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.

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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. Challenge #4: Regulatory and market access hurdles The regulatory and health technology assessment (HTA) pathways for rare disease therapies are complex and vary by region.

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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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The Pharma Data

JUNE 25, 2025

As of the closing of the transaction, all shares of Regulus common stock, previously traded on the Nasdaq Stock Market under the ticker symbol RGLS, have been delisted. With the acquisition finalized, Regulus Therapeutics has ceased to operate as an independent publicly traded company.

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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.

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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.

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The Pharma Data

JULY 2, 2025

Strategic Expansion with INZ-701 The centerpiece of this acquisition is INZ-701, an investigational enzyme replacement therapy currently in advanced clinical development for the treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) Deficiency. per share in cash. LLC, which served as its exclusive financial advisor.

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.

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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.

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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. Consider Fig.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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The Pharma Data

JANUARY 24, 2021

. (“Citius” or the “Company”) (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0

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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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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.

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

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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. Japan, and China.

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Drug Target Review

JUNE 11, 2025

Multimodality however can detect and connect trends (and in future generate content) across different modalities and therefore allows for better interpretability, which builds trust between regulators, researchers and industry stakeholders. He holds a master’s degree from University of Salerno in political sciences and marketing.

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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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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.

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Drug Target Review

APRIL 3, 2024

I had to learn to actively make noise, advertise my work, engage in discussions, network with peers, and become active in self-marketing. 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.

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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].

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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.

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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.

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LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. And many that have solid preclinical and even clinical data are left on the shelf due to portfolio prioritization processes or because the therapeutic area is no longer core to that company’s strategy.

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PPD

OCTOBER 2, 2024

To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.

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Drug Target Review

SEPTEMBER 26, 2023

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. Regul Toxicol Pharmacol RTP. Another area in need of attention is central nervous system (CNS)-safety testing. 2018;53(4):519–25.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. Such meetings should also be multi-disciplinary, not discipline-specific.

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The Pharma Data

NOVEMBER 11, 2021

Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Wegovy for chronic weight management in adults with obesity. Wegovy is a once-weekly semaglutide 2.4 Food and Drug Administration (FDA).

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The Pharma Data

MARCH 15, 2021

Within each of our therapeutic areas, we have various products in development. The clinical development process. The clinical development process is divided into phases that help us learn important information in a step wise fashion. Partnering with patients in clinical development. Neuroscience.

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Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies?

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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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The Pharma Data

DECEMBER 12, 2020

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. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) in January 2021 and was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in the EU in May 2021. Additionally, it has been submitted for marketing authorization in China, as well as multiple other countries worldwide. Kenilworth, NJ, USA).

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The Pharma Data

NOVEMBER 18, 2020

19, 2020 /PRNewswire/ — NeoDynamics AB (publ, (Spotlight Stock Market: NEOD), a MedTech company dedicated to advancing diagnosis and care of breast cancer, announces today that the Company has received the first UK order from the Buckinghamshire Healthcare NHS Trust, London , of its pulse biopsy system, NeoNavia. STOCKHOLM , Nov.

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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.

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Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Sponsors need to carefully consider how they will prove safety and efficacy in a manner sufficient to satisfy the regulators.

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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. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

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