Pharmaceutical Technology

MAY 31, 2023

In vivo and in vitro pre-clinical studies demonstrated that CFT8919 provides wider coverage of on-target resistant mutations and intracranial activity, indicating its potential to be effective against brain metastases. Betta will be responsible for the development, manufacture and commercialisation of CFT8919 in the licensed territories.

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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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Drugs In-Vivo In-Vitro Contract Manufacturing 99

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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In-Vitro Regulation Manufacturing Licensing 81

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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In-Vitro Manufacturing Antibody Regulation 59

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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In-Vitro Manufacturing Life Science Development 52

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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Trials Clinical Trials Clinical Trials Antibody 97

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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In-Vitro Regulation Manufacturing Development 59

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

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Development Drugs Bioavailability In-Vivo 246

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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Marketing In-Vitro Manufacturing Development 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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Vaccine Vaccination Development Life Science 105

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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In-Vitro Manufacturing Development 40

Roots Analysis

SEPTEMBER 4, 2024

The main purpose of in vitro diagnostic solutions is to perform non-invasive / minimally invasive test procedures in order to detect a variety of health conditions using samples, such as blood, tissue or urine. Such tests help to diagnose health conditions, monitor treatments, perform disease screening and aid in early diagnosis of diseases.

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Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Approaches to Pharmacokinetic Analysis.

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Production Bioavailability In-Vivo In-Vitro 133

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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In-Vitro Manufacturing Regulation Drugs 59

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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In-Vitro Engineer Production Regulation 59

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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In-Vitro Engineer Drugs Pharma Companies 52

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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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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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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Development Engineer Manufacturing In-Vitro 52

XTalks

JULY 28, 2020

Excipients can take many forms, such as bulking agents, binders, coatings and colourants, and they are chosen based on their ability to aid in drug delivery, administration and even in pill identification and prevention of counterfeiting. But just how inert are these excipients?

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Protein Drugs In-Vitro Scientist 103

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.

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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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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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Regulation In-Vitro Manufacturing Life Science 52

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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Medicine In-Vitro Reagent Branding 52

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. SCF : LDT, unmet need within an integrated healthcare system.

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Regulation Manufacturing Production Compliance 64

FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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In-Vitro Regulation Production Development 69

XTalks

SEPTEMBER 20, 2024

Vittoria’s investigational CAR-T therapy leverages gene editing to modulate the CD5 signaling pathway and a shorter manufacturing time to enhance efficacy and improve manufacturing efficiencies and vein-to-vein time. Such challenges highlight a significant unmet need and call for further advancements in the field.

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Gene Editing Manufacturing Gene In-Vivo 52

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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Regulation In-Vitro Development Gene Therapy 64

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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In-Vitro Production Trials Manufacturing 52

pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

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Contamination In-Vitro Production Containment 52

The Pharma Data

MARCH 3, 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 (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine.

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Medicine In-Vitro Packaging Packaging 52

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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In-Vitro Regulation Manufacturing Radiology 52

FDA Law Blog

JUNE 14, 2021

The outcome was not a surprise, because the FDCA was designed for regulatory oversight of medical device manufacturing and distribution, not clinical laboratory testing. By Jeffrey K. Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation.

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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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The Pharma Data

DECEMBER 20, 2020

. PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. ” ABOUT ALLOY THERAPEUTICS Alloy Therapeutics is a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all.

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Antibody In-Vivo In-Vitro Scientist 52

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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Regulation Compliance In-Vitro Cosmetics 40

The Pharma Data

DECEMBER 14, 2020

Manufacturers regularly review the design of their product, including labelling and IFU based on customer feedback. In the early phases of the COVID-19 pandemic, in vitro diagnostics (IVDs) were rapidly developed, validated and verified, and then rolled out. Check the IFU for each incoming consignment to detect any changes to the IFU.

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Reagent In-Vitro Production Regulation 52