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. Taken together, there is the risk of shortages of medical devices on the EU market.

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Pfizer

JANUARY 27, 2023

This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

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BioSpace

JULY 3, 2022

Rather than selling, Novartis could spin Sandoz off into its own separate entity with its own listing on a stock exchange.

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FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. An existing monkeypox virus test kit available for POC or home diagnostic use in international markets. The focus of the program is for both molecular and antigen tests that can be used in either point-of-care settings or home use.

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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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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

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This article will focus on one such area of great unmet need and promise: women’s health. This is likely in part because their byproduct, lactic acid, is known to inhibit pathogenic bacteria 25.

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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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FDA Law Blog

DECEMBER 13, 2022

Gibbs — It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here ). However, not all LDTs currently on the market would qualify for grandfathering. Javitt & Jeffrey N. Emphasis added).

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pharmaphorum

OCTOBER 27, 2022

Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. Why is guidance needed? What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.

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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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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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The Pharma Data

APRIL 7, 2021

today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. The assay is now available for all markets accepting the CE Mark. The assay is now available for all markets accepting the CE Mark. said Thomas Schinecker, CEO Roche Diagnostics.

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FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. By Adrienne R. The Draft Guidance provides specific examples illustrating the application of each scenario.

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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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Camargo

FEBRUARY 16, 2021

However, if another sponsor has already obtained ODD for the same drug and condition and a marketing application has been approved, the new sponsor has the added requirement of providing a plausible hypothesis as to why the proposed drug may be clinically superior to the first already marketed drug in order to obtain ODD.

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Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . The Food and Drug Administration (FDA) is the federal entity in the U.S. When Does an IND go into Effect? . The IND goes into effect; and .

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. The outlook towards sustainability has been rapidly changing in the business landscape as more companies adopt sustainable business practices.

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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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Drug Discovery World

DECEMBER 8, 2023

Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The once-fictional artificial intelligence (AI) depicted in literature and movies has transitioned into a tangible and easily accessible tool in our modern world. Here’s what this means for pharmaceutical leaders and patients.

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Camargo

MARCH 25, 2021

Per the FDA’s guidance on RPDD : In vitro data supporting the mechanism of action of the drug in the disease or in a related disease may suffice for rare pediatric disease designation, whereas that level of data would not generally suffice for orphan-drug designation. Criteria for Rare Pediatric Disease Designation.

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FDA Law Blog

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. The primary barrier to bringing new antigen tests to market has been FDA’s minimum requirement of 80% sensitivity for authorization. By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices.

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FDA Law Blog

JANUARY 3, 2022

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. As of the latest count, FDA has granted more than 420 Emergency Use Authorizations (EUAs) for COVID In Vitro Diagnostics (IVDs) (25 of which were laboratory developed tests).

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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. With no competition in the market and impressive performance, Humira reported approximately $21.2 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

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Roots Analysis

JANUARY 14, 2024

Like all drugs, biologics are regulated by the FDA. It is worth mentioning that in vitro gene expression requires a suitable host for the production of a specific gene product. Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics.

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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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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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FDA Law Blog

JANUARY 3, 2022

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. As of the latest count, FDA has granted more than 420 Emergency Use Authorizations (EUAs) for COVID In Vitro Diagnostics (IVDs) (25 of which were laboratory developed tests).

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XTalks

JANUARY 8, 2021

Statutory standards for premarket approval including de novo marketing authorization and 510(k) clearance are maintained under the program’s guidelines. In vitro diagnostics that monitor and evaluate serious adverse events associated with newly approved drugs may also qualify. Concerns Raised by AdvaMed. More Specifics.

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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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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. Mullen — Happy Birthday Laboratory Developed Tests (LDTs).

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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. Etta Biotech is a leading cell electroporation technology and equipment supplier. JS Bio’s parent company.

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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

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

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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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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pharmaphorum

NOVEMBER 4, 2020

However, in vitro or binding-based efficacy insight needs to be confirmed by reliable clinical evidence, as shown by the outcomes of COVID-19 trials with remdesivir and hydroxychloroquine. million worldwide and continues to increase despite the global public health measures that have been put in place.

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