Pharmaceutical Technology

NOVEMBER 22, 2022

The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. 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.

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pharmaphorum

SEPTEMBER 29, 2022

She is the Co-Chair of the firm’s Health Care Practice Group, Co-Chair, Health Care & Life Sciences Sector – Medical Devices, and a core member of the firm’s life sciences and telemedicine industry teams. In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered.

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XTalks

DECEMBER 13, 2024

XTALKS WEBINAR: Enhance Early Biomarker Discovery: Translating In Vitro and In Vivo Multi-Omics Oncology Data Live and On-Demand: Thursday, January 16, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how to harness the full potential of multi-omics data and advanced patient models to drive early biomarker discovery.

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pharmaphorum

OCTOBER 27, 2022

These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. What is the scope of the Guidance? Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.

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XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. What is Flow Cytometry?

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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. SK Chemicals is a leading company in the fields of chemistry and life science. SK Chemicals is a leading company in the fields of chemistry and life science.

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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

DECEMBER 28, 2023

This results in anemia, characterized by a decreased number of RBCs, and jaundice, indicated by high bilirubin levels, typically appearing within the first days or weeks of life. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

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XTalks

JUNE 27, 2022

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. In a joint press release , the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.

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XTalks

SEPTEMBER 30, 2020

The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University. The findings reveal a critical role for IFNs in fighting COVID-19 infection, positioning them to be a potential therapeutic target in the disease. percent of men.

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XTalks

FEBRUARY 1, 2023

The IoPPN researchers therefore set out to see whether blood from MCI patients could influence neurogenesis in in vitro models involving human brain cells. The researchers found that factors in the blood can potentially predict the risk of developing the disease years before a clinical diagnosis is made.

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XTalks

MARCH 1, 2021

Sera from individuals will also be taken to evaluate neutralization of different SARS-CoV-2 strains in in vitro studies. The third booster will be given to participants from the Phase I study in the US. They will be given the opportunity to receive a third 30 µg booster six to 12 months after having received the initial two-dose schedule.

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XTalks

SEPTEMBER 7, 2021

On the other hand, in vitro studies show that the co-administration of bamlanivimab and etesevimab retains activity against the Delta variant, but not against Delta plus and some of the earlier variants. However, new data shows that while those variants may be resistant to the drugs, the currently dominating Delta variant may not be.

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pharmaphorum

OCTOBER 4, 2022

Such non-device CDS are: (1) not intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (Criterion 1); (2) intended for the purpose of displaying, analysing, or printing medical information about a patient or other medical information (e.g.

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The Pharma Data

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

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XTalks

APRIL 13, 2021

Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?-synuclein, synuclein, a protein involved in the formation of amyloid deposits in the brain characteristic of Parkinson’s disease and other neurodegenerative disorders, is also implicated in melanoma. Excessive levels of

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XTalks

JULY 28, 2020

According to the team – who published their findings in the journal Science – their research is the first to investigate whether these pervasive, “inactive” compounds have any effects on key molecular targets involved in health. But just how inert are these excipients?

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XTalks

JANUARY 9, 2023

Gilead Sciences, Inc. Its mechanism of action differs from currently approved antivirals and has thus far shown no cross-resistance in vitro to other drug classes. Over time, HIV attacks the immune system, progressing from acute infection to chronic HIV infection where those infected are minimally symptomatic.

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XTalks

JANUARY 6, 2021

When the pandemic broke, we thought this was a once in a lifetime, all-hands-on-deck situation and joined the fight,” said Dr. Brody, who is also a professor at Uniformed Services University for the Health Sciences and senior author on the study. The study was led by neuroscientists Thomas J. “TJ” TJ” Esparza, BS, and David L.

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XTalks

NOVEMBER 4, 2020

This means that mothers may be able to transmit allergies to their babies prenatally, helping explain why some infants display them very early on in life. They reported their findings last week in the journal Science. Allergies begin very early in life,” said Associate Professor Ashley St.

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XTalks

JULY 13, 2022

has provided an easy way to provide patients and clinicians with potentially life-saving information,” said George Bakris, MD, Director of the Comprehensive Hypertension Center, University of Chicago and the American Diabetes Association, in Healthy.io’s press release. Healthy.io Healthy.io An ACR urine reagent dipstick/strip.

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XTalks

AUGUST 9, 2023

Notably, when tested at concentrations up to 30 μM (18 μg/mL) in vitro — which is around 1,100 times the suggested human ocular dose — lotilaner doesn’t affect mammalian GABA-mediated chloride channels. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis? percent were diagnosed with Demodex blepharitis.

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Pharma Business Blog

FEBRUARY 7, 2023

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR) 1 and (EU) 2017/746 (IVDR) 2. Sandra Ragaz, Partner, Leader Pharma & Life Science – International Indirect Tax & Regulatory Sandra.ragaz@pwc.ch

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XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows.

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XTalks

MARCH 11, 2021

We have learned about the shortcomings in our government and healthcare systems, our lack of public health emergency preparedness and the remarkable ways people and science can come together in global disasters. With vaccine shortages and slow rollouts in many parts of the world, the COVID-19 way of life continues in many places.

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The Pharma Data

JANUARY 19, 2021

The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). Ortho Clinical Diagnostics is a leader in in vitro diagnostics. On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization.

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pharmaphorum

JUNE 9, 2022

In its Strategic Priorities on AMR , the WHO made clear that “unless we act now, common diseases will become untreatable and modern life-saving procedures riskier to perform” as AMR proliferates. “How Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 The challenge with traditional antibiotics .

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The Pharma Data

DECEMBER 22, 2020

Available since 2017 as an in vitro diagnostic assay (IVD) in Europe and the United States, Japanese clinical geneticists can now have access to this assay to help identify a definitive genetic diagnosis for their patients. SANTA CLARA, Calif.–( –( BUSINESS WIRE )– Agilent Technologies Inc.

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pharmaphorum

MARCH 11, 2021

Diagnostics was never a Cinderella sector; Britain has the fifth largest in vitro diagnostics (IVD) market in Europe, not gigantic but significant nevertheless. The subsequent roll out of PCR testing has highlighted how effective and valuable relatively inexpensive tests can be in halting the spread of COVID-19.

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XTalks

JANUARY 27, 2021

The company used in vitro neutralization antibody studies to evaluate the activity of Moderna’s vaccine-generated antibodies in human sera against several variants of the novel coronavirus, including the B.1.1.7 The in vitro study evaluated the ability of mRNA-1273-generated antibodies to neutralize the new SARS-CoV-2 variants.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. They can be used in patient selection, stratification, risk mitigation and assessment of safety and efficacy endpoints.

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XTalks

NOVEMBER 7, 2022

Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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XTalks

JANUARY 22, 2021

MedFluid’s in vitro diagnostic (IVD) platform fAST is based on microfluidics as its core technology. MedFluid founder and head of microfluidics R&D Bon Lee said that according to the World Health Organization (WHO), antimicrobial resistance was one of the ten threats to global health in 2019. “It

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XTalks

SEPTEMBER 20, 2024

With a PhD in immunology and a career rooted in Philadelphia, Nick’s path was inspired by his interactions with prolific life science executives and witnessing groundbreaking innovations from institutions like Penn and the Children’s Hospital of Philadelphia (CHOP).

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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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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. According to the agency, the virus is found primarily in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas where the virus-carrying mosquitos are endemic.

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FDA Approval Vaccine Vaccination In-Vitro 59

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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