The Pharma Data

NOVEMBER 21, 2021

The FDA approved Voxzogo under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint. 3] Achondroplasia is caused by mutations in the FGFR3 gene. Inheritance is autosomal dominant.[1][2]

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XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5

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pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

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Pharmaceutical Technology

OCTOBER 13, 2022

The drug won its original FDA approval in May last year to treat heavy menstrual bleeding that accompanies uterine fibroids in premenopausal women. In August this year, it gained a second FDA endorsement to treat moderate to severe endometriosis.

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pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster. Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects.

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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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XTalks

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations. In April 2016, Janssen Biotech, Inc.

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XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

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pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. The biotech isn’t revealing how much it intends to charge for the new medicine, saying it will do so closer to launch later this year.

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XTalks

FEBRUARY 5, 2024

As we delve into the specifics of these best-selling oncology drugs, we uncover the underlying factors contributing to their market dominance, from clinical efficacy and safety profiles to strategic market positioning and patient accessibility.

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

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Delveinsight

AUGUST 2, 2020

The dynamics of the cancer cachexia market is expected to gain momentum as several companies are testing the waters, advancing cancer cachexia pipeline. Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others.

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pharmaphorum

OCTOBER 11, 2020

When added to standard treatment with hormone-based drugs, Ibrance (palbociclib) was unable to achieve better iDFS than hormone therapy alone in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early-stage breast cancer.

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Delveinsight

AUGUST 31, 2021

FDA’s Green Flag to Ascendis’s Once-Weekly SKYTROFA for Treatment of Pediatric Growth Hormone Deficiency. Growth Hormone Deficiency , commonly known as dwarfism, can constitute short stature and complications with metabolism, which arise due to inadequate production of growth hormones by the pituitary gland inside the body.

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XTalks

MARCH 8, 2024

The biosimilar injections, Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz), are approved as interchangeable biosimilars to Prolia and Xgeva, respectively. Despite the approvals, the market launches of Jubbonti and Wyost are uncertain due to ongoing patent litigation between Sandoz and Amgen.

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XTalks

FEBRUARY 3, 2023

Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. This approval follows the promising results of the Phase III EMERALD global clinical trial published in the Journal of Clinical Oncology.

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pharmaphorum

DECEMBER 23, 2020

Originally developed to treat late-stage EGFR-mutated disease, the ADAURA study tested Tagrisso as an adjuvant treatment in patients with early disease following surgery. The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year.

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XTalks

NOVEMBER 10, 2021

Related: GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer. It was developed based on Nobel Prize-winning findings of how cells sense and adapt to oxygen availability. Kidney dysfunction in CKD leads to impaired production of the hormone, particularly in more advanced disease. What is Daprodustat?

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XTalks

FEBRUARY 5, 2024

As we delve into the specifics of these best-selling oncology drugs, we uncover the underlying factors contributing to their market dominance, from clinical efficacy and safety profiles to strategic market positioning and patient accessibility.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) approval and the launch of Aminocaproic Acid Tablets USP, 500mg. market for this product is approximately $12.7 “This is ANI’s seventh generic product launch in 2020 and reaffirms our commitment to increasing the pace of market introductions for our products.

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Delveinsight

DECEMBER 7, 2020

For instance, the shortage of healthcare professionals can be tackled by creating better diagnostic and treatment procedures, integrating solutions developed by physicians worldwide, and providing them seamlessly over a platform accessed by all practicing physicians. Key Players in the MedTech.

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Drug Discovery World

MAY 9, 2024

DDW Editor Reece Armstrong speaks to Michael Wyand, Chief Executive Officer/Director, Oxeia Biopharmaceuticals about the development of the company’s treatment for concussion (OXE103) and the current lack of effective therapies for brain injuries. There are now a number of companies at various stages of developing a concussion drug.

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STAT News

DECEMBER 5, 2022

… Johnson & Johnson said it does not intend to make an offer for Horizon Therapeutics, days after the developer of medicines for rare autoimmune and inflammatory diseases revealed it was in talks with the company , Bloomberg News writes. We hope you have a smashing day and, of course, encourage you to keep in touch.

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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. The post ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition appeared first on Pharmaceutical Technology.

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Drug Discovery World

JUNE 12, 2024

The hormone GLP-1 (glucagon-like peptide-1) and its receptor agonists (GLP-1RAs) have emerged as a compelling class of drugs to tackle diabetes, particularly due to their remarkable efficacy in lowering obesity levels, a fundamental contributing factor of type 2 diabetes.

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XTalks

SEPTEMBER 17, 2020

While the table lists acceptable surrogate endpoints for trials of more common conditions, such as asthma, type 2 diabetes and various cancer types, the document also provides key information to developers of certain rare disease therapies. Both surrogate endpoints could be used to support traditional approval of a new drug or biologic.

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XTalks

MAY 17, 2023

Astellas Pharma recently announced the US Food and Drug Administration (FDA) approval of their new medication, Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. Hormone replacement therapy is thought to be one of the most effective treatments for vasomotor symptoms.

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XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. GLP-1 agonists were first developed as diabetes treatments.

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The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. Pfizer Inc. for a pediatric dose.

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Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). GlobalData’s report assesses how Pembrolizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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The Pharma Data

AUGUST 3, 2021

billion in acquired in-process research & development (acquired IPR&D) associated with our acquisition of Five Prime Therapeutics, partially offset by increased revenues. pts Research & Development $ 1,082 $ 964 12% $ 1,036 $ 936 11% % of product sales 17.7% GAAP earnings per share (EPS) decreased 73% to $0.81 39.3% (25.8)

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XTalks

DECEMBER 22, 2021

The development and widespread adoption of new technologies is key to revolutionizing the way we diagnose, prevent, treat and manage disease. They can be developed and adapted quickly. The market for mRNA-based vaccines and therapeutics is projected to grow from $46.7 percent, according to a report by BCC Research.

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Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

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The Pharma Data

FEBRUARY 8, 2021

Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. 2 ERLEADA ® received U.S.

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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. Trodelvy Boxed Warning.

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