Pharmaceutical Technology

AUGUST 15, 2023

A deep understanding of regional differences in regulations and marketing is critical for global launches.

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Packaging Packaging Marketing Regulation 130

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing. Container Closure Systems. Container closure systems are highly regulated by health agencies.

Packaging 98

Packaging Packaging Containment Production 98

Roots Analysis

APRIL 21, 2022

Sustainable packaging is defined as packaging that is safe for individuals, as well as the environment, while meeting all requirements for performance, cost and ease of fabrication. The continuously growing pipeline of pharmaceutical drug candidates has inadvertently led to an increase in the demand for product packaging solutions.

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Roots Analysis

APRIL 20, 2022

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. In addition, over the next five years, the global pharmaceutical market is projected to grow at a CAGR of 4.7%, with global drug sales anticipated to raise revenues worth USD 1.5 trillion in 2023.

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Pharma Packaging Solutions

OCTOBER 6, 2021

Over the years, more and more pharmaceutical companies have moved away from in-house packaging operations and toward pharmaceutical contract packaging. Packaging Innovation. Packaging Innovation. Developing new packaging formats can be expensive, and not every new design will have staying power.

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Packaging Packaging Pharma Companies Contract Packaging 52

Camargo

OCTOBER 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence.

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Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.”

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Pharmaceutical Technology

NOVEMBER 24, 2022

South African bio-pharmaceutical firm Biovac and the International Vaccine Institute (IVI) in South Korea have signed a licencing and technology transfer agreement for developing and manufacturing an oral cholera vaccine (OCV). The post Biovac and IVI enter deal to develop oral cholera vaccine appeared first on Pharmaceutical Technology.

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Vaccination Vaccine Development Manufacturing 147

BioPharma Reporter

NOVEMBER 3, 2021

CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drug delivery systems for newly developed biologics along with medical and diagnostic products.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Regulatory decisions come in. Source: GlobalData Pharmaceutical Intelligence Center. NICE decisions.

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Drug Discovery World

AUGUST 4, 2022

It may seem counterintuitive to spend time and money on planning for containment and delivery systems for a drug in the earliest stages of discovery when the chances of that molecule making it to market are still quite low. However, starting early can greatly improve the efficiency and speed of the development process. Never too early.

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Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. When PREA was first instituted, the statutory requirements did not apply to products that received Orphan Drug Designation (ODD). emphasis added).

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Drug Discovery World

NOVEMBER 10, 2022

A new polymer-based drug delivery system for mRNA and other nucleic acids has won the CPHI Excellence in Pharma Award in the category “Packaging and Drug Delivery”. . The system was developed by Evonik Health Care together with researchers at Stanford University. .

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Drug Delivery Systems Drug Delivery Drugs Packaging 98

Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

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Camargo

DECEMBER 9, 2020

Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information. Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US.

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pharmaphorum

FEBRUARY 10, 2021

A new EU-funded project called In Silico World aims to encourage the use of simulation for drug and medical device development. As these solutions are further developed, the consortium will produce data collections for validation, regulatory pathways and technical standards.

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Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

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Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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Pharma Mirror

NOVEMBER 4, 2022

Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation (TSE: 4543) and a leading manufacturer of injection, primary container, and infusion therapy devices, has today announced it will expand its contract development and manufacturing services for parenteral drugs to global customers.

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Drug Discovery World

JULY 25, 2023

DDW recently hosted Where are the breakthroughs in mRNA drug discovery and development? In this webinar, sponsored by Elegen, attendees learnt about the breakthroughs in mRNA drug discovery and development. The post Further insight into breakthroughs in mRNA drug discovery appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MAY 4, 2023

Previous attempts to interrupt TGF-β pathway signaling in cancer have been thwarted by drug-associated toxicities and activation of resistance pathways by the tumour. Catherine Pickering, Chief Executive Officer of iOnctura, said: “IOA-359 is an exciting addition to our preclinical pipeline.

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pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Connected Drug Delivery Devices. Hear about new technological advances in the delivery of large volume drugs. Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives.

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Drugs Packaging Packaging Drug Delivery 52

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. A summary of these new state law developments is included below.

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pharmaphorum

AUGUST 5, 2020

SMi presents the 4 th Annual Ophthalmic Drugs Conference taking place on the 23 rd -24 th November 2020, in London. Workshop will be on ‘Ophthalmic Drug Delivery Development – Trials and Tribulations’. Understanding the pharmacological challenges for DD and development pathway including cost and timelines.

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Pharmaceutical Technology

AUGUST 10, 2022

Catale n t has signed an agreement for the acquisition of full-service specialty Contract Development and Manufacturing Organization (CDMO) Metrics Contract Services for $475m from Mayne Pharma. It also has two packaging lines that can accommodate a wide range of development and commercial supply programmes.

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Packaging Packaging Bioavailability Manufacturing 147

Drug Discovery World

JUNE 23, 2023

A guide to using adeno-associated virus (AAV) vectors in gene therapy This webinar will help you understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development.

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FDA Law Blog

JANUARY 3, 2024

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. In all of these letters, CVM alleges that the distributors who “take orders” are selling unapproved drug products—typically for infection control—for use in fish and, in some cases birds.

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Pharma Packaging Solutions

SEPTEMBER 22, 2023

Biologics are drug products that are manufactured using materials from living sources. Because biosimilars have a more streamlined development process than biologics, they are typically more affordable. Biopharma Packaging from Tjoapack One thing biologics and biosimilars have in common is that they both require high-quality packaging.

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pharmaphorum

OCTOBER 12, 2022

The 2023 Transdermal and Microneedle Drug Delivery Conference will explore real world applications of microneedles in drug delivery and strategies for advanced and user-centric device design. The two-day agenda offers you peer-to-peer networking with CEO’s, Senior Vice presidents, Directors, Heads of Product Development and many more.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.

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Packaging Packaging Compliance Manufacturing 130

BioPharma Reporter

MAY 24, 2023

Bora Pharmaceuticals is a pharmaceutical company that provides solutions for the development, manufacturing, and packaging of pharmaceutical products. In the large molecule space, it offers comprehensive services from the development of mammalian cell lines through cGMP production of drug substance.

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World of DTC Marketing

SEPTEMBER 23, 2021

The suggestion by Pfizer’s CEO that drug pricing negotiations with the government would slow innovation is PR doubletalk. trillion social spending package. trillion social spending package. Here is his rationale: “ When we asked the Pfizer colleagues to develop a Covid-19 vaccine in l ess than a year, you did.

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Pharma Mirror

SEPTEMBER 27, 2021

New York/USA, At Interphex 2021 in New York, Syntegon (formerly Bosch Packaging Technology) presents new solutions for lab-scale and small batch filling of solid and liquid pharmaceuticals. The need for smaller quantities of highly potent drugs is rising continuously.

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Packaging Packaging Development Drugs 130

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA.

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Pharmaceutical Technology

MAY 1, 2023

Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). It has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US.

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Pharmaceutical Technology

MAY 26, 2023

Sandoz chief medical officer and biopharmaceuticals development platform head Florian Bieber stated: “Sandoz is one of the first to have its applications for a proposed biosimilar denosumab accepted by the EMA. “If

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Marketing Packaging Packaging Medicine 130

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The FDA governs the drug and biologic approval process in the United States, while the EMA serves the European Union (EU) plus Iceland, Norway, and Liechtenstein.

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