XTalks

NOVEMBER 6, 2024

Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements. Across the industry, recent innovations in drug delivery signal a creative shift towards ease of administration and expanded treatment options.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

XTalks

OCTOBER 23, 2024

Unlike drugs that alter metabolism or appetite by interacting with hormones, the pill functions entirely mechanically. This approach aims to help users control portions and calorie consumption without the need for surgery, such as gastric banding or bypass, or the side effects commonly associated with appetite-suppressing drugs.

Production 104

Production Hormones Drugs Trials 104

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.

FDA Approval 246

FDA Approval HR Drugs Hormones 246

BioSpace

JANUARY 3, 2021

Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug, somatrogon, after the U.S. FDA recently accepted the companies’ regulatory submission for the therapy.

Hormones 99

Hormones Drugs Development 99

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.

Hormones 242

Hormones Containment Branding Drugs 242

Pharmaceutical Technology

FEBRUARY 9, 2023

Ibutamoren mesylate is under clinical development by Lumos Pharma and currently in Phase II for Growth Hormone Deficiency. According to GlobalData, Phase II drugs for Growth Hormone Deficiency have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. Buy the report here.

Hormones 100

Hormones Drugs Clinical Trials Clinical Trials 100

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

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 23, 2024

Drugs like Ozempic are very effective at helping most people who take them lose weight. Semaglutide (sold as Wegovy and Ozempic) and tirzepatide (sold as Zepbound and Mounjaro) are the most well known in the class of drugs that mimic hormones to reduce feelings of hunger.

Doctors 189

Doctors Doctor Hormones Drugs 189

XTalks

JULY 6, 2023

Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla).

Hormones 98

Hormones FDA Approval Clinical Trials Clinical Trials 98

Pharmaceutical Technology

NOVEMBER 21, 2023

Despite a US FDA rejection for the drug earlier this year, the European Commission has approved Yorvipath for chronic hypoparathyroidism.

Hormones 130

Hormones Drugs 130

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.

Hormones 92

Hormones Drugs Production Development 92

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.

Hormones 98

Hormones Research Development Drugs 98

Pharmaceutical Technology

JULY 13, 2022

Under the deal, the companies will also develop various other drugs that act on cytochrome P450 11A1 (CYP11A1), an enzyme vital for steroid production. Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer.

Development 264

Development Hormones Production Marketing 264

Pharmaceutical Technology

SEPTEMBER 12, 2022

Baudry is also the chief scientific advisor at NeurAegis, a preclinical-stage company developing a concussion drug. While there is an unmet need, drug development remains slow due to neurological complexity. “We Other approaches include Neuronasal’s through-the-nose drug based on N-acetylcysteine (NAC).

Development 235

Development Drugs Hormones Research 235

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.

Hormones 75

Hormones Trials Clinical Trials Clinical Trials 75

BioSpace

JUNE 27, 2023

Overcoming an FDA rejection in January 2022, Pfizer and OPKO’s Ngenla will provide a long-acting, reduced-frequency treatment option for children with growth hormone deficiency.

Hormones 74

Hormones Drugs 74

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.

Insulin 182

Insulin Hormones Drugs Clinical Trials 182

pharmaphorum

AUGUST 1, 2024

Bayer files elinzanetant as a non-hormonal treatment for menopausal symptoms, with Astellas' first-to-market Veozah in its sights

Hormones 115

Hormones Drugs Marketing 115

XTalks

MARCH 17, 2025

Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating. Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections.

Hormones 59

Hormones Drugs Sales Insulin 59

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.

HR 130

HR Drugs Hormones Medicine 130

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.

Drugs 147

Drugs Hormones Sales Medicine 147

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review.

HR 245

HR Hormones Trials Protein 245

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

HR 264

HR Hormones FDA Approval Antibody 264

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.

Hormones 246

Hormones Clinical Trials Clinical Trials Licensing 246

BioSpace

DECEMBER 21, 2020

Myovant's oral Orgovyx beat out Abbvie's injectable Lupron in achieving medical castration levels in patients.

Hormones 105

Hormones FDA Approval Drugs 105

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.

Hormones 98

Hormones Drugs Trials Manufacturing 98

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. In these subjects, the median progression-free survival (PFS) following Enhertu treatment was 9.9

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

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.

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

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.

Hormones 65

Hormones Drugs 65

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).

Hormones 91

Hormones Drugs Regulation Marketing 91

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

Hormones 109

Hormones Drugs Marketing 109

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. If approved, ObsEva’s drug will add another once-daily competitor to the ring.

Hormones 98

Hormones Drugs FDA Approval Sales 98

XTalks

DECEMBER 13, 2024

The study will assess the drugs effects on body weight, safety and tolerability over a 42-week period. Petrelintide, administered once a week under the skin, targets obesity through its action as an amylin analog, a hormone co-secreted with insulin from the pancreas.

Drugs 102

Drugs Hormones Trials Clinical Trials 102

XTalks

NOVEMBER 21, 2024

These gut hormones are released in response to nutrient intake and play a crucial role in the incretin effect, which enhances insulin secretion. The drug also alleviated heart failure symptoms and improved patients’ physical limitations compared with placebo. In contrast, only 29.7 billion, falling short of analysts’ projections of $3.7

Sales 105

Sales Insulin Drugs Trials 105

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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Sales Drugs Hormones Pharma Production 98

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…

Hormones 98

Hormones Drugs Clinical Trials Clinical Trials 98

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. Without proper PTH function, patients may face kidney and bone complications.

Trials 59

Trials Hormones Engineer Licensing 59