Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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HR Hormones FDA Approval Antibody 264

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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pharmaphorum

DECEMBER 23, 2020

There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. The antibodies produced as a result lodge in the kidneys, causing severe complications. months, compared with 6.7 Neurology on the march.

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XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

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HR Hormones FDA Approval Antibody 52

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 is also looking to get FDA approval for chronic rhinosinusitis with nasal polyps, as is GlaxoSmithKline’s Nucala.

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Trials FDA Approval Drugs Hormones 94

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. NGM120 is a first-in-class antagonistic antibody, which binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15).

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

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FDA Approval Antibody DNA Hormones 52

XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review. billion to $1.28

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XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

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FDA Approval Gene Hormones Drugs 52

The Pharma Data

AUGUST 30, 2021

Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. About Tecentriq. receptors. Source link: [link].

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Medicine Antibody Hormones Development 52

The Pharma Data

AUGUST 3, 2021

For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. percentage points primarily due to product mix, including COVID-19 antibody shipments to Lilly that began this quarter, profit share and royalties. Cost of Sales margin increased 1.6 Tax Rate increased 5.6 In May, the U.S.

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The Pharma Data

MARCH 11, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Thyroiditis can present with or without endocrinopathy.

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Trials Hormones Genome Genomics 52

The Pharma Data

APRIL 7, 2021

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study. About Trodelvy.

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The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. receptors. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: [link].

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The Pharma Data

JULY 23, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Thyroiditis can present with or without endocrinopathy.

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Hormones Trials Genome Genomics 52

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

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The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Institute hormone replacement therapy for endocrinopathies as warranted.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

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The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Institute hormone replacement therapy for endocrinopathies as warranted.

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Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 31, 2021

FDA approval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2To date, more than 40,000 patients worldwide have been treated with ERLEADA ®. 2] ERLEADA ® received U.S. For more information, visit www.ERLEADA.com. About Cetrelimab. ERLEADA ® IMPORTANT SAFETY INFORMATION 2.

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XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

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FDA Approval HR Hormones Antibody 98

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated.

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FDA Approval Containment Hormones Dermatology 40

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Research Hormones Protein Regulation 98

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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The Pharma Data

JANUARY 4, 2021

Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. .

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Medicine Immune Response Protein Gene 52

XTalks

NOVEMBER 26, 2024

Keytruda (Pembrolizumab) Keytruda 2023 sales: $25.011 billion Company/developer: Merck Date of first US Food and Drug Administration (FDA) approval: September 4, 2014 Indications Keytruda is FDA-approved for: Unresectable or metastatic melanoma.

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XTalks

DECEMBER 6, 2024

While both semaglutide and tirzepatide have a glucagon-like peptide-1 (GLP-1) agonist component, tirzepatide also acts as an agonist of the gastric inhibitory polypeptide (GIP) hormone; this serves as a differentiator between the two and could explain tirzepatides stronger weight loss effects.

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Trials Clinical Trials Clinical Trials Marketing 98

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

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The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Isolated growth hormone deficiency. ?

Medicine 52

Medicine Production FDA Approval Development 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Isolated growth hormone deficiency. ?

Medicine 40

Medicine Production FDA Approval Development 40

The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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