Drug Discovery World

OCTOBER 18, 2023

The platform aims to overcome the limitations associated with adherent cell culture and assaying workflows by enabling small colonies of cells to be moved and frozen in their adherent state, increasing the volume of data collected per experiment and reducing the resource demands of in vitro drug discovery.

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Pharmaceutical Technology

OCTOBER 5, 2022

Autologous CAR-T therapy does not easily lend itself to treating CLL, as it relies on extracting functional T-cells from the patient’s blood and genetically modifying them in vitro. Autologous CAR-T agents are now becoming the standard of care for patients in the third line and later settings, providing lucrative returns for these agents.

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FDA Law Blog

SEPTEMBER 27, 2022

The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements. The program provides support to manufacturers by providing both analytical and clinical testing that meets FDA requirements for an EUA submission.

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FDA Law Blog

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

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Drug Discovery World

AUGUST 9, 2022

Provider to the life sciences industry BioIVT has acquired enzymes manufacturer Cypex in a bid to enhance its product portfolio. . Based in Dundee, Cypex manufactures recombinant xenobiotic metabolizing enzymes with its product portfolio covering a wide range of proteins involved in drug metabolism. .

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The Pharma Data

SEPTEMBER 17, 2020

Industry body says in vitro diagnostics are vital to clearing the backlog of undiagnosed conditions. Ahead of the upcoming comprehensive spending review, The British In Vitro Diagnostics Association (BIVDA) has called for more support for the UK in vitro diagnostics (IVD) industry. Source link.

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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. “We understand that diagnostic manufacturers often have diverse needs. Banczyk has expertise in medical and IVD filtration devices. Xu joined Sartorius in 2002.

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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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FDA Law Blog

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., By Allyson B. Devices Marketed Under an Enforcement Policy.

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BioTech 365

OCTOBER 6, 2020

Developed by Resolution Medical, an in vitro diagnostic and medical device manufacturer, the innovative 3D-printed sterile swab is … Continue reading →

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FDA Law Blog

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy test clearance in 1978.

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The Pharma Data

MAY 17, 2021

The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests. .

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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.

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FDA Law Blog

MARCH 31, 2024

A fundamental divide is over whether LDTs and in vitro diagnostic products (IVDs) should continue to be regulated differently or if legislation can be crafted and enacted that will cover both types of products. This seems to have been the outcome that many lawmakers desired. These are areas where “revenue is modest,” she said.

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pharmaphorum

JANUARY 18, 2022

Developing Complex, Translatable and Physiologically-Relevant Cellular Models in vitro. Key Benefits of Attending: • Discuss the uses of advanced cell technologies to construct in vitro models of human tissues. Workshop Leader: Kenny Dalgarno, Professor of Manufacturing Engineering, Newcastle University. Who Should Attend?

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pharmaphorum

AUGUST 10, 2020

Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses. Pfizer will provide contract manufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead.

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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. – The extension is directly applicable, therefore changing the date on the individual certificates is not necessary.

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XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. Surmodics will manufacture and supply the device and realize revenue from product sales to Abbott as well as a share of profits from Abbott’s third-party sales. The balloon is designed for the treatment of patients with peripheral artery disease.

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FDA Law Blog

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

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FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

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XTalks

DECEMBER 14, 2023

We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.” It is used at home and in clinical settings. In case any issue is detected, the machine should not be used.

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The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. Series B in October.

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pharmaphorum

OCTOBER 12, 2020

Over the past few years, 3D Cell Culture has gained momentum within the pharmaceutical industry due to the benefits that this model offers for in vitro applications patient-derived tissues, drug discovery, predictivity and validation, and safety and toxicity. 3D-cellculture.com/PR1. . Workshop B – 13.30 – 17.30

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Drug Discovery World

DECEMBER 8, 2023

These therapeutics are complex and one of the major bottlenecks in their development is avoiding downstream impurities during manufacturing, which can cause major safety concerns. Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector.

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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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pharmaphorum

AUGUST 4, 2022

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

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Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

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The Pharma Data

MARCH 23, 2022

About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. Roche remains hopeful the war will reach a peaceful resolution as soon as possible. Source link: [link].

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Drug Discovery World

MAY 16, 2023

Curbishley explains that as the wave of new therapies in development continues to increase, global pressures on manufacturing availability will become more acute. What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? DDW’s Megan Thomas finds out.

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Pharmaceutical Technology

NOVEMBER 22, 2022

This approach to vaccination offers many advantages to developers, including quick development, high potency, a favorable safety profile, and the potential for cost-effective manufacturing. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. Single- and multi-nation funding opportunities flooded in.

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Drug Discovery World

AUGUST 22, 2023

In many cases, it is also challenging to apply traditional bioequivalence methods or to ensure clarity about the comparison model (in-vitro/in-vivo) needed to gain health authority approval. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

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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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Drug Discovery World

JULY 31, 2023

1 According to Dr Streefkerk, “this means that we need better treatments.” CellProthera is aiming to do this by getting more stem cells out of a patient’s own bone marrow, expanding them according to GMP manufacturing, and then delivering them back to patients into the heart. Unfortunately, this is not enough,” Dr Streefkerk states.

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Medicine Clinical Trials Clinical Trials Manufacturing 52

pharmaphorum

MARCH 4, 2021

The government has already pledged £9 million in clinical scale mRNA manufacturing to create a library of vaccines against COVID-19 variants – and in his budget announcement, Sunak gave a further £5 million to the project. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

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The Pharma Data

DECEMBER 20, 2020

In the rejection, the agency indicated they need to conduct pre-approval inspections at two of scPharmaceuticals’ third-party manufacturing facilities that they couldn’t do because of travel restrictions related to the COVID-19 pandemic. The drug is a once-daily, beta-3 adrenergic agonist. and Europe, including Russia.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate.

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