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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Drug Target Review

APRIL 30, 2025

Faster time-to-market and reduced costs. Its AI platforms are designed specifically for CGT, capable of handling complex biological data, integrating with laboratory and manufacturing systems, and adapting to evolving research and clinical needs. The result? Kosten Digital was established to bridge this gap.

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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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Drug Target Review

JULY 7, 2025

The shift is not only ethical but also pragmatic: the agency cited goals such as lowering research and development costs, accelerating time to market and improving translational relevance between preclinical and clinical outcomes. Guide for the Care and Use of Laboratory Animals. Alternatives to Laboratory Animals , 50(3).

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The Pharma Data

OCTOBER 27, 2020

HYDERABAD, India–( BUSINESS WIRE )– Dr. Reddy’s Laboratories Ltd. About Dr. Reddy’s : Dr. Reddy’s Laboratories Ltd. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. 28, 2020 10:09 UTC. KMP* – Key Managerial Personnel.

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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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Alta Sciences

JUNE 6, 2025

For biotechnology and pharmaceutical companies, automation can decrease their drug-to-market development time and remain financially competitive in an evolving market. My experience as an optimization scientist has shown how automation can be a valuable tool to support drug development for sponsors of all sizes.

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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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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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Therapies Clinical Supply Clinical Trials Trials 72

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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Laboratories FDA Regulations Licensing 81

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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Agency IQ

DECEMBER 15, 2023

Key stakeholders weigh in on FDA’s Laboratory Developed Test Rule. The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. They don’t like what they see.

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Laboratories Science FDA Regulations 40

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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DNA Laboratories Disease Engineering 144

Drug Target Review

JUNE 30, 2025

The integration of machine learning enables the team to predict which novel proteins are most likely to play critical roles in disease – all before any laboratory work begins. Real, personalised medicine, not just marketing. That means more targeted therapies, higher efficacy and better patient outcomes.

Disease 59

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Drug Target Review

JUNE 19, 2025

This focus has allowed the company to serve not only large-scale industry users, but also academic groups and researchers in emerging markets who may otherwise lack access to advanced automation. .” Opentrons has prioritised accessibility in its system design, creating modular, user-friendly platforms.

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Drug Target Review

MAY 14, 2025

For example, in supply chain, when launching a new product to market with limited sales data, domain expertise becomes critical. What makes this an exciting time is that laboratory automation technology has matured significantly in recent years. These two halves of the problem are coming together.

Drugs 69

Drugs Science Government Production 69

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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Translation

JUNE 11, 2025

market preparation. In Japan, Bayer’s Collaborate to Cure Hub focuses on connecting domestic innovation with global opportunity through structured mentoring and business development.

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Science International Disease Laboratories 52

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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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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Protein Expression Laboratories DNA Engineering 112

The Pharma Data

JUNE 15, 2025

Furthermore, QIAGEN will validate the diagnostic panel’s performance and robustness, ensuring its utility across a range of laboratory settings. This process includes securing appropriate regulatory approvals and developing a clear market access strategy alongside stakeholders, payors, health care providers, and regulators.

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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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The Pharma Data

JUNE 13, 2025

The two companies have signed a Memorandum of Understanding (MoU) to provide comprehensive support and resources to Japanese drug-discovery startups, helping them bring their innovations from laboratory benches toward eventual global delivery of new medicines.

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The Pharma Data

JUNE 26, 2025

The campus design is anchored by a Z-shaped laboratory and R&D office complex that forms a prominent urban frontage—serving as both a gateway to innovation and a symbolic link between science and the broader community.

Laboratories 40

Laboratories Science Pharmaceuticals Compliance 40

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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Laboratories FDA Regulations Production 64

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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Clinical Trials Laboratories Regulations Clinical Research 59

The Pharma Data

JUNE 24, 2025

These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success. With Bio-Techne’s global distribution network and integrated analytical platforms like the MauriceFlex™, more laboratories can now seamlessly adopt these standards into their workflows.

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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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Science Laboratories Research Regulations 105

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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Drug Target Review

JUNE 19, 2025

Still, Bazan says “Vertex’s work has been so important for the pain field – to get eyes on the large market size that matches the significant societal and clinical need for pain innovation.” SRP-001 has already moved beyond the laboratory. Unlike the newly approved NaV1.8 Crucially, it is not associated with abuse potential.

Clinical Trials 52

Clinical Trials Molecular Biology Treatment Trials 52

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.

Laboratories 52

Laboratories Engineering Production Science 52

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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LifeSciVC

JUNE 12, 2025

Josh’s work at the Marine Biological Laboratory unlocked the potential of utilizing an endogenous protein to make a single alphabet change on RNA (RNA editing), a process that was precise, reversible and had druglike characteristics. (Academic specializing in RNA editing). These are exciting times for us at Korro, and the field in general!

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RNA Protein Expression DNA Science 68

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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The Pharma Data

JUNE 24, 2025

This expanded partnership reflects Bayer’s ongoing commitment to strengthening its presence in China—home to the world’s second-largest pharmaceutical market—and underscores its strategic vision to bolster healthcare innovation through cross-sector collaboration.

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