XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. Importantly, all five cases of severe disease observed in the trial occurred in the placebo group. 1.351 variant.

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XTalks

MAY 1, 2023

This makes Qalsody the first approved treatment to target a genetic cause of ALS. Since SOD1 mutations were first identified as a cause of ALS 30 years ago, the familial ALS community has been searching for genetically targeted treatments. To date, over 200 mutations in the SOD1 gene have been associated with the development of ALS.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., combined dose groups; 6.5%

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The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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The Pharma Data

DECEMBER 16, 2020

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. About NVX-CoV2373.

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The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma.

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pharmaphorum

AUGUST 16, 2020

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. DMD is a rare genetic disorder that leads to progressive muscle degeneration and weakness. It is injected into a patient’s muscle tissue.

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XTalks

JUNE 16, 2021

Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351 PREVENT-19 is a randomized, placebo-controlled, observer-blinded study that is evaluating the safety, efficacy and immunogenicity of NVX-CoV2373, which contains Novavax’s patented saponin-based Matrix-M adjuvant. 1.351 Variant Shared by Protein Vaccine Maker.

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The Pharma Data

JULY 27, 2021

Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

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Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods? Acta Pharm Sin B. eLife 10:e67106.

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The Pharma Data

NOVEMBER 3, 2020

Nasdaq:LOGC) (LogicBio), a company dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms, announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LEXINGTON, Mass.,

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Delveinsight

AUGUST 17, 2021

Few of the common adverse reactions observed in patients who underwent Keytruda and Lenvima combination in clinical trials are fatigue , diarrhea , musculoskeletal pain , hypothyroidism, hypertension , stomatitis , decreased appetite, rash, nausea and decreased weight. Global President, Vaccines, Pfizer.

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The Pharma Data

APRIL 18, 2022

The approval is based on Takeda’s New Drug Application (NDA) submission which included interim results from a Phase 1/2 studyconducted by Takeda in Japan and several studies conducted by Novavax, including two pivotal Phase 3 clinical trials in the U.K., TAK-019 Clinical Trial. ml dose of TAK-019 at both vaccinations.

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Drug Discovery World

DECEMBER 14, 2023

As well as the Cancer Research UK Scotland Institute, Cancer Research UK awards grants to research groups at universities and funds Experimental Cancer Medicine Centres (ECMCs) in Glasgow and Edinburgh, which deliver clinical trials of new experimental treatments.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Empowering Life. www.sanofi.com.

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XTalks

JUNE 29, 2022

Treatment with Breyanzi is a tailored method of treatment which involves the genetic reprogramming of T cells. Immunotherapy techniques use monoclonal antibodies to target malignant cells. Rituximab, a chimeric anti-CD20 monoclonal antibody, became a breakthrough treatment method in 1997 for non-Hodgkin’s lymphoma.

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The Pharma Data

OCTOBER 18, 2020

AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. Cautionary Note Regarding Forward Looking Statements.

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pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells.

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The Pharma Data

OCTOBER 22, 2020

Additional details on the INTERLINK-1 clinical trial can be found here. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date. About Cetuximab: Cetuximab is an anti-EGFR monoclonal antibody.

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The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

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Pharmaceutical Technology

AUGUST 5, 2022

According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials. But 10% of the cases are caused by genetic factors, meaning patients inherit the condition through familial links.

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pharmaphorum

SEPTEMBER 18, 2020

Having already acquired UK-based Cambridge Antibody Technology in 2006, AstraZeneca merged these two companies to create a dedicated global biologics organisation known as MedImmune. Bestseller Nexium had become available in approximately 100 markets over the past seven years since launch. A comeback story?

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The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3.

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Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Later, scientists took advantage of antibodies’ natural tendency to seek out specific antigens and created antibody therapies that guide T cells towards the cells they are supposed to destroy.

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The Pharma Data

JULY 6, 2021

1 These results confirm the favourable safety profile of Hemlibra, as previously demonstrated in the phase III HAVEN clinical trials. Spark Therapeutics will share updated data from the ongoing phase I/II clinical trial of SPK-8011, an investigational AAV-based gene therapy developed for the treatment of haemophilia A.

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The Pharma Data

AUGUST 13, 2020

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Forward-Looking Statements.

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The Pharma Data

JUNE 25, 2021

“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. Glenn, M.D.,

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The Pharma Data

SEPTEMBER 20, 2020

About KRAS The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers. The Phase 2 CRC trial is expected to have a data readout in 2021. Additional information about CodeBreaK clinical trials can be found at [link].

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The Pharma Data

AUGUST 13, 2020

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Forward-Looking Statements.

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The Pharma Data

SEPTEMBER 16, 2020

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com. Additional information about CodeBreaK clinical trials can be found at [link]. The webcast will be archived and available for replay for at least 90 days after the event.

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XTalks

OCTOBER 26, 2023

The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA. Both influenza and SARS-CoV-2 have RNA as their genetic material. An RNA genome enables the genetic material to mutate more rapidly. remains the dominant variant.

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