Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients.

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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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XTalks

APRIL 9, 2025

Continued approval will depend on verification of clinical benefit from the ongoing ALIGN studys longterm analysis of estimated glomerular filtration rate decline. Beyond Vanrafia, Novartis is advancing zigakibart, a subcutaneously administered antiAPRIL monoclonal antibody in PhaseIII development for IgAN.

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FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

MARCH 10, 2025

The FDA has approved Celltrions Omlyclo (omalizumab-igec) as an interchangeable product to Xolair. Omlyclo marks Celltrions fourth FDA approval in barely three months this year a significant milestone signaling the companys rapid advancement in the biosimilar space.

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Allergies FDA Approval Antibody Trials 66

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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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. Evidence for the Efficacy of Riabni.

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FDA Approval Antibody Clinical Trials Clinical Trials 96

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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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

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.

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XTalks

JULY 14, 2022

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. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

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FDA Approval Antibody Trials Drugs 105

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

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

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Pharmaceutical Technology

APRIL 24, 2023

In 1974, Dr. Robert Langer was part of the first cohort of researchers to begin nanoparticle research , as his lab at Cornell University developed tiny particles to deliver large molecules for angiogenesis. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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STAT News

DECEMBER 23, 2022

Food and Drug Administration approved a new treatment for patients with follicular lymphoma, a slow-growing type of blood cancer, said Genentech , its maker and a subsidiary of Roche. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response.

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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

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.

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Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The international T1D network TrialNet’s research was instrumental in the FDA’s approval of the first drug to delay T1D in at-risk people.

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Insulin FDA Approval Research Development 246

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

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Thanks to research that has delivered innovative and effective medicines, people with CLL can remain on therapy for years so tolerability is an important consideration.

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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. According to the Centers for Disease Control and Prevention (CDC) , 45.8 GlobalData is the parent company of Pharmaceutical Technology.

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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. Mammen added that, “For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients.”.

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FDA Approval Clinical Trials Clinical Trials Trials 71

XTalks

AUGUST 2, 2022

Benlysta (belimumab) is a biologic therapy, a human monoclonal antibody. Autoreactive B cells release antibodies like other B cells do, except they release autoantibodies. Register for this free webinar to learn why patient-centricity is important in rare disease research. How Benlysta (belimumab) Works.

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FDA Approval Antibody Bacteria Protein 94

Pharmaceutical Technology

SEPTEMBER 2, 2022

This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. lenalidomide) + a steroid ± an anti-CD38 antibody. Should CAR-T cells, or antibodies be used first?

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XTalks

FEBRUARY 12, 2025

Nerandomilast is Boehringers next candidate for PPF and IPF following their FDA-approved treatment, Ofev (nintedanib) one of only two approved therapies for IPF, alongside pirfenidone. Recent advances highlight a broader wave of innovation in pulmonary fibrosis research.

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Clinical Trials Clinical Trials Trials FDA Approval 66

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.

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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. Lerner researchers developed a novel artificial intelligence platform to identify potential drugs for COVID-19, finding melatonin to be a promising candidate.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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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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Pharmaceutical Technology

SEPTEMBER 15, 2022

Regeneron’s windfall of $16.1bn in revenue for the year was largely due to its Covid-19 monoclonal antibody therapy, REGEN-COV; due to its ineffectiveness against the Omicron variant, however, its success is expected to be short-lived. Moderna’s Covid-19 vaccine, Spikevax, also contributed to the company’s $18.5bn in revenue for the year.

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XTalks

NOVEMBER 15, 2023

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s press release. The data showed a 98.9

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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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Antibody Clinical Trials Clinical Trials Medicine 52

Pharmaceutical Technology

AUGUST 16, 2022

Of this amount, Horizon plans to recognise research and development (R&D) costs of nearly $32.5m antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. Q32 is entitled to get $55m as initial consideration and staged development funding during the option period.

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XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold.

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XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. 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.

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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. Basel, 17 August 2020.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 28, 2023

The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. Key among them has been the extension of Syngene’s research collaboration with leading biotech company Amgen Inc. until 2026. until 2026.

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XTalks

JANUARY 21, 2025

Skovronsky, MD, PhD, chief scientific officer, and president of Lilly Research Laboratories and Lilly Immunology, in the news release. With Omvoh approved in both Crohns disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them.

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