Drug Discovery World

JANUARY 31, 2024

The treatment decision followed previous case reports where adult patients with breast cancer, being treated with the same drug, were shown to have experienced high blood glucose profile. The medication regulates cell growth, proliferation and development and insulin signalling.

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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. That leaves three years for pharma companies to prepare.

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pharmaphorum

JULY 7, 2021

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

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XTalks

JANUARY 16, 2023

Novo Nordisk announced in a press release last week that a label update for their type 2 diabetes treatment Rybelsus (semaglutide) was approved from the US Food and Drug Administration (FDA). Often, diabetes medication or insulin therapy are used as management tools.

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pharmaphorum

MARCH 21, 2022

Provention is seeking approval of teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals, hoping the drug can become the first disease-modifying therapy in these patients. In the latter, teplizumab wasn’t able to show an impact on insulin use or HbA1c, an indirect measure of glucose control over time.

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Drug Discovery World

MAY 25, 2023

Following the Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provides a snapshot of drug discovery in Scotland. Although target directed drug discovery is the most common approach, it is slow and expensive and has high attrition rates.

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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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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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XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. The drug is taken once a day in conjunction with diet and exercise. What is the Animal Drug Regulatory Process?

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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. So, it remains to be seen if and when interchangeable Semglee will have any meaningful effect on insulin prices in the near future.

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Drug Discovery World

NOVEMBER 14, 2022

Alternative to insulin. Early-stage biopharma company Atrogi initiated a Phase I study for its drug candidate ATR-258 targeting type 2 diabetes in Germany, which is expected to announce results at the end of the year. . Find out more: New human beta cell model enables discoveries in diabetes research .

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pharmaphorum

JUNE 2, 2022

R&D into orphan drugs is growing alongside the number of approved treatments, providing treatments for rare diseases that previously did not have any. This is why the action by the US in 1983 and subsequently the European Commission Regulation No. It is estimated that between 3.5 The price is right.

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The Pharma Data

MARCH 3, 2022

Use of the drug verapamil to treat Type 1 diabetes continues to show benefits lasting at least two years, researchers report in the journal Nature Communications. Type 1 diabetes is an autoimmune disease that causes loss of pancreatic beta cells, which produce endogenous insulin. There is no current oral treatment for this disease.

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pharmaphorum

JULY 27, 2021

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. People with type 1 diabetes cannot produce insulin.

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XTalks

OCTOBER 11, 2023

While the link between GLP-1 inhibitors and gastrointestinal side effects has been known for diabetics taking the drugs, this is the first study that was conducted among non-diabetics taking them for weight loss. Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes.

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The Pharma Data

DECEMBER 15, 2020

CHIPCREEN BIOSCIENCES remains as the owner and manufacturer of the drug. In September 2019 , the New Drug Application (NDA) of Chiglitazar Sodium was accepted by Center for Drug Evaluation. SH) was founded in Shenzhen on 2001, specializing in the research and development of novel small molecule drugs.

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Drug Discovery World

NOVEMBER 16, 2022

The new funding will power the expansion of Juvena’s drug discovery platform and advance the company’s biologics pipeline targeting chronic and age-related diseases. . These limitations have constrained biopharma’s approach to studying the role of secreted proteins only as drug targets or biomarkers, rather than drug agents themselves. .

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XTalks

JULY 3, 2023

Making for another landmark cell and gene therapy approval this month, the US Food and Drug Administration (FDA) has signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes. Lantidra is thought to increase insulin secretion through the infusion of allogeneic insulin-producing islet beta cells.

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XTalks

SEPTEMBER 29, 2023

Furthermore, the report listed an additional 35 potential risks, identified by EREN members representing a range of global food safety organizations including the World Health Organization (WHO) and the US Food and Drug Administration (FDA).

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pharmaphorum

OCTOBER 9, 2022

UK-based PureTech – which develops its own therapies and also has interests in a wide range of companies including digital health players Akili and Sonde as well as drug developers Vedanta, Gelesis and Follica – said it has “exchanged indicative, non-binding proposals” with Nektar that have no guarantee of leading to a deal.

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Drug Discovery World

JULY 13, 2023

Following the death of a cancer patient after they were given an unlicensed drug, Diana Spencer unpacks the practice of prescribing unlicensed and off-label medicines. This month, a cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of the chemotherapy drug cabazitaxel.

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XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. One of the reasons behind this gap is the US Food and Drug Administration’s (FDA) “ generally recognized as safe ” — or GRAS — designation.

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Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Like all drugs, biologics are regulated by the FDA.

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Delveinsight

AUGUST 20, 2020

regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) letter, which could cause a significant delay for any future approval, and canceled what would have been the first-ever approval for gene therapy in the bleeding disorder. J&J inks USD 6.5

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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. While weight loss effects can vary depending on the drug, studies show that all GLP-1 meds can result in an average weight loss of about 10.5

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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. ANDA applications rely on an approved product, provided in the FDA’s Orange Book as the Reference Listed Drug (RLD).

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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. .

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Pharmacy Checkers

JULY 2, 2019

[vi] In recognizing that price is an obstacle to access to medicines, Global Health Organizations can play a more constructive, forward-thinking role by promoting an open Internet through which regulated medicines can be purchased across borders both safely and at lower cost. whereas, the patient doing the importing in the U.S. See [link].

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XTalks

JULY 19, 2023

The US Food and Drug Administration (FDA) has classified this as a Class I recall , the agency’s most serious level of recall. In the affected population, Medtronic has documented 28 incidents, 22 injuries, but fortunately, no deaths related to this problem.

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pharmaphorum

OCTOBER 2, 2020

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. Self-care via TikTok. You don’t really think of TikTok and B2B marketing together, but why not?

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Druggist

MAY 6, 2021

It is also one of the most prescribed drugs overall in the UK. As with other drugs, it is possible to experience side effects during the treament or medicine may not be suitable. Metformin can commonly cause gastrointestinal side effects and this very often leads to switching to another drug. Drug classification.

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Delveinsight

AUGUST 25, 2021

The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic and brand-name drugs as well as medical devices.

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The Pharma Data

MAY 14, 2021

For three decades I had the pleasure of working with some of the brightest minds in this field and I have seen tens of game-changing drugs take birth, as well as how these drugs are being tested before being launchedâ?¦. It may also improve your sensitivity to insulin, which means it works better in your body.

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XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Both surrogate endpoints could be used to support traditional approval of a new drug or biologic.

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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