Development, FDA Approval, In-Vitro and Protein

FDA-approved drug sensitises brain cancer cells to radiotherapy

Drug Discovery World

JANUARY 23, 2023

This action sensitised GBM cells to radiotherapy both in vitro and in vivo (in mouse models). “Our research has revealed cladribine as a radiosensitiser for GBM treatment by drug repurposing, which can offer multiple advantages,” says Prof Youn. “Our GBM is a WHO grade IV brain tumour with dismal prognosis.

FDA Approval

FDA Approval Drugs In-Vivo In-Vitro

Repurposing FDA-approved drugs may help combat COVID-19

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

FDA Approval

FDA Approval Drugs Protein In-Vitro

FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Jude Children’s Research Hospital.

FDA Approval

FDA Approval Protein In-Vitro Medicine

Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.

FDA Approval

FDA Approval DNA Protein In-Vitro

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease.

Clinical Trials

Clinical Trials Clinical Trials In-Vitro Protein

Biologics – The Next Step in Revolutionary Medication

Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. They are different from small molecules in terms of their size and complexity.

Contract Manufacturing

Contract Manufacturing Manufacturing Protein Bacteria

Brain Awareness Week 2024: A Spotlight on Brain Health and New Treatments for Neurological Diseases

XTalks

MARCH 6, 2024

Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

FDA Approval

FDA Approval In-Vitro Research Marketing

FDA Action Alert: Urovant, Athenex, scPharmaceuticals and Vertex

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. The FDA completed a class 2 response in July 2020.

In-Vitro

In-Vitro FDA Approval Manufacturing Drugs

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

The Pharma Data

MAY 17, 2023

Roche’s Chief Medical Officer and Head of Global Product Development. “I Roche’s Chief Medical Officer and Head of Global Product Development. Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS. “I

FDA Approval

FDA Approval In-Vitro Trials Clinical Trials

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

Clinical Trials

Clinical Trials Clinical Trials Trials FDA Approval

What the Glycome Can Tell Us About Persistent HIV Infection

XTalks

AUGUST 12, 2020

The identification of T cells that essentially ‘hide’ the virus has significant implications for developing therapeutic strategies to improve the treatment and long-term management of HIV. Related: FDA Approves Rukobia for HIV Patients with Limited Treatment Options. The research study was published in Cell Reports.

RNA

RNA Protein DNA In-Vivo

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer

The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.

Medicine

Medicine Containment In-Vitro Development

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

Medicine

Medicine In-Vitro Antibody Development

Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. Single- and multi-nation funding opportunities flooded in.

Manufacturing

Manufacturing Vaccination Vaccine RNA

Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. 1) Medtronic 2022 Revenue: Medtronic reported an annual revenue of $31.69

FDA Approval

FDA Approval Production Sales In-Vitro

Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

Gene Therapy

Gene Therapy In-Vitro Gene Medicine

Pfizer Responds to Research Claims

Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. 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. and around the world.

Research

Research Vaccination Vaccine Drugs

CytoDel Announces Pre-Clinical Data on Cyto-111 as Antidote to Botulinum Neurotoxin (BoNT) Published in Science Translational Medicine

The Pharma Data

JANUARY 6, 2021

Supports the Development of New Approaches to Treat Multiple Neurological Diseases. The main objective of the study was to develop and test a post-symptomatic botulism antidote that could rescue symptomatic animals challenged with a lethal dose of BoNT. NEW YORK, Jan. 07, 2021 (GLOBE NEWSWIRE) — CytoDel, Inc.

Medicine

Medicine Antibody Protein In-Vitro

Can liquid biopsies transform precision medicine?

Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4.

Medicine

Medicine DNA Genome Genomics

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

Using bispecific antibodies to advance cancer immunotherapy

pharmaphorum

NOVEMBER 2, 2021

Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed. They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours.

Antibody

Antibody Immune Response Production Engineer

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

The Pharma Data

SEPTEMBER 10, 2020

OCREVUS is the first and only treatment approved for both relapsing MS (RMS) and primary progressive MS (PPMS) and now more than 170,000 people have been treated with OCREVUS globally in clinical trial and real-world settings; favourable benefit-risk profile remains consistent over 7 years. Separate data from a U.S.

In-Vitro

In-Vitro FDA Approval Medicine Clinical 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

Roche’s Chief Medical Officer and Head of Global Product Development. “We Roche’s Chief Medical Officer and Head of Global Product Development. “In Phase IIIb clinical trial programme of higher-dose OCREVUS (ocrelizumab) to evaluate impact on reducing disability progression in RMS and PPMS.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

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

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials

Clinical Trials Clinical Trials Antibody Medicine

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

HR

HR In-Vitro Development Clinical Trials

Advances in neuroscience drug discovery

Drug Discovery World

FEBRUARY 22, 2024

According to Medicine Discovery Catapult, these include: “Navigating the complexity of the CNS; understanding the disease pathology, and accessing predictable in vitro and in vivo cell models 2 ”. But psychopharmacology developments petered out, and few new drugs reached the market during the last four decades. to £104.7m

Drugs

Drugs Gene Clinical Trials Clinical Trials

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 per share amounts).

Vaccination

Vaccination Vaccine Production Sales

Roche announces results from Evrysdi

The Pharma Data

FEBRUARY 25, 2021

The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment with proven efficacy in adults, children and infants 2 months and older. The study also found that treatment with Evrysdi increased the levels of survival of motor neuron (SMN) protein by a median 1.9-fold

FDA Approval

FDA Approval Protein Medicine In-Vitro

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. Roche’s Chief Medical Officer and Head of Global Product Development. Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years.

Protein

Protein In-Vitro Medicine FDA Approval

Clinical Research Informer

FDA-approved drug sensitises brain cancer cells to radiotherapy

Repurposing FDA-approved drugs may help combat COVID-19

Trending Sources

FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

Biologics – The Next Step in Revolutionary Medication

Brain Awareness Week 2024: A Spotlight on Brain Health and New Treatments for Neurological Diseases

FDA Action Alert: Urovant, Athenex, scPharmaceuticals and Vertex

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

The Utility of Liquid Biopsy in Oncology Clinical Trials

What the Glycome Can Tell Us About Persistent HIV Infection

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

Pfizer Responds to Research Claims

CytoDel Announces Pre-Clinical Data on Cyto-111 as Antidote to Botulinum Neurotoxin (BoNT) Published in Science Translational Medicine

Can liquid biopsies transform precision medicine?

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Using bispecific antibodies to advance cancer immunotherapy

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

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

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

Janssen Presents Results from Phase 3 ACIS

Advances in neuroscience drug discovery

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Roche announces results from Evrysdi

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

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