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.

RNA

PPD

JUNE 17, 2025

In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6 Expansion into non-footprint countries Many clinical development projects are confined to regions where sponsors have a direct presence.

Clinical Development

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.

Drugs

Conversations in Drug Development Trends

JULY 3, 2025

In practice, these regulations created substantial bottlenecks. For instance, the regulations required patients to remain in close proximity to the healthcare facility for a full four weeks, which became difficult if the patient needed to transfer hospitals or lived far away from certified centers.

Therapies

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

Drug Target Review

AUGUST 8, 2025

Market outlook: A new wave of biologics The biologics market is evolving rapidly. As clinical adoption accelerates and regulatory approvals increase, there are now four FDA-approved T cell engagers and 17 bispecific antibody therapies available on the global market. References PatSnap Synapse. Bispecific Beacon.

Engineering

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers.

Drug Development

The Pharma Data

JUNE 22, 2025

Exelixis Reports Positive Phase 3 Results for Zanzalintinib and Atezolizumab Combo in Metastatic Colorectal Cancer Exelixis , has announced promising topline results from the STELLAR-303 phase 3 pivotal clinical trial, a major milestone in the development of its investigational therapy zanzalintinib.

Trials

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.

Therapies

The Pharma Data

AUGUST 3, 2025

Nielsen officially joins the company on August 1, 2025, and will oversee Genmab’s operations in Germany—Europe’s largest pharmaceutical market and a pivotal launchpad for biotech growth in the region. Germany is not only a significant healthcare market but also a gateway to broader European access.

Therapies

The Pharma Data

JUNE 13, 2025

This framework brings together regulators from multiple jurisdictions to enable faster, more unified reviews of oncology medicines. Currently, marketing authorization applications for KEYTRUDA, based on the results from KEYNOTE-689, are under review by health authorities in Israel, Canada, Australia, Singapore, Brazil, and Switzerland.

FDA Approval

Drug Target Review

MAY 26, 2025

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. “Regulators are also much more interested in the manufacturing process, especially when it comes to stability.”

Drug Development

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.

Therapies

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

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

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.

Marketing

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

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

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.

Therapies

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.

Production

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.

Biosimilars

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

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.”

Drug Development

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

Marketing

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.

Clinical Research

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.

Laboratories

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.

FDA

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

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.

Science

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

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

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

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.

Clinical Trials

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.

Drugs

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).

Treatment

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.

Clinical Trials

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?

Treatment