Pharmaceutical Technology

DECEMBER 12, 2022

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Additionally, Kite will make other potential payments to Arcellx.

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Pharmaceutical Technology

OCTOBER 24, 2023

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Many test methods have thus been developed. Free Webinar.

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Drug Patent Watch

JANUARY 14, 2025

But how do companies develop these cost-effective alternatives? Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1]. ”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation.

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Pharmaceutical Technology

OCTOBER 19, 2023

AN2 Therapeutics has signed an agreement for advancing the development of a new boron-containing small molecule to treat Chagas disease.

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Pharmaceutical Technology

JUNE 14, 2023

This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

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Camargo

NOVEMBER 11, 2020

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. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.

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Rethinking Clinical Trials

OCTOBER 2, 2023

The Patient-Centered Outcomes Core has developed a new tool kit to provide resources to support the capture of patient-reported outcome (PRO) measures in diverse study populations. The post October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs appeared first on Rethinking Clinical Trials.

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Pharma Times

FEBRUARY 12, 2024

The platform delivers digitalised patient data to improve clinical trials and development

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Pharmaceutical Technology

MARCH 7, 2025

How to ensure safety and quality in pharmaceutical facilities when using HPAPIs in drug development. Read more here.

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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. Orientation.

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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. That potential has now been realized.

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Camargo

DECEMBER 10, 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. Voxzogo Approved as a Growth-Improvement Therapy for Children with Dwarfism.

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Pharmaceutical Technology

OCTOBER 6, 2022

from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.

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XTalks

JANUARY 30, 2025

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients.

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Pharmaceutical Technology

MAY 10, 2023

This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government. While both Descovy and Truvada contain emtricitabine, they feature different forms of the antiviral tenofovir.

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Camargo

JANUARY 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. If you are developing a combination product, Camargo can help you design the fastest, most efficient path to approval. Co-Authors: Ken Phelps.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.

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Medical Xpress

MAY 16, 2023

A vegan diet does not affect maternal breastmilk concentrations of vitamin B2 and carnitine, nutrients essential for the developing infant. These are the results of an Amsterdam UMC study, presented today at the 55th Annual Meeting of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).

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Pharmaceutical Technology

AUGUST 3, 2022

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.

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Camargo

APRIL 20, 2021

This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players. Become Fluent in the Drug Development “Languages.”. The language of accounting, to optimally allocate capital to maximize results.

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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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Packaging Packaging Manufacturing Development 130

Pharma Times

MARCH 27, 2023

Company is developing a therapy containing an enzyme cloned from medical maggots

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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. A lesser-known provision also grants the same seven-year market exclusivity if the sponsor demonstrates that it does not expect to recover the development costs from selling the drug. Ken Phelps. Bill Stoltman, JD.

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Bio Pharma Dive

MARCH 20, 2023

Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing.

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Pharmaceutical Technology

MAY 2, 2023

As a result, the EUAs of the original monovalent mRNA vaccines developed by Pfizer/BioNTech and Moderna for the prevention of Covid-19 have been revoked, meaning they are no longer authorised for use in the US. Novavax is currently developing a bivalent Omicron-specific vaccine with plans to commercialise the updated vaccine later this year.

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Drug Patent Watch

MARCH 12, 2025

For generic drug manufacturers, stability testing is a critical step in the development process. Container Closure System : How will the drug interact with its packaging? Learn more about the importance of stability testing in generic drug development: [link] This is particularly important for drugs that are sensitive to light.

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Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

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Pharmaceutical Technology

JUNE 9, 2023

VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1%

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs. Containment challenges.

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Medical Xpress

FEBRUARY 15, 2023

Human sweat contains chemical information including blood metabolites, ion concentrations, and nutrients. Monitoring this information using a wearable sensor can allow non-invasive (i.e., without blood sampling), real time health status tracking.

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Medical Xpress

APRIL 6, 2023

In a recent study, researchers at Penn State found that broccoli contains certain molecules that bind to a receptor within mice and help to protect the lining of the small intestine, thereby inhibiting the development of disease. The findings lend support to the idea that broccoli truly is a "superfood."

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Pharmaceutical Technology

AUGUST 1, 2022

The mRNA-1273.222 vaccine containing the BA.4/5 4/5 Omicron strain is being developed in line with the latest recommendations from the Food and Drug Administration (FDA). Last month, the company announced the advancement of two bivalent candidates based on various population health security approaches in different countries.

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XTalks

JUNE 10, 2021

Researchers at Massachusetts Institute of Technology (MIT) have designed the world’s first digital fabric fiber that contains digital devices which can sense, analyze and store health data, and use it to infer a person’s activity and state of health. The digital fibers can be sewn into clothing to help monitor bodily functions.

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Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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STAT News

MARCH 16, 2023

Experts have long understood that a new polio vaccine developed to try to minimize the risks associated with the oral polio vaccine made by Albert Sabin might also cause the problem it was created to sidestep. It’s now clear that theoretical risk is a real one. The “2” signals the vaccine targets type 2 polioviruses.)

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Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective.

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