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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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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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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FDA Approval Hormones Trials Clinical Trials 244

XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

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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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Hormones Clinical Trials Clinical Trials Licensing 246

XTalks

MARCH 17, 2025

billion, primarily linked to initiating Phase III trials for petrelintide as a stand-alone therapy, with sales-based milestones that could push the total value to $5.3 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.

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Hormones Drugs Sales Insulin 59

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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Trials Hormones Sales Drugs 124

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).

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Development Drugs Hormones Research 235

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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Insulin Hormones Drugs Clinical Trials 182

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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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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XTalks

DECEMBER 13, 2024

Zealand Pharma has commenced its global Phase IIb ZUPREME-1 trial, enrolling the first participant to evaluate petrelintide, a long-acting amylin analog, as a potential investigational treatment for people with overweight or obesity. The study will assess the drugs effects on body weight, safety and tolerability over a 42-week period.

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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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XTalks

FEBRUARY 5, 2025

a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 If successful, Phase III trials are expected to follow shortly thereafter.

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XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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XTalks

MARCH 18, 2025

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. These promising figures had set high expectations for subsequent trials. The other Phase III trial, STOP-HS2, showed a 42.3% for placebo.

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Trials Clinical Trials Clinical Trials Hormones 59

XTalks

FEBRUARY 21, 2025

This capital will accelerate the companys clinical programs and support its pipeline of investigational drugs aimed at treatments for metabolic diseases like Prader-Willi syndrome (PWS). In the gut, these receptors prompt the release of hormones such as cholecystokinin and GLP-1, which together signal satiety.

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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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XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.

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Trials Drugs Clinical Trials Clinical Trials 96

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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pharmaphorum

JULY 17, 2024

Bayer has the result it was hoping for in the phase 3 ARANOTE trial of Nubeqa in metastatic, hormone-sensitive prostate cancer (mHSPC), a key part of its plan to build the drug into a €3 billion-a-year blockbuster.ARANOTE compared Nubeqa (darolutamide) to placebo given with standard androgen deprivation therapy (ADT) and showed a significant improvement (..)

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Radiology Trials Hormones Drugs 80

pharmaphorum

DECEMBER 3, 2021

Bayer’s Nubeqa is making headway as a treatment for castration-resistant prostate cancer (CRPC), but could be on track to expand the eligible patient population for the drug thanks to new phase 3 data. The ARASENS trial was carried out in men whose HSPC had spread or metastasised to other parts of the body.

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Trials Sales Hormones Drugs 107

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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Hormones Drugs FDA Approval Sales 98

pharmaphorum

AUGUST 11, 2020

Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats.

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Drugs Hormones Marketing Trials 98

XTalks

JANUARY 29, 2025

Eli Lilly launched a 75-second TV commercial called Change in November 2024 to promote the companys GLP-1 obesity drug Zepbound (tirzepatide). This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval.

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FDA Approval Drugs Hormones Marketing 71

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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pharmaphorum

MAY 16, 2022

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control.

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XTalks

MAY 17, 2023

Astellas Pharma recently announced the US Food and Drug Administration (FDA) approval of their new medication, Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. Hormone replacement therapy is thought to be one of the most effective treatments for vasomotor symptoms.

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pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks. The post CHMP clears way for EU approval of Novartis’ MS drug appeared first on.

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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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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

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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XTalks

JULY 17, 2024

Sweden-based biotech Camurus shared positive Phase III trial data for CAM2029, one of its lead candidates, in patients with the rare hormonal disorder acromegaly. Due to its ability to mimic somatostatin, octreotide is used to treat various conditions associated with excessive hormone production.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

Avéma, for example, specialises in small molecule, oral solid, and liquid dose drugs. generic drugs at both small development companies and multinational pharmaceutical companies. One of the first things Avéma does with a new project is to evaluate the drug molecule to make sure it's a fit for available facilities.

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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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XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. What Is a Surrogate Endpoint?

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