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.

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Pharmaceutical Technology

MARCH 2, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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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]

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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.

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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.

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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. .

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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.

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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).

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The Pharma Data

AUGUST 15, 2021

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The WELIREG label contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. WELIREG is the first HIF-2? of patients.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.–(

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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.

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Delveinsight

DECEMBER 7, 2020

Development in the technology has made it possible for solutions to surface, primarily related to R&D, clinical trials, and diagnostics and treatment, as well as patient management, leading to even more significant innovative potential and promise for AI in the industry.

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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+

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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].

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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.

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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.

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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).

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XTalks

MARCH 1, 2021

And while conventional dry eye can have a number of causes — including blepharitis, hormone-related changes in post-menopausal women and contact lens use — mask-associated dry eye is largely cropping up in people who wear face masks for extended periods during the day. The Future of Dry Eye Disease Therapy.

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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.

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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.

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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.

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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.

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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.

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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. •.

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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.

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The Pharma Data

JULY 12, 2021

There will also be updates from the Phase 3 DRIVE-AHEAD trial evaluating DELSTRIGO (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg) in previously untreated participants with HIV-1. Islatravir Safety Analysis Through Week 96 from a Phase 2 Trial in Treatment Naïve Adults with HIV-1 Infection. Abstract 2361.

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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.

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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.

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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.

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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.

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