The Pharma Data

AUGUST 27, 2020

The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

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Delveinsight

SEPTEMBER 30, 2021

The company has also filed for the US Food and Drug Administration (FDA) for clearance. According to DelveInsight’s analysis , the approval of RETINA-AI Galaxy software will be a game-changer in the annual examination of the eye in diabetic patients. Paige obtains first-ever FDA approval for AI product in digital pathology.

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XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis?

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.

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XTalks

DECEMBER 28, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.

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The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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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.

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The Pharma Data

JANUARY 6, 2021

SK Chemicals has shared their expertise in these diseases and validated the predicted targets and compounds through in vitro and in vivo studies. The compound in the patent was discovered by Standigm Insight , an AI-aided drug-repurposing platform. This patent is just the beginning of many results expected from our extended collaboration.

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BioSpace

JUNE 16, 2022

The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.

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Camargo

MARCH 25, 2021

Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products beyond the incentives offered by the ODD program. The FDA must deem the application eligible for priority review (i.e., The estimated demand in the US for the product.

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XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Join us as we explore the inspiring journey and significant contributions of these top 10 medical device companies.

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pharmaphorum

MARCH 15, 2022

The TruSight Oncology in vitro diagnostic (IVD) test is being launched first in Europe and according to Illumina’s cancer head Kevin Keegan can match patients with suitable therapies “according to clinical guidelines or clinical trials, based on their tumour profile.”

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The Pharma Data

JANUARY 27, 2021

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

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XTalks

AUGUST 8, 2024

The US Food and Drug Administration (FDA) has approved Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma who have specific HLA types and have undergone prior chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

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XTalks

APRIL 18, 2024

There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

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The Pharma Data

OCTOBER 14, 2021

Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over available therapies that have received full FDA approval.

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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. and more than 2.3

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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.

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The Pharma Data

JANUARY 6, 2021

Following in vitro validation of therapeutic mechanisms, efficacy studies were conducted in mice, guinea pigs and rhesus macaque monkeys. The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re.

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

MAY 17, 2023

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS).

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pharmaphorum

NOVEMBER 2, 2021

Clinical interest in bsAbs gained momentum following the promising data and market success of blinatumomab (BLINCYTO®, Amgen), a fragment-based bispecific T cell engager (BiTE), which first received FDA approval in 2014 and EMA approval in 2015. Simplified schematic overview of the proposed mechanisms of action for bsAbs.

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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).

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XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The balloon is designed for the treatment of patients with peripheral artery disease.

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XTalks

NOVEMBER 15, 2023

The FDA says chikungunya is an emerging global health threat as at least 5 million cases of chikungunya virus infection have been reported in the last 15 years. Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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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.

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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. ” The findings published today (Feb. ” The findings published today (Feb.

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XTalks

APRIL 27, 2022

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. The drug is approved for children hospitalized with COVID-19 or non-hospitalized children who fall under the high-risk category for developing severe COVID-19. “As

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The Pharma Data

SEPTEMBER 6, 2020

This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. months, not reached). 2 The most common adverse reactions (?

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XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.

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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.

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XTalks

DECEMBER 11, 2023

Their groundbreaking Tablo Hemodialysis System, cleared by the US Food and Drug Administration (FDA) for use from hospital to home, signifies a monumental leap in technology, revolutionizing the dialysis experience for patients while streamlining operational aspects for providers. In 2021, Axonics achieved an impressive revenue of $180.3

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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.

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FDA Law Blog

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).

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