Pharmaceutical Technology

APRIL 14, 2023

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

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Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company offers consumer, prescription and automation products. Its investigational medicinal products comprise R-107, R-131 and R-147.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products. The company offers consumer, prescription and automation products. Its investigational medicinal products comprise R-107, R-131 and R-147.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

XTalks

AUGUST 15, 2023

Preservatives and additives serve as routine ingredients for manufacturers, extending the shelf-life of food products. Unfortunately, these dyes are often in food products intended for infants and young children, but no precautionary labeling is mandated domestically. That’s because American pork contains growth hormones.

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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.

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Drug Discovery World

NOVEMBER 22, 2023

The European Commission (EC) has granted marketing authorisation for YORVIPATH (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. YORVIPATH is Ascendis Pharma’s prodrug of parathyroid hormone (PTH 1-34), administered once daily.

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XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. Read on to learn about the top five foods banned in Europe, and why.

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FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

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FDA Law Blog

JUNE 28, 2023

In September 1998, CVM published Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods With Drug Claims , which provides guidance on how CVM regulates substances for animals. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

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XTalks

OCTOBER 5, 2023

This is because the US has more lenient food ingredient regulations thanks to US Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) designation. The brand has consistently shown that products free from GMOs, herbicides, preservatives and toxic chemicals can also prioritize taste.

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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. Growing evidence continues to show fundamental links between the nervous system and the gut microbiome.

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Hormones Regulation Research Production 98

Roots Analysis

OCTOBER 24, 2023

HPAPIs, due to their selective mode of action, are effective in much smaller quantities than other therapeutic products. This has led to their widespread production and extensive use in the treatment of various indications including hormonal imbalances, oncological disorders and respiratory disorders.

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pharmaphorum

MARCH 29, 2021

The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences. The recommendation was based on interim study data that showed regdanvimab may reduce the rate of hospitalization among patients receiving the treatment.

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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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pharmaphorum

JUNE 16, 2022

A personalised, treatment plan for patients with breast cancer is the first digital health product to emerge from a newly-announced partnership between digital health specialist Sidekick and pharma group Eli Lilly.

Hormones 103

Hormones Pharma Companies Regulation Drugs 103

The Pharma Data

NOVEMBER 21, 2021

People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. 1][2] Some people with achondroplasia may have delayed motor development early on, but cognition is normal.[3] Inheritance is autosomal dominant.[1][2]

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XTalks

MARCH 13, 2024

Hormone-based therapeutics aim to delay glaucoma progression by enhancing estrogen’s potential protective effects. Secondly, other funded research is exploring differential gene expression regulated by DNA methylation.

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XTalks

OCTOBER 11, 2023

Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes. They mimic the action of GLP-1, a hormone that helps regulate blood sugar levels by enhancing insulin secretion.

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Drugs Insulin Hormones FDA Approval 59

pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

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Dermatology Drugs Hormones FDA Approval 52

Delveinsight

AUGUST 31, 2021

FDA’s Green Flag to Ascendis’s Once-Weekly SKYTROFA for Treatment of Pediatric Growth Hormone Deficiency. Growth Hormone Deficiency , commonly known as dwarfism, can constitute short stature and complications with metabolism, which arise due to inadequate production of growth hormones by the pituitary gland inside the body.

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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.

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XTalks

NOVEMBER 6, 2023

High doses correlated with an increase in serum bromide levels, thyroid follicular cell hypertrophy, an uptick in thyroid-stimulating hormone (TSH) and a reduction in thyroxine (T4), especially in male rats.

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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?) Product Information. 19, 2:10 PM CEST]. Prostate Cancer. 177 Lu-PSMA-617. 16, 08:30 AM CEST.

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The Pharma Data

MAY 15, 2021

Product Name: The Longevity Breakthrough Your Doctor Won't Tell You About. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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XTalks

NOVEMBER 9, 2023

Zepbound contains mimetics of the GLP-1 and GIP hormones that regulate appetite and blood sugar. The companies continue to roll out manufacturing expansion plans to help ramp up production. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

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Pfizer

AUGUST 15, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. Herbal Products: St. AUTHORIZED USE.

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The Pharma Data

MAY 16, 2021

Product Name: Audio Crystal Therapy One Time Offer. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. So How Does These Products Work ?

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XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults.

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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., Melatonin controls the sleep-wake cycle (24-hour cycle). 1,640 Reviews.

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Pfizer

JANUARY 27, 2023

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. AUTHORIZED USE The U.S.

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The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

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XTalks

MARCH 25, 2024

The drugs, which include Novo Nordisk’s semaglutide products Ozempic and Weogvy as well as Victoza (liraglutide), and Eli Lilly’s tirzepatide formulation for type 2 diabetes Mounjaro and obesity version Zepbound, have sparked both enthusiasm and debate within the medical community and the public.

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The Pharma Data

OCTOBER 14, 2020

The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy. WAKIX may reduce the effectiveness of hormonal contraceptives. Use in Specific Populations.

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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. Saxenda ® (liraglutide 3.0

Medicine 52

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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.

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Roots Analysis

AUGUST 31, 2023

Type of Gene Regulation Based on the type of transcription factor ( activators / repressors ), gene regulation has been categorized into positive and negative gene regulation. Negative Gene Regulation: Repressor is a protein molecule that initiates negative regulation.

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