pharmaphorum

DECEMBER 1, 2022

Exploring the implementation of complex in-vitro models for drug development. 3D Cell Culture has gained increasing momentum in the pharmaceutical industry over recent years, with the global 3D Cell Culture market predicted to reach a value of $3.48 Billion by 2028. Billion by 2028. Event Hashtag: #3DCellCulture2023. Who Should Attend?

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FDA Law Blog

SEPTEMBER 27, 2022

The program is currently not accepting applications for antibody tests (HPM has blogged previously about FDA’s Monkeypox Policy here ). An existing monkeypox virus test kit available for POC or home diagnostic use in international markets.

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FDA Law Blog

DECEMBER 13, 2022

However, not all LDTs currently on the market would qualify for grandfathering. FDA has, in fact, been very resistant to allowing home collection devices on the market, but that’s another story for another day.) Javitt & Jeffrey N. It has undergone dramatic recent growth, due in part to COVID-19. Emphasis added).

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

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Life Science Antibody In-Vivo In-Vitro 52

Roots Analysis

NOVEMBER 30, 2021

Most of the facilities are providing in vitro bioassay services for cell and gene therapies. How Players are Complying with Developing Market? To get detailed information on the key players, strategic initiatives in this domain, likely partners for cell and gene therapy service providers, and the likely market evolution.

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The Pharma Data

SEPTEMBER 1, 2020

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. Food and Drug Administration (FDA).

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In-Vitro Antibody Medicine Clinical Trials 52

BioSpace

JUNE 16, 2022

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

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FDA Approval In-Vitro Marketing Development 40

The Pharma Data

JANUARY 19, 2021

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. The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). TCR2 Therapeutics – The Cambridge, Mass.

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XTalks

APRIL 18, 2024

However, Roche has several CSF tests on the market, which include assays in the company’s Elecsys line that are used in conjunction with PET in the diagnosis and monitoring of the disease. A positive result on the test indicates a high likelihood of amyloid presence, as confirmed by amyloid PET scans or cerebrospinal fluid (CSF) testing.

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Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

JUNE 12, 2023

As technology continues to revolutionize every sector of our lives, the medical device industry stands at the forefront of this innovation, playing a pivotal role in enhancing patient care, improving diagnostic accuracy and transforming treatment modalities. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

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XTalks

APRIL 2, 2021

In a pivotal Phase III trial involving adolescents 12 to 15 years of age, Pfizer/BioNTech’s COVID-19 vaccine trial results show that its vaccine, BNT162b2, has a demonstrated efficacy of 100 percent and elicits strong antibody responses. 1.351, offers much-needed reassurance, as does its durability over a period of at least six months.

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Vaccination Vaccine Trials Clinical Trials 59

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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Clinical Trials Clinical Trials Trials Production 52

The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Head of Medical and Marketing Division at Celltrion Healthcare. “We

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XTalks

SEPTEMBER 7, 2021

After a two-month long halt, federal officials have given the go-ahead to resume nationwide distribution of Eli Lilly’s COVID-19 monoclonal antibodies bamlanivimab and etesevimab. However, studies now show the COVID-19 monoclonal antibodies can work against the variant. 1 and Beta/B.1.351, 1.351, respectively).

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Antibody In-Vitro Drugs Sales 97

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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Antibody Vaccination Vaccine In-Vitro 52

XTalks

DECEMBER 13, 2024

Blenrep was previously withdrawn from the US market in 2022 after the DREAMM-3 trial failed to confirm its initial accelerated approval. The therapy is also under review in other major markets globally. DREAMM-7, an international, open-label trial, enrolled 494 participants with at least one prior multiple myeloma therapy.

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Antibody In-Vivo Trials In-Vitro 99

Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). Additionally, in the trial, the antibody cocktail was found to be well-tolerated.

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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.

RNA 97

RNA In-Vitro Genotype Marketing 97

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. Sartorius understands the need for continuous innovation in the highly regulated and price-sensitive diagnostics market. Banczyk has expertise in medical and IVD filtration devices.

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In-Vitro Manufacturing Production Antibody 52

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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FDA Approval In-Vitro Research Development 69

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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Antibody Licensing Licensing Development 52

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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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

DECEMBER 15, 2022

Woxström, a 26-year veteran of AstraZeneca, will lead sales, marketing, and commercial operations for 30 European countries plus Canada. Prior to 2022, she did sales and marketing at Pfizer, Allergan, DuPont Pharma, and Johnson & Johnson. The month of November saw a number of notable hires and personnel moves in biotech and pharma.

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The Pharma Data

JANUARY 16, 2021

Its proprietary large-capacity flow electroporator, X-Porator F1, is one of the only two products of its kind in the world, and leads the market with its outstanding performance and customer value. molecular assessment within two weeks after receiving plasmids, to advance R&D process for antibody drug development.

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Protein Production Antibody In-Vitro 52

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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In-Vitro Containment Radiology Life Science 71

Roots Analysis

OCTOBER 22, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. It is important to highlight that IVT mRNAs are structurally similar to natural mRNAs and can be used to express proteins through genetic engineering.

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RNA Protein Genetics Gene Expression 40

The Pharma Data

SEPTEMBER 3, 2020

This test is also available in markets accepting the CE mark. Additionally, it is available in markets accepting the CE mark. As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients.

In-Vitro 40

In-Vitro Antibody Medicine Clinical Trials 40

FDA Law Blog

JANUARY 3, 2022

There is also a wide variety of tests, including PCR assays, antigen tests, and antibody tests, and at least 16 over-the-counter assays (4 of which were authorized in the past month). Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed.

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In-Vitro Regulation Manufacturing Development 52

FDA Law Blog

JANUARY 3, 2022

There is also a wide variety of tests, including PCR assays, antigen tests, and antibody tests, and at least 16 over-the-counter assays (4 of which were authorized in the past month). Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed.

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In-Vitro Manufacturing Development Regulation 52

The Pharma Data

AUGUST 3, 2021

Istodax remains on the market for treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. In 2011, Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, received accelerated approval by the U.S. senior vice president, Hematology Development, Bristol Myers Squibb.

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In-Vitro Nurses Gene Expression Medicine 52

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Antibody In-Vivo Vaccine Vaccination 52

The Pharma Data

MAY 4, 2021

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study. months compared with chemotherapy (median OS=20.2

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Protein HR In-Vitro Medicine 52

The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Medicine Vaccine 52

The Pharma Data

JANUARY 17, 2021

After a single vaccination, neutralizing antibodies against COVID-19 were observed in more than 90% of volunteers at Day 29 and 100% of the volunteers between the ages of 18 and 55 at Day 57. The neutralizing antibodies were stable through Day 71, which was the latest available timepoint in the study. Here’s a look at last week’s news.

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Immune Response Antibody Trials Clinical Trials 52

Delveinsight

JANUARY 12, 2021

It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences. million after Birinapant successfully becomes a part of the Phase I trials.

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Licensing Licensing Antibody Gene Therapy 52

Pharmaceutical Technology

AUGUST 26, 2008

“It has to be recognised that antibody therapy does not fit everyone and that small molecule therapy may be more appropriate for some people due to cost considerations.” It was once derided as the stuff of science fiction, but in recent years, biotechnology has emerged as an important growth area in pharmaceuticals.

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