Camargo

MARCH 25, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Rare Pediatric Disease Designation.

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Advarra

SEPTEMBER 23, 2022

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. .

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FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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Advarra

AUGUST 31, 2022

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market. Meeting with the Regulators. Regulators are not your adversaries.

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Drug Discovery World

DECEMBER 8, 2023

Investments in AI and related technologies are driving this seismic shift where modest improvements in early-stage drug development success rates enabled by AI and machine learning could lead to an additional 50 novel therapies over 10 year s, a more than $50 billion opportunity.

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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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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. Notably, FDA did not grant marketing authorization of an OTC COVID test until June 6, 2023, when Cue Health finally received de novo authorization.

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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. Sartorius understands the need for continuous innovation in the highly regulated and price-sensitive diagnostics market. Xu joined Sartorius in 2002.

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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. Like all drugs, biologics are regulated by the FDA.

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Drug Discovery World

MAY 16, 2023

What opportunities and challenges are emerging and can therapies get to market faster? Moreover, he says that global supply chain pressures will continue into 2023, combined with instability in the financial markets that will make cost of goods high on his watchlist of risks to manage. DDW’s Megan Thomas finds out.

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The Pharma Data

OCTOBER 27, 2020

European market launch of both COVID-19 tests planned for Q1 2021. The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. 25-minute RT-PCR lab test to complement 15-minute rapid test. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD.

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FDA Law Blog

JANUARY 3, 2022

As we chronicle in an article that appears in the current edition of the Food and Drug Law Journal , FDA’s policies for reviewing COVID assays, have been a contributing factor. This article ( link ), which is made available with the permission of the Food and Drug Law Institute, examines multiple facets of FDA’s regulation of COVID assays.

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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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pharmaphorum

NOVEMBER 4, 2020

Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease… It is not surprising there is no recommended drug treatment for COVID-19, except dexamethasone and remdesivir, despite little evidence that this drug reduces mortality”.

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FDA Law Blog

JANUARY 3, 2022

As we chronicle in an article that appears in the current edition of the Food and Drug Law Journal , FDA’s policies for reviewing COVID assays, have been a contributing factor. This article ( link ), which is made available with the permission of the Food and Drug Law Institute, examines multiple facets of FDA’s regulation of COVID assays.

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pharmaphorum

DECEMBER 16, 2020

We’ve also seen a very mixed picture in the market for pharmaceuticals,” he says. There have also been many pragmatic collaborations between companies, sites and regulators that have helped keep research and HTA going – such as the more flexible rules introduced by the MHRA.”. Strength in the second wave.

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The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

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XTalks

DECEMBER 19, 2023

In the fast-evolving pharmaceutical landscape, tracking the top-selling drugs offers valuable insights into trends, healthcare priorities and the dynamics of the global market. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales.

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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. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

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FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. By Jeffrey N. Gibbs & Allyson B. It has been a long, strange trip ever since.

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The Pharma Data

NOVEMBER 4, 2020

CENTOGENE’s SARS-CoV-2 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic patients and probands according to the recommended testing by public health authority guidelines. CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov.

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Delveinsight

JANUARY 18, 2021

The present Angelman syndrome treatment market revolves around the management of symptoms rather than curing the condition. . Several pharmaceutical and biotech companies in the Angelman syndrome market are exploring the novel curative approaches. As a consequence, Ovid halted everything related to OV101 and Angelman syndrome.

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FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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XTalks

APRIL 2, 2021

Pfizer and German partner BioNTech are preparing to promptly submit the updated COVID-19 vaccine trial results to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2.

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Drug Discovery World

APRIL 12, 2023

This paid-for advertorial by CN Bio appeared in DDW Volume 24 – Issue 2, Spring 2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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Drug Discovery World

JANUARY 20, 2023

This paid-for advertorial by CN Bio appeared in the SLAS 2023 Supplement, Volume 24 – Issue 1, Winter 2022/2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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The Pharma Data

APRIL 28, 2021

Food and Drug Administration (FDA) in nearly 20 years. We’ve already invested in assets that, if approved, could help address drug-resistant bacterial infections and critical viral infections; with this acquisition, we look forward to progressing the development of a novel anti-fungal as well.”. and Scedosporium spp).

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. .

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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pharmaphorum

OCTOBER 18, 2021

For some countries, it has taken many years to approve a drug that was already available elsewhere, and such delays clearly have a negative impact on patients in those countries. Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). And there are many.

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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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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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Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world.

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Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

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Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., They can be essential for selecting appropriate participants, identifying potential adverse reactions, and studying how a drug affects the human body. This includes both unapproved IVDs and marketed IVDs used off-label.

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pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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