Drug Discovery World

NOVEMBER 16, 2022

Cyclica has received a grant from the Bill & Melinda Gates Foundation to apply its AI-enabled drug discovery platform to new therapeutic options for multiple low-data biological targets. . The end goal is to expand the range of accessible non-hormonal contraceptive choices for women in developing countries. . The post CAD$2.4M

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Fierce Pharma

JUNE 28, 2023

With a blessing Wednesday for once-weekly growth hormone deficiency (GHD) drug Ngenla, the New York pharma giant has racked up four approvals from the agency over the last five weeks. Pfizer is on an FDA heater. Pfizer is on an FDA heater.

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Outsourcing Pharma

APRIL 24, 2024

revealed that XTANDITM (enzalutamide) has received a label extension from the European Commission, marking it as the inaugural and only novel hormone therapy endorsed for high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer (nmHSPC) treatment in the European Union (EU).

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STAT News

AUGUST 8, 2022

A drug that has been used to slow progression of kidney and cardiovascular disease in people with type 2 diabetes may also help people with chronic kidney disease who do not have diabetes, according to findings published Monday in the European Heart Journal.

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Fierce Pharma

NOVEMBER 15, 2022

Lumos' oral growth hormone drug falls short of Novo's injectable incumbent at interim analysis. Tue, 11/15/2022 - 08:42.

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Scienmag

APRIL 26, 2021

Credit: VCU Massey Cancer Center The hormone prolactin has long been understood to play a vital role in breast growth and development and the production of milk during pregnancy.

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Bio Pharma Dive

MARCH 6, 2023

A yearslong regulatory battle over the hormonal shot Makena is approaching its end, with consequences for both preterm birth prevention and the agency’s authority to withdraw drugs shown to be ineffective in follow-up testing.

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BioSpace

OCTOBER 7, 2020

Pfizer and Opko Health reported their Phase III clinical trial of somatrogan met the primary endpoint compared to Genotropin (somatropin) for treating children 3 to 18 years of age with growth hormone deficiency.

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Scienmag

APRIL 6, 2021

Research provides insight into mechanistic factors that alter hepatic drug disposition during pregnancy Credit: BioIVT BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it will be hosting a webinar on April 8 at 11 a.m.

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BioTech 365

FEBRUARY 22, 2021

Global Hormonal Replacement Therapy (HRT) Drugs Market Report 2020-2030 – ResearchAndMarkets.com Global Hormonal Replacement Therapy (HRT) Drugs Market Report 2020-2030 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Drugs For Hormonal Replacement Therapy Global Market Report 2020-30: COVID-19 Impact and Recovery” (..)

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pharmaphorum

MARCH 19, 2024

New phase 3 data sets up filings for Bayer's non-hormonal menopause symptom treatment elinzanetant and a challenge to Astellas’ first-to-market Veozah

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Pharmaceutical Technology

JULY 8, 2022

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. Nerlynx is the first drug in Specialised Therapeutics’ therapeutic portfolio to obtain approval in the region.

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The Pharma Data

DECEMBER 21, 2020

Food and Drug Administration (FDA) has now approved the very first oral drug to treat the millions of men affected. . Because prostate cancer is fueled by testosterone production, both drugs decrease levels of the hormone in the body. . However, Myovant’s drug dropped the percentage of major cardiovascular events to 2.9%

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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.

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Hormones FDA Approval Licensing Licensing 244

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy. On July 13, 2023, the U.S.

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The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. The approval of NGENLA will be significant for children with growth hormone deficiency in the U.S. NYSE: PFE) and OPKO Health Inc. prescribing in August 2023.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

The 'life-extending' drug combination is recommended for usage in adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received hormone therapy.

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Drug Discovery World

FEBRUARY 12, 2024

million grant to engineer microbial cell factories to produce membrane proteins which will support future drug screening and sustainable chemical production. Membrane proteins are crucial molecules on the surface of cells with numerous biological functions, such as sensing hormones or cell communication.

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The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Food and Drug Administration announced Friday. MONDAY, Dec.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. This opinion is intended for use of the drug as a first-in-class treatment for adults with moderately to severely active UC.

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XTalks

JANUARY 23, 2024

Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development.

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BioTech 365

APRIL 26, 2021

United States Generic Drugs Market Report 2020-2026: Focus on CNS, Cardiovascular, Dermatology, Genitourinary/Hormonal, Respiratory, Anti-infective & Oncology – ResearchAndMarkets.com United States Generic Drugs Market Report 2020-2026: Focus on CNS, Cardiovascular, Dermatology, Genitourinary/Hormonal, Respiratory, Anti-infective & (..)

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The Pharma Data

APRIL 28, 2023

FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya ® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5 cm/year vs. 11.7

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The Pharma Data

NOVEMBER 20, 2020

20, 2020 — Hormone therapy can be a lifesaver for men with prostate cancer , but it also appears to put some at increased risk of heart problems, a new study reports. Prostate cancer is fueled by male hormones, which are called androgens. But questions have arisen about the effects of long-term hormone therapy on heart health.

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Hormones Insulin Research Doctors 52

Fierce Pharma

SEPTEMBER 6, 2023

Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues.

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Pharmaceutical Technology

OCTOBER 13, 2022

In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. The hormone is produced endogenously in the body by the pineal gland. For Colonis’s melatonin drug, it is recommended that children take 1-2mg before bed.

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Drugs Hormones Sales Medicine 147

STAT News

MARCH 21, 2023

A new obesity treatment being developed by Altimmune met goals for weight loss in a mid-stage clinical trial, but the data showed it doesn’t have a leg up on other popular drugs on the market. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

FEBRUARY 9, 2023

According to GlobalData, Phase I drugs for Turner Syndrome have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Ibutamoren mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Drug Discovery World

NOVEMBER 7, 2023

The hormone treatment was already authorised for use in the treatment of breast cancer in post-menopausal women and has been used off-label for prevention. Anastrozole is an aromatase inhibitor, which works by cutting down the amount of the hormone oestrogen that a patient’s body makes by blocking an enzyme called ‘aromatase’.

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Hormones Drugs Development Trials 52

pharmaphorum

MARCH 4, 2024

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan in breast and lung cancer.

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Drug Discovery World

FEBRUARY 20, 2024

One example is that the model can circumvent the difficulties in demonstrating in vivo drug efficacy which arise because of mouse specific metabolism issues. Gates Foundation grant to accelerate global drug discovery appeared first on Drug Discovery World (DDW). A key stage of compound progression. The post $2.3m

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pharmaphorum

MAY 20, 2021

NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. Hormone relapsed disease has stopped responding to hormone therapy and is usually treated with ADT alone or with Bayer’s Nubeqa (darolutamide) and ADT.

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Hormones Drugs Trials Manufacturing 98

Pharmaceutical Technology

FEBRUARY 24, 2023

According to GlobalData, Phase III drugs for Type 2 Diabetes have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how (LAI-287 + semaglutide)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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BioTech 365

JUNE 11, 2021

Food and Drug Administration Review Period for TransCon™ hGH (Lonapegsomatropin) for Pediatric Growth Hormone Deficiency Ascendis Pharma A/S Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ hGH (Lonapegsomatropin) for … Continue reading →

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Drug Discovery World

MARCH 27, 2024

To reduce their risk of relapse, patients undergo five to ten years of hormone therapy to target any remaining cancer cells. I hope our early findings will next lead to research to target these dormant breast cancer cells so that one day, without the need for years of hormone therapy, patients can be sure that their cancer will not return.”

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Drug Discovery World

DECEMBER 9, 2022

The drug capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most common type of breast cancer. . Capivasertib is a potential first-in-class drug that blocks activity of the cancer-driving protein molecule AKT. months to 7.2 months to 7.2

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pharmaphorum

FEBRUARY 18, 2022

Bayer now says it expects to make €3 billion in sales for its prostate cancer treatment Nubeqa, up from an earlier estimate of €1 billion, after reviewing new data for the drug in metastatic hormone-sensitive tumours. The post Bayer triples sales forecast for prostate cancer drug Nubeqa appeared first on.

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