XTalks

JANUARY 6, 2021

Researchers at the National Institutes of Health (NIH) in the US have isolated small antibodies called “nanobodies” from a llama named Cormac that can block the SARS-CoV-2 coronavirus. Nanobodies are about a quarter of the size, and approximately one tenth of the weight, of a typical human antibody. TJ” Esparza, BS, and David L.

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The Pharma Data

JANUARY 6, 2021

Studies Show Cyto-111 Enables Delivery of Antibodies to Previously Inaccessible Intraneuronal Targets without the need for a Viral Vector or Transfection. The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re. NEW YORK, Jan.

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The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June. months, 39.4%

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. and around the world.

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The Pharma Data

OCTOBER 9, 2021

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice).

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The Pharma Data

OCTOBER 14, 2021

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. This designation for gantenerumab marks the 39th Breakthrough Therapy Designation for Roche’s portfolio of medicines.

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XTalks

MARCH 1, 2021

In addition, the companies are also engaged in discussions with regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency, with respect to a registration-enabling study for the evaluation of a variant-specific vaccine with a new mRNA code. The new mRNA sequence would be based on the B.1.351

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The Pharma Data

APRIL 7, 2021

Anti-p53 antibodies are antibodies that mistakenly target a patient’s own tissues, leading to a growth of solid tumors. today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. said Thomas Schinecker, CEO Roche Diagnostics.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

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The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S.

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The Pharma Data

OCTOBER 14, 2021

Roche today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

AUGUST 31, 2020

Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate.

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The Pharma Data

JANUARY 19, 2021

Ortho Clinical Diagnostics is a leader in in vitro diagnostics. On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization. The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). TCR2 Therapeutics – The Cambridge, Mass.

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The Pharma Data

AUGUST 6, 2020

Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified. This includes studies evaluating Tecentriq both alone and in combination with other medicines. OS follow-up is planned to continue until final analysis.

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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. 1.351, offers much-needed reassurance, as does its durability over a period of at least six months.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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The Pharma Data

AUGUST 9, 2020

Roche is studying additional investigational medicines in inflammatory bowel diseases. Roche is studying additional investigational medicines in inflammatory bowel diseases. Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies.

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The Pharma Data

SEPTEMBER 19, 2020

Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy. Roche’s Chief Medical Officer and Head of Global Product Development. from 41.1% (95% CI: 33.6–48.9)

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data.

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The Pharma Data

MAY 15, 2023

If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.” 1,2 Vabysmo’s safety profile was consistent with previous trials. Roche’s Chief Medical Officer and Head of Global Product Development. “If In BALATON, vision gains were +16.9

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The Pharma Data

APRIL 12, 2023

4-7 Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME. Chief Medical Officer and Head of Global Product Development.

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Scienmag

SEPTEMBER 18, 2020

Antibody-like proteins that capture and neutralize SARS-CoV-2 Scientists have used a new high-speed, in vitro selection method to isolate 9 antibody-like proteins (ALPs) that bind to the SARS-CoV-2 virus – 4 of which also exhibited neutralizing activity – within 4 days, according to a new study.

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). Additionally, in the trial, the antibody cocktail was found to be well-tolerated.

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Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Monoclonal antibodies (mAbs). Somatic cells. Gene and cellular therapies. Recombinant therapeutic proteins. Interferons.

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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. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.

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The Pharma Data

JUNE 17, 2022

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The two antibodies also were fully active against Alpha, Beta, Gamma, and Delta variants. 2 subtypes.

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XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. ENSPRYNG was recently approved by the U.S.

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The Pharma Data

NOVEMBER 23, 2021

Vital results from the phase I/ II GO29781 study, presented for the first time and featured in the ASH press programme, showing mosunetuzumab, a CD20xCD3 T- cell engaging bispecific antibody immunotherapy, achieved high response rates with a manageable safety profile. The safety profile was similar for Polivy plus R-CHP versus R-CHOP.1

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The Pharma Data

MAY 18, 2021

If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU. ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks.

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The Pharma Data

DECEMBER 29, 2020

Innovative, novel approach to treat and protect against SARS-CoV-2 using thermoresponsive virus-targeting nanoparticles as an inhalation medicine. Program includes development of a heat-sensitive fluorescent SARS-CoV-2 detection assay through patient mucosal sampling.

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The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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pharmaphorum

DECEMBER 15, 2022

Boehringer Ingelheim taps new head of medicine. As we reported 4th November, Boehringer Ingelheim brought on former Novartis neurosciences head Lykke Hinsch Gylvin (pictured below) into the role of head of medicine and chief medical officer. Read on for a round-up of some of the biggest moves that crossed our desks.

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The Pharma Data

APRIL 27, 2021

The FDA’s Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval. Roche’s Chief Medical Officer and Head of Global Product Development.

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