The Pharma Data

MARCH 8, 2022

The Label-CO-VAC continues to encourage COVID-19 vaccine manufacturers to induce and give data to WHO on the performance of current and variant-specific seeker COVID-19 vaccines, including the breadth, magnitude, and continuity of humoral and cell- intermediated vulnerable responses to variants through monovalent and/ or multivalent vaccines.

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Vaccination Vaccine Manufacturing Development 52

Roots Analysis

MARCH 1, 2024

In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products.

Packaging 52

Packaging Packaging Production Manufacturing 52

Drug Discovery World

JANUARY 30, 2024

He said: “Increasing the level of automation and standardisation is not only the way to reduce manufacturing costs, but also paves the way for follow-on approvals once a platform technology is part of an approval.  One option is that manufacturers will need to provide a product guarantee or refund the cost in a pay-for-performance model.

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Gene Therapy Manufacturing Gene Clinical Trials 71

pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

Drug Delivery 52

Drug Delivery Drugs Manufacturing Marketing 52

Pharmaceutical Technology

MAY 1, 2023

Under the deal terms, Shunxi will have licence to develop, manufacture, and commercialise CTH-004 to treat several solid tumours including ovarian cancer in Greater China, including Hong Kong, Taiwan, Mainland China, and Macao. Cartherics will retain all the development and commercialisation rights for the therapy outside Greater China.

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Gene Therapy Gene Development Clinical Trials 130

Pharmaceutical Technology

MAY 2, 2023

IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000. Although a subset of patients derives long-term benefits from IO therapies, a high percentage of patients still fail to respond or develop resistance to IO therapy.

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Genetic Engineering Antibody Clinical Trials Clinical Trials 130

The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. ” Clover’s COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag © technology. SHANGHAI , Nov.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 This is not the first treatment to come with a high price tag.

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Gene Therapy Marketing Gene Drugs 263

XTalks

JULY 16, 2021

But yet, the price tag is still higher than real meat. This includes manufacturing capabilities, facility design, equipment and other technologies. The largest plant-based meat players’ facilities resemble boutiques when compared to the scale of manufacturing facilities for animal-based meat products. Turning a Profit.

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Protein Production Manufacturing Branding 105

XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 While the two therapies are similar in design, they are manufactured differently. Any gene therapy company you can name off the top of your head … they’re all facing the same problems around manufacturing and [production controls].”.

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Gene Therapy FDA Approval Gene Clinical Trials 95

Drug Discovery World

JULY 25, 2023

We have shown that the excipient does not only work for our SNAP-tag lipid (SNaP) LNP, but also for the commercialised vaccines. The excipient is listed in the pharmacopoeia as an inactive ingredient and therefore can easily added to an existing formulation.

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Drugs Packaging Packaging Manufacturing 52

XTalks

FEBRUARY 27, 2024

Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” More than 30 ATCs are already prepared to collect and ship tumor tissue from patients for Amtagvi manufacturing, said Iovance.

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FDA Approval Manufacturing In-Vivo Trials 52

XTalks

NOVEMBER 3, 2022

Although the company is planning to double capacity through a new manufacturing expansion in North Carolina planned for the end of 2023, company executives are warning of supply challenges. The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication.

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Sales FDA Approval Production Insulin 98

The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. —- End —-.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

DECEMBER 13, 2023

XTALKS WEBINAR: Cryopreservation Best Practices for Cell & Gene Therapy Source Material Live and On-Demand: Monday, January 22, 2024, at 11am EST (4pm GMT/UK) Register for this free webinar to learn about cryopreservation, a vital step in the manufacturing of today’s cell and gene therapies. How do Casgevy and Lyfgenia Work?

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: CSL Behring LLC. Manufacturer: bluebird bio, Inc.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

World of DTC Marketing

JUNE 23, 2021

The story of how a drug that’s never even been proven to work is now poised to rake in billions of dollars for its manufacturer, impose needless suffering on millions of families, and destabilize Medicare and Medicaid in the process, goes well beyond the failures of what should be the toughest regulatory body of the U.S. government.

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Drugs FDA Approval Doctors Doctor 218

pharmaphorum

JANUARY 11, 2021

Late last year, bluebird’s shares tanked after the FDA laid out additional manufacturing standards for its lead gene therapy product, Lentiglobin, in sickle cell anaemia that could hold up filing until late 2022. million price tag.

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Gene Therapy Gene Genetic Disease Manufacturing 59

The Pharma Data

DECEMBER 3, 2020

Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag © Technology. Trimer-Tag © is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. About Dynavax.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

NOVEMBER 27, 2022

Fully integrated and automated ingredient to consumer batch tracking using barcoding, RFID tagging, or IoT temperature logging and timestamping significantly reduces the chance of these mix-ups, providing complete traceability records from ingredient manufacturer to patient, and ensures the safety of the product. About the author.

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Production Manufacturing Drugs Marketing 105

The Pharma Data

JANUARY 31, 2021

Clover’s vaccine candidate has the potential to be manufactured at scale and stored in a regular refrigerator which makes it suitable for use around the globe, including in low-resource settings. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Pharmacy Checkers

FEBRUARY 21, 2020

unless the drug manufacturer wants it (or the government says it’s an emergency, which is irrelevant for our purposes). The new restriction means that a person can’t import foreign FDA-approved drugs for commercial use unless the manufacturer allows it. if such drug is manufactured outside the United States.”. Emphasis added.

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Drugs FDA Approval Manufacturing Pharmacy 61

XTalks

JUNE 28, 2023

million price tag of Elevidys, a one-time gene therapy. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

JANUARY 21, 2022

This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”. In recent years, revolutionary medicines have come with price tags to match, but this is simply a symptom of our current model.

Medicine 52

Medicine Marketing Manufacturing Production 52

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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Production Pharma Production Pharma Companies Drugs 264

XTalks

JUNE 8, 2021

With a price tag of over $2.5 One of the main reasons why Zolgensma has such a hefty price tag is because it has a small market size in the drug manufacturing industry and hence limited potential to save lives on a large scale. Discovering and manufacturing a new drug can cost billions of dollars.

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Gene Therapy Gene Protein Trials 110

XTalks

NOVEMBER 24, 2022

UniQure will manufacture Hemgenix at its Lexington, Massachusetts site. While the price tag of Hemgenix is quite steep, CSL Behring told Fierce Pharma that the cost of treating patients with moderate to severe hemophilia to healthcare systems is more than $20 million over their lifetimes.

Gene Therapy 52

Gene Therapy Gene FDA Approval Genetics 52

Drug Discovery World

MAY 22, 2023

There’s an element of stability that CGTs must achieve to encourage developers, investors, and manufacturers to take the jump to back them. But are these price tags a barrier to access? The cost 2022 has not been shy of approvals – Uniqure and CSL’s Haemophilia B drug even nabbed the title of “Most Expensive Drug” at $3.5

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

FDA Law Blog

JULY 20, 2021

The new rule applies not only to product labeling, but to any “mail order catalog” or “mail order promotional material” that includes a seal, mark, tag, or stamp that labels a product as having been made in the United States. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America).

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Production Sales Regulation Packaging 76

XTalks

NOVEMBER 10, 2020

Implementing these technologies would require investing in handheld computers and tablets, barcode label printers and scanners, and special labels and tags. Blockchain and IoT could help minimize food waste by ensuring proper transportation, storage and tracking of product perishability.

Production 105

Production Sales Manufacturing Regulation 105

pharmaphorum

DECEMBER 23, 2022

price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. Add to this the considerable cost of these medications – the first approved CAR-T, Novartis’ Kymriah (tisagenlecleucel), had a U.S.

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Development Drugs Clinical Development Antibody 52

XTalks

AUGUST 25, 2021

But without food sampling, consumers may not be able to justify the $6 price tag, let alone be aware of the brand. . Them paying for the bars at cost allowed us to continuously manufacture, which allowed us to keep going and keep our team in stock.”.

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Branding Marketing Nurses Production 98

XTalks

OCTOBER 28, 2021

While demand for vegan baking ingredients is on the rise, especially among Gen Z and millennial consumers, they remain specialty items and command larger price tags — the Climate Hero Super Cake is no exception.

Protein 98

Protein Packaging Packaging DNA 98

Drug Discovery World

JANUARY 10, 2023

We are vertically-integrated from immunisation through manufacturing and validation. Pillar 5: Protein OE/Epitope Tags. For over 50 years, Bethyl Laboratories (now a Fortis Life Sciences brand) has been dedicated to improving lives by supporting scientific discovery through qualified antibody products and custom services.

Antibody 52

Antibody Protein Reagent Scientist 52

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. This approach remains logistically complex, which builds the desire for allogeneic treatments that can be manufactured from unrelated donors on a larger scale.

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Gene Therapy Gene Engineer Production 147

Intouch Solutions

APRIL 11, 2024

Manufacturing : Improved operations, efficiency, and production costs. Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials.

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Compliance Marketing Drugs Pharma Companies 52

XTalks

FEBRUARY 14, 2023

Spending on the nutrition title alone is expected to push the price tag for the next Farm Bill to more than $1 trillion over the next ten years.

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Packaging Packaging Production Marketing 98