XTalks

APRIL 3, 2024

The RBCs in circulation are marked by proteins in the complement system for removal by the spleen and liver. While Soliris had its market launch 17 years ago with $3.2 billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year.

FDA Approval 81

FDA Approval Sales Trials Development 81

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

FDA Approval 95

FDA Approval Genetics Gene Therapy Gene 95

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 121

FDA Approval Sales Protein Trials 121

XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death.

FDA Approval 95

FDA Approval Trials Drugs Immune Response 95

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s

FDA Approval 87

FDA Approval Dermatology Trials Clinical Trials 87

XTalks

JUNE 13, 2024

The market for hemp beverages has been growing rapidly in recent years. The passing of the 2018 Farm Bill, which legalized hemp production, boosted the market, allowing companies to explore hemp as a primary ingredient. It is also high in protein — about 43 percent protein by weight — making it an ideal source of plant-based protein.

Marketing 52

Marketing Protein Regulation Production 52

XTalks

OCTOBER 4, 2022

“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release. How Does Rolvedon Work?

FDA Approval 85

FDA Approval Clinical Trials Clinical Trials Trials 85

XTalks

FEBRUARY 26, 2024

After a 16- to 20-week treatment period, among those who received Xolair, 68 percent were able to eat at least a single 600-mg dose of peanut protein without moderate to severe allergic symptoms (such as whole-body hives, persistent coughing or vomiting) compared to six percent who received placebo.

Allergies 77

Allergies FDA Approval Drugs Protein 77

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events. billion in 2032.

FDA Approval 71

FDA Approval Clinical Trials Clinical Trials Trials 71

XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

FDA Approval 98

FDA Approval Antibody Drugs Protein 98

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Avacincaptad pegol can bind to and inhibit the complement protein C5, preventing the cleavage of C5 into C5a and C5b and significantly reducing membrane attack complex (MAC) formation.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

DECEMBER 13, 2023

The disease occurs due to a point mutation in the hemoglobin beta globin ( HBB ) gene that codes for one of the proteins that make up hemoglobin, the oxygen carrier in red blood cells. Morgan analysts were also hopeful about bluebird’s clearer commercialization plan for Lyfgenia and market readiness from Zynteglo.

Gene Therapy 93

Gene Therapy Gene FDA Approval In-Vivo 93

XTalks

JULY 7, 2023

Pfizer’s alopecia JAK inhibitor Litfulo (ritlecitinib) has become its fourth US Food and Drug Administration (FDA) approved product in the past several weeks. Litfulo is entering the alopecia market to rival Eli Lilly’s Olumiant (baricitinib), which was approved as the first drug for alopecia areata a year ago.

Marketing 84

Marketing FDA Approval Trials Drugs 84

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company’s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. today announced U.S. Read more about Roche innovation in MMR biomarker testing.

FDA Approval 52

FDA Approval DNA Reagent Protein 52

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Tyrosine Kinase Inhibitors for Cancer Treatment Tyrosine kinases, or TKs, are a group of signaling molecules that affect multiple downstream proteins.

FDA Approval 82

FDA Approval Life Science Clinical Trials Clinical Trials 82

XTalks

JUNE 6, 2024

billion in 2023, their first non-full year on the market. The prefusion conformation of the F protein is highly conserved across both RSV-A and RSV-B subtypes. mRESVIA’s approval was based on data from the Phase III ConquerRSV study involving 37,000 adults 60 years of age and older across 22 countries. billion pounds ($1.5

FDA Approval 52

FDA Approval Vaccination Vaccine Trials 52

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

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 2024, several blockbuster neurology medications are set to lead the market, capturing the attention of healthcare professionals, investors and patients alike.

FDA Approval 81

FDA Approval Drugs Botox Sales 81

The Pharma Data

MARCH 22, 2023

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

FDA Approval 40

FDA Approval Generic Pharmaceutical Medicine Protein 40

XTalks

AUGUST 19, 2022

Beta thalassemia is a rare inherited blood disorder caused by mutations in the beta-globin gene leading to a reduced amount, or complete absence, of the beta chains of the oxygen-carrying hemoglobin protein in red blood cells. The estimated incidence of the disorder worldwide is one in 100,000. Zynteglo’s hefty price tag of $2.8

Gene Therapy 75

Gene Therapy FDA Approval Gene Clinical Trials 75

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 14, 2022

Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial. binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4. The ADC comprises an FR?-binding

Antibody 246

Antibody FDA Approval Clinical Trials Clinical Trials 246

Delveinsight

FEBRUARY 9, 2021

The move came not long after healthcare investor giant Deerfield Management has forged a partnership to create the Center for Protein Degradation, investing worth USD 80 million. European Marketing Authorisation to ViiV Healthcare’s Rukobia for Multidrug-resistant HIV. A lot has been achieved in the HIV treatment market sphere.

FDA Approval 52

FDA Approval Marketing Research Protein 52

STAT News

NOVEMBER 23, 2022

Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder , STAT writes. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company.

Gene Therapy 97

Gene Therapy FDA Approval Gene Genetics 97

XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A In February 2023, Pfizer revealed that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Abrysvo. percent and severe RSV-associated LRTD by 94.1

Vaccination 96

Vaccination Vaccine FDA Approval Protein 96

pharmaphorum

AUGUST 6, 2020

This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term. Blenrep is also set for approval in Europe in the coming months after a positive opinion from the CHMP scientific committee at the end of last month.

FDA Approval 70

FDA Approval Antibody Drugs Packaging 70

Pharmaceutical Technology

APRIL 28, 2023

Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn. The significant sales growth of Ozempic reinforces its continued dominance in the type 2 diabetes market.

Sales 130

Sales Insulin Marketing FDA Approval 130

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 Undoubtedly, this has played a factor in the success of market-leading PD-1 inhibitors, Merck & Co.’s

Gene Therapy 263

Gene Therapy Marketing Gene Drugs 263

Pharmaceutical Technology

DECEMBER 23, 2022

It acts by hindering the protein shell (capsid) of the HIV-1 virus to hamper the viral lifecycle’s steps. Sunlenca is also said to be the first-ever capsid inhibitor-based HIV therapy to receive such approval. These subjects also had a mean rise in CD4 count of 82 cells/µL.

Drugs 147

Drugs FDA Approval Clinical Trials Clinical Trials 147

Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Myasthenia Gravis Approved Therapies. Some of the approved drugs are: Prograf (Tacrolimus).

Marketing 85

Marketing Antibody Drugs Sales 85

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD.

Sales 147

Sales Drugs Antibody FDA Approval 147

Pharmaceutical Technology

AUGUST 23, 2022

On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. 5-adapted bivalent vaccine will be made readily available for shipping.

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

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. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 79

FDA Approval Drugs Sales Development 79

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD.

Sales 130

Sales Drugs Antibody FDA Approval 130

The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

FDA Approval 40

FDA Approval DNA Protein In-Vitro 40