Bio Pharma Dive

JANUARY 18, 2024

The biotech will receive $500 million upon FDA approval of its rare disease drug acoramidis after selling 5% sales royalties to two investment firms.

FDA Approval 176

FDA Approval Drugs Sales 176

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019.

Drugs 264

Drugs FDA Approval Containment Licensing 264

Bio Pharma Dive

AUGUST 29, 2024

Nipocalimab is one of several drugs J&J has forecast for multi-billion dollar sales. The company’s initial application is for its use in myasthenia gravis.

FDA Approval 135

FDA Approval Drugs Sales 135

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

FDA Approval 130

FDA Approval Manufacturing Production Protein 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. Pfizer reaped $36.8bn from Comirnaty, the highest revenue generated from Covid-19 vaccine sales worldwide. YoY revenue growth.

Vaccination 272

Vaccination Vaccine Sales Generic Drugs 272

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

XTalks

JANUARY 3, 2025

The global market for eye drugs continues to grow as vision-related conditions, particularly among aging populations, drive demand for innovative therapies. In this blog, we delve into the recent sales data to highlight the top three best-selling eye drugs in 2023. Fourth-quarter US net sales of Eylea in 2023 totaled $1.34

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Sales FDA Approval Drugs Medicine 85

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

FDA Approval 124

FDA Approval Sales Protein Trials 124

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.0mg, for the treatment of type 2 diabetes.

Sales 130

Sales Insulin Marketing FDA Approval 130

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation. percent of US sales revenue from Niktimvo.

FDA Approval 99

FDA Approval Drugs Gene Trials 99

XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 The FDA approved 2.5

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

pharmaphorum

JULY 10, 2024

After short but worrying delay, Arcutis gets FDA approval for flagship drug Zoryve in atopic dermatitis, which could further unlock sales growth

FDA Approval 116

FDA Approval Sales Drugs 116

XTalks

APRIL 3, 2024

The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).

FDA Approval 102

FDA Approval Sales Trials Development 102

Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

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Drugs Drug Delivery FDA Approval Licensing 147

pharmaphorum

OCTOBER 30, 2024

Novartis says FDA approval for frontline use of its leukaemia drug Scemblix will boost the number of eligible patients four-fold, as it hunts blockbuster sales

FDA Approval 115

FDA Approval Sales Drugs 115

STAT News

DECEMBER 12, 2022

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

FDA Approval 98

FDA Approval Sales Drugs Clinical Trials 98

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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Clinical Trials Clinical Trials FDA Approval Trials 234

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

Gene Therapy 95

Gene Therapy Sales Gene FDA Approval 95

XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. Related: Nerivio: New Drug-Free Wearable Technology Used to Treat Migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s Top researchers who advised the U.S.

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FDA Approval Drugs Doctors Doctor 239

XTalks

JUNE 3, 2024

Biocon Biologics’ Yesafili (aflibercept-jbvf) and Biogen and Samsung Bioepis’ jointly developed Opuviz (aflibercept-yszy) have been given the green light by the US Food and Drug Administration (FDA) as the first interchangeable biosimilars to blockbuster eye drug Eylea. In 2022, global Eylea sales hit $9.6

FDA Approval 98

FDA Approval Sales Clinical Trials Clinical Trials 98

XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. billion in sales in 2020 and has been outselling Merck’s previous shot, Pneumovax 23, by almost five to one.

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

Pharmaceutical Technology

NOVEMBER 11, 2022

For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In October, the US Food and Drug Administration (FDA) approved the company’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) for treating adults with unresectable hepatocellular carcinoma.

FDA Approval 242

FDA Approval Clinical Trials Clinical Trials Sales 242

pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

FDA Approval 98

FDA Approval Trials Sales Drugs 98

pharmaphorum

JANUARY 18, 2025

Can a new FDA approval in colorectal cancer kickstart sales growth for Amgen's KRAS inhibitor Lumakras

FDA Approval 95

FDA Approval Sales Drugs 95

XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

FDA Approval 66

FDA Approval Sales Antibody Protein 66

XTalks

OCTOBER 4, 2022

The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

Pharmacy Checkers

NOVEMBER 12, 2020

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Prescription Drug Importation.” Bollyky and Aaron S.

FDA Approval 62

FDA Approval Drugs Filler Manufacturing 62

XTalks

JULY 14, 2022

Rare and rheumatic disease-focused biotech Horizon Therapeutics has received expanded approval from the US Food and Drug Administration (FDA) for its gout injection Krystexxa (pegloticase) to include its co-administration with the immunomodulator methotrexate. It is the first and only biologic approved for the condition.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

World of DTC Marketing

MARCH 10, 2022

AbbVie’s wall of patents protecting its top-selling drug Humira will keep another would-be competitor from entering the U.S. Sales of Humira earned AbbVie $20.7 AbbVie won dozens of additional patents — what critics call a “patent thicket” — that extended the exclusive market for the drug. Richard Gonzalez, C.E.O.

FDA Approval 205

FDA Approval Drugs Branding Sales 205

pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Sales Antibody Drugs 93

XTalks

NOVEMBER 1, 2024

The neurology drug market continues to be dynamic with novel treatments that cater to a broad range of neurological and psychiatric conditions. In this blog, we highlight the top 20 best-selling neurology drugs to watch in 2024, based on 2023 sales statistics.

FDA Approval 85

FDA Approval Drugs Botox Sales 85

pharmaphorum

NOVEMBER 24, 2020

With this third indication, Xofluza has become the first single-dose medicine approved for this new use also known as post-exposure prophylaxis. This provides a more convenient alternative to older drugs such as Roche’s own Tamiflu (oseltamivir), which is taken once daily for 10 days in this indication.

FDA Approval 105

FDA Approval Medicine Licensing Licensing 105

Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. Additionally, it intends to start a fixed-dose, placebo-controlled, pivotal Phase III trial in ADHD paediatric and adolescent patients in the middle of this year.

FDA Approval 147

FDA Approval Life Science Sales Marketing 147

XTalks

JANUARY 29, 2025

Eli Lilly launched a 75-second TV commercial called Change in November 2024 to promote the companys GLP-1 obesity drug Zepbound (tirzepatide). This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval.

FDA Approval 71

FDA Approval Drugs Hormones Marketing 71