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

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

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 Vaccine Vaccination Antibody 98

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

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.

Vaccine 111

Vaccine Vaccination 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

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

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 .

Vaccine 98

Vaccine Vaccination Manufacturing Production 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

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

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

The Pharma Data

OCTOBER 26, 2020

AR-711 is a fully human immunoglobulin 1, or IgG1, monoclonal antibody discovered from screening the antibody secreting B-cells of convalescent COVID-19 patients. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus. About AR-711. The Company is utilizing its proprietary ?PEX

Antibody 52

Antibody Genetic Engineering Development Clinical Trials 52

XTalks

AUGUST 2, 2024

Nemolizumab is a monoclonal antibody that targets IL-31, a cytokine responsible for many atopic dermatitis symptoms. The US Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review, with a decision expected by the end of this year.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

XTalks

JANUARY 12, 2023

With data recently published from a large global confirmatory Phase III clinical trial (Clarity AD) , Eisai will also file a supplemental Biologics License Application (sBLA) to the FDA to have Leqembi approved under the traditional pathway, too. Viehbacher, President and CEO of Biogen, in the press release.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

XTalks

APRIL 2, 2021

In a pivotal Phase III trial involving adolescents 12 to 15 years of age, Pfizer/BioNTech’s COVID-19 vaccine trial results show that its vaccine, BNT162b2, has a demonstrated efficacy of 100 percent and elicits strong antibody responses. The vaccine was well-tolerated in both age groups. 1.351 lineage.

Vaccine 59

Vaccine Vaccination Trials Clinical Trials 59

XTalks

SEPTEMBER 17, 2020

However, due to serious risks – including the drug’s potential to stimulate the production of anti-metreleptin antibodies and an increased risk of lymphoma – it is only available through a Risk Evaluation and Mitigation Strategy mandated by the FDA. What Is a Surrogate Endpoint? Primary Hyperoxaluria Type 1 (PH1).

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

NOVEMBER 5, 2020

Most recently, Holland served as Global Head of licensing at Lonza AG. Prior to Lonza, she led External Science and Partnering across the globe for Sanofi R&D. Previously, he was an associate director at Navigant Life Science Consulting. Daniel Geffken was named interim chief financial officer of CalciMedica.

Genomics 40

Genomics Genome Medicine Life Science 40

XTalks

JUNE 12, 2023

This acquisition granted BD access to advanced assays licensed from the EuroFlow Consortium, an independent scientific network in hematology and immunology. This extended BD’s already established 12-year licensing collaboration with EuroFlow, bolstering its portfolio of assays.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

XTalks

MAY 30, 2024

Potential New CIDP Treatment: argenx’s Efgartigimod Alfa The US Food and Drug Administration (FDA) has accepted argenx’s supplemental Biologics License Application (sBLA) for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for priority review to treat CIDP.

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

The Pharma Data

DECEMBER 23, 2020

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccine Vaccination Immune Response 40

Pharmaceutical Technology

FEBRUARY 3, 2023

This is really what has been very challenging for upscaling viral vector production and what leads some companies that have in-licensed projects with a huge amount of viral vector to slightly panic about future production,” she says. Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp.

Genomics 244

Genomics Genome Medicine Gene Therapy 244

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

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

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

JANUARY 29, 2021

Data from Eli Lilly and Company’s (NYSE: LLY) Phase III clinical trial evaluating its monoclonal antibody drugs bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) show that combining the two significantly reduced the risk of COVID-19 hospitalizations and death by 70 percent. percent) compared with 36 events (7.0

Antibody 96

Antibody Clinical Trials Clinical Trials Trials 96

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. What is a Biosimilar? Biosimilars are the “generic” drugs of the biopharma world.

Production 78

Production Insulin Branding Generic Drugs 78

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

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

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

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