FDA Approval, Protein Expression and Treatment

FDA Approval

Protein Expression

Treatment

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development

Drug Development Treatment Drugs FDA Approval

New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis

The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data.

Treatment

Treatment Disease FDA Approval Clinical Trials

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Trending Sources

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

The Pharma Data

NOVEMBER 26, 2020

(NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A.,

Disease

Disease Treatment Clinical Trials FDA

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

Clinical Trials

Clinical Trials Disease Treatment Trials

Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)

The Pharma Data

SEPTEMBER 8, 2020

Overviews of clinical trials and scientific rationale will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 11-13 September 2020. “We

Clinical Trials

Clinical Trials Trials Disease FDA Approval

Biopharma Money on the Move: December 2 – 8

The Pharma Data

DECEMBER 8, 2020

Li stated, “One in every six people in China is living with a CNS condition, yet there are relatively few effective treatments available today, underscoring the urgent need to develop and deliver novel, effective therapies. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.

RNA

RNA Therapies Disease Protein Expression

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

The Pharma Data

SEPTEMBER 2, 2020

New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence. Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations.

Clinical Trials

Clinical Trials Disease Treatment Therapies

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Alzheimer’s Disease (AD). P6: Neuromuscular Disorders and Clinical Trials.

Clinical Trials

Clinical Trials Trials Disease Therapies

mRNA Cancer Vaccines and Therapies: An Overview

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.

Vaccine

Vaccine Therapies Clinical Trials Small Molecule

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

JANUARY 15, 2021

hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu ( fam-trastuzumab deruxtecan -nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In the U.S.,

Treatment

Treatment Trials Disease Therapies

Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

The Pharma Data

SEPTEMBER 28, 2021

additionally , all five babies maintained the power to swallow and were ready to feed exclusively orally after 12 months of treatment. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Evrysdi for the treatment of SMA in adults and youngsters 2 months aged and older.

Clinical Trials

Clinical Trials Protein Expression Therapies FDA

BioSpace Global Roundup: Cevec Licenses AAV Program to Biogen

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration gave it the green light to initiate a Phase III study of tesamorelin for the treatment of adults with Nonalcoholic Steatohepatitis (NASH) with liver fibrosis. Vivity received FDA approval in February 2020. provided an update on its ongoing NASH program. This week, the company said the U.S.

Licensing

Licensing Licensing Clinical Trials Vaccine

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Conversations in Drug Development Trends

MAY 30, 2024

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials. Initial approval in 2022: FDA, U.S.

Treatment

Treatment Clinical Trials Small Molecule Therapies

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

The Pharma Data

OCTOBER 26, 2020

The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system. PBMC and tissue samples were collected longitudinally prior to and during the treatment period.

Vaccine

Vaccine Trials Treatment Virus

Drug Discovery Digest

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis

Trending Sources

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)

Biopharma Money on the Move: December 2 – 8

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

mRNA Cancer Vaccines and Therapies: An Overview

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

BioSpace Global Roundup: Cevec Licenses AAV Program to Biogen

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

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