XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

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XTalks

OCTOBER 22, 2021

The US Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar for Humira (adalimumab) for the treatment of several inflammatory conditions. This means AbbVie, maker of the world’s top-selling drug Humira, could be in for some stiff competition.

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Drug Discovery World

APRIL 27, 2023

Biotechnology company Tiziana Life Sciences is initiating a programme to develop intranasal foralumab for the treatment or prevention of type 1 diabetes. With the FDA approval of the humanised anti-CD3 mAb TZIELD (teplizumab-mzwv injection) and then its subsequent announced acquisition of Provention Bio by Sanofi for $2.9

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XTalks

JUNE 8, 2022

Amgen’s Riabni, a CD20-directed cytolytic antibody and biosimilar to Rituxan, got approval from the FDA on Monday for adults with moderate to severe rheumatoid arthritis. B-cell targeted therapy with the monoclonal antibody Rituxan (rituximab) is used to treat RA. million Americans.

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XTalks

FEBRUARY 29, 2024

Two years after its approval in 2021 , Biogen has decided to pull the plug on its Alzheimer’s drug Aduhelm (aducanumab). In a statement , the company said it will discontinue Aduhelm to focus efforts on its other amyloid beta-directed antibody Leqembi (lecanemab) for Alzheimer’s and focus on developing other new treatments.

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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.

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Drug Discovery World

JULY 2, 2024

DDW’s Diana Spencer takes a closer look into why Switzerland is such a life sciences powerhouse and how Swiss researchers are advancing new technology and tackling modern health challenges. Switzerland, however, boasts three (or arguably, four) separate yet complimentary centres of life science innovation.

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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).

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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.

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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.

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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). Bladder cancer is the tenth most commonly diagnosed cancer worldwide.

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XTalks

JANUARY 5, 2021

Both drug discovery and drug repurposing to manage and treat the disease will also continue as experts learn more about the virology and epidemiology of the novel SARS-CoV-2 coronavirus that wreaked havoc in 2020. These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity.

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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. Dupixent is approved for patients 12 years of age or older (weighing over 40 kg) at a dose of 300 mg per week. On Friday, Regeneron Pharmaceuticals, Inc.

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XTalks

NOVEMBER 3, 2021

The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). Read the full articles here: FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Kids 5 to 11.

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XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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XTalks

JULY 28, 2021

In this episode, Ayesha discusses a set of recommendations for use of the new FDA-approved Alzheimer’s treatment Aduhelm (aducanumab) published by an expert panel, which was shared at the Alzheimer’s Association International Conference (AAIC) 2021 this week. Subscribe to the Xtalks Food Podcast to never miss a new episode.

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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.

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XTalks

APRIL 23, 2021

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer.

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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. It only needs two refills a year.

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XTalks

NOVEMBER 1, 2022

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. Photo courtesy of AbbVie. . They are chronic and progressive, meaning they will worsen over time without proper intervention.

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pharmaphorum

JULY 19, 2021

A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route. Through partnership and innovation in solving the technical challenges, the development of new complex drug classes can rapidly address challenging medical needs.

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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.

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XTalks

AUGUST 2, 2022

On July 27, 2022, GSK announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) as an intravenous treatment for lupus and active lupus nephritis (LN) in children between the ages of 5 and 17 who are receiving standard therapy. How Benlysta (belimumab) Works.

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XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG).

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XTalks

JANUARY 9, 2023

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Related: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic.

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XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

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XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Immunotherapy techniques use monoclonal antibodies to target malignant cells. Product logo and product image courtesy of Bristol Myers Squibb.

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XTalks

JULY 8, 2022

The US Food and Drug Administration (FDA) has issued a warning for Secura Bio’s Copiktra (duvelisib) after a clinical trial found the drug was associated with a higher risk of serious side effects including a “possible” increased risk of death. In April 2022, the FDA revoked the FL approval at the request of Secura Bio.

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Roots Analysis

DECEMBER 18, 2023

The next generation drug conjugate is relatively a new concept. This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Endocyte also developed other small molecule drug conjugates for the treatment of cancer and renal disorders.

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XTalks

JANUARY 25, 2021

GlaxoSmithKline’s (GSK) ViiV Healthcare — which focuses on HIV treatments and prevention — has received approval from the US Food and Drug Administration (FDA) for its highly anticipated injectable HIV treatment. percent having no detectable loads on traditional three-drug regimens in the same period.

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XTalks

JUNE 16, 2023

Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab.

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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.

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XTalks

FEBRUARY 22, 2024

AstraZeneca and Daiichi Sankyo announced the US Food and Drug Administration’s (FDA) approval of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). The date by which the FDA is expected to make a regulatory decision, as per the Prescription Drug User Fee Act, falls in the last quarter of 2024.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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XTalks

DECEMBER 28, 2023

HDFN is a condition where the mother’s antibodies attack the red blood cells (RBCs) of the fetus or newborn, leading to hemolysis, or rapid destruction of the baby’s RBCs. Currently, there are no approved non-surgical treatments for pregnancies at high risk of this condition.

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