Pharmaceutical Technology

AUGUST 12, 2022

A specifically engineered HER2-directed antibody drug conjugate (ADC), Enhertu is being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca. Enhertu is claimed to be the first HER2-directed therapy to receive approval for treating HER2 mutant metastatic NSCLC patients. “We In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

Bio Pharma Dive

AUGUST 14, 2023

Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

FDA Approval 246

FDA Approval Protein Antibody Drugs 246

Bio Pharma Dive

JULY 17, 2023

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

FDA Approval 237

FDA Approval Antibody Drugs Development 237

BioSpace

AUGUST 17, 2023

The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab-bbfg) makes it the first and only treatment indicated for children and adults with CHAPLE disease.

Antibody 95

Antibody FDA Approval 95

pharmaphorum

DECEMBER 19, 2023

Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies. This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry.

Antibody 115

Antibody FDA Approval Pharma Companies Drugs 115

Pharmaceutical Technology

AUGUST 8, 2022

With the approval for this indication, AstraZeneca is entitled to make a milestone payment of $200m to Daiichi Sankyo under a partnership deal signed in 2019. A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo.

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Fierce Pharma

AUGUST 10, 2023

Johnson & Johnson is digging its multiple myeloma moat deeper thanks to FDA approval for another novel drug. The FDA has signed off on the company's Talvey, a first-in-class bispecific antibody targeting GPRC5D. Johnson & Johnson is digging its multiple myeloma moat deeper.

FDA Approval 96

FDA Approval Antibody Drugs 96

Pharmaceutical Technology

MAY 25, 2023

Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. It will be offered to patients in prefilled syringe and autoinjector administration options.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

Pharmaceutical Technology

JULY 18, 2023

AstraZeneca’s Beyfortus becomes the first preventative option specifically designed for infants in their first RSV season.

FDA Approval 130

FDA Approval Antibody 130

Pharmaceutical Technology

AUGUST 10, 2023

Janssen’s bispecific antibody received accelerated approval as a subcutaneous therapy based on Phase II trial data.

FDA Approval 130

FDA Approval Antibody Trials 130

Pharmaceutical Commerce

FEBRUARY 21, 2024

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

FDA Approval 52

FDA Approval Antibody 52

Pharmaceutical Technology

AUGUST 21, 2023

The monoclonal antibody is the first to be approved for both adult and paediatric patients with CHAPLE disease.

FDA Approval 130

FDA Approval Antibody 130

Bio Pharma Dive

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

FDA Approval 171

FDA Approval Drugs Protein Antibody 171

Bio Pharma Dive

SEPTEMBER 29, 2020

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

FDA Approval 352

FDA Approval Antibody Vaccination Vaccine 352

Bio Pharma Dive

SEPTEMBER 21, 2021

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

FDA Approval 279

FDA Approval Drugs Antibody Medicine 279

Drug Discovery World

MARCH 12, 2024

Here, experts weigh in on the future of monoclonal antibodies (mAbs). Amanda Halford, President Bioprocess, Cytiva “In 2024, the emphasis will remain on novel mAbs, specifically antibody drug conjugates. Innovations include next-generation antibodies with improved efficacy and reduced side effects.

Antibody 81

Antibody FDA Approval Drugs Development 81

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.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

pharmaphorum

OCTOBER 4, 2022

The approval brings hope to many, with breast cancer having surpassed lung cancer to become the most commonly diagnosed cancer in the world: there are approximately 2.3 The post Roche gets FDA approval for HER2 breast cancer diagnostic appeared first on. HER2 is a receptor protein that accelerates cancer cell growth.

FDA Approval 105

FDA Approval Protein Antibody Engineer 105

XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. These antibodies play a crucial role in providing protection by effectively neutralizing the cytotoxic lethal toxin and edema toxin of B. The recommended administration involves two doses, each of 0.5 Overall, 66.3

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

XTalks

OCTOBER 27, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma. Tecvayli is a first-in-class, bispecific T-cell engager antibody administered as a subcutaneous treatment.

FDA Approval 52

FDA Approval Antibody Drugs Trials 52

Pharmaceutical Technology

JUNE 15, 2023

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours. ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells.

FDA Approval 130

FDA Approval Antibody Clinical Trials Clinical Trials 130

Fierce Pharma

JULY 18, 2023

After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee's calendar to determine its place in U.S.

Antibody 86

Antibody Vaccination Vaccine FDA Approval 86

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.

FDA Approval 118

FDA Approval Antibody Marketing 118

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8

FDA Approval 97

FDA Approval Antibody Immune Response Drugs 97

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC).

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

Pharmaceutical Technology

MAY 16, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody directed against aggregated soluble (protofibril), as well as insoluble forms of Aβ. In January 2023, the US Food and Drug Administration (FDA) approved lecanemab under the accelerated approval pathway to treat AD.

Antibody 130

Antibody FDA Approval Branding Regulation 130

Drug Discovery World

FEBRUARY 19, 2024

The US Food and Drug Administration has approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of metastatic, unresectable melanoma. The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

FDA Approval 52

FDA Approval Contract Manufacturing Manufacturing Trials 52

Bio Pharma Dive

AUGUST 4, 2023

The treatment, which won FDA approval in July, is expected to be available by the start of the typical RSV season this fall.

FDA Approval 130

FDA Approval Antibody 130

XTalks

NOVEMBER 2, 2022

In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson’s bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US.

FDA Approval 52

FDA Approval Life Science Antibody Drugs 52

BioSpace

OCTOBER 23, 2023

The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.

FDA Approval 114

FDA Approval Branding Antibody Regulation 114

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

Antibody 98

Antibody Marketing Drugs Licensing 98

Drug Discovery World

FEBRUARY 15, 2024

DDW Editor Reece Armstrong speaks to Tracy M Woody , President and Chief Executive Officer of Cessation Therapeutics, about the company’s goal to develop an antibody therapy to prevent fentanyl overdoses. As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose.

Antibody 59

Antibody FDA Approval Drugs Development 59

Drug Discovery World

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC).

FDA Approval 52

FDA Approval Antibody Trials Drugs 52

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.”

FDA Approval 122

FDA Approval Antibody Drugs Production 122

BioTech 365

JANUARY 28, 2022

FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss – Vabysmo … Continue reading →

FDA Approval 52

FDA Approval Antibody 52

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.

FDA Approval 98

FDA Approval Production Insulin Antibody 98