The Pharma Data

JANUARY 22, 2021

When multiple mutations occur at the receptor-binding domain of the spike protein, it renders antibodies ineffective. Novavax’s vaccine is a recombinant protein vaccine adjuvanted with Novavax’s nanoparticle technology, Matrix-M, which enhances immune response in recipients.

Vaccine 52

Vaccine Vaccination Protein Immune Response 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 Trials 59

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. At the BIO International Convention, Carey Connolly, Ph.D.,

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

The Pharma Data

DECEMBER 21, 2020

Targeted protein degradation (TPD) is an approach whereby the body’s natural process for degrading proteins is diverted using small molecule drugs to eliminate disease-causing proteins. However, there has so far been limited progress in applying this exciting approach to membrane-associated proteins such as GPCRs.

Protein 40

Protein Drugs Development Production 40

pharmaphorum

MARCH 21, 2022

The US regulator cleared BMS’ LAG-3 drug relatlimab as a fixed-dose combination with its PD-1 inhibitor Opdivo (nivolumab) – under the Opdualag brand name – in patients aged 12 or over with unresectable or metastatic melanoma.

FDA Approval 52

FDA Approval Regulation Drugs Trials 52

The Pharma Data

OCTOBER 6, 2021

“With our facilities set up as multi-product plants and flexible line structures, we are able to supply a variety of molecule formats, such as monoclonal antibodies, enzymes, cytokines and other recombinant proteins for patients with unmet medical needs,” said Uwe Buecheler, Head of Business Unit Biopharmaceuticals. .

Production 52

Production Contract Manufacturing Manufacturing Branding 52

XTalks

MAY 31, 2023

One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A). Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Production 97

Delveinsight

AUGUST 13, 2020

Gluten is a protein in wheat, barley, rye, and other grains and is what makes dough elastic and gives bread its chewy texture. Takeda is finally developing TAK-101 , a disease-modifying agent, and an extremely novel immune modifying biodegradable nanoparticle encapsulating gliadin proteins for the treatment of CD.

Marketing 52

Marketing Trials Antibody Pharma Companies 52

Delveinsight

SEPTEMBER 8, 2021

It is sold under the brand name Plaquenil and is available only by prescription. Baricitinib, also known as LY3009104 or INCB028050 , is a novel orally bioavailable inhibitor of the tyrosine-protein kinase JAK1 or JAK2. percent ) who were anti-dsDNA autoantibody-positive (“Antibody Positive”). Baricitinib (INCB-028050).

Marketing 52

Marketing Sales FDA Approval Antibody 52

XTalks

NOVEMBER 1, 2024

Price of Ocrevus: $78,858 annually Why it sold so well: Ocrevus is a therapeutic monoclonal antibody that offers a unique scientific approach to treating MS. It is a biologic drug available exclusively as a brand-name medication, with no generic or biosimilar forms available. Price of Zolgensma: Zolgensma has a price of $2.1

FDA Approval 85

FDA Approval Drugs Botox Sales 85

The Pharma Data

NOVEMBER 23, 2020

Ltd are gaining an extremely valuable access to Yangtze River Pharmaceutical’s strong brand reputation and market experience in China. We aim to make full use of our brand advantage and market experience to deliver the biosimilars with extensive clinical needs to the broad China market.

Manufacturing 40

Manufacturing Medicine Marketing Containment 40

XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. Biogen’s nusinersen (brand name Spinraza) is an antisense oligonucleotide (ASO) therapy that is administered directly into the CNS by intrathecal injection through lumbar puncture.

Trials 83

Trials Drug Delivery Drugs Gene 83

Roots Analysis

MAY 24, 2024

Further, a wide variety of molecules, such as antibodies, peptides, proteins and small molecules, can be delivered using autoinjectors, demonstrating their versatility in healthcare domain. The use of autoinjectors allows the patients to administer the medications at home, reducing the need for frequent visits to healthcare facilities.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

The Pharma Data

JANUARY 6, 2021

Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. At the same time, the Group aims to increase its earning power and create value through innovation and growth. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5

Vaccine 52

Vaccine Vaccination Development Production 52

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. Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts.

Production 78

Production Insulin Branding Generic Drugs 78

pharmaphorum

DECEMBER 18, 2020

Originally approved in 2011 as an IV therapy for adults with SLE, a debilitating autoimmune disease, GSK got a green light for the subcutaneous formulation in 2017 and last year extended the label of the antibody to include paediatric patients aged over five.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

XTalks

MAY 25, 2021

Biosimilar and interchangeable products can expand treatment options and lower drug and healthcare costs by offering a cheaper alternative with the same effectiveness; essentially a non-branded version of a biologic such as monoclonal antibodies, proteins and vaccines. million in 2019, according to Fortune Business Insights.

Production 98

Production Drugs Marketing Sales 98

XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. Why it did so well: Herceptin, representing a 25-year legacy of innovation, holds the distinction of being the first fully humanized antibody approved by the FDA in 1998. billion in the first quarter of 2023.

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

DECEMBER 17, 2020

Lupus causes the production of proteins called autoantibodies in the immune system, which attack tissues and organs, including the kidneys. There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). at the time of the announcement. Athenex, Inc.

FDA Approval 52

FDA Approval Genome Genomics Production 52

Delveinsight

AUGUST 13, 2020

Approval History: In September 2017, FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma.

Antibody 40

Antibody Medicine Trials Development 40

The Pharma Data

AUGUST 3, 2021

New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. In the U.S., Cost of Sales margin increased 1.6 Tax Rate increased 5.6

Sales 52

Sales Production Antibody Development 52

pharmaphorum

SEPTEMBER 18, 2020

The name Zeneca was invented by a branding consultancy who had been instructed to find a name which was memorable, had no associations with other companies, nor was offensive in any language”. The profits from these products funded the development of new drugs, such as gastroesophageal treatment Losec and cardiovascular treatment Aptin.

Pharma Companies 116

Pharma Companies Sales Vaccine Vaccination 116

XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. Why it did so well: Herceptin, representing a 25-year legacy of innovation, holds the distinction of being the first fully humanized antibody approved by the FDA in 1998. billion in the first quarter of 2023.

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

APRIL 23, 2021

It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, under the brand name Venclexta, and commercialised by AbbVie outside of the US. About Venclyxto ® ( venetoclax ) Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein.

Medicine 40

Medicine In-Vitro Antibody Development 40

XTalks

APRIL 11, 2024

On the other hand, Abecma is now approved as a third-line treatment for patients with triple-class-exposed disease, which means previous treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. Plasma cells help fight infections by producing antibodies.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 14, 2023

In all the cases, the cell culture media needs to be optimised to improve its performance and achieve higher yields of the desired protein. Recombinant insulin is used as a supplement in the upstream manufacturing of a range of biologic drugs, including recombinant proteins, such as monoclonal antibodies, viral vectors, and viruses.

Insulin 130

Insulin Production Antibody Protein 130

Find Me Cure

APRIL 23, 2020

Vandalizing cell towers is not going to get rid of this new virus in the corona family and avoiding certain brands of beer is not a good prevention strategy. . This means that in order for herd immunity to work, 50-70% of the world population needs to get infected and then develop antibodies. .

Immune Response 117

Immune Response Antibody Scientist Development 117

The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Commenting on this novel immunotherapy regimen, Prof.

Vaccine 40

Vaccine Vaccination Trials Containment 40

The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Dupixent ® total prescriptions (TRx) increased 51% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. CHC decreased 7.3% In the U.S.,

Sales 52

Sales Vaccine Vaccination Medicine 52

XTalks

MAY 2, 2024

Among these are Madrigal Pharmaceuticals’ resmetirom (branded Rezdiffra) , which secured FDA approval in March for the treatment of nonalcoholic steatohepatitis (NASH) and sotatercept (commercial name Winrevair) for pulmonary hypertension (PAH). Since January, the FDA has already signed off on more than a dozen novel drugs.

Drugs 52

Drugs FDA Approval Vaccine Vaccination 52

Intouch Solutions

FEBRUARY 28, 2025

While every female cell has two X chromosomes, one X chromosome is disabled to ensure that the right levels of proteins are produced from that chromosome pair. The way the second chromosome is shut down generates unfamiliar molecular structures that can trigger antibodies and lead to autoimmune disorders.

Branding 59

Branding Hormones Research Genetics 59

The Pharma Data

DECEMBER 20, 2020

It is an optimized, non-chemically modified mRNA that codes for the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany.

Trials 52

Trials Gene Therapy Vaccine Vaccination 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. VENCLEXTA ® /VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. BTK signaling is needed by specific cancer cells to multiply and spread. The full U.S.

Medicine 52

Medicine Production FDA Approval Development 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. About VENCLEXTA ® /VENCLYXTO ® (venetoclax) VENCLEXTA ® /VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Medicine 40

Medicine Production FDA Approval Development 40

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.;

Vaccine 40

Vaccine Vaccination Production Sales 40

The Pharma Data

OCTOBER 27, 2020

27, 2020 — Testing of Eli Lilly’s antibody drug for hospitalized COVID-19 patients has been halted because the treatment doesn’t help them recover from their infection. A similar, two-antibody cocktail from Regeneron Pharmaceuticals Inc. is selling the drug under the brand name Veklury. TUESDAY, Oct.

Antibody 52

Antibody Trials Drugs Clinical Trials 52

XTalks

SEPTEMBER 14, 2020

Moderna, for one, recently reported positive results in older adults between 56 and 71, as well as those 71 years of age and older, who reportedly mounted levels of neutralizing antibodies against the SARS-CoV-2 virus after two doses of its vaccine that were comparable to those seen in younger adults. Johnson & Johnson’s COVID-19 Vaccine.

Vaccine 92

Vaccine Vaccination Antibody Life Science 92