The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 40

FDA Approval Hormones Production Drugs 40

The Pharma Data

AUGUST 17, 2021

Lyumjev ® and Humalog ® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin. Your doctor is the best person to help you decide if these medicines are right for you.

Insulin 52

Insulin FDA Approval Doctor Doctors 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. Cachexia is a complex metabolic syndrome, which is characterized by the loss of fat and muscles in the body.

Marketing 94

Marketing Pharma Companies Development Hormones 94

XTalks

AUGUST 15, 2023

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval 52

FDA Approval Gene Hormones Drugs 52

XTalks

SEPTEMBER 13, 2024

This month, CVS launched a birth control prescribing service at its pharmacy locations in Massachusetts, allowing pharmacists to evaluate patients and prescribe hormonal contraceptives, addressing gaps in reproductive health access. CVS Health (CVS) Market Capitalization : $95.74 McKesson (MCK) Market Capitalization : $89.78

Marketing 98

Marketing Pharmacy Gene Therapy Hormones 98

XTalks

SEPTEMBER 12, 2024

Xtandi for Non-Metastatic Prostate Cancer In late 2023, Pfizer and Astellas’ Xtandi (enzalutamide) received the US Food and Drug Administration (FDA) approval for use in non-metastatic castration-sensitive prostate cancer (nmCSPC) patients. Prostate Cancer Awareness Month is a time to act.

Research 52

Research Clinical Trials Clinical Trials Hormones 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

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.

Research 112

Research Vaccine Vaccination Drugs 112

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. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. Both surrogate endpoints could be used to support traditional approval of a new drug or biologic.

Trials 98

Trials Gene Hormones Clinical Trials 98

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. However, the use of hormone replacement therapy comes with its set of challenges.

Hormones 244

Hormones FDA Approval Licensing Licensing 244

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.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.

Hormones 98

Hormones Drugs FDA Approval Sales 98

XTalks

NOVEMBER 2, 2020

This includes compromising the functioning of the adrenal glands, which can potentially lead to adrenal insufficiency, resulting in inadequate production of steroid hormones. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., PONENTE Trial.

Trials 94

Trials FDA Approval Drugs Hormones 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

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. It can be due to a damaged pituitary gland or another gland called the hypothalamus.

Hormones 52

Hormones FDA Approval Drugs Trials 52

pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

Drugs 98

Drugs Hormones FDA Approval Clinical Trials 98

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.

Vaccine 40

Vaccine Vaccination Production Sales 40

XTalks

NOVEMBER 26, 2024

Keytruda (Pembrolizumab) Keytruda 2023 sales: $25.011 billion Company/developer: Merck Date of first US Food and Drug Administration (FDA) approval: September 4, 2014 Indications Keytruda is FDA-approved for: Unresectable or metastatic melanoma. Genmab earns royalties from Janssen Biotech, Inc.

Sales 105

Sales FDA Approval Drugs Marketing 105

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. While hormone therapies are allowed in the US, the age limit for this is dependent on the geographical area.

Drugs 360

Drugs Hormones Trials FDA Approval 360