PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials

The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

Clinical Development

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

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. Disclaimer. About Sandoz.

Biosimilars

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. With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

Drug Development

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

Clinical Research

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. Disclaimer. About Sandoz.

Biosimilars

FDA Law Blog: Biosimilars

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. In other words, it’s a sweeping application across the industry.

FDA

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

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.

Treatment

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. If medicines are to be used in children, they need to be studied in pediatric populations to ensure they are safe and effective.

Clinical Trials

The Pharma Data

JANUARY 24, 2021

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures. About Citius Pharmaceuticals, Inc. CRANFORD, N.J. ,

Marketing

The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link].

Clinical Trials

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. What Are Radiopharmaceuticals?

Clinical Trials

The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

Science

The Pharma Data

DECEMBER 17, 2020

Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

Small Molecule

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.,

FDA Approval

Cytel

MAY 7, 2024

This legislation emerged from a pressing need to address “orphan” conditions, i.e., conditions that were abandoned or “orphaned” by the pharmaceutical industry, deemed unprofitable due to the small number of affected patients (fewer than 200,000 Americans).

Marketing

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

The Pharma Data

MARCH 15, 2021

This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Local authorities, such as the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the U.S. We are committed to Good Clinical Practice. Neuroscience.

Clinical Trials

LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. Specialty companies can play an important role in accelerating clinical development, especially in rare diseases like cystic fibrosis by being strategically opportunistic and moving quickly.

Clinical Research

The Pharma Data

OCTOBER 14, 2020

. Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. 15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. CHATHAM, N.J., 1 Noyce RS, et al.

Vaccine

Altus Drug Development

MAY 31, 2022

Value-added pharmaceutical products can deliver a wide variety of improvements for patients and healthcare professionals. Drug reformulation Pharmaceutical formulation is a process where different chemical substances are combined to produce a new medicine. What type of improvement can value-added medicines deliver?

Treatment

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Ther Innov Regul Sci. Rockley KL.

Drugs

The Pharma Data

JANUARY 12, 2021

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

Science

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. 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.

Clinical Research

Altus Drug Development

JUNE 28, 2022

Ensuring access to safe and effective treatments is the main challenge faced by pharmaceutical companies big and small. Value-added medicines offer an efficient method to meet the needs of patients while stimulating innovation in the pharmaceutical industry. What R&D efforts are needed to develop value-added medicines?

Pharmaceutical Companies

The Pharma Data

JUNE 28, 2021

It has a serious impact on the lives of patients, their families and loved ones,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division. Bayer is proud of the approval of vericiguat in Japan and the contribution it has shown in clinical trials.”.

Treatment

The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. View the full release here: [link].

Regulations

The Pharma Data

JANUARY 19, 2021

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

Clinical Trials

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Source link.

Clinical Trials

The Pharma Data

JANUARY 31, 2021

Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. . TOKYO and CAMBRIDGE, England , Feb. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

Structure Based Drug Design (SBDD)

Agency IQ

JANUARY 4, 2024

But while the ideas proposed by the agency are likely of interest to regulators, the report doesn’t spend much time thinking about how it might improve its processes to benefit external stakeholders. The GGP regulation describes how the agency solicits or collects feedback on guidance documents, including in advance of publication.

FDA

The Pharma Data

JANUARY 14, 2021

Clinical Development – Pipeline Review. He leads a group that investigates the effect of the tumor microenvironment on tumor development and progression, particularly the role of cancer-associated fibroblasts in regulating immune escape and tumor invasion. End.

Clinical Trials

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Vaccine

Agency IQ

JULY 21, 2023

released both a coordinated plan on artificial intelligence (AI) and a proposal for a regulation. The coordinated plan intends to promote AI innovation by “setting enabling conditions for AI development and uptake in the EU” as well as ensuring “that AI works for people and is a force for good in society.”

Science

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Treatment induced sustainable clinical responses and reduced systemic inflammation. The human monoclonal antibody targets specific immune plasma cells. Daratumumab already is approved for the treatment of multiple myeloma.

Disease