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.

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FDA Approval Antibody Immune Response Drugs 97

Pharmaceutical Technology

OCTOBER 25, 2022

In September, the company’s Imfinzi (durvalumab) plus ch emotherapy received FDA approval for the treatment of locally advanced or metastatic biliary tract cancer in adults. Regulatory applications for combination therapy for advanced liver cancer treatment are currently being reviewed in Japan, Europe and various other countries. .

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Protein Immune Response Antibody FDA Approval 173

STAT News

DECEMBER 23, 2022

In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response. The most common side effect was an overactive immune response called cytokine release syndrome, reported by 39% of patients. Continue to STAT+ to read the full story…

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FDA Approval Immune Response Drugs Research 98

XTalks

NOVEMBER 5, 2024

The FDA-approved FluMist , featured as one of TIME’s Best Inventions of 2024, exemplifies the appeal of needle-free, self-administered nasal vaccines for influenza. Polyrizon’s focus on intranasal protection aligns with a rapidly expanding market in drug delivery innovation.

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Drug Delivery Drugs Immune Response Allergies 111

XTalks

JULY 26, 2023

Related: Brukinsa (zanubrutinib) Gets FDA Approval for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Up to 37 percent of newly diagnosed AML patients have a mutation in the FLT3 gene and of these, 80 percent are FLT3 -ITD mutations. months for patients receiving Vanflyta compared to 12.4

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FDA Approval Immune Response Drugs Trials 98

XTalks

DECEMBER 29, 2023

Classified as a bispecific T-cell engager (BiTE molecule), tarlatamab consists of two essential parts: one binds to T-cells, vital in immune response, and the other targets cancer cells. Tarlatamab differs from conventional chemotherapy as it’s an immunotherapy designed to help immune cells detect, attach to and fight cancer cells.

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Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

SEPTEMBER 25, 2024

The candidate, MPV/S-2P, uses a murine pneumonia virus to deliver the stabilized spike protein, aiming to activate immunity both in the blood and in the respiratory tract’s mucosal tissues — where many respiratory viruses take hold.

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FDA Approval Vaccine Vaccination Pharmacy 52

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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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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FDA Approval Vaccine Vaccination Containment 52

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Development Production Immune Response Licensing 161

XTalks

JUNE 5, 2023

Abrysvo functions as a vaccine by triggering an immune response specifically aimed at RSV preF, which provides protection against RSV-induced LRTD. Safety and Efficacy of Abrysvo The FDA’s approval of Abrysvo is supported by compelling clinical evidence. percent and severe RSV-associated LRTD by 94.1 billion by 2028.

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Vaccine Vaccination FDA Approval Protein 98

XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. The results showed that the vaccine had no serious safety concerns and elicits immune responses against four different strains of the influenza virus.

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Life Science FDA Approval Vaccine Vaccination 40

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

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Immune Response Medicine Vaccine Vaccination 52

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Moreover, 40-50% of patients experience recurrent disease requiring the need for cystectomy, which is associated with significant risks and bladder-sparing treatment options remain limited.

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Antibody Trials Clinical Trials Clinical Trials 52

XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Moreover, 40-50% of patients experience recurrent disease requiring the need for cystectomy, which is associated with significant risks and bladder-sparing treatment options remain limited.

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Antibody Trials Clinical Trials Clinical Trials 52

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.

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Insulin Drugs FDA Approval Immune Response 97

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. At six months, 29.5

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Vaccine Vaccination Immune Response Trials 105

Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. With the world watching, the biopharmaceutical community got to work.

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Manufacturing Vaccine Vaccination RNA 130

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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FDA Approval Manufacturing In-Vivo Trials 52

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

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Immune Response Dermatology Clinical Trials Clinical Trials 105

XTalks

NOVEMBER 3, 2021

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. 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).

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Life Science Drug Delivery Systems Vaccine Vaccination 52

XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. The vaccine is given in two doses.

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Vaccine Vaccination Immune Response Protein 59

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The corticosteroid then works to relieve swelling, redness and itching by targeting the immune response that drives dry eye disease flares. . Over-the-counter treatments fail due to the body’s natural protective system.

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FDA Approval Immune Response Drug Delivery Drugs 52

pharmaphorum

APRIL 26, 2022

The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones. If approved by the FDA, the treatment would become the first microbiome-based treatment to receive approval. Compelling advantages.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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Vaccine Vaccination Immune Response Protein 52

XTalks

AUGUST 17, 2020

Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses. Cell-based immune therapies, including CAR-T cell therapy, have had some marked success, particularly in hematological cancers such as acute lymphocytic leukemia (ALL). Nature by Design.

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Protein Engineer Immune Response In-Vivo 98

pharmaphorum

APRIL 20, 2022

Adding vidutolimod gives Regeneron an opportunity for combination therapies with its own immuno-oncology drugs, headed by its Sanofi-partnered PD-1 inhibitor Libtayo (cemiplimab) which is FDA-approved for skin cancers cutaneous squamous cell carcinoma and basal cell carcinoma and non-small cell lung cancer.

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Immune Response Antibody FDA Approval Trials 52

XTalks

MARCH 8, 2024

This evidence included comparisons of the products using an extensive array of physicochemical tests and biological assays to confirm the biosimilars’ similarity in efficacy, safety and immune response to the original drugs, the FDA explained.

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Drugs FDA Approval Production Immune Response 59

pharmaphorum

JUNE 9, 2021

Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. In two phase 3 trials in adults reported last year, V114 stimulated immune responses to all serotypes in the shot.

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Vaccine Vaccination Immune Response Regulation 52

pharmaphorum

JANUARY 5, 2021

Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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Immune Response FDA Approval Drugs Sales 52

The Pharma Data

DECEMBER 31, 2020

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

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Vaccine Vaccination FDA Approval Hormones 52

The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

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Vaccine Vaccination Immune Response FDA Approval 52

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). News information is not all-inclusive and updates are published once a week on Tuesdays. . .

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Antibody Vaccine Vaccination Manufacturing 52

XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. In early 2021, the FDA approved Pfizer’s Panzyga for the treatment of CIDP.

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FDA Approval Immune Response Trials Drug Delivery 40

The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Source: Novavax, Inc. . Posted: November 2020.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

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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Drugs FDA Approval Vaccine Vaccination 52

The Pharma Data

MARCH 29, 2022

The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).

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Vaccine Vaccination FDA Approval Immune Response 52