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.

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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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BioTech 365

SEPTEMBER 4, 2020

– Prescription Drug User Fee Act (PDUFA) target action date of June 25, 2021 – – FDA indicated that it is currently not planning to hold an Advisory Committee Meeting – COPENHAGEN, Denmark, Sept. 04, 2020 (GLOBE NEWSWIRE) — Ascendis … Continue reading →

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Hormones Licensing Licensing Drugs 40

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.

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Drugs Hormones FDA Approval Clinical Trials 98

pharmaphorum

AUGUST 16, 2022

Immunomedics had licensed the rights to the drug in Asian markets to Everest in 2019 for $65 million upfront and with up to $710 million in potential milestones, including $65 million due on US approval.

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Licensing Licensing Hormones Drugs 52

pharmaphorum

AUGUST 11, 2020

If successful the company hope the drug will steal market share from hormone replacement therapies such as Pfizer’s Premarin, which has been on the market for decades and has several safety warnings, including endometrial cancer and heart disease.

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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.

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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. “We believe ODM-208 has the potential to complement our existing programme in prostate cancer,” he added.

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Licensing Licensing Hormones Sales 52

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.

Hormones 98

Hormones Marketing Trials DNA 98

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.

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Drugs Hormones Genome Genomics 103

Pharmaceutical Technology

FEBRUARY 14, 2023

The company filed heterocyclic composition patents in areas such as PAD4 inhibitors, factor Xa inhibitors, and nuclear hormone receptor modulators. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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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

JUNE 4, 2021

Those include studies in the pre-chemotherapy setting in CRPC, as well as in metastatic hormone-sensitive prostate cancer (HSPC) patients who are treatment-naïve or with only short-term use of standard first-line hormonal therapies. billion along with its developer Advanced Accelerator Applications in 2017.

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Hormones Licensing Licensing Drugs 87

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

pharmaphorum

MARCH 29, 2021

Verastem’s oral PI3K inhibitor Copiktra (duvelisib) also got a positive opinion from the CHMP to treat relapsed or refractory chronic lymphocytic leukaemia and refractory follicular lymphoma, which was recently licensed to Secura Bio for $311 million.

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Antibody Hormones Medicine Licensing 76

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.

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The Pharma Data

SEPTEMBER 15, 2020

The first of the two deals will focus on the development of Seattle Genetics’ LIV-1 inhibitor iadiratuzumab vedotin alone and in combination with MSD’s blockbuster immunotherapy drug Keytruda (pembrolizumab) as a treatment for triple-negative breast cancer, hormone receptor-positive breast cancer and other solid tumours which express LIV-1.

Genetics 52

Genetics Development Hormones Licensing 52

pharmaphorum

FEBRUARY 21, 2022

AZ and Daiichi are meanwhile continuing to explore new uses for the drug, and recently started dosing patients in DESTINY-Breast11, a phase III trial of Enhertu in neoadjuvant HER2-positive breast cancer, and TROPION-Breast01 in hormone receptor-positive HER2-negative breast cancer. AZ paid a hefty $1.4

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XTalks

JUNE 5, 2023

Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating. Furthermore, patients should only purchase Ozempic, Wegovy or other medications from licensed healthcare providers or pharmacies.

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The Pharma Data

MAY 14, 2021

It is a laser targeted combination of powerful series of protocols set in a unique order and timing aimed at naturally eliminating all types of acne in as little as 7 days, restoring your intestinal and hormonal balance and thus helping you gain the lasting perfect clear skin you deserve. ClickBank is the retailer of products on this site.

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Production Hormones Sales Licensing 52

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. Can you get melatonin on Amazon.co.uk?

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Pharmacy Licensing Licensing Medicine 98

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.

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Clinical Trials Clinical Trials Trials Drugs 52

XTalks

AUGUST 15, 2023

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Niraparib is also sold by GSK under the name Zejula in other indications. In April 2016, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Gene Hormones Licensing 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.

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FDA Approval Protein Genetics RNA 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. Terns schedules to bring a third candidate into the clinic this year, TERN-501, a thyroid hormone receptor (THR) beta-agonist.

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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. Cachexia is a complex metabolic syndrome, which is characterized by the loss of fat and muscles in the body.

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Marketing Pharma Companies Development Hormones 94

The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

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Protein Development HR Hormones 52

Velocity Clinical Research

JUNE 27, 2023

Novo Nordisk announced that a biologics license application for the insulin icodec has been submitted for FDA review. “A once-weekly basal insulin has the potential to change how we treat people with type 2 diabetes needing basal insulin replacement.” Trial results were presented at the ADA sessions and published in NEJM.

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Insulin Trials Hormones Clinical Trials 52

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.

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The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. [vii] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

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Drugs Clinical Trials Clinical Trials Hormones 40

XTalks

SEPTEMBER 17, 2020

Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed.

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Trials Gene Hormones Clinical Trials 98

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.

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The Pharma Data

MARCH 25, 2022

Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. in November 2021.

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Licensing Licensing Drugs Medicine 52

The Pharma Data

OCTOBER 14, 2020

The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy. WAKIX may reduce the effectiveness of hormonal contraceptives. Use in Specific Populations.

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The Pharma Data

FEBRUARY 25, 2021

and Eli Lilly and Company (NYSE: LLY) announced today a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin solutions, currently in development. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin. Welldoc, Inc.,

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Insulin Medicine Hormones Development 40

The Pharma Data

MAY 13, 2021

Your mind is in control of your body, muscles, ligaments, tendons, joints, bones, arteries, veins, organs, hormones, and every cell in your. License Agreement (‘EULA’). Self-hypnosis gives you. this ability in order for you to control and achieve perfect health. look anywhere else. maintain perfect and radiant health!

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Production Hormones Licensing Licensing 52