Drug Discovery World

MAY 1, 2024

DDW’s Megan Thomas speaks to industry experts and thought leaders about the potential for therapeutic antibodies in 2024. Many of the best-selling drugs in 2023 were monoclonal antibody (mAB) therapies, including Keytruda (pembrolizumab), Humira (adalimumab), and Dupixent (dupilumab) 1.

Antibody 59

Antibody FDA Approval Drugs Development 59

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

JULY 25, 2023

“The approval of Cyfendus vaccine is symbolic of Emergent’s longstanding partnership with the US government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development, in the company’s press release. What Is Anthrax? How Does Cyfendus Work?

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. A fully human anti-IL-7R?

Development 130

Development Clinical Trials Clinical Trials Regulation 130

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

NOVEMBER 14, 2022

The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy. The company has also announced the initial closing of its second equity round of financing.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Clinical trials have demonstrated the efficacy and safety of Susvimo in treating wet AMD.

FDA Approval 104

FDA Approval Clinical Trials Clinical Trials Sales 104

XTalks

JULY 14, 2022

Uncontrolled gout is defined as gout that is unmanageable and/or develops resistance to conventional therapies. Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. It is already approved for three other diseases, and EoE is the first gastrointestinal disease included in this group.

FDA Approval 105

FDA Approval Antibody Clinical Trials Clinical Trials 105

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Drug Discovery World

JULY 14, 2022

Biotech company Actigen has moved closer to clinical trials for rare disease treatment for Hunter syndrome, following a pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA). ? . Hunter syndrome .

Clinical Trials 52

Clinical Trials Clinical Trials Trials FDA Approval 52

XTalks

MAY 17, 2024

Xtalks spoke with Richard Philipson, MD, Chief Medical Officer (CMO) at Calliditas Therapeutics, a Sweden-based company with full commercial operations in the US focused on developing treatments for rare diseases to learn more about the continuing evolution of rare disease drug development.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

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

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. 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.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Premarket Approval (PMA) process (CBER). Regulatory Considerations for Biologics. BLA process (CBER). NDA process (CBER).

Development 161

Development Production Immune Response Licensing 161

XTalks

AUGUST 10, 2022

In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. The approval makes Enhertu the first approved drug for this indication.

Life Science 52

Life Science FDA Approval Drugs Licensing 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 trial has enrolled over 1,400 adult participants with a history of migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Pharmaceutical Technology

OCTOBER 26, 2022

The treatment is indicated for such patients who had received four or more previous lines of therapy, including an immunomodulatory drug, proteasome inhibitor and anti-CD38 monoclonal antibody. Based on the response rate from a trial, the regulatory agency approved the indication under an accelerated approval process.

Antibody 130

Antibody FDA Approval Clinical Trials Clinical Trials 130

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Global President, Vaccines, Pfizer.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

The Pharma Data

JANUARY 17, 2021

In particular, two new drugs developed by Hanmi Pharmaceutical Co., are expected to be approved by the U.S. FDA this year. as a treatment for metastatic breast cancer, under priority review by FDA are about to announce the results of their BLA/NDA approval (biologics license application; BLA), respectively.

FDA Approval 52

FDA Approval Drugs Licensing Licensing 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Pharmaceutical Technology

NOVEMBER 3, 2022

This approval has been granted for once-a-day 25mg tablets of Vemlidy for usage in paediatric patients aged 12 years and above with compensated liver disease. Trial 1092 met the primary endpoint of the percentage of subjects with HBV deoxyribonucleic acid (DNA) levels less than 20 IU/ml following 24 weeks of treatment.

DNA 130

DNA FDA Approval Clinical Trials Clinical Trials 130

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). It was developed with Genmab.

FDA Approval 52

FDA Approval Drug Delivery Doctors Doctor 52

Drug Discovery World

DECEMBER 21, 2023

DDW’s top 10 most popular articles for 2023 reflect the key subjects in drug discovery and development. In a record year for gene therapy approvals, it isn’t surprising that cell & gene therapy (CGT) has been a hot topic. Other biotechnologies coming to the fore this year were antibody-drug conjugates and CRISPR gene editing.

Gene Therapy 59

Gene Therapy Gene Antibody FDA Approval 59

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. The trials assessed measures of improvements in skin clearance, itch relief, disease extent and severity.

FDA Approval 98

FDA Approval Drugs Sales Trials 98

Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma.

Antibody 298

Antibody Trials Clinical Trials Clinical Trials 298

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 52

Drug Discovery World

MARCH 29, 2024

The top stories: Novo Nordisk acquires cardiovascular therapies developer Novo Nordisk has acquired Cardior Pharmaeuticals for up to €1.025 billion, including an upfront payment and additional payments if certain milestones are achieved. News round-up for 25-29 March by DDW Digital Content Editor Diana Spencer.

Drugs 52

Drugs FDA Approval Antibody Trials 52

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab outside of Europe.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS) We are extremely glad to.

Clinical Trials 130

Clinical Trials Clinical Trials Antibody Development 130

Drug Discovery World

DECEMBER 22, 2023

There have been some ground-breaking advances in women’s health this week, with new treatments for hot flushes and pregnancy sickness, and a discovery that could aid in development of treatments for secondary breast cancer.

Drugs 52

Drugs Antibody FDA Approval Clinical Trials 52