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. In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%

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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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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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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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pharmaphorum

AUGUST 4, 2022

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. Lenvima combination.

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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. . The Phase III study was conducted as an open-label trial with patients receiving either an Orgovyx pill daily or injections of Abbvie’s Lupron as an injection every three months. Photo courtesy of Myovant. .

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pharmaphorum

OCTOBER 17, 2022

Bayer has added another clinical trial to its extensive phase 3 programme for oral neurokinin antagonist elinzanetant, hoping to show that it can treat vasomotor symptoms (VMS) in breast cancer patients. The post Bayer extends elinzanetant trials to include breast cancer appeared first on. There are around 2.3

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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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pharmaphorum

MARCH 14, 2022

Shares in Sanofi were on the slide this morning after the drugmaker revealed that one of its top pipeline prospects – selective oestrogen receptor degrader (SERD) amcenestrant – stumbled in a mid-stage breast cancer trial. The post Sanofi takes a hit as hotly tipped breast cancer drug fails trial appeared first on.

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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. The submission of the NDA was based on the findings of the CAPItello-291 Phase III trial.

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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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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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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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pharmaphorum

MARCH 23, 2021

The big Swiss pharma added this drug to its pipeline after it swooped for Endocyte and so far it looks like a good piece of business, with potential blockbuster sales predicted for the drug if it makes it to market. The company hopes that the drug could become a targeted therapy, covering more than 80% of people with prostate cancer.

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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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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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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

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Drug Discovery World

MARCH 21, 2023

Pfizer and Astellas have announcesd positive top-line results from the Phase III EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Patients in the trial will be followed for a subsequent final OS analysis.

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Medical Xpress

NOVEMBER 11, 2022

A Monash University-led trial of a new drug known as Q-122 therapy significantly reduced the number and severity of hot flashes and night sweats in women who have been diagnosed with breast cancer. It also improved their sleep and had no serious adverse effects.

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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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pharmaphorum

OCTOBER 11, 2020

Pfizer already makes big revenues from its breast cancer drug Ibrance, but a late-stage trial failure has set back its hopes of even loftier sales – and set up a challenge from Eli Lilly’s rival drug Verzenio. The post Ibrance trial failure dashes Pfizer’s growth hopes for the drug appeared first on.

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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. As per the agreement, the companies will jointly develop and market ODM-208.

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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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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.

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XTalks

OCTOBER 25, 2023

Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies.

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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. in trial subjects versus those who received ADT plus docetaxel.

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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

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The Pharma Data

AUGUST 28, 2020

A new breast cancer drug, called TTC-352, can halt the spread of the disease and is safe according to a Phase 1 clinical trial. The drug is being developed and tested by researchers at the University of Illinois at Chicago and is a type of hormone therapy, which targets oestrogen receptor-positive types of breast cancer.

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BioSpace

OCTOBER 28, 2020

On October 14th, Amolyt Pharma announced the first dosing in its Phase I trial of AZP-3601 in healthy subjects, a momentous occasion capping off years of hard work in pre-clinical development. The drug aims to walk the biological tightrope in the management of hypoparathyroidism, a rare disease c.

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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.

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pharmaphorum

FEBRUARY 26, 2021

In the final draft guidance, NICE recommended Kiskali be taken out of the Cancer Drugs Fund, which has been providing interim reimbursement since 2019 until further trial data emerged addressing uncertainties about overall survival and cost-effectiveness. months in the fulvestrant group to 40.2

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pharmaphorum

FEBRUARY 21, 2022

In contrast, up to 55% of all patients with breast cancer have tumours with a HER2-low score, as defined in the DESTINY-Breast04 trial, and approval in this group could unlock $3 billion in additional sales for Enhertu, according to analysts at Credit Suisse. AZ paid a hefty $1.4 AZ paid a hefty $1.4

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STAT News

JANUARY 25, 2023

… Merck is discontinuing a late-stage trial of its blockbuster immunotherapy Keytruda in some prostate cancer patients after interim data showed it was unlikely to meet the study’s main goals , Reuters writes. The Continue to STAT+ to read the full story…

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Drug Discovery World

OCTOBER 18, 2023

In an early clinical trial, researchers showed that blocking the messages cancer uses to hijack white blood cells can re-sensitise a subset of advanced prostate cancers to treatment – shrinking tumours or halting their growth. It’s hugely rewarding to see our theory proven in a trial of patients with this disease.

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Drug Discovery World

MARCH 24, 2023

There have also been positive trial results announced in prostate cancer, pancreatic cancer and breast cancer. The post This week in drug discovery (20-24 March) appeared first on Drug Discovery World (DDW).

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Advarra

JUNE 30, 2023

The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible for Medicaid in April 2022. However, a year has passed with no further updates on this letter or Medicaid beneficiaries enrolling in clinical trials. outlining routine costs in clinical trials.

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XTalks

NOVEMBER 29, 2023

David Cameron, Chair of the Breast International Group (BIG) , we delve into the landscape of breast cancer research today, clinical trials and the incorporation of the patient voice in breast cancer research. Breakthroughs in Treatment BIG has been at the forefront of numerous clinical trials.

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