XTalks

MAY 2, 2022

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? Presently, Eisai expects a submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lecanemab for the treatment of early AD in the second quarter of 2022.

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

pharmaphorum

JULY 18, 2022

You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. CD4s are present to stimulate B cells, so they keep producing antibodies, whereas CD8 or inner cells go after infected cells, killing them before the virus spreads.

Vaccination 138

Vaccination Vaccine Development Immune Response 138

XTalks

FEBRUARY 12, 2025

Similarly, Mediar Therapeutics entered a global licensing agreement with Eli Lilly to advance MTX-463, a first-in-class human IgG1 antibody that neutralizes WISP1-mediated fibrotic signaling, into a Phase II trial.

Clinical Trials 66

Clinical Trials Clinical Trials Trials FDA Approval 66

Delveinsight

DECEMBER 8, 2020

KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus. KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.

Licensing 52

Licensing Licensing Gene Therapy Antibody 52

XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Vic-]Trastuzumab Duocarmazine Mechanism of Action.

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

XTalks

OCTOBER 22, 2024

Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. targeting antibody-drug conjugate. On the other hand, Merck & Co. directed ADC SKB315.

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Few details of the deal were disclosed in the announcement. A second liver biopsy will be performed after 18 months.

Licensing 52

Licensing Licensing Protein Antibody 52

XTalks

DECEMBER 13, 2024

Blenrep is an antibody-drug conjugate (ADC) created by linking a B-cell maturation antigen (BCMA)-targeting monoclonal antibody to a potent cytotoxic agent, auristatin F, using a stable, non-cleavable linker technology. Recent regulatory milestones further bolster Blenreps momentum.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. This gives lerodalcibep an edge to approved PCSK9 inhibitors.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

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

pharmaphorum

SEPTEMBER 7, 2020

AbbVie has claimed rights to an immuno-oncology antibody from I-Mab in what is thought to be a record licensing deal involving a Chinese biotech. According to I-Mab, its antibody has a lower tendency than other anti-CD47 drugs in development to bind to normal red blood cells, which it says should minimise side effects.

Drugs 66

Drugs Antibody Clinical Trials Clinical Trials 66

The Pharma Data

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer. Graham earned an M.D.,

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. These antibodies play a crucial role in providing protection by effectively neutralizing the cytotoxic lethal toxin and edema toxin of B. The recommended administration involves two doses, each of 0.5 Overall, 66.3

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

XTalks

NOVEMBER 4, 2022

In the announcement, Pfizer said it plans to submit a Biologics License Application (BLA) to the FDA by the end of this year for the vaccine candidate and other regulatory authorities thereafter in the coming months. In a Phase III clinical trial, the two pharma giants revealed one of the candidate antibodies, nirsevimab, led to 74.5

Vaccine 97

Vaccine Vaccination Clinical Trials Clinical Trials 97

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. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

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. This is why methotrexate was paired with it, as methotrexate is used to treat inflammatory conditions like arthritis.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval. Priced at $3.5

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

XTalks

JULY 17, 2023

targeted monoclonal antibody is being evaluated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2-positive. This investigational first-in-class Claudin 18.2 Zolbetuximab functions by binding to the CLDN18.2

Clinical Trials 95

Clinical Trials Clinical Trials Trials Antibody 95

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. Two years after its approval in 2021 , Biogen has decided to pull the plug on its Alzheimer’s drug Aduhelm (aducanumab).

Drugs 59

Drugs FDA Approval Antibody Life Science 59

XTalks

MARCH 1, 2021

The third dose will be administered to the participants regardless of antibody titer levels. After the third dose, antibody levels will be assessed at the time of the third dose, and then one week and one month thereafter.

Vaccination 111

Vaccination Vaccine Development In-Vitro 111

pharmaphorum

NOVEMBER 22, 2022

It also says it will focus on technological areas where it has strength, such as antibody-drug conjugates. That diversified model makes it a small player in pharma than many of its peers, but new chief executive Belén Garijo has made it clear her ambition is to grow that side of the business through bolt-on deals, licensing and partnerships.

Production 52

Production Licensing Licensing Antibody 52

XTalks

SEPTEMBER 13, 2021

ProQR announced yesterday that it had landed a global licensing and research collaboration with Eli Lilly and Company “focused on the discovery, development and commercialization of potential new medicines for genetic disorders in the liver and nervous system.”. ProQR could also receive an additional $1.25

RNA 105

RNA Genetics Genetic Disease Medicine 105

XTalks

AUGUST 20, 2020

Stepping away from its cardiovascular and diabetes research, Hudson touted the potential of Sanofi’s Dupixent, an antibody drug approved to treat asthma and atopic dermatitis, saying, “Dupixent has the chance to be one of the most successful medicines in the history of the industry,” in a media call.

Development 98

Development Trials Drugs Licensing 98

XTalks

APRIL 26, 2021

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. R21/MM vaccinated participants had high titers of malaria-specific anti-NANP antibodies 28 days after the third vaccination, which were almost doubled with the higher adjuvant dose.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . ” About the author .

Vaccination 98

Vaccination Vaccine Manufacturing Production 98

XTalks

APRIL 23, 2021

Dostarlimab is a programmed death receptor-1 (PD-1) blocking antibody that targets the PD-1/PD-L1 pathway to block its inhibition of T cell function, allowing the immune cells to seek out and destroy cancer cells. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody DNA 105

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Tegoprubart is an anti-CD40L antibody designed to inhibit the CD40 and CD11 costimulatory signaling pathways. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

XTalks

OCTOBER 26, 2020

Provention is developing an investigational anti-CD3 monoclonal antibody called PRV-031 (teplizumab), which is designed to delay onset, or prevent T1D in at-risk individuals. The company began rolling submission of a biologic license application (BLA) to the FDA for teplizumab back in April. T1D Therapy and Prevention.

Insulin 98

Insulin Packaging Packaging Doctor 98

pharmaphorum

SEPTEMBER 30, 2020

The combined company will be called Vincera and will focus its initial energies on a clinical-stage PTEFb/CDK9 inhibitor and preclinical bioconjugation platform, both licensed from German group Bayer. This is the latest in a recent clutch of biotech SPACs. Those are all in early preclinical development.

Life Science 64

Life Science Drugs Development Licensing 64

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). First, there is a lab-made antibody that locks onto TROP2, the marker found on most NSCLC tumors. This antibody guides the therapy to the cancer.

Antibody 59

Antibody Clinical Trials Clinical Trials Trials 59

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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. The rest will be invested in “highly impactful existing companies.” The promise to partners is to “move quickly.

RNA 52

RNA Antibody Life Science Protein 52

XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Antibody 59

pharmaphorum

FEBRUARY 5, 2021

The agreement with Branson’s VG Acquisition Corp ties in with an emerging trend among life sciences companies to forego the usual initial public offering (IPO) route and instead merge with an already-listed special purpose acquisition company (SPAC). 23andMe – which will be valued at around $3.5

Genetics 52

Genetics DNA Life Science Clinical Trials 52

Delveinsight

JANUARY 19, 2021

Enhertu is an antibody-drug conjugate (ADC) that comprises a humanized anti-HER2 IgG1 monoclonal antibody. CABIM plans to help make new therapeutics, medicines, and technologies accessible to patients and strengthen Greater Boston’s position as the world’s life science capital.

Manufacturing 40

Manufacturing Gene Therapy Life Science FDA Approval 40

XTalks

SEPTEMBER 17, 2020

Immunomedics has plans to submit a Supplemental Biologics License Application to support the full approval of Trodelvy in the US in the last quarter of 2020. Trodelvy is an antibody-drug conjugate (ADC).

HR 72

HR Medicine Drugs Licensing 72

XTalks

NOVEMBER 2, 2020

Fasenra (benralizumab) is a monoclonal antibody that binds to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to almost completely eradicate eosinophils via apoptosis (programmed cell death). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co.,

Trials 94

Trials FDA Approval Drugs Hormones 94