pharmaphorum

MARCH 8, 2021

The cost-effectiveness agency is assessing use of Lynparza (olaparib) in patients with tumours that carry BRCA1 or BRCA2 mutations who have previously been treated with the hormone therapies abiraterone and enzalutamide but have relapsed. The post NICE says no to AZ’s Lynparza for prostate cancer appeared first on.

Hormones 98

Hormones Marketing Trials DNA 98

pharmaphorum

AUGUST 11, 2020

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. A phase 3 trial is expected to begin in 2021 and the company says that the compound could generate peak sales of more than a billion euros globally.

Drugs 98

Drugs Hormones Marketing Trials 98

pharmaphorum

FEBRUARY 1, 2021

Kesimpta (ofatumumab) started life as an oncology drug and was first developed by Genmab and licensed to GlaxoSmithKline who marketed under the brand name Arzerra to treat chronic lymphocytic leukaemia.

Drugs 98

Drugs Hormones FDA Approval Clinical Trials 98

Drug Discovery World

APRIL 6, 2023

Men in England and Wales with advanced, incurable prostate cancer who have BRCA1/2 mutations in their tumours and who have seen their cancer progress despite hormone therapy will also have access to olaparib.

Hormones 52

Hormones Gene Scientist Clinical Trials 52

pharmaphorum

JULY 13, 2022

Merck & Co has added another clinical-stage drug to its oncology pipeline via a licensing agreement with Finland’s Orion for ODM-208, a prostate cancer candidate currently in phase 2 testing. It is currently in a phase 2 trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), said Merck.

Licensing 52

Licensing Licensing Hormones Sales 52

Drug Discovery World

JUNE 1, 2023

6 Also in May 2023, Shanghai-native LaNova Medicines entered into an exclusive license agreement with AstraZeneca for LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D).

Antibody 98

Antibody Marketing Drugs Licensing 98

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. It can be due to a damaged pituitary gland or another gland called the hypothalamus.

Hormones 52

Hormones FDA Approval Trials Drugs 52

pharmaphorum

JULY 14, 2022

“We must, however, recognise the unacceptably difficult journey to get to this point for those affected; ten agonising months since Trodelvy was licensed by the MHRA,” said the patient organisation’s chief executive Baroness Delyth Morgan.

Drugs 104

Drugs Hormones Genome Genomics 104

pharmaphorum

JUNE 4, 2021

Novartis’ big investment in radiopharmaceuticals for cancer seems to have paid off, after lead candidate 177Lu-PSMA-617 helped men with advanced prostate cancer and few treatment options live longer in a phase 3 trial. billion takeover of Endocyte in 2018. After a median follow-up of 20.9 months, compared to 3.4 months, respectively.

Hormones 88

Hormones Licensing Licensing Drugs 88

Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. GLP-1 is a hormone that is produced naturally in the brain and the gut in response to food ingestion.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Velocity Clinical Research

JUNE 27, 2023

Trial results were presented at the ADA sessions and published in NEJM. Novo Nordisk announced that a biologics license application for the insulin icodec has been submitted for FDA review. Dr. Frias is the lead author for Eli Lily’s Phase 2 trial for orforglipron for type 2 diabetes.

Insulin 52

Insulin Trials Hormones Clinical Trials 52

The Pharma Data

MAY 14, 2021

Description: Acne No More is a clinically proven 5-step multi-dimensional clear skin system that has been polished and perfected over 13 years of research, trial, and error. intended to replace medical advice offered by a physician or other licensed. Neither ClickBank nor the author. healthcare provider.

Production 52

Production Hormones Sales Licensing 52

Pharmaceutical Technology

AUGUST 4, 2022

Earlier in March, researchers from the University of Minnesota shared their findings from a preclinical study featuring a non-hormonal pill that may move into human trials in the near future. Hormonal approaches popular. Over the course of the day, you’re releasing a pretty constant amount of hormones.

Hormones 306

Hormones Development Trials Pharmacy 306

Druggist

FEBRUARY 28, 2021

Melatonin is a hormone that is released at night by the pineal gland located in the brain. In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. Slenyto tablets have a specific licensed use. Is melatonin effective sleep aid medicine?

Pharmacy 98

Pharmacy Licensing Licensing Medicine 98

Delveinsight

JANUARY 7, 2021

The immunotherapy pipeline is led by an in-licensed EP4 antagonist that Ikena is testing combined with Keytruda in phase 1b/2 colorectal and non-small cell lung cancer clinical trials. Eli Lilly backed Terns Pharmaceuticals now has two NASH candidates in clinical trials. Ikena will back a pipeline that falls into two categories.

RNA 52

RNA Clinical Trials Clinical Trials Bioavailability 52

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. The company is currently preparing for further clinical trials in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).

Marketing 94

Marketing Pharma Companies Development Hormones 94

The Pharma Data

JULY 22, 2021

ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. The estrogen receptor is a well-known disease driver in most breast cancers.

Protein 52

Protein Development HR Hormones 52

XTalks

JUNE 20, 2022

Alnylam’s Onpattro was its first licensed and approved RNAi therapy for ATTR polyneuropathy. TTR is made in the liver and is involved in carrying the thyroid hormone thyroxine (T4) and retinol (vitamin A) to the liver. Evaluate Vantage speculates that given Amvuttra’s potential for ATTR cardiomyopathy, the drug could reach $1.8

FDA Approval 98

FDA Approval Protein Genetics RNA 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). As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”. by blinded independent central review.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. The candidate demonstrated 64.7%

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

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

Pfizer

JANUARY 27, 2023

telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: Sufficient information is not available to assess renal and hepatic function. No dosage adjustment is needed in patients with mild renal impairment.

Marketing 75

Marketing Production Drugs Licensing 75

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 52

FDA Approval Hormones Production Drugs 52

Pfizer

AUGUST 15, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., PAXLOVID is not authorized for use for longer than 5 consecutive days.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. month OS benefit compared to SOC chemotherapy in the DESTINY-Breast04 trial.

HR 162

HR Marketing Hormones FDA Approval 162

The Pharma Data

APRIL 23, 2021

The ongoing phase 1 GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumours. Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. About GARNET.

Antibody 52

Antibody Hormones Licensing Licensing 52

The Pharma Data

DECEMBER 9, 2020

announced a research collaboration to develop hormone receptor antagonist (GHRA) peptides as potential treatments for acromegaly, a rare but serious endocrine disorder with significant unmet medical need. Amolyt has also acquired an option to license the identified candidates for future clinical development.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

The Pharma Data

OCTOBER 26, 2020

I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”. billion related to certain license and collaboration agreements, and certain other items.

Sales 40

Sales Vaccination Vaccine Production 40

pharmaphorum

SEPTEMBER 21, 2022

Takeda has decided that there is a future for its aurora kinase A inhibitor alisertib after it failed a phase 3 trial in lymphoma – but the company won’t be taking the drug forward itself. Takeda is also in line for just over $287 million in potential milestone payments, plus royalties on net sales if it reaches the market.

Drugs 64

Drugs HR Licensing Licensing 64

Pfizer

DECEMBER 13, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Drugs 110

Drugs Licensing Licensing Production 110

XTalks

NOVEMBER 2, 2020

Results from the world’s largest steroid sparing trial in severe asthma patients conducted to date show that AstraZeneca’s Fasenra (benralizumab) can eliminate the use of maintenance oral corticosteroids (OCS) in OCS-dependent asthma patients. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., PONENTE Trial.

Trials 94

Trials FDA Approval Hormones Drugs 94

Druggist

NOVEMBER 27, 2020

The approval decision for drug licensing comes from information gathered during clinical trials. The primary evidence comes from the clinical trial involving 1440 patients with acne vulgaris. At the end of the 12-week trial, the treatment was successful in 18.4% Is clascoterone effective in the treatment of acne?

Hormones 98

Hormones Clinical Trials Clinical Trials Containment 98

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

JANUARY 27, 2023

Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. No dosage adjustment is needed in patients with mild renal impairment.

Research 112

Research Vaccination Vaccine Drugs 112

pharmaphorum

JUNE 8, 2022

The passport means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced in 2020, which reduces the review time for a new medicine to 150 days.

Gene Silencing 52

Gene Silencing Drugs Medicine Regulation 52

Druggist

MAY 6, 2021

Licensed use. Insulin: a hormone that allows glucose (sugar) to be used for energy in the body. Modified-release metformin can be offered on a trial basis instead of standard release metformin to patients who experience gastrointestinal side effects (NICE, 2020). Summary of the post: What is metformin? Drug classification.

Insulin 98

Insulin Branding Drugs Licensing 98

The Pharma Data

MAY 13, 2021

Product Name: Unblock My Hormones And Start Burning Fat TODAY With HB5. Click here to get Unblock My Hormones And Start Burning Fat TODAY With HB5 at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.

Hormones 52

Hormones Insulin Production Packaging 52