XTalks

MARCH 19, 2025

Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism. AstraZeneca received eneboparatide during its $1.05 Without proper PTH function, patients may face kidney and bone complications.

Trials 59

Trials Hormones Engineer Licensing 59

Pharmaceutical Technology

APRIL 14, 2023

The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label. Mirikizumab also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

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Manufacturing Drugs Hormones Packaging 130

Scienmag

JANUARY 19, 2022

Seeking to better understand the key role the female hormone estrogen plays in maintaining energy balance and weight control, a group led by researchers at Baylor College of Medicine looked into estrogen interactions with specific brain regions that provide these anti-obesity benefits.

Regulation 64

Regulation Research Hormones Medicine 64

Pharmaceutical Technology

OCTOBER 13, 2022

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). The hormone is produced endogenously in the body by the pineal gland.

Drugs 147

Drugs Hormones Sales Medicine 147

Worldwide Clinical Trials

JULY 8, 2024

In nuclear medicine, radiopharmaceuticals play a pivotal role in two primary applications: Diagnostic Imaging Radiopharmaceuticals are administered to patients, where they accumulate in specific organs or tissues of interest.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. T3 is a major hormone in the blood that regulates thyroid levels.

Drugs 317

Drugs Gene Hormones Clinical Trials 317

XTalks

JANUARY 9, 2024

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues.

Hormones 105

Hormones Antibody Trials Production 105

Scienmag

MARCH 29, 2021

No FDA regulations in place to alert patients when medication is derived from animals More physicians and pharmacists are advocating for patients to be made aware of animal byproducts contained in common medications, according to new research in the Journal of Osteopathic Medicine.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Its investigational medicinal products comprise R-107, R-131 and R-147. Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others.

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Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Its investigational medicinal products comprise R-107, R-131 and R-147. Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

XTalks

NOVEMBER 15, 2021

Now, new research shows that the brain hormone serotonin may cause gut inflammation that could trigger flare-ups in Crohn’s disease. Waliul Khan, senior author on the study and professor of pathology and molecular medicine at McMaster University, said in an interview with Medical News Today.

Hormones 98

Hormones Regulation Research Production 98

Scienmag

JANUARY 26, 2021

Hormone treatment can help reduce cysts in fruit fly renal tubules, according to Cassandra Millet-Boureima and Chiara Gamberi Credit: Concordia University A hormone commonly associated with sleep-wake regulation has been found to reduce cysts in fruit flies, according to Concordia researchers.

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Hormones Research Regulation Medicine 52

XTalks

JULY 19, 2024

These advertisements, often found on social media platforms, search engines and various websites, frequently violate advertising guidelines and regulations. LegitScript noted that 83 percent of problematic ads for GLP-1 medications are being promoted in jurisdictions where advertisements for prescription medicines are prohibited.

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Pharmacy Drugs Production Sales 104

The Pharma Data

OCTOBER 21, 2020

21, 2020 — Low levels of thyroid hormone during pregnancy may contribute to the development of attention deficit hyperactivity disorder in the child, new research suggests. Thyroid hormones play an important role in the growth and development of the fetal brain, especially during the first trimester of pregnancy, the researchers said.

Hormones 52

Hormones Gene Research Medicine 52

Druggist

FEBRUARY 28, 2021

Melatonin is a hormone that is released at night by the pineal gland located in the brain. In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., Is melatonin effective sleep aid medicine? How to get melatonin in the UK?

Pharmacy 98

Pharmacy Licensing Licensing Medicine 98

pharmaphorum

JUNE 16, 2022

It is tailored to patients being treated with Lilly’s oncology drugs – which include blockbuster CDK 4/ 6 inhibitor Verzenio (abemaciclib) for hormone receptor-positive, HER2-negative breast cancer – and is expected to make its debut in Germany in July.

Hormones 103

Hormones Pharma Companies Regulation Drugs 103

pharmaphorum

JULY 29, 2021

Advanz hiked the price of a pack of liothyronine tablets – used to treat thyroid hormone deficiency – from £20 in 2009 to £248 in 2017, taking advantage of a lack of competition for the drug even though it was out of patent. The regulator said that in addition to the fines, the NHS may choose to pursue the companies for damages in the courts.

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Drugs Marketing Generic Drugs Hormones 98

Scienmag

NOVEMBER 18, 2020

A new Children’s Hospital Los Angeles study shows that machine learning could aid clinicians with a rare hormone disorder. Congenital adrenal hyperplasia (CAH) is a disorder that affects the adrenal gland’s ability to release hormones that regulate the body’s response to stress and illness.

Hormones 40

Hormones Regulation Medicine 40

pharmaphorum

JUNE 8, 2022

The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport ‘, a designation designed to speed up NHS access to promising new medicines. The study is enrolling adults whose blood pressure is not adequately controlled by standard medicines.

Gene Silencing 52

Gene Silencing Drugs Medicine Regulation 52

FDA Law Blog

AUGUST 4, 2023

Other anabolic steroids are approved only for use in veterinary medicine. A drug or hormonal substance, other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone not listed in 21 C.F.R. It amends and merely updates DEA regulations for consistency with DASCA’s amendments to the CSA.

Hormones 52

Hormones Drugs Manufacturing Regulation 52

pharmaphorum

AUGUST 16, 2022

On the same day as it reported encouraging new data for its cancer drug Trodelvy, Gilead Sciences has agreed a deal to buy rights to the drug in Asia held by Chinese drugmaker Everest Medicines. Everest has meanwhile also filed for approval of the drug in the same indication with regulators in South Korea, Taiwan and Hong Kong.

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Licensing Licensing Hormones Drugs 52

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5

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Trials Drugs FDA Approval Clinical Trials 98

The Pharma Data

NOVEMBER 11, 2021

Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Wegovy for chronic weight management in adults with obesity. mg is an analogue of the human glucagon-like peptide-1 (GLP-1) hormone.

Medicine 52

Medicine Hormones Production Trials 52

pharmaphorum

SEPTEMBER 3, 2021

When I began being interested in medicine, I met a lot of closed doors with scepticism, from not just the medical professional, but from the musical profession too. One of the reasons is that, in the late part of the 20th century, coming into our current century, science caught up with music in terms of the body and medicine.

Medicine 64

Medicine Development Regulation Hormones 64

The Pharma Data

MARCH 27, 2021

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda ® is expanded for the treatment of obesity in adolescents aged 12–17 years. About the phase 3 trial (NCT02918279). Saxenda ® (liraglutide 3.0

Medicine 52

Medicine Trials Hormones Clinical Trials 52

XTalks

JUNE 27, 2022

The BRAF gene regulates cell growth, proliferation and apoptosis. Both Tafinlar and Mekinist target the RAS/RAF/MEK/ERK pathway , which regulates cell growth and survival; however, each affects different kinases. These types of treatments represent the goal of precision medicine , where therapies are tailored to specific patient types.

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Clinical Trials Clinical Trials Trials Gene 52

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Manufacturing Hormones Contamination Containment 40

XTalks

MARCH 25, 2024

They work by mimicking the action of the naturally occurring hormone GLP-1, which is involved in regulating blood sugar and appetite. Medicines have side effects, but the important part is that they’re mild to moderate in the research studies,” said Velazquez. Oprah asked why coverage of weight loss drugs is still limited.

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Drugs Medicine Life Science Production 105

The Pharma Data

AUGUST 30, 2021

Key abstracts accepted by ESMO include: Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2?) 19, 2:10 PM CEST]. Abstract Title. Abstract Number. Prostate Cancer. 177 Lu-PSMA-617. 16, 08:30 AM CEST.

HR 52

HR Production Trials Containment 52

The Pharma Data

JANUARY 27, 2021

These include in-vitro assays, cell-based phenotypic assays, safety pharmacology and efficacy, ADME toxicology, medicinal chemistry design, synthetic chemistry, and custom proteins and assay development capabilities. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect.

In-Vitro 52

In-Vitro Containment Drugs Production 52

pharmaphorum

APRIL 28, 2022

Additionally, regulators recognise the inherent difficulties of finding sufficient populations to study rare diseases, so requirements for clinical rigour can actually be lighter, which can also lead to savings. But they also don’t have to invest in mass market advertising.

Pharma Companies 59

Pharma Companies Branding Development Marketing 59

The Pharma Data

APRIL 11, 2023

The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program.

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Research Clinical Trials Clinical Trials Trials 40

The Pharma Data

DECEMBER 14, 2020

adults, and researchers now report that the drinks also hinder hormones that quell hunger and regulate appetite. She’s an associate professor of medicine specializing in diabetes and childhood obesity at the University of Southern California’s Keck School of Medicine. The study was published Dec.

Hormones 52

Hormones Containment Insulin Regulation 52

pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

Antibody 78

Antibody Hormones Medicine Licensing 78

XTalks

MARCH 1, 2021

And while conventional dry eye can have a number of causes — including blepharitis, hormone-related changes in post-menopausal women and contact lens use — mask-associated dry eye is largely cropping up in people who wear face masks for extended periods during the day.

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Sales Drugs Life Science Containment 119

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.

HR 98

HR FDA Approval Gene Trials 98

pharmaphorum

AUGUST 8, 2022

The US regulator has approved Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), adding to its earlier indication in non-metastatic castration-resistant prostate cancer (nmCRPC). billion) blockbuster.

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Sales Hormones Marketing FDA Approval 59