Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

Clinical Trials 130

Clinical Trials Clinical Trials Insulin Medicine 130

Pharmaceutical Technology

MARCH 28, 2023

Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D).

Gene Editing 235

Gene Editing DNA Gene Gene Therapy 235

pharmaphorum

APRIL 9, 2021

Provention licensed rights to teplizumab from MacroGenics in 2010, eight years after former licensee Lilly abandoned the drug in the wake of a failed phase 3 trial looking at its role in treating newly-diagnosed T1D patients. Photo by Dennis Klicker on Unsplash.

Antibody 98

Antibody Insulin Trials Production 98

XTalks

OCTOBER 22, 2021

Cyltezo is a biosimilar to its reference product Humira, and also interchangeable with it, meaning it can be substituted for Humira by a pharmacist without requiring physician approval. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

pharmaphorum

MAY 21, 2021

In an interview with pharmaphorum, CEO Sarah Howell said the goal of the listing on London’s Alternative Investment Market (AIM) is to build the business in preparation for potential future product launches. Its second product is an ultra-concentrated rapid acting insulin, which could be a rival for concentrated insulins taken at meal times.

Insulin 52

Insulin Drugs Production Marketing 52

Druggist

MAY 6, 2021

Licensed use. Beta-cells : cells present in the pancreas, which produce insulin. Insulin: a hormone that allows glucose (sugar) to be used for energy in the body. It mainly reduces the production of glucose in the liver and stops glucose from being absorbed in the intestine. Metformin does not increase insulin release.

Insulin 98

Insulin Branding Drugs Licensing 98

Pharmaceutical Technology

APRIL 12, 2023

Later, Novo Nordisk could potentially give Aspect up to $650 million in future payments for each product arising from the partnership. Under the agreement, Novo Nordisk will gain an exclusive, global license to use Aspect’s pancreatic tissue platform to develop a maximum of four treatments for diabetes and/or obesity.

Insulin 234

Insulin Production Development Sales 234

XTalks

JUNE 5, 2023

GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. Patients and healthcare professionals should understand that certain semaglutide products may not contain the same active ingredient as FDA-approved semaglutide.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

Drugs 94

Drugs Medicine Regulation Licensing 94

FDA Law Blog

NOVEMBER 16, 2021

That section of the bill – along with the other accompanying sections and parts of the bill – would amend Title XI of the Social Security Act to create a new part – Part E – requiring the HHS Secretary to establish a “Fair Price Negotiation Program” intended to lower prices for certain high-priced single-source drugs and biological products.

Generic Drugs 52

Generic Drugs Manufacturing Drugs Licensing 52

pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . The global training hub.

Vaccination 98

Vaccination Vaccine Manufacturing Production 98

pharmaphorum

SEPTEMBER 1, 2020

Whilst the scientific revolution of the 17th century had spread ideas of rationalism and experimentation, and the industrial revolution had transformed the production of goods in the late 18th century, the marrying of the two concepts for the benefit of human health was a comparatively late development.

Medicine 145

Medicine Insulin Pharmacy Drugs 145

Roots Analysis

FEBRUARY 22, 2022

Given the inherent benefits of autoinjectors, a number of players have launched their proprietary products in combination with autoinjectors for use across a wide array of disease indications. The US healthcare industry is reported to endure the cost burden of more than USD 1 billion every year due to these injuries.

Drug Delivery 52

Drug Delivery Production Marketing Development 52

Druggist

MAY 12, 2021

In this post, I will briefly review the use of Celevac,:what it is and talk about alternative options (prescription and over the counter products) which have similar use to Celevac. Read more in the section about alternative products. Licensed use of Celevac tablets: Constipation. What is Celevac? To help with diarrhoea.

Containment 97

Containment Production Pharmacy Licensing 97

Druggist

OCTOBER 4, 2020

Customers may need to get larger Fybogel packs from a pharmacy counter as products available for self-selection may be smaller in size. Ispaghula Husk Orange Drink Ispaghula Husk Orange Drink is a very similar product to Fybogel, providing for the same amount of ispaghula husk per serving – 3.5g. £9.99 delivery 6.

Containment 98

Containment Pharmacy Bacteria Sales 98

Pharmaceutical Technology

AUGUST 15, 2022

The country has a long history of leadership and innovation in this field, from the discovery of stem cells and insulin to the invention of the world’s first pacemaker and much more. Over the past five years, the life sciences sector produced a total of 83 commercialised or licensed products and services.

Life Science 130

Life Science Research Manufacturing Insulin 130

The Pharma Data

APRIL 1, 2021

Editor ’ s Note: This investment in a new vaccine manufacturing facility further demonstrates Sanofi’s overall growth strategy , with vaccines contributing as a key growth driver through differentiated products, market expansion and new launches. About Fluzone High-Dose Quadrivalent influenza vaccine.

Vaccination 52

Vaccination Vaccine Manufacturing Insulin 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

JUNE 12, 2023

In Medtronic’s annual report, CEO Geoff Martha attributes their success in this area to their comprehensive suite of products and solutions, which equip clinicians with the tools necessary for optimal atrial fibrillation care. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

MAY 13, 2021

Product Name: Unblock My Hormones And Start Burning Fat TODAY With HB5. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

Hormones 52

Hormones Insulin Production Packaging 52

The Pharma Data

MAY 15, 2021

Product Name: (1) Every Morning 12,342+ People Use This "3-Letter Timing Hack" That 92% of Women Have No Idea Exists. Now that you know the TRUTH about how weight loss really works…And now you know LumaSlim is the only product with scientifically proven ingredients that Activate Your Fat-Burning Switch in as little as 30 minutes….

Production 52

Production Packaging Packaging Sales 52

FDA Law Blog

FEBRUARY 7, 2022

While we recognize that OPDP also cited the absence of “material information from the warning and precaution for hypoglycemia with concomitant use of insulin secretagogues or insulin” this was the last issue cited and likely not the basis for issuing the Untitled Letter.).

Insulin 40

Insulin FDA Approval Drugs Production 40

Pharmacy Checkers

MARCH 11, 2020

The agency has created a well-thought-out roadmap for states and other non-federal entities to safely import medications directly from licensed and qualified Canadian wholesale pharmacies that charge lower prices than their U.S. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

The Pharma Data

MAY 6, 2021

Pandemic Delayed Some FDA Plant Inspections, Product Approvals ( Bloomberg ) ( Pink Sheet ). FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). Lilly inks smart insulin pen deals with Roche, Dexcom and more ( Fierce ). In Focus: International.

Sales 52

Sales Vaccination Vaccine Gene Therapy 52

The Pharma Data

AUGUST 3, 2021

– Revenue from all key products grew in the quarter and 2021 year-to-date. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. volume was driven by certain key growth products, including Trulicity, Taltz, Verzenio, Jardiance, Retevmo and Emgality.

Antibody 52

Antibody Sales Production Development 52

The Pharma Data

DECEMBER 27, 2020

Tyvaso DPI, previously referred to as Treprostinil Technosphere ® , is an investigational drug-device combination product comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation.

Production 52

Production Drugs Containment Bioinformatics 52

FDA Law Blog

DECEMBER 3, 2023

covered insulin product or vaccine). Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024.

Manufacturing 105

Manufacturing Drugs Compliance Pharmacy 105

Drug Discovery World

SEPTEMBER 6, 2022

With the sector looking strong it would be easy to think of the cell & gene sector as being resilient to challenge but this is never the case in pharma: fierce competition can result in fluctuating valuations for listed companies and the regulatory hurdles of pharma means that many companies won’t ever see their product reach the bedside. .

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

XTalks

SEPTEMBER 17, 2020

In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval. The tumor secretes adrenocorticotropic hormone (ACTH), which stimulates cortisol production. What Is a Surrogate Endpoint?

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. [vii] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

The Pharma Data

DECEMBER 15, 2020

The company will use its Tepezza (teprotumumab-trbw), an insulin-like growth factor type-1 receptor inhibitor that’s already approved for treating thyroid eye disease. Anti-CD40L Antibody.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52