Delveinsight

JANUARY 5, 2021

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device.

Hormones 52

Hormones FDA Approval Drugs Trials 52

WCG Clinical

OCTOBER 8, 2024

The cinchona tree’s bark has been used in Andean cultures to treat fever and contains quinine, which is an essential compound in treating malaria. The barbasco root is a plant used in Mexican traditional medicine that has been used to develop synthetic hormones. [1]

Clinical Research 52

Clinical Research Research Vaccination Vaccine 52

XTalks

FEBRUARY 7, 2023

Current treatments for HR+ breast cancer patients include hormonal therapies, chemotherapies for those that do not respond to hormonal therapy alone and targeted therapies, either stand-alone or in combination with hormonal therapies. Trodelvy contains a monoclonal antibody linked to the anticancer cytotoxic drug SN-38.

HR 52

HR Hormones FDA Approval Antibody 52

FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Manufacturing Drugs Regulation 52

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

AUGUST 30, 2021

New Kisqali ® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2? Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. 19, 2:10 PM CEST]. Abstract Title.

HR 52

HR Production Trials Containment 52

Druggist

FEBRUARY 28, 2021

Melatonin is a hormone that is released at night by the pineal gland located in the brain. Cochrane looked at a number of trials that involved airline passengers, airline staff and military personnel who used melatonin or placebo ( a dummy pill) to evaluate the effectiveness of melatonin. Melatonin liquid (Melatonin oral solution).

Pharmacy 98

Pharmacy Licensing Licensing Medicine 98

The Pharma Data

SEPTEMBER 3, 2020

The research, published in the journal Gut, revealed that 83% of aggressive, metastatic-like tumours contained particularly high levels of a gene called TLR3, part of a damage-alert system that mimics the infection response triggered by viruses, drawing immune cells to the tumour. Source link.

Research 52

Research Genetic Analysis Gene Scientist 52

The Pharma Data

APRIL 13, 2022

MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

Drugs 52

Drugs Hormones Medicine Production 52

Druggist

MAY 22, 2021

Gaviscon Advance and Double Action contain sodium alginate, which creates a ‘ hj ‘ in the stomach, preventing acid from escaping and therefore help to control symptoms of heartburn. Two main factors contribute to the presence of dyspepsia in the pregnancy: hormonal changes. acid reflux, nausea, or.

Containment 52

Containment Production Pharmacy Medicine 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

Trialfacts

NOVEMBER 23, 2022

Location: California Clinical Trials Medical Group 1560 East Chevy Chase Drive, Suite 140 Glendale, CA 91206. CNP is a hormone produced by the body that plays an important role in the bone growth of children. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. Your Rights.

Clinical Trials 52

Clinical Trials Clinical Trials Research Hormones 52

Trialfacts

MARCH 1, 2023

A placebo looks like the study treatment but does not contain the active components. Our key areas of focus are currently hormones, cognition, TMS. Marc Russo Genesis Research Services bring a range of clinical trial opportunities to our community, including world-first studies for pain management and healthy volunteer studies.

Research 52

Research Clinical Trials Clinical Trials Containment 52

Olympian Clinical Research

NOVEMBER 6, 2023

While the exact cause is unknown, factors like genetics, inflammation, and hormones play a role. Here are some common triggers of HS: Hormonal Changes: Many individuals with HS report flare-ups during periods of hormonal change, such as menstruation, pregnancy, or menopause.

Hormones 52

Hormones Doctor Doctors Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

XTalks

MARCH 15, 2023

Strattera’s active ingredient is the SNRI atomoxetine hydrochloride while Qelbree contains viloxazine hydrochloride, a serotonin-norepinephrine modulating agent (also a SNRI). Norepinephrine is a hormone and neurotransmitter that helps in alertness and maintaining control in high-stress situations.

Drugs 98

Drugs Sales Trials Marketing 98

The Pharma Data

AUGUST 17, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell [i]. by blinded independent central review. with a DoR range of 2.6-35.8+

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

The Pharma Data

MARCH 7, 2022

The trial targeted a 30% reduction in the risk of disease progression or death. The trial targets a 30% reduction in the risk of disease progression or death and is powered to detect a statistically significant difference of at least 0.9 months in median PFS. More information about TROPiCS-02 is available at [link].

HR 52

HR Hormones Medicine Trials 52

pharmaphorum

JULY 28, 2022

The American Heart Association issued a statement last year highlighting the risks of visceral and abdominal fat (VAT), calling for clinical trials of therapies to reduce it, as well as greater efforts to encourage patients to exercise and improve their diets.

Biobanking 52

Biobanking Gene Gene Silencing Drugs 52

The Pharma Data

JANUARY 27, 2021

We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

In-Vitro 52

In-Vitro Containment Drugs Production 52

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).

Gene 52

Gene Hormones DNA Medicine 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception : Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. FDA Emergency Use Authorization Statement.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

Marketing 75

Marketing Production Drugs Licensing 75

XTalks

NOVEMBER 9, 2023

Zepbound contains mimetics of the GLP-1 and GIP hormones that regulate appetite and blood sugar. Zepbound’s approval was based on data from two Phase III trials with 2,519 patients who had obesity or overweight with at least one weight-related condition. The larger of the two trials enrolled adults without diabetes.

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

Olympian Clinical Research

MARCH 3, 2023

When we are under stress, our bodies release cortisol, a hormone that can weaken the skin’s natural barrier and make it more susceptible to irritation and inflammation. These products often contain harsh chemicals that can irritate the skin, strip it of its natural oils, and cause an inflammatory response.

Clinical Research 52

Clinical Research Production Containment Research 52

The Pharma Data

JANUARY 10, 2021

We expect to further advance our late stage endocrinology pipeline with the anticipated approval and launch in the United States and the approval in Europe of TransCon hGH for pediatric growth hormone deficiency, and to obtain phase 3 results for TransCon PTH in adult hypoparathyroidism. Pipeline Updates. •.

Hormones 40

Hormones Clinical Development Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 24, 2020

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers. The drug candidate is currently engaged in a phase IIb clinical trial in prostate cancer, a study that aims to recruit more than 175 patients and that involves centres both in Europe and in the US.

Drugs 40

Drugs Clinical Trials Clinical Trials Hormones 40

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. months) will be presented.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

JULY 23, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types.

Hormones 52

Hormones Trials Genomics Genome 52

The Pharma Data

MARCH 11, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types.

Trials 52

Trials Hormones Genome Genomics 52

Pfizer

JANUARY 27, 2023

In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

OCTOBER 14, 2020

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. WAKIX may reduce the effectiveness of hormonal contraceptives. Adverse Reactions. Use in Specific Populations.

FDA Approval 40

FDA Approval Hormones Production Drugs 40

The Pharma Data

FEBRUARY 8, 2021

Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials.

HR 52

HR Hormones Development Production 52

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] v] ERLEADA ® is being studied in five Phase 3 clinical trials. For more information about ERLEADA ® , visit www.ERLEADA.com. *© All rights reserved.

HR 52

HR In-Vitro Development Clinical Trials 52

Roots Analysis

AUGUST 31, 2023

Further, the transcription factors contain two molecular domains, the DNA binding domain and the activation domain. Moreover, some transcription factors contain additional domains, such as ligand binding domain in order to interact with chemical signals.

Gene 40

Gene Gene Therapy Gene Expression Regulation 40

The Pharma Data

APRIL 23, 2021

The ongoing phase 1 GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumours. containing regimen. Hormone replacement therapy for endocrinopathies should be instituted as warranted. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe.

Antibody 40

Antibody Hormones Licensing Licensing 40