The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted The information contained in this release is as of September 28, 2022. Tue, 09/27/2022 - 16:15. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 20, 2020

. PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. ” ABOUT ALLOY THERAPEUTICS Alloy Therapeutics is a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all. .”

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif. Reese , M.D.,

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The Pharma Data

DECEMBER 11, 2020

The test has been designed to quantitatively measure of immunoglobulin G (IgG) antibodies to aid clinicians in identifying patients with an immune Covid-19 response pre- and post-vaccination. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”.

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pharmaphorum

JUNE 9, 2022

mRNA-1273.214 stimulated almost twice the neutralising antibody levels against the Omicron strain than Spikevax , with a significantly higher response also seen against other variants of concern, one month after administration, according to the company. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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XTalks

JANUARY 31, 2022

The third group will contain unimmunized individuals who will get three doses of the omicron shot. Neutralizing Antibody Data for Omicron Targeting. The study showed that antibody neutralization against omicron decreased by 6.3-fold Moderna will be evaluating its omicron targeting booster through extension of an earlier study.

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pharmaphorum

OCTOBER 2, 2020

It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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Camargo

DECEMBER 13, 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. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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The Pharma Data

APRIL 3, 2021

The study aimed to determine whether an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine (referred to by the Alliance as CoVIg-19) could reduce the risk of disease progression when added to standard of care treatment including remdesivir in hospitalized adult patients at risk for serious complications.

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Pharmaceutical Technology

APRIL 16, 2023

But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible. mL or less and use a prefilled syringe (PFS) with a staked needle as the drug’s primary container.

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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). THOUSAND OAKS, Calif.

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pharmaphorum

NOVEMBER 16, 2020

The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s defense against Herceptin biosimilars. Despite the impact of the pandemic on cancer care, Perjeta grew 17% to CHF 2.9 billion ($3.2

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pharmaphorum

OCTOBER 31, 2022

s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). Indeed, Regeneron believes that the success with Ebola could potentially have ushered in “a new era in which monoclonal antibodies could be used to fight viral diseases and global pandemics.”.

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XTalks

JANUARY 9, 2024

New treatments being evaluated in these cancers include Eli Lilly’s Retevmo (selpercatinib) and Blueprint Medicines and Genentech’s Gavreto (pralsetinib), which target mutations in the rearranged during transfection ( RET ) gene. Blocking BAFF interaction : Belimumab, which is an anti-BAFF monoclonal antibody in a Phase II trial.

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Pharmaceutical Technology

AUGUST 24, 2022

The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% With an increased focus on personalized medicine, including immunotherapy, there’s high demand for FCM. CAGR between 2020 and 2028.

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The Pharma Data

DECEMBER 5, 2020

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. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator.

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Roots Analysis

JUNE 6, 2024

Reduced Medication Errors: As the autoinjectors contain the exact dose of medication, they enable reduced dosing errors. To know more details of the autoinjectors market visit here >> [link] The post Injecting Innovation: The Rising Trend of Autoinjectors in Modern Medicine appeared first on Blog.

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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., President and Chief Scientific Officer of Regeneron.

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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. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

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The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Our ambition is to be the world’s leading and most valued generics company.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration, European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the United Kingdom. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Additional terms of the agreement were not disclosed. About NVX-CoV2373. and Australia.

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The Pharma Data

DECEMBER 12, 2020

We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.” ” Ludwig Hantson , Ph.D., Strategic rationale.

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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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pharmaphorum

SEPTEMBER 16, 2020

Medicines typically prescribed to treat SA can be ineffective. Patients with SEA can be put on a biologic drug to reduce inflammation in the airways, and there are a number of monoclonal antibody drugs available or in development. Severe asthma (SA) affects 15% of suffers and usually appears in adults. Severe or Eosinophilic?

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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).

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The Pharma Data

JANUARY 27, 2021

RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). (Nasdaq: CASI), a U.S. Wei-Wu He , Ph.D., About BioInvent. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

JANUARY 26, 2021

22 in the Annals of Internal Medicine. Data were included from 61 eligible studies and reports, of which 43 and 18, respectively, used polymerase chain reaction testing of nasopharyngeal swabs to detect current SARS-CoV-2 infection and antibody testing to detect current or prior infection. TUESDAY, Jan. Oran and Eric J. Topol, M.D.,

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The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

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pharmaphorum

FEBRUARY 2, 2022

Along with the one-off settlement, Gilead has agreed to pay ViiV a 3% royalty rate on Biktarvy sales and any other bictegravir-containing product in the US until 5 October 2027, when ViiV’s US patent on dolutegravir expires.

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The Pharma Data

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A?)

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

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The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

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The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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Roots Analysis

FEBRUARY 15, 2022

ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Over time, the intellectual property related to ADC payloads / warheads has grown at a significant rate, primarily for ADCs containing auristatin, calicheamicin and maytansinoids as payloads. Web: [link].

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