XTalks

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations. In April 2016, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

Delveinsight

JANUARY 5, 2021

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. The drug has already received orphan drug designation in South Korea in October 2020.

Hormones 52

Hormones FDA Approval Trials Drugs 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. Drug Enforcement Administration. Drug Enforcement Administration. WAKIX is administered orally, once daily in the morning upon wakening.

FDA Approval 52

FDA Approval Hormones Production 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. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [vii]

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Phase II randomised, double-blind, placebo-controlled study demonstrated that the drug as well-tolerated and a higher dose even helped in gaining weight.

Marketing 94

Marketing Pharma Companies Development Hormones 94

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval.

Trials 98

Trials Gene Hormones Clinical Trials 98

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

HR 162

HR Marketing Hormones FDA Approval 162

Pfizer

JANUARY 27, 2023

COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. AUTHORIZED USE The U.S.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev ® and Humalog ® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Insulin 52

Insulin FDA Approval Doctors Doctor 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. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

NOVEMBER 2, 2020

Fasenra was approved in 2017 as an add-on treatment for patients aged 12 years and older with severe asthma (specifically, severe eosinophilic asthma) in the US, EU, Japan and other countries to reduce events of worsening symptoms. Related: Dexamethasone Becomes First Drug Shown to Reduce COVID-19-Related Mortality.

Trials 94

Trials FDA Approval Hormones Drugs 94

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tarlatamab (AMG 757). Tezepelumab.

Sales 52

Sales Production Antibody 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). If approved, TicoVac would be the first vaccine in the U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

MARCH 16, 2023

Many politicians have cited doubts about the potential “harm” caused by puberty blockers and hormone therapies associated with gender-affirming care and concerns about incorrect treatment as major factors. This has pushed clinicians to explore different routes to prove the validity of these drugs.

Drugs 360

Drugs Hormones Trials FDA Approval 360