New Drug Approvals

JULY 25, 2025

2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. 10] Society and culture Legal status Santhera Pharmaceuticals signed an agreement with Catalyst Pharmaceuticals for the North American commercialization of vamorolone in July 2023. [20] Retrieved 14 March 2024. 7 November 2023.

FDA 62

FDA FDA Approval Treatment Clinical Trials 62

The Premier Consulting Blog

DECEMBER 10, 2024

Key components of the CMC section The CMC section of an NDA contains detailed information on the following aspects of the investigational drug: Drug substance or active pharmaceutical ingredient (API). The objective is to demonstrate that the manufacturing process consistently produces a product that meets all predefined specifications.

Marketing 52

Marketing Production Compliance Regulations 52

Drug Patent Watch

JANUARY 9, 2025

The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation. Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. How can you ensure your CDMO is up to scratch?

Compliance 52

Compliance Drug Development Pharma Companies Therapies 52

Codon

JANUARY 5, 2025

To scale-up manufacturing, Cohn asked around and was put in touch with Victor Conquest, a bright technical executive at Armour Laboratories, a pharmaceutical manufacturer in Chicago. With the construction of the pilot plant, Cohn built a scientific environment at Harvard that mimicked commercial pharmaceutical factories in one fell swoop.

Laboratories 105

Laboratories Science Production Research 105

BioPharma Drive: Drug Pricing

JUNE 24, 2025

But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

RNA 219

RNA Drugs Therapies Licensing 219

BioPharma Drive: Drug Pricing

JULY 14, 2025

PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes. By Jonathan Gardner • Sept. By Jonathan Gardner • Sept.

Production 152

Production Drugs Therapies Clinical Trials 152

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on.

Drugs 81

Drugs Packaging Compliance Regulations 81

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. Understanding Generic Drugs: The Basics Before diving into educational strategies, let’s refresh our understanding of generic drugs and their importance in healthcare. What Are Generic Drugs?

Drugs 71

Drugs FDA Doctors Trials 71

Drug Patent Watch

MARCH 19, 2025

Navigating the Complex World of Drug Patents: A Comprehensive Strategy is Key As a pharmaceutical professional, you know that developing new medications is a costly and time-consuming process. In today's highly competitive pharmaceutical landscape, it's essential to stay ahead of the curve when it comes to patent management.

Drugs 40

Drugs Packaging Pharmaceuticals Production 40

Codon

JULY 14, 2025

My goal is not only to tell the story of a pharmaceutical staple but to share what my decades-long work in evidence synthesis in epidemiology has taught me about researching scientific history. In this article, Eichengrün stated that he was appointed, in 1895, to establish and manage a pharmaceutical laboratory at Bayer.

Treatment 85

Treatment Laboratories Disease Drugs 85

Drug Patent Watch

FEBRUARY 17, 2025

The generic drug approval process is a complex, multi-step journey that involves several stakeholders, including pharmaceutical companies, regulatory agencies, and healthcare professionals. The journey to approval is often shrouded in mystery, but it's a crucial process that affects millions of people worldwide.

Packaging 52

Packaging Drugs FDA Pharmaceutical Companies 52

New Drug Approvals

JULY 18, 2025

Detailed numbers are provided by Genuine in the slides and the medication package insert. [14] Common (> 1%) side effects include nausea, elevated blood lipids, fever, insomnia, tiredness, and diarrhea. 17] Azvudine is toxic to the reproductive system of rats and rabbit. . 98 : 379–386. doi : 10.1016/j.jpba.2014.06.019. 2014.06.019.

RNA 62

RNA Clinical Trials Trials Virus 62

Drug Discovery Today

APRIL 14, 2023

Through a series of exclusive interviews and a survey of industry insiders, Connect in Pharma names the top pharmaceutical and manufacturing-related trends of 2023

Packaging 113

Packaging Production Pharmaceuticals 113

Drug Discovery Today

MAY 19, 2023

Technology gurus, consultancy experts and motivational speakers from a wide range of industries are calling for a new, modern era of pharmaceutical packaging and manufacturing that utilises high-tech and innovative thinking from other industries.

Pharmaceuticals 113

Pharmaceuticals Packaging 113

The Pharma Data

APRIL 27, 2022

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies.

Packaging 52

Packaging Pharmaceuticals Pharma Companies Pharmaceutical Companies 52

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

The Pharma Data

DECEMBER 10, 2020

Sildenafil, Trazodone Tablets Recalled After Being Packaged Together. 10, 2020 — Sildenafil and trazodone tablets have been recalled by pharmaceutical distributor AvKARE because the drugs were “inadvertently packaged together” when they were bottled by a third-party vendor, according to the company.

Packaging 52

Packaging Pharmaceuticals Production Drugs 52

Drug Discovery Today

AUGUST 31, 2022

In the lead up to the inaugural launch of Connect In Pharma, co-founder Wilfried Phipps provides insight into what visitors can expect at this new annual event designed to help shape the future of pharmaceutical packaging and manufacturing projects

Packaging 113

Packaging Pharmaceuticals 113

thought leadership

MARCH 26, 2024

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation 1 to revise many of the currently applicable Regulations.

Pharmaceuticals 52

Pharmaceuticals Packaging Regulations Science 52

DrugBank

JANUARY 22, 2025

Environmental Impacts of Traditional Pharmaceutical Production Traditional pharmaceutical manufacturing is complex, with each phase contributing to environmental degradation. The extraction and synthesis of active pharmaceutical ingredients (API) utilize vast amounts of water and energy.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Production Government 52

Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more.

Drug Development 96

Drug Development Production Pharmaceutical Companies Clinical Trials 96

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Fierce BioTech

JANUARY 3, 2025

This joint webinar presentation by West and Groninger, explores the unique challenges of Cell and Gene Therapies, mRNA LNP therapeutics particularly regarding cold storage requirements and their impact on packaging solutions. Click here to login. Listing Image WestPharma_ListingLogo_250x190.png On Demand Start Date Wed, 02/12/2025 - 11:00

Packaging 52

Packaging Therapies Pharmaceuticals Treatment 52

Fierce BioTech

JANUARY 3, 2025

Innovations in aseptic processing for container closure systems dwunderlin Fri, 01/03/2025 - 14:26 Wed, 02/12/2025 - 10:00 Resource Type Webinar Jim Thompson Julian Petersen Duration 60 Minutes The pharmaceutical landscape is shifting from blockbuster drugs to personalized treatments, driving the need for innovative container closure systems.

Packaging 52

Packaging Therapies Pharmaceuticals Treatment 52

The Open Targets Blog

OCTOBER 24, 2023

  Together with Ray Kamalika, a research bioinformatician at OMass Therapeutics, he developed Otargen , an R package offering a suite of functions to facilitate the retrieval and analysis of Open Targets Genetics data, including specialised plotting functions to help visualise the information.   Have you used Otargen?

Bioinformatics 62

Bioinformatics Packaging Pharmaceutical Companies Pharma Companies 62

Drug Target Review

AUGUST 6, 2024

They provide pharmaceutical companies with the expertise and infrastructure needed to overcome technical, logistical and regulatory hurdles, ensuring efficient development, high-quality standards and timely market entry. By partnering with CDMOs, pharmaceutical companies can share the risks associated with ADC development and manufacturing.

Therapies 120

Therapies Pharmaceutical Companies Disease Treatment 120

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. has a strong voice in the world. citizens; 2.

Pharmaceuticals 40

Pharmaceuticals Regulations Packaging Marketing 40

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. What will the orphan drug market exclusivity haircut mean for industry?

Marketing 52

Marketing Packaging Regulations Drugs 52

Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

Fierce BioTech

MAY 2, 2024

West Pharmaceutical Services (West) and Cytiva have teamed up to offer innovative and versatile fill finish solutions to efficiently meet the unique demands of advanced pharmaceutical applications. In this webinar, you will learn about: The challenges and risks related to the packaging and filling of high-value drug products.

Therapies 52

Therapies Packaging Pharmaceuticals Production 52

Drug Target Review

JULY 18, 2023

If we look at the pharmaceutical industry’s discovery and development success rate over the last 20 to 30 years, it has not improved, staying stubbornly at around 10 percent. With support from pharmaceutical companies, ultimately, the answer to this question should be yes. Will systems like the NHS be able to deliver it?

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Quanticate

AUGUST 27, 2021

Even though R as a programming language is constantly growing in popularity in the pharmaceutical industry, it is still quite unpopular to use R in the preliminary stages of research like importing data from different sources, tidying it, calculating new variables in datasets and making other amendments available in SAS data steps.

Packaging 52

Packaging Pharmaceuticals Research 52

BioPharma Drive: Drug Pricing

JUNE 23, 2025

The pharmaceutical industry is exploring alternatives such as oral formulations, sublingual dissolvables, and transdermal methods to improve sustainability and patient convenience, though scientific hurdles like bioavailability remain.

Treatment 130

Treatment Drugs Therapies FDA 130

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. PPD ® Laboratory services are backed by a proven track record with over three decades of experience providing CMC pharmaceutical testing.

Laboratories 52

Laboratories Assay Development Small Molecule Drug Development 52

The Pharma Data

DECEMBER 10, 2020

” Sildenafil and T razodone T ablets Recalled After Being Packaged Together. Sildenafil and trazodone tablets have been recalled by pharmaceutical distributor AvKare because the drugs were “inadvertently packaged together” when they were bottled by a third-party vendor, according to the company.

Packaging 52

Packaging FDA Pharmaceuticals Production 52

The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5

Packaging 52

Packaging FDA International Pharmaceuticals 52

The Pharma Data

MARCH 15, 2022

Teva is donating medicines valued at over $11M, for acute therapies in support of Ukrainian refugees The donations include over 1 million packages of antibiotics and other essential medicines as well as hygienic products for Ukrainian infants and children. Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Packaging Therapies 52