’s drug trumped Novo’s. percent more than placebo when used in combination with a long-acting insulin.

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Insulin Life Science Drugs Sales 52