XTalks

JANUARY 5, 2021

These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity. Eli Lilly’s bamlanivimab and Regeneron’s monoclonal antibody cocktail REGEN-COV2 which consists of two monoclonal antibodies, casirivimab and imdevimab, were approved in 2020 for use in the treatment of COVID-19 patients.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

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FDA Approval Trials Antibody DNA 105

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.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98

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.

FDA Approval 97

FDA Approval Genome Genomics DNA 97

XTalks

FEBRUARY 29, 2024

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. After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023.

Drugs 59

Drugs FDA Approval Antibody Life Science 59

XTalks

JULY 10, 2023

UCB specializes in the discovery and development of innovative medicines for severe diseases that affect the immune system or central nervous system. Rystiggo (rozanolixizumab) is a medication indicated for the treatment of gMG in adult patients who test positive for AChR or MuSK antibodies. What Is Generalized Myasthenia Gravis (gMG)?

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

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 Most TEAEs were mildly or moderately severe and resulted in a low frequency of treatment discontinuation.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

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.

FDA Approval 52

FDA Approval Drugs Antibody Medicine 52

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

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Gene Therapy Gene FDA Approval Antibody 98

XTalks

AUGUST 15, 2023

Approximately 10 to 15 percent of patients with mCRPC have alterations in the BRCA gene — this subset of patients is likely to have aggressive disease, poor outcomes and a shorter survival time, according to information in a press release from Johnson & Johnson announcing Akeega’s FDA approval.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

XTalks

MAY 29, 2024

J&J’s pharma group, Innovative Medicine, generated $54.76 The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. Johnson & Johnson Revenue in 2023: $85.16 In 2023, the company experienced an annual growth rate of 6.5 billion last year, up 4.2

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Pharma Companies Sales FDA Approval Vaccination 52

XTalks

MAY 29, 2024

Vertex launched its cystic fibrosis medicine Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in 2019. Looking ahead, Pfizer plans to leverage its expertise in protein engineering and medicinal chemistry to further develop Seagen’s antibody-drug conjugate (ADC) technology.

Medicine 52

Medicine Marketing FDA Approval Development 52

XTalks

MAY 24, 2024

Carbone, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center, in a recent press release. Imdelltra is a novel immunotherapy, where a bispecific antibody binds to both CD3 on T cells and DLL3 on tumor cells.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Spevigo is the first approved treatment option for GPP in adults. Clinical Trial Behind Spevigo.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Dermatology 52

XTalks

MARCH 28, 2024

Furthermore, the introduction of multi-targeted kinase inhibitors and monoclonal antibodies is also being examined as a possible form of therapy. Building Cancer Awareness and Empowering Métis Youth: Featuring Jordyn Playne, President, Métis Nation of Ontario Youth Council – Xtalks Life Science Podcast Ep.

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Gene Editing Life Science Clinical Trials Clinical Trials 59

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 101

FDA Approval Drugs Sales Development 101

pharmaphorum

SEPTEMBER 21, 2021

“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” said Pam Cheng, AZ’s executive vice president of global operations and IT.

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Manufacturing Life Science FDA Approval Medicine 59

XTalks

MARCH 8, 2024

Denosumab is a RANKL (receptor activator of nuclear factor kappa beta ligand) monoclonal antibody that blocks the ability of RANKL to bind to its receptor RANK. Jubbonti is the first interchangeable biosimilar approved to treat osteoporosis and increase bone mass.

Drugs 59

Drugs FDA Approval Production Immune Response 59

Roots Analysis

DECEMBER 18, 2023

This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Similar to the structure of the antibody drug conjugates, these next generation drug conjugates use a non-antibody-based targeting ligand, a cytotoxic payload and a linker.

Drugs 40

Drugs FDA Approval Antibody Development 40

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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Allergies FDA Approval Drugs Protein 100

Delveinsight

JANUARY 19, 2021

A Sweet Year For Daiichi/ AZ As Enhertu Gets FDA Approval For Gastric Cancer. Enhertu is an antibody-drug conjugate (ADC) that comprises a humanized anti-HER2 IgG1 monoclonal antibody. The approval is based on the positive results from the randomised Phase 2 trial conducted in Japan and South Korea.

Manufacturing 40

Manufacturing Gene Therapy Life Science FDA Approval 40

Pharmaceutical Technology

DECEMBER 22, 2022

AstraZeneca and Daiichi Sankyo win the Business Expansion award this year as their collaboration bears more fruit in terms of new approvals. Blueprint Medicines wins the Financing award this year after securing significant financing partnerships worth up to $1.25bn. Innovation.

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Insulin Production Development Genetics 130

XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

MAY 2, 2023

In December 2021, AstraZeneca and Amgen’s Tezspire (tezepelumab) was approved by the FDA for patients 12 years of age and older with severe asthma that is not controlled by their current asthma medicine. Regeneron and Sanofi’s Dupixent (dupilumab) received FDA approval in 2018 for the treatment of moderate-to-severe asthma.

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Protein FDA Approval Clinical Trials Clinical Trials 109

The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.

RNA 52

RNA Antibody Life Science Protein 52

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

Research 98

Research Hormones Protein Regulation 98

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. But there was some considerable progress in other fields of medicine even though research efforts were diverted away, reports Richard Staines.

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Marketing Gene Silencing Gene Drugs 96

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

JANUARY 6, 2023

Last week, the FDA approved a new infusible medication from TG Therapeutics for adults with relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome (CIS), relapsing-remitting (RR) MS, and active secondary progressive MS (SPMS). Briumvi (ublituximab-xiiy) Clinical Trial Results.

FDA Approval 94

FDA Approval Clinical Trials Clinical Trials Antibody 94

XTalks

DECEMBER 19, 2023

billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. billion Company: Pfizer Diseases it is FDA-approved to treat: COVID-19 Cost: The price of Paxlovid oral tablet is around $10 for a supply of 30 tablets.

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Sales FDA Approval Drugs Vaccination 64

XTalks

MAY 25, 2021

A biosimilar, which is essentially a generic biologic, is defined by the US Food and Drug Administration (FDA) as a biological product that is highly similar to and has no clinically meaningful differences from an already approved biological medicine (the “reference medicine”).

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Production Drugs Marketing Sales 98

XTalks

MAY 31, 2023

Headquartered in California, Acelyrin is a late-stage clinical biopharmaceutical company dedicated to expediting the development and delivery of groundbreaking medicines in the field of immunology. If tecarfarin receives FDA approval, the company anticipates annual revenues of approximately $1 billion in the US market.

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Clinical Trials Clinical Trials Trials Production 97

XTalks

JUNE 5, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior VP and chief scientific officer, Vaccine Research and Development at Pfizer, in the company’s news release.

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Vaccination Vaccine FDA Approval Protein 98

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

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Sales Manufacturing FDA Approval Life Science 98

XTalks

AUGUST 17, 2020

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. The design of the immune biologic puts these elements together on an antibody scaffold. Image from Cue Biopharma.

Protein 98

Protein Engineer Immune Response In-Vivo 98

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo.

FDA Approval 98

FDA Approval HR Hormones Antibody 98