Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Pfizer maintained its third-place position in the market in 2022, reporting a market capitalization of $287.6 witnessed the biggest market capitalization growth of 45.3% trillion to $3.61 billion on Dec 31, 2022.

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Pharmaceutical Technology

MAY 25, 2023

It is already the first proposed high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar in the world to receive marketing authorisation from the European Commission. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody.

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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. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

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FDA Approval Dermatology Sales Clinical Trials 264

Pharmaceutical Technology

OCTOBER 7, 2022

Additionally, the company granted Sanofi an exclusive right of first negotiation (ROFN) to attain international rights to market teplizumab for T1D indications for a one-time payment of $20m. An anti-CD3 monoclonal antibody, teplizumab is in the developmental stage to delay T1D.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

pharmaphorum

DECEMBER 30, 2021

Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. “We look forward to working with the FDA in their review of our teclistamab submission.”

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FDA Approval Antibody Drugs Production 122

Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

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Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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FDA Approval Licensing Licensing Antibody 264

XTalks

OCTOBER 22, 2021

Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.

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BioSpace

OCTOBER 26, 2023

Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.

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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.

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XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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Pharmaceutical Technology

SEPTEMBER 13, 2022

Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload. As Trodelvy will have the first-in-class advantage in the HER2-negative setting, dato-DXd would have to demonstrate superior efficacy to dominate this market.

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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

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FDA Approval Antibody Drugs Protein 98

XTalks

DECEMBER 20, 2024

The US Food and Drug Administration (FDA) has approved Celltrions Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for the treatment of several immune-mediated diseases. Since September 2024, a new Stelara biosimilar has been approved nearly every month, reflecting a rapid shift in the global biosimilar market.

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XTalks

OCTOBER 22, 2024

Astellas Pharma has won approval from the US Food and Drug Administration (FDA) for Vyloy (zolbetuximab) as a first-line treatment for adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 targeting antibody-drug conjugate.

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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. Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo is administered as a single dose with Imfinzi, followed by Imfinzi infusions every four weeks.

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FDA Approval Trials Drugs Immune Response 98

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.

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Pharmaceutical Technology

DECEMBER 20, 2022

The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Bayer recorded a negative market capitalization growth of 22.3% trillion in Q2 2022 to $3.14

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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.

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BioSpace

JUNE 15, 2023

With Roche’s FDA approval on Thursday, both companies' bispecific antibodies will hit the market this summer for relapsed or refractory diffuse large B-cell lymphoma.

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Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.

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BioPharma Reporter

SEPTEMBER 17, 2024

The original concerns of the US regulatory agency over the manufacturing of Eli Lillyâs Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday.

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STAT News

NOVEMBER 14, 2022

The Food and Drug Administration on Monday approved a new treatment for patients with advanced ovarian cancer — an antibody that delivers a targeted dose of chemotherapy directly to cancer cells. market in more than seven years, and the first approval of a wholly owned medicine in Immunogen’s 41-year history.

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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.

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FDA Approval Antibody Drugs Packaging 87

XTalks

MAY 25, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab’s Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two or more lines of systemic therapy.

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Antibody FDA Approval Drugs Trials 98

XTalks

FEBRUARY 26, 2024

Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure. Xolair is a monoclonal antibody that binds to IgE, a type of antibody in the body that triggers allergic reactions, to block it from binding to its receptors.

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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. This includes a greater focus on digital campaigns and diversifying marketing campaigns with race and ethnicity insights.

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pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

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Marketing Antibody Medicine FDA Approval 98

BioPharma Reporter

JUNE 20, 2024

Biotest, a subsidiary of Grifols, has received FDA approval for Yimmugo, a treatment for primary antibody deficiency syndromes (PID)

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FDA Approval Antibody Regulation Marketing 52

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. The pain relief effects were sustained for up to 48 hours.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Pharmaceutical Technology

SEPTEMBER 2, 2022

Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. lenalidomide) + a steroid ± an anti-CD38 antibody. The first anti-BCMA product to enter the R/R market was GlaxoSmithKline’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin-blmf), gaining FDA approval in 2020.

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XTalks

JANUARY 21, 2022

For AbbVie’s Rinvoq, the FDA approval is an expansion of its approval for the treatment of rheumatoid arthritis and psoriatic arthritis. On the other hand, this is the first US approval for Cibinqo. Dupixent has been a market hit since it was first approved by the FDA in 2017.

FDA Approval 98

FDA Approval Drugs Sales Trials 98

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. The two types of candidates currently in the pipeline can be categorised as monoclonal antibodies and vaccines. per 100,000.

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XTalks

OCTOBER 6, 2020

FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial. Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both the soluble and transmembrane bioactive forms of human TNF-alpha.

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pharmaphorum

AUGUST 17, 2020

The big Swiss pharma had been hoping for approva l in patients regardless of whether they have anti-aquaporin-4 (AQP4) antibodies. But so far Roche has not produced enough data in the broader patient group and the FDA has instead approved Enspryng in patients producing the AQP4 antibodies.

FDA Approval 66

FDA Approval Antibody Branding Trials 66

Pharmaceutical Technology

JANUARY 18, 2023

Under the latest agreement, AffaMed Therapeutics will get exclusive rights for importing, marketing, promoting, distributing, and detailing Galcanezumab after receiving approval in Mainland China. The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP).

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Antibody FDA Approval Production Gene 130

Pharmaceutical Technology

MAY 12, 2023

In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year. The new monoclonal antibody fragment bentracimab is designed to reverse the antiplatelet activity of ticagrelor, a reversible oral P2Y12 platelet inhibitor.

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