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. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,

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The Pharma Data

JANUARY 17, 2021

As a bioscience accelerator at the leading-edge of the life science industry, XPhyto will target growth through commercialization of existing products and focused investment in impact driven innovation with the potential for extreme value creation. SOURCE: XPhyto Therapeutics Corp.

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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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Pharma in Brief

NOVEMBER 5, 2023

201/96 under the Ontario Drug Benefit Act ( ODBA Regulations ). 935 under the Drug Interchangeability and Dispensing Fee Act ( DIDFA Regulations ). In both Regulations, the new exception would apply where the drug product is “not a new drug as defined in the Food and Drug Regulations ”.

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XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. The TPO receptor agonist regulates blood platelet production by binding to and activating TPO receptors on megakaryocyte cells and inducing signalling cascades that increase platelet production.

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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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 implant) is around $1,006.

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Pharma in Brief

JUNE 21, 2020

On June 19, 2020, the Patented Medicine Prices Review Board ( PMPRB ) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. Background. New patented medicines.

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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 implant) is around $1,006.

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FDA Approval Drugs Sales Development 52

XTalks

JUNE 16, 2023

Lawmakers are discussing whether the FDA should have the power to order manufacturers to report significant increases in demand that could trigger a shortage and even require the stockpiling of critical drugs. The FDA recently announced it is working with foreign companies to increase the US supply of cisplatin.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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The Pharma Data

JANUARY 27, 2021

CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT ) (“ XPhyto ” or the “ Company “) is pleased to announce its drug formulation and delivery business strategy and milestones for 2021. Further, Vektor is currently engaged in the development of a sublingual drug formulation for a major European generic drug company.

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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

SEPTEMBER 14, 2020

Meanwhile, N95 masks are in such short supply that regulators have told healthcare workers they can be used multiple times with little evidence that disinfecting them works. The main reason the elastomeric respirators are being so little used?

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