Pharmaceutical Technology

MAY 26, 2023

The pricing of insulin medications on these rogue, unapproved, unclassified pharmacies is really low. Ozawa says that the rogue pharmacies cater to people looking for cheaper essential drugs like insulin. “It She explains that this is particularly an issue for addictive and potentially harmful stimulants such as Adderall.

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Camargo

OCTOBER 14, 2020

The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Approval came with a required post-marketing commitment to evaluate the device’s performance in the real world.

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XTalks

OCTOBER 7, 2024

The US Food and Drug Administration (FDA) has issued a Class I label for the recall of Medtronic’s MiniMed insulin pumps. The devices are used to regulate blood glucose levels by delivering precise amounts of insulin based on readings from an integrated continuous glucose monitor (CGM).

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Insulin Regulation Drug Delivery Drugs 52

BioPharma Reporter

FEBRUARY 16, 2022

Multiple pharma R&D teams are seeking to transform how diabetes treatment is managed.

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Pharma R&D Insulin Regulation Marketing 118

XTalks

JULY 14, 2023

s Tandem Mobi insulin pump for individuals six years of age and older with diabetes. Tandem has dubbed The Mobi to be the world’s smallest insulin pump. The Tandem Mobi is designed for use as part of an automated insulin delivery (AID) system. Users can also self-administer bolus insulin doses manually.

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Insulin Regulation Marketing Drugs 52

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S.

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Insulin Production FDA Approval Generic Drugs 52

FDA Law Blog

AUGUST 12, 2021

On July 30, 2021, FDA approved Semglee (insulin glargine-yfgn), an insulin product that relies on Lantus (insulin glargine) as its reference product. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

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Insulin Production FDA Approval Marketing 98

BioPharma Reporter

APRIL 17, 2023

The South Korean company is set to create a new facility in West Virginia to house insulin manufacturing and to deliver its insulin products in the country.

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Insulin Manufacturing Production Regulation 52

BioPharma Reporter

JULY 16, 2024

Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.

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Insulin Manufacturing Regulation Marketing 52

XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. billion in 2021 to $61.6 billion by 2030.

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pharmaphorum

JULY 27, 2021

It plans to launch a mandatory cash tender offer to purchase the remaining shares in the company for the same price later and complete the acquisition entirely before the end of the third quarter – assuming it gets approval from the French financial regulator. The deal values Voluntis at around $79 million (around $95 million).

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Drug Delivery Insulin Cosmetics Development 111

Pharmaceutical Technology

DECEMBER 15, 2022

With many classes of antimicrobial agents on the market, it can be difficult to choose the right one for a new formulation. When choosing an antimicrobial API, it is very likely that local regulations will demand a cGMP ingredient. Is recombinant insulin a factor to consider for viral production? Free Whitepaper.

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Insulin Production Compliance Manufacturing 130

World of DTC Marketing

JUNE 16, 2021

The May 2021 KFF Health Tracking Poll finds about two-thirds of adults say there is “not as much regulation as there should be” when it comes to limiting the price of prescription drugs. About eight in ten across partisans say profits made by pharmaceutical companies are a “major factor” in the price of prescription drugs.

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Outsourcing Pharma

JULY 18, 2023

Convatec Group, a medical products and technologies company focused on chronic conditions, has partnered with Tandem Diabetes Care on a new five-inch infusion set for Tandem Mobi, the worldâs smallest durable automated insulin delivery system.

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Insulin Manufacturing Production Regulation 80

pharmaphorum

JULY 7, 2021

Despite those concerns, an advisory committee to the regulator voted in favour of approval in May – albeit by a less than convincing 10 to 7 margin – which seemed to tip the balance in favour of approval.

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Drugs Insulin Contract Manufacturing Antibody 98

pharmaphorum

MAY 21, 2021

Arecor Therapeutics is planning to float on the London stock market, to raise funding and awareness for its developmental portfolio of biologic drugs, which are based on already-marketed drugs reformulated to provide extra benefits for patients. . Howell said: “We think of those companies as potential future partners. .”

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Insulin Drugs Production Marketing 52

XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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Production Insulin Branding Generic Drugs 78

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. It’s much needed. It’s a hot area.” trillion Consolidated Appropriations Act.

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Drugs Gene Therapy Regulation Insulin 130

XTalks

JULY 15, 2024

Congenital HI is a genetic disorder that causes excessive insulin production by the pancreas, which lowers plasma or blood sugar. Avexitide differs from the current lot of GLP-1s on the market, which are agonists of the GLP-1 receptor. This action helps mitigate hypoglycemia by reducing insulin secretion and stabilizing glucose levels.

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Drugs Insulin Life Science Marketing 52

XTalks

JULY 15, 2024

Congenital HI is a genetic disorder that causes excessive insulin production by the pancreas, which lowers plasma or blood sugar. Avexitide differs from the current lot of GLP-1s on the market, which are agonists of the GLP-1 receptor. This action helps mitigate hypoglycemia by reducing insulin secretion and stabilizing glucose levels.

Insulin 52

Insulin Drugs Life Science Marketing 52

pharmaphorum

JUNE 14, 2021

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021.

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pharmaphorum

JANUARY 24, 2023

Venture capital poured into the pandemic biotech markets and not every investment was good quality. Market volatility, inflation, and raised interest rates will all make investors cautious. Medicines distribution and supply is also an energy intensive and regulated business. Medicines manufacturing is energy intensive.

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Medicine Manufacturing Marketing Regulation 98

XTalks

OCTOBER 2, 2024

It made its market debut at the end of August and is available for purchase online for $99 for a one-month supply or an ongoing subscription for $89 a month. The FDA-approved, OTC CGM device is designed for adults 18 years of age and older who are not taking insulin and want to monitor their glucose levels without needing a prescription.

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Insulin Marketing FDA Approval Packaging 52

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Both drugs continue to dominate the diabetes and GLP-1 markets. It’s been widely marketed and is considered a leading medication in the SGLT2 inhibitor class. percent in the fourth quarter and decreased 56.7

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Sales Insulin FDA Approval Drugs 52

Pharmaceutical Technology

MARCH 23, 2023

It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease. A 2019 study has revealed that androgens play a key role in regulating female fertility and androgen receptors are prevalent in the origins of the condition.

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Development Insulin Hormones Research 130

Outsourcing Pharma

JULY 18, 2023

Convatec Group, a medical products and technologies company focused on chronic conditions, has partnered with Tandem Diabetes Care on a new five-inch infusion set for Tandem Mobi, the worldâs smallest durable automated insulin delivery system.

Insulin 52

Insulin Manufacturing Production Regulation 52

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Post-market, combination products potentially face the same enforcement scrutiny as single-entity medical devices. By John W.M.

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pharmaphorum

MARCH 21, 2022

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status.

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Drugs Insulin Contract Manufacturing Clinical Trials 52

XTalks

MAY 2, 2023

The GI measures how quickly a carbohydrate-containing food raises blood sugar levels, with high glycemic foods causing rapid spikes in blood sugar levels that can lead to insulin resistance and other health problems. markets its tagatose-based product as a low-calorie and low-glycemic sweetener. CJ CheilJedang Corp.

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Insulin Bacteria Containment Production 98

BioSpace

JULY 3, 2022

Rather than selling, Novartis could spin Sandoz off into its own separate entity with its own listing on a stock exchange.

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XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. Since 1975, obesity rates have almost tripled worldwide.

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Trials Drugs FDA Approval Clinical Trials 98

pharmaphorum

OCTOBER 2, 2020

You don’t really think of TikTok and B2B marketing together, but why not? The audit shows that product safety, efficacy and regulation are the primary drivers of trust in self-care. When looking at regions, Europe scores high in trust as a result of its focus on policy, testing and regulation control. Ed Hudson, Create Health.

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Regulation Doctors Doctor Production 111

XTalks

FEBRUARY 6, 2024

Fractyl Health’s common stock commenced trading on the Nasdaq Global Market under the ticker symbol “GUTS” on February 2, 2024. Revita, an outpatient endoscopic procedural therapy, which aims to eliminate insulin needs and enhance glycemic control by ablating dysfunctional duodenal mucosa.

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Gene Therapy Gene Clinical Trials Clinical Trials 98

The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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Insulin Drugs Production Clinical Trials 40

pharmaphorum

NOVEMBER 18, 2022

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

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Drugs FDA Approval Insulin Clinical Trials 52

pharmaphorum

OCTOBER 19, 2021

Multiple biosimilars of Humira have been approved by the FDA, but so far none have been launched because AbbVie reached an agreement with biosimilar producers to defer entry into the market until 2023 in order to resolve patent litigation.

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Sales Production Insulin FDA Approval 40

XTalks

OCTOBER 11, 2023

Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes. They mimic the action of GLP-1, a hormone that helps regulate blood sugar levels by enhancing insulin secretion.

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Drugs Insulin Hormones FDA Approval 59