Pharmaceutical Technology

JULY 15, 2025

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. by market close.

Packaging

Pharmaceutical Technology

JULY 18, 2025

Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. Moreover, other threats to the early-stage drug development for rare diseases are also a concern. How will RFK Jr’s American dream for vaccines play out?

Drug Development

Pharmaceutical Technology

JULY 18, 2025

The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved. How will RFK Jr’s American dream for vaccines play out?

Communication

pharmaphorum

FEBRUARY 10, 2021

As these solutions are further developed, the consortium will produce data collections for validation, regulatory pathways and technical standards. The post EU-funded project encourages use of simulation in drug development appeared first on.

Drug Development

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

Packaging

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.

Packaging

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions

Syner-G

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

Documentation

Syner-G

SEPTEMBER 20, 2023

By: Mayuri Mutha, Senior Manager, CMC Development & Project Management Joseph Sclafani PhD, Director, CMC Development & Project Management Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization.

Drug Development

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

Packaging

Pharmaceutical Technology

SEPTEMBER 8, 2022

The companies offer various solid dose products and services including, but not limited to, formulation and analytical development, manufacturing capabilities, technology transfer and scale-up, quality and regulatory support, commercial manufacturing, packaging, and warehousing.

Dosage

Pharmaceutical Technology

SEPTEMBER 23, 2022

And, because it also manufactures products, its staff is current on regulatory requirements and FDA/ICH Guidance documents. Since CDMOs have different material handling capabilities, when choosing a partner, it’s important to understand if the drug will involve a controlled substance, hormone, small molecule or biological.

Packaging

European Pharmaceutical Review

JANUARY 13, 2025

3 Encouragingly, there are many examples of the life sciences sector seeking to embrace sustainable drug development; reconciling the drive for innovation with the need to reduce waste and emissions produced during the R&D process, as well as throughout the product lifecycle. 5 However, the benefits are well documented.

Packaging

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

Packaging

Pharmaceutical Technology

NOVEMBER 28, 2022

We source as much of the materials as we possibly can locally, even packaging,” he notes. When we need new packaging, it is really simple to get and it is quick. To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page.

Packaging

PharmaTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. It uses terms like “to the extent possible”, thus allowing for methodological developments pushing the ability to detect structural details in ever greater and more precise ways.

Dosage

PharmaTech

JUNE 23, 2025

Discussion topics Part two of this series ( click here for part one ) addresses numeric calculations for types of bulk drugs. It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties.

Compounding

pharmaphorum

JANUARY 18, 2022

Who should Attend: Drug-delivery developers. Primary Packaging material designers. Secondary packagers. Smart device developers. Training device developers. Drug developers. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion.

Packaging

PharmaTech

JULY 24, 2025

full transcript below In Part 3 of our multi-part interview series, Jason Waite, an international trade expert at Alston & Bird, outlines how proposed sector-specific tariffs on pharmaceutical products could significantly disrupt the United States drug development landscape.

Dosage

Quality Matters

JUNE 6, 2023

Despite being called “inactive” ingredients, excipients in medicines play a vital role in drug development, delivery, effectiveness, and stability. Comprising up to 90% of individual drug products, excipients function as binders, disintegrants, solubilizers, coatings, preservatives, colors, and flavorings.

Dosage