Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

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.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

pharmaphorum

JUNE 4, 2021

At the moment, Xofigo is the only approved TAT on the market, but Bayer is also developing a pipeline of other candidates based on thorium-227 linked to antibodies or small-molecule drugs. The technology behind the drug was licensed from Weill Cornell Medicine and Johns Hopkins University in the US.

Antibody 82

Antibody Licensing Licensing Protein 82

Pharmaceutical Technology

FEBRUARY 14, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin 1, which are now well established in the industry.

Antibody 130

Antibody Hormones DNA Licensing 130

XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. This investigational first-in-class Claudin 18.2

Clinical Trials 95

Clinical Trials Clinical Trials Trials Antibody 95

The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

pharmaphorum

DECEMBER 22, 2020

GlaxoSmithKline has closed the year with a flurry of deals, leaving its development pipeline bulging like Santa’s sack as chief scientific officer Hal Barron pursues a strategy to develop “transformational medicines”. The antibody targets PVRIG, an inhibitory protein expressed on natural killer cells (NK cells) and T-cells.

Licensing 52

Licensing Licensing Genetics Sales 52

The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 9, 2022

CSL Behring has a commercialisation and license agreement to develop EtranaDez. Haemophilia A is caused by insufficient levels of the clotting protein factor VIII, while patients with haemophilia B lack adequate factor IX levels. A fair price for CSL Behring’s haemophilia B treatment etranacogene dezaparvovec would be between $2.93–2.96

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

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. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells.

Antibody 40

Antibody Production Trials Medicine 40

pharmaphorum

DECEMBER 21, 2020

Compared with many of the established names in pharma these companies are young upstarts but they have managed to achieve what other big names in the industry have failed to do and harness the power of mRNA to make medicine. In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.

Vaccination 111

Vaccination Vaccine Doctors Doctor 111

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Expected to enroll 415 participants; interim results expected in Q3 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. .

Immune Response 52

Immune Response Licensing Licensing Sales 52

Delveinsight

AUGUST 13, 2020

The researchers cite data in the New England Journal of Medicine, showing Black Americans account for a disproportionate number of COVID-19 cases in the U.S. Roche has transferred its anti-CSF1R monoclonal antibody emactuzumab to Celleron Therapeutics. Protein implication in Alzheimer’s could enhance cancer immunotherapy.

Trials 52

Trials Research Drugs Protein 52

pharmaphorum

MAY 18, 2021

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

Immune Response 64

Immune Response Vaccination Vaccine Gene Sequencing 64

pharmaphorum

DECEMBER 15, 2020

When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains resistant to existing antibacterial medicines. Phase 1 data from 300 healthy females have so far shown a favourable safety profile, while generating high levels of long-lasting antibodies.

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 52

The Pharma Data

JUNE 7, 2022

“We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology. Transaction Terms.

Vaccination 52

Vaccination Vaccine Development Clinical Trials 52

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. The promise to partners is to “move quickly. Reduce cost. Tackle the toughest problems in drug development.” Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52

pharmaphorum

JANUARY 31, 2022

It’s a setback to Pfizer’s late-stage pipeline, given that at one point the company was projecting $3 billion in potential sales for vupanorsen, which targets ANGPTL3 protein and is playing catch-up in the category with Regeneron’s already-marketed Evkeeza (evinacumab).

Production 52

Production Vaccination Vaccine Trials 52

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Antibody 52

Antibody Medicine Production In-Vitro 52

The Pharma Data

APRIL 16, 2021

“Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19,” said Daniel Skovronsky, M.D., Lilly remains committed to developing complementary neutralizing antibodies to address potential SARS-CoV-2 variants that may arise in the future.

Antibody 52

Antibody Development Medicine Protein 52

The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Eli Lilly and Company (NYSE: LLY) today announced changes to the purchase agreements with the U.S.

Antibody 52

Antibody Protein Scientist Development 52

Delveinsight

FEBRUARY 16, 2021

The data was presented at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and also published in the New England Journal of Medicine. Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, a protein. The therapy is the first therapy of its kind to target the Nectin-4 protein.

Marketing 52

Marketing Protein Bioavailability Drugs 52

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.

Production 52

Production Antibody Sales Manufacturing 52

The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

FEBRUARY 12, 2022

Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company (NYSE: LLY) announced today. “As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. About bebtelovimab.

Antibody 40

Antibody Trials Clinical Trials Clinical Trials 40

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Click here for resources related to Lilly ‘s COVID-19 efforts and here for baricitinib’s EUA.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. ” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy.

Antibody 130

Antibody Licensing Licensing Production 130

The Pharma Data

DECEMBER 19, 2020

Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. W911QY-20-C-0100.

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

OCTOBER 30, 2020

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. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. Cohort 3: patients on mechanical ventilation.

Production 52

Production Antibody Manufacturing Trials 52