BioTech 365

SEPTEMBER 24, 2021

FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency … Continue reading → Pfizer and OPKO Announce Extension of U.S.

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Hormones Licensing Licensing 40

XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4

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Hormones Drugs Sales Insulin 59

Pharmaceutical Technology

MAY 25, 2023

Adalvo has entered a strategic licensing agreement with Swiss pharmaceutical company EQL Pharma for Mellozzan (melatonin) outside Europe and the US. Mellozzan contains the sleep hormone melatonin and is indicated for use in children with attention deficit hyperactivity disorder (ADHD) and sleep difficulties.

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Hormones Engineer Containment Licensing 130

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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Hormones Drugs FDA Approval Sales 98

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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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

XTalks

JANUARY 16, 2025

It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone. Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022. Thyroid eye disease affects an estimated 200,000 individuals in the US every year.

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Trials Clinical Trials Clinical Trials Insulin 59

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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Drugs Hormones Marketing Trials 98

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.

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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.

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HR Marketing Hormones FDA Approval 162

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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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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Trials Sales Hormones Drugs 132

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 88

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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Antibody Hormones DNA Licensing 130

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

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 78

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

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

XTalks

JULY 19, 2024

Consumers should be wary of any online offer for prescription medications that seems too good to be true, and they should always consult with a licensed physician before starting any new medication,” he explained. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.

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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

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.

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Hormones FDA Approval Drugs Trials 52

Druggist

SEPTEMBER 7, 2020

It is a pharmacy only medication licensed for ‘short-term’ treatment of pain experienced at the bedtime. Sominex: restrictions on age and duration of the treatment Sominex is licensed for children and adults who are 16 years or older. Who should not have over the counter sleeping tablets? Learn more about Nytol liquid.

Containment 94

Containment Pharmacy Production Licensing 94

pharmaphorum

SEPTEMBER 21, 2022

Puma reckons that alisertib has potential in hormone receptor-positive, HER2-negative breast cancer, triple-negative breast cancer (TNBC), and SCLC, based on the results of already completed mid-stage trials. The post Takeda farms out cancer drug alisertib to Puma Biotech appeared first on.

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Drugs HR Licensing Licensing 64

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 Production 52

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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FDA Approval Containment Drugs Pharmacy 98

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

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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Druggist

MAY 6, 2021

Licensed use. Insulin: a hormone that allows glucose (sugar) to be used for energy in the body. There are other Sulfonylureas licensed in the UK to treat type-2 diabetes, but less commonly prescribed. Pioglitazone is the only thiazolidinedione licensed currently in the UK for the treatment of diabetes. Conclusion.

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Insulin Branding Drugs Licensing 98

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

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

XTalks

SEPTEMBER 12, 2024

Vir Biotechnology’s PSMA-Targeted Therapy Vir Biotechnology — who entered a new licensing agreement with Sanofi this month — secured exclusive rights to a clinical-stage dual-masked PSMA-targeted T-cell engager (SAR446329) for mCRPC patients. Prostate Cancer Awareness Month is a time to act.

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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.,

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Drugs Licensing Licensing Production 110

XTalks

SEPTEMBER 13, 2024

This month, CVS launched a birth control prescribing service at its pharmacy locations in Massachusetts, allowing pharmacists to evaluate patients and prescribe hormonal contraceptives, addressing gaps in reproductive health access. CVS Health (CVS) Market Capitalization : $95.74

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Marketing Pharmacy Gene Therapy Hormones 98

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.

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XTalks

NOVEMBER 2, 2020

This includes compromising the functioning of the adrenal glands, which can potentially lead to adrenal insufficiency, resulting in inadequate production of steroid hormones. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., PONENTE Trial.

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Trials FDA Approval Drugs Hormones 94

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

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.

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