Pharmaceutical Technology

AUGUST 23, 2022

On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted 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. 5-adapted bivalent vaccine will be made readily available for shipping.

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Vaccination Vaccine Gene Therapy Protein 130

pharmaphorum

JANUARY 11, 2023

Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-transcriptional regulation (i.e.

Protein 102

Protein Regulation FDA Approval Licensing 102

pharmaphorum

FEBRUARY 11, 2021

ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role in the development of AD dementia. In AD, the protein goes haywire, forming tangles that have been linked to cell damage and neuronal death.

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Antibody Protein Vaccination Vaccine 128

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

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. PALO ALTO, Calif., 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc.

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

XTalks

JANUARY 4, 2024

Hemophilia B, also known as congenital Factor IX (FIX) deficiency or Christmas disease, is a rare genetic bleeding disorder caused by a deficiency or defect in the FIX clotting protein. Treatment involves replacing the missing FIX clotting protein, traditionally through regular infusions. Priced at $3.5

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

XTalks

FEBRUARY 20, 2024

Consequently, this damage causes blood and protein leakage into the urine. Tarpeyo marks the first FDA-approved treatment aimed at mitigating the loss of kidney function in adults with primary IgA nephropathy. Moreover, the injury may progress to the scarring of nephrons, the filtering structures housing the glomeruli.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

Drug Discovery World

JUNE 1, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2. Under the terms of the licensing agreement, AstraZeneca will be granted an exclusive global license to research, develop, and commercialize LM-305.

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Antibody Marketing Drugs Licensing 98

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

FDA Approval 52

FDA Approval Production Research Doctors 52

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

pharmaphorum

OCTOBER 3, 2022

DMD is a severe, progressive muscle-wasting genetic condition caused by the lack of a protein called dystrophin. Translarna was the first licensed treatment for DMD which addresses the loss of dystrophin. The post Translarna not approved by NICE for DMD on NHS appeared first on.

Gene Therapy 95

Gene Therapy Gene FDA Approval DNA 95

Pharmaceutical Technology

APRIL 13, 2023

Sickle cell disease is an inherited blood disorder that is caused by mutations in the HBB gene, which codes for the oxygen-carrying protein haemoglobin in red blood cells. While Vertex and CRISPR submitted the Biologics License Application (BLA) for exa-cel earlier this April, bluebird has yet to do so for lovo-cel.

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

Pharmaceutical Technology

NOVEMBER 9, 2022

An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. 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.

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). GPCR – G protein-coupled receptors. . TOKYO and CAMBRIDGE, England , Dec.

Licensing 40

Licensing Licensing Production Development 40

Drug Discovery World

NOVEMBER 14, 2023

AstraZeneca initiated the SUPERNOVA Phase I/III trial of AZD5156 (a combination of AZD3152 and cilgavimab) in pre-exposure prophylaxis of Covid-19, following the company licensing AZD3152 from RQ Bio in May 2022. On 6 January 2023, the FDA approved lecanemab-irmb via the Accelerated Approval pathway for the treatment of Alzheimer’s disease.

Antibody 59

Antibody Development FDA Approval Trials 59

XTalks

FEBRUARY 22, 2024

AstraZeneca and Daiichi Sankyo announced the US Food and Drug Administration’s (FDA) approval of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). TROP2 is a protein that is widely present in most tumors associated with NSCLC.

Antibody 59

Antibody Clinical Trials Clinical Trials Trials 59

Delveinsight

AUGUST 13, 2020

The licensing agreement comes almost two years after Roche dropped the tumor microenvironment modulator after putting it through a clutch of early-phase studies in solid tumor patients. Protein implication in Alzheimer’s could enhance cancer immunotherapy. Roche offloads clinical-phase cancer drug to Celleron.

Trials 52

Trials Research Drugs Protein 52

Delveinsight

AUGUST 4, 2020

MorphoSys, Incyte gets an early FDA nod for Monjuvi, an alternative to CAR-T for B-cell malignancies. Not long ago, the companies inked an oncology pact to develop and commercialize MorphoSys’ anti-CD19 antibody Monjuvi jointly.

Cardiology 55

Cardiology Antibody FDA Approval Trials 55

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Currently, the only other viable malaria vaccine, known as RTS,S/AS01 (Mosquirix), has a demonstrated efficacy of 55.8

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Vaccination Vaccine Immune Response Trials 105

XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

DECEMBER 20, 2020

Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex,” said Johnson Lau, chairman and chief executive officer of Athenex. and Europe, including Russia. Most Read Today.

In-Vitro 52

In-Vitro FDA Approval Manufacturing Drugs 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

Licensing 52

Licensing Licensing Drugs Gene 52

Drug Discovery World

OCTOBER 4, 2022

New York-based Oligomerix is an emerging clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterised by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) to Alzheimer’s disease (AD).

Development 52

Development In-Vivo Compound Screening Clinical Development 52

The Pharma Data

DECEMBER 8, 2020

The company’s product candidates consist of novel human cells engineered to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, diabetes and lysosomal storage disorders. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.

RNA 52

RNA Antibody Life Science Protein 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

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

Research 112

Research Vaccination Vaccine Drugs 112

Drug Discovery World

MARCH 7, 2023

She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. She joined Novo Nordisk in 1997 and has held various scientific and leadership positions within Protein Engineering Research and Biopharmaceuticals.

Life Science 98

Life Science DNA Clinical Development Development 98

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. A second liver biopsy will be performed after 18 months.

Licensing 52

Licensing Licensing Protein Antibody 52

Pharmaceutical Technology

NOVEMBER 1, 2022

An oral inhibitor of exportin 1 (XPO1), Nexpovio works by selectively attaching to hindering the nuclear export protein XPO1. It prevents the tumour suppressor, growth regulatory and anti-inflammatory proteins’ nuclear export, causing their build-up in the nucleus and boosting their anti-cancer activity in the cell.

Protein 130

Protein FDA Approval Production Licensing 130

The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?1%,

HR 52

HR Antibody FDA Approval Licensing 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

Delveinsight

AUGUST 10, 2021

FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC. This approval was based on Phase III KEYNOTE-522 trial (NCT03036488) and became the first immunotherapy regimen to be approved in high-risk early-stage TNBC , marking a milestone for breast cancer patients.

Trials 94

Trials FDA Approval Drugs Marketing 94

Pfizer

NOVEMBER 2, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection. INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

Pfizer

DECEMBER 8, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, SARS-CoV-2 led to a global pandemic with more than 6.5 million deaths ii and a high socio-economic burden worldwide.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

FDA Approval 52

FDA Approval Vaccination Vaccine Containment 52

Pfizer

OCTOBER 20, 2022

PREVNAR 20® is Pfizer’s next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). On June 8, 2021, Pfizer announced the U.S.

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Vaccination Vaccine Containment Immune Response 40