XTalks

JULY 27, 2023

Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging?

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Roots Analysis

FEBRUARY 1, 2024

Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology, and process development. Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products.

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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

FEBRUARY 16, 2022

In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1] Our Social Media Platform.

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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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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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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 guidance also contains some useful information, despite the limitations described above. FDA Publishes ICH Guidelines on Continuous Manufacturing.

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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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World of DTC Marketing

OCTOBER 28, 2021

SUMMARY: Large-cap pharma companies are trading higher in the morning hours after White House unveiled a framework for a deal on President Biden’s social spending package on Thursday leaving out a key provision that allowed Medicare to negotiate lower prescription drug prices. Most people in pharma lie to themselves. It’s Amazon.

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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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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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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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Drugs Production Licensing Licensing 59

XTalks

MAY 18, 2023

The wireless charger — the transmitter — contains a metallic coil that converts electrical energy into a magnetic field, which is then collected and reverted into electricity by the receiver inside the implanted device. billion in 2022. This figure is expected to more than double and reach $98.5 billion by 2032.

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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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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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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

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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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Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Biologics development is a complex and expensive process. The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Increasing drug failure rates and essential drug shortages have driven the growth of the compounding pharmacies market, which has a high growth potential, especially in emerging economies. Packaging. • Test method development. It may provide access to discontinued drugs and allows for alternative compounded dosage forms.

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Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

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Pharmaceutical Technology

FEBRUARY 7, 2023

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. One general trend throughout Europe is the use of cost-containment measures to control public spending.

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pharmaphorum

NOVEMBER 17, 2021

SMi Group’s 14 th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2022 – 12 th – 13 th January 2022. Sustainability for Drug Devices Focus Day – 14 th January 2022. The Future of Drug Delivery and Combination Product Device Design. London, UK www.pre-filled-syringes.com/Pharmaphorum.

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Pharmaceutical Technology

NOVEMBER 25, 2022

The demand for PDFs of drugs spanning a broad range of therapeutic areas will likely continue to grow. But the challenges for drug producers developing PDFs are numerous and varied. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing.

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Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Integrated analytical services for pharmaceuticals.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. ADME studies require the use of a radiolabeled version of the investigational drug. ADME studies require the use of a radiolabeled version of the investigational drug.

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XTalks

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

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XTalks

SEPTEMBER 13, 2022

While the US Food and Drug Administration (FDA) would normally issue a recall, no recall was issued because the products are no longer available for purchase. The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. “The Coli illness.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies.

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XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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XTalks

FEBRUARY 13, 2024

Such developments have led to a more vigilant stance against deceptive marketing practices, pushing for transparency and honesty in food advertising. The complaint highlighted that these drinks did not contain any of the advertised mango, açaí berry or passion fruit.

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Drug Discovery World

MAY 2, 2023

Steve Wowk , VP, Business Unit and General Management of Integrated DNA Technologies, shared with DDW the value of CRISPR-Cas9 in drug discovery. Today, scientists leverage this defence mechanism to learn more about the genomic alterations in diseased states as well as the impact of drug treatments on the human genome.

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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