Elrig

JUNE 15, 2023

We're Hiring - Marketing & Sales Assistant We’re Hiring! We are looking for an Events Marketing & Inside Sales Assistant to support the Marketing Manager, Business Development and Operations Team in all ELRIG’s marketing and sales activities, as well as day to day implementation of marketing tasks.

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Alta Sciences

NOVEMBER 13, 2024

Their three state-of-the-art bioanalytical laboratories feature mirrored operations and uniform protocols to maintain consistency and quality across client projects, ensuring reliable, high-quality data regardless of location. Lynne Le Sauteur, Vice President of Laboratory Sciences at Altasciences.

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thought leadership

SEPTEMBER 7, 2023

Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. In this blog post, we will explore the value of market access analysis and its role in the development of medical products.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

Modifying and expanding the cells in a GMP laboratory. While many market-approved cell therapies available today are autologous products, allogeneic interventions are growing more common. At a high level, the process involves: Collecting cells from the patient (autologous) or processing healthy donor cells (allogeneic).

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

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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LifeSciVC

APRIL 26, 2024

Fundamentally, even during tighter markets like today, great talent is always a very constrained resource, and spreading it too thinly across too many companies isn’t good for the ecosystem. Overall, this contraction is a strong positive sign of healthy discipline, and should be good for the sector’s mid- and long-term prospects.

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Agency IQ

JULY 26, 2024

reference laboratories for high-risk diagnostics The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Reference Laboratories: E.U. Top IVDR Notified Body concern: Lack of E.U.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). Fincoeur et al.

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DrugBank

MARCH 28, 2024

Space biosciences are on the verge of becoming one of the largest total addressable markets to ever exist, opening up vast opportunities for economic growth and scientific discovery.    In the realm of space exploration, one critical yet often overlooked aspect is the impact of space conditions on human health.

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Common Sense for Drug Policy Blog

FEBRUARY 14, 2024

Growth of Novel Potent Opioids (NPOs) in the Unregulated Drug Market "Novel potent opioids (NPOs) are novel nonfentanyl opioids in the illicit opioid supply. Synthetic opioids are one of the fastest growing classes of opioids being detected in patients in the emergency department (ED) with opioid overdose (OD).

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FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.

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Quanticate

JUNE 13, 2024

The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

FDA noted that because the scope of ISO 13485’s complaint handling requirements are “substantially similar to the QS Regulation for complaints”, FDA believes that laboratories that satisfy the current QSR complaint requirements “will meet the amended QS Regulation requirements” for complaints.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance.

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Codon

AUGUST 26, 2024

Brian Wang (co-founder of the nonprofit Panoplia Laboratories ) outlines his approach to making broad-spectrum antivirals. Last year, several colleagues and I joined these efforts by co-founding Panoplia Laboratories , a nonprofit organization developing broad-spectrum antivirals using tools from synthetic biology.

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FDA Law Blog: Biosimilars

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. 3] FDA further assumes that these laboratories collectively perform roughly 80,000 LDTs.

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FDA Law Blog: Biosimilars

MARCH 31, 2024

They believe any regulatory oversight for laboratory developed tests (LDTs) should be mandated by Congress, rather than the Executive Branch. The majority of witnesses, along with several of the Congressional members, agreed that legislation is the appropriate path to regulating laboratory developed tests.

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FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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sptlabtech

MARCH 20, 2024

By optimizing common laboratory tasks and processes, lab automation continues to demonstrate its value to the life science community. In drug discovery , automated platforms facilitate high-throughput screening of therapeutic candidates, accelerating the discovery process and bringing life-saving treatments to market more quickly.

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Codon

DECEMBER 10, 2023

The Higgs boson was discovered at CERN, a sprawling particle physics laboratory that cost more than $10 billion to build. This is the reason why many biologics — medicines made by, or extracted from, living cells — don’t make it to market. coli in a soluble form, and these low “hit” rates slow progress.

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The Connected Lab

MARCH 17, 2021

This allowed for laboratories to rapidly scale their COVID-19 operations to help reduce the spread of disease and restore economies and communities. The focus on creating a digitally connected laboratory environment to automate and accelerate science, remains a focus in the pharmaceutical industry. References: LaBerge, Laura, et al.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

Perhaps this is why FDA is trying to preemptively reclassify most of the high-risk tests currently on the market and signaling that it expects most future companion diagnostic and infectious disease IVDs would be regulated as class II devices going forward.

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FDA Law Blog: Biosimilars

MARCH 16, 2023

This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2. a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis.

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FDA Law Blog: Biosimilars

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. We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States.

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The Pharma Data

SEPTEMBER 28, 2021

Roche is looking to expand availability of those tests beyond CE markets within the future. the power to consolidate and automate a wider array of testing on one platform helps to extend operational efficiency, maximise laboratory space and minimise capital investment.

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The Connected Lab

OCTOBER 6, 2021

This present-day industrial revolution, known as Pharma 4.0 , is accelerating innovation and creating opportunities to shorten development timelines and cut the cost of bringing new medicines to market. With laboratory data used to make critical decisions downstream, it is essential that information is accurate and complete.

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Broad Institute

JULY 17, 2024

Predictive models don’t eliminate laboratory experiments, but they can help researchers narrow the selection pool of potential drugs, allocating more time and resources to experiment on the more promising candidates. A fourth is in the works.

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Drug Target Review

NOVEMBER 15, 2023

As scientists struggled with limited laboratory space and capacity, a much more collaborative approach was essential, including the need to work across other internal facilities and engage external CRO partners. David Bardsley Commercial Director, Cresset As Commercial Director David heads up the Sales and Marketing team at Cresset.

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The Pharma Data

DECEMBER 15, 2020

16, 2020 /PRNewswire/ — Lipidor AB (Nasdaq First North: LIPI) announced today that the Company has signed a new cooperation agreement with Aurena Laboratories AB. Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products.

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Elrig

APRIL 7, 2025

Dr Del Trezise Chair of ELRIG, andStrategy Development, Laboratory Products and Services at Sartorius Mel has been an outstanding leader, guiding ELRIG through significant growth, including navigating the COVID-19 pandemic, expanding the professional team, and embedding meaningful EDI principles.

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The Pharma Data

JANUARY 24, 2021

With this acquisition, Calibre Scientific bolsters its strength in the chromatography market and continues to broaden its life sciences presence in Europe. Headquartered in Paris, France, AIT supplies public and private researchers and pharmaceutical laboratories. LOS ANGELES, Jan. Source link.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). At the core of the new FDA Proposed Rule is the redefinition of IVDs to encompass those manufactured by laboratories, leading to a more uniform regulation in line with other IVDs.

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The Connected Lab

JUNE 2, 2021

Acceleration through exponential technologies: The growing affordability of exponential technologies, such as artificial intelligence, advanced robotics, 3D printing and drones, is bringing these once cost-prohibitive tools to the mass market. Join our Laboratory 4.0 value chain. With Pharma 4.0 The post Pharma 4.0:

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The Pharma Data

MAY 15, 2023

Thermo Fisher Scientific & Pfizer Partner to Expand Localized Access to Next Generation Sequencing-Based Testing for Cancer Patients in International Markets Pfizer and Thermo Fisher Scientific Inc. In many parts of the world, access to next-generation sequencing may be limited or unaffordable for cancer patients.

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Vial

MAY 20, 2024

The global preclinical CRO market was estimated to be valued at US$5.7 Most notably, preclinical research can be distinguished by their need for a series of extensive laboratory testing performed on non-human models, such as cell cultures and animals. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2

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FDA Law Blog: Drug Discovery

SEPTEMBER 10, 2023

In contrast, as the guidance explains, a non-interventional study (also referred to as an observational study) is a type of study in which patients received the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol. Non-interventional studies thus do not require an IND.

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The Pharma Data

DECEMBER 15, 2020

The Antigen ELISA is a laboratory test able to be applied in semi quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale. Based on the well-known ELISA technology, the SARS-CoV-2 Antigen assay can be performed in most diagnostic laboratory settings and automatically processed on all open ELISA platforms.

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