PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

Biosimilars 52

Biosimilars Clinical Development Production Government 52

Drug Target Review

DECEMBER 13, 2023

The study mentions the overlap in genes associated with Fatigue Dominant long COVID and ME/CFS, including those involved in circadian rhythm regulation and insulin regulation. How do these genetic similarities provide insights into the commonalities between these conditions and their biological mechanisms?

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Bioinformatics Disease Regulations Immune Response 145

The Pharma Data

JULY 28, 2021

Orexin plays a critical role in regulating a person’s sleep wake cycle, and supports the body’s natural wake promoting pathways in the brain.”.

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Clinical Development Therapies Laboratories Treatment 52

PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

PPD

OCTOBER 17, 2024

Drug developers of all sizes are working to optimize each step in the clinical research process from site selection to complex logistics, managing evolving regulations, and patient recruitment and retention strategies. Leverage our global footprint and hands-on support to quickly and safely address unmet medical needs.

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Therapies Clinical Trials Clinical Research Trials 97

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

Biosimilars 40

Biosimilars Clinical Development Production Government 40

Drug Target Review

JULY 20, 2023

Additionally, they identified overlaps between the genes associated with fatigue-dominant long COVID and ME/CFS, especially those involved in circadian rhythm regulation and insulin regulation. Genes unique to the fatigue-dominant subgroup were enriched in metabolic pathways such as MAPK/JNK signalling.

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Clinical Development Regulations Disease Treatment 75

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). One example of such a genetics exercise is represented in Fig.

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Production Small Molecule Regulations Trials 117

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). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena.

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Laboratories Clinical Development FDA Regulations 52

Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

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Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor.

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Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

Fierce BioTech

MAY 15, 2024

But many life sciences organizations still rely on complex legacy IT infrastructures and struggle to make sense of constantly growing amounts of sensitive, regulated data. The cloud provides a better solution.

Science 52

Science Clinical Development Regulations Research 52

Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

Clinical Trials 52

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

Marketing 59

Marketing Pharmaceutical Companies Regulations Pharmaceuticals 59

Conversations in Drug Development Trends

AUGUST 23, 2023

To spur more frequent engagement between patients, sponsors, and regulators, Richie Kahn and Jenn McNary co-founded Canary Advisors , a patient engagement consultancy that works to better align development programs with patient needs.

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FDA Trials Clinical Trials Disease 96

FDA Law Blog: Biosimilars

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers.

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Cytel

APRIL 5, 2024

Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing clinical development environment, sponsors face many challenges when designing clinical trials.

Clinical Trials 45

Clinical Trials Trials Clinical Development Regulations 45

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”

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Clinical Trials Trials FDA Regulations 105

Drug Target Review

APRIL 3, 2024

So far, GDF-15 has mainly been known as an important factor in feto-maternal tolerance and a regulator of nausea, anorexia, and food aversion in different diseases, including cancer and the pregnancy complication hyperemesis gravidarum. She has established a track record as a successful leader and entrepreneur in the biotech industry.

Science 105

Science Clinical Development Treatment DNA 105

Drug Target Review

DECEMBER 27, 2023

Aside from CD24, there are several other ‘don’t eat me’ signals that have been characterised, and there are multiple programmes currently in clinical development that target these signals. We are building a pipeline of first-in-class and best-in-class drugs against these targets.

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Immune Response Science Clinical Development Drugs 105

Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. Cell adhesion molecules and their roles and regulation in the immune and tumor microenvironment. Cancer Immunology Research. Frontiers in Immunology.

Treatment 98

Treatment Therapies Clinical Development Cell Biology 98

Alta Sciences

NOVEMBER 15, 2024

As the CRO, our role is to provide a broader perspective and identify additional areas where our expertise can support their development program,” explains Lisa. For example, at Altasciences, we can discuss clinical development strategies that include adding study arms such as ethnobridging , or early precision QT analysis assessments.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. With over 25 years of experience in the pharmaceutical industry, Donello has been instrumental in drug discovery and development.

Treatment 52

Treatment Licensing Licensing Science 52

SugarCone Biotech

JUNE 10, 2024

[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. This is where things get interesting due to the complexity of the immune system and its regulation.

Immune Response 88

Immune Response Production Regulations Clinical Trials 88

LifeSciVC

APRIL 2, 2024

We are confident that there is room for improvement over existing cystic fibrosis (CF) therapies because we have not yet achieved fully normalized function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Science 69

Science Small Molecule International Clinical Development 69

PPD

OCTOBER 2, 2024

For our clients, the ability to outsource these capabilities is a marked improvement compared to hiring, training and maintaining a large workforce to fulfill every aspect of clinical operations — a feat made even more complicated by workloads that can fluctuate widely depending on the number of products under development.

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Clinical Trials Clinical Development Clinical Research Trials 52

The Pharma Data

APRIL 14, 2021

2 The use of Xolair across allergic asthma, CIU and nasal polyps is based on its well-established efficacy and safety profile and supported by a robust clinical development program, including 10 Phase III studies. Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval in 2003. In the U.S.,

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FDA Approval Clinical Development FDA Treatment 52

Cytel

JUNE 19, 2024

Historically, many drugs have been prescribed to children even though this patient population have largely been excluded from clinical trials. There is an obvious logic.

Clinical Trials 59

Clinical Trials Regulations Drug Research Pharmaceuticals 59

PPD

SEPTEMBER 6, 2023

For sponsors with employees in Europe or Latin America, outsourcing arrangements must comply with applicable Acquired Rights Directive (ARD) regulations, stipulating employees’ rights to retain their jobs when work is transferred to another company. A well-managed rebadging model represents an ideal pathway to full ARD compliance.

Clinical Research 59

Clinical Research Regulations Packaging Drug Development 59

Agency IQ

APRIL 8, 2024

medical and diagnostic device regulations established expert panels. Expert panels have two main tasks under these regulations: To provide opinions/views and ad hoc advice. For a fee, manufacturers can also consult with expert panels on clinical development plans and clinical investigation proposals (MDR Article 106(11)).

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Clinical Development Regulations Laboratories Production 40

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. View source version on accesswire.com: [link].

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Many companies are unable to develop these niche therapies because of the associated costs and limited financial return.

Therapies 52

Therapies Clinical Trials FDA Trials 52

Metabolite Tales Blog

DECEMBER 19, 2023

The term “validated” in this instance is not considered the same as validation related to regulated studies in HA guidelines. . > 90% do not use fully validated methods as per the Health Authority (HA) guidelines on bioanalysis method validation. Instead, the use of a well characterised fit-for-purpose assay is recommended.

Pharma Companies 52

Pharma Companies Drug Development Trials Compliance 52

PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. Here’s how we do it.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

The Pharma Data

NOVEMBER 2, 2020

2, 2020 — An experimental antibody drug that targets one of the body’s key metabolism regulators may help obese people lose weight — at least briefly. Adiponectin helps regulate blood sugar and fatty acid breakdown. vice president, clinical development, Principia Biopharma, South San Francisco; Donna Ryan, M.D.,

Drugs 52

Drugs Regulations Science Research 52