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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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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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. billion in just one year and a quarter.

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XTalks

JUNE 10, 2024

Efruxifermin is a novel Fc-FGF21 fusion protein designed to emulate the activity of native FGF21, an endogenous hormone that regulates metabolism and alleviates cellular stress. No serious adverse events related to the drug were reported. MASH is intricately linked to cardiovascular, kidney and metabolic disorders.

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Drug Discovery World

NOVEMBER 16, 2022

The new funding will power the expansion of Juvena’s drug discovery platform and advance the company’s biologics pipeline targeting chronic and age-related diseases. . These limitations have constrained biopharma’s approach to studying the role of secreted proteins only as drug targets or biomarkers, rather than drug agents themselves. .

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. Drug Enforcement Administration. Drug Enforcement Administration. WAKIX is administered orally, once daily in the morning upon wakening.

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XTalks

OCTOBER 11, 2023

While the link between GLP-1 inhibitors and gastrointestinal side effects has been known for diabetics taking the drugs, this is the first study that was conducted among non-diabetics taking them for weight loss. Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes.

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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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Hormones FDA Approval Development Genetics 60

pharmaphorum

JULY 19, 2022

Lynparza has been a very successful drug for the AZ and Merck alliance, generating $2.75 billion for AZ last year across its eight FDA-approved indications, while Merck booked $989 million from its share of profits from the drug.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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XTalks

JUNE 27, 2022

Novartis’ Tafinlar and Mekinist received FDA approval for the treatment of unresectable or metastatic solid tumors with the BRAF V600E mutation. The latest approval extends the potential benefits of this combination to treat patients with any type of solid tumor, expanding upon its previous indications.

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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

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults.

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo. percent and 22.5

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XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. While weight loss effects can vary depending on the drug, studies show that all GLP-1 meds can result in an average weight loss of about 10.5

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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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Drug Discovery World

MAY 9, 2024

RA: Tell us how OXE103 works? MW: OXE103 (ghrelin) is a 28 amino acid neuro-peptide hormone that crosses the blood brain barrier and is responsible for maintaining brain energy homeostasis and neuroprotection related to neuronal cell preservation, axonal connectivity and decreased inflammation.

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The Pharma Data

FEBRUARY 8, 2021

Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. DRUG INTERACTIONS. About Metastatic Castration-Sensitive Prostate Cancer.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

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FDA Law Blog

OCTOBER 28, 2021

Butler — Having a hand in the FDA approval of important new prescription drugs is one of the things that makes our work at HPM so gratifying. Other considerations might include the specific hormones in the product, the levels of hormones, the side effect profile, ease of use, and the ability to comply with the labeled regimen.

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Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). and around the world.

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The Pharma Data

JULY 22, 2021

In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from KEYNOTE-775/Study 309. KENILWORTH & WOODCLIFF, N.J.–(BUSINESS today announced that the U.S.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). AMG 451 / KHK4083.

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The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). PRESCRIBING INFORMATION.

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Drug Discovery World

AUGUST 21, 2023

However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited. The regulator had already approved the combination treatment in advanced cancers the previous year. appeared first on Drug Discovery World (DDW).

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Intouch Solutions

AUGUST 5, 2021

This then leads many of those same people to online forums like the TransDIY subreddit that’s dedicated to do-it-yourself hormone replacement therapy, or DIY HRT. DIY HRT is a combination of non-prescribed, often unregulated, hormone medicines and self-performed surgeries that are administered without the supervision of an HCP.

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The Pharma Data

JUNE 24, 2021

Food and Drug Administration (FDA) has approved MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 The FDA approval of MYFEMBREE represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S.” .

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. DRUG INTERACTIONS. Effect of ERLEADA ® on Other Drugs — ERLEADA ® is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. 2 ERLEADA ® received U.S.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

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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

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). If approved, TicoVac would be the first vaccine in the U.S.

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XTalks

MAY 20, 2022

Eli Lilly’s diabetes and weight loss shot tirzepatide, known by its trade name Mounjaro, received a much-anticipated nod from the US Food and Drug Administration (FDA) last week for the treatment of diabetes. The injection is intended to regulate blood sugar, in conjunction with diet and exercise, in adults with type 2 diabetes.

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