pharmaphorum

JUNE 6, 2022

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . “Manufacturers get a bad rap as being the source of high pricing for patient meds.

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Pharma in Brief

NOVEMBER 5, 2023

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. Requirements for obtaining a listing are set out in O.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. mg capsules is $24,576.

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FDA Law Blog

MARCH 6, 2024

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent. Biologic Drugs.

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XTalks

JANUARY 31, 2023

As Amazon continues to ramp up its healthcare portfolio, the online behemoth rolled out RxPass last week, a flat fee drug program through which customers can buy an unlimited amount of commonly prescribed generic medications for $5 a month. The list of available medicines includes about 50 generic drugs.

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Pharma in Brief

APRIL 29, 2021

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme. [1]. 1, particularly section 80.2, 13, [link].

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. mg capsules is $24,576.

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FDA Approval Drugs Sales Development 52

Pharmaceutical Technology

NOVEMBER 29, 2022

On November 17, VistaGen Therapeutics announced the publication of data with its drug AV-101, which has ketamine-like effects, in a non-human primate model of Parkinson’s disease. The drug is also known for its illegal recreational use. There are also gaps in the fundamental understanding of the drug’s mechanism of action.

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XTalks

SEPTEMBER 20, 2023

SmithRx, a pharmacy benefits management (PBM) company, joined forces with TheracosBio to facilitate patients’ access to the newly approved type 2 diabetes medication, Brenzavvy (bexagliflozin), through the Mark Cuban Cost Plus Drug Company platform. ” What is SmithRx? . ” What is SmithRx?

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Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments.

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XTalks

AUGUST 30, 2022

Whether you are a director, manager or hold a C-suite role within a pharma, biotech, medical device or life science organization, it is important to understand which leadership styles are currently gaining much influence in the industry. Visionary Leadership. A visionary sees what no one else can see especially in the present time.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022.

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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.

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XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030.

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Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Generics in the Market.

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Drug Discovery World

AUGUST 8, 2023

DDW’s Megan Thomas takes a deeper look into why India is ramping up drug discovery research, and explores the country’s innovation hubs of interest. Generics According to a McKinsey report on the Indian pharmaceutical market, drug prices in India are among the lowest in the world, driven by intense generics competition 3.

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The Pharma Data

JANUARY 17, 2021

Clinical validation of transdermal and sublingual drug formulations. Psychedelic API production, drug formulation and clinical integration. Drug Formulations and Delivery. Vektor also successfully developed a sublingual drug formulation on contract for a major generic drug manufacturer and distributor.

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Pharma in Brief

JUNE 21, 2020

They include: (1) new factors for assessing excessive pricing, (2) new powers to collect information regarding these factors, (3) new obligations to report indirect price adjustments, (4) risk-based reporting obligations for OTC and generic drugs, and (5) a revised list of international price comparator countries (the PMPRB11 ).

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The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Psychedelic transdermal and sublingual drug formulation development. Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

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XTalks

SEPTEMBER 14, 2020

Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? production and that treatment with this new drug may boost the lung’s antiviral defenses against the virus. percent in 2021.

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. The report says the infrastructure around regulators vendors and the support industry will have to significantly change.

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year.

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