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.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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., Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.

Regulation 98

Regulation Medicine Generic Drugs Containment 98

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.,

Regulation 98

Regulation Drugs Manufacturing Production 98

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 ”.

Drugs 52

Drugs Regulation Production Generic Drugs 52

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.

Medicine 40

Medicine Regulation Sales Generic Drugs 40

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.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Moreover, the generic drugs of Zyban are also approved, while for Chantix, its patent is soon going to expire in 2021 in the EU and in 2022 in Japan. Generics in the Market.

Marketing 52

Marketing FDA Approval Branding Production 52

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]”.

Production 52

Production Generic Drugs Drugs Bioequivalency 52

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.

Regulation 52

Regulation Manufacturing Drugs Medicine 52

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.

FDA Approval 101

FDA Approval Drugs Sales Development 101

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.

FDA Approval 52

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.

Drugs 98

Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

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.

Life Science 105

Life Science Generic Drugs Drug Delivery Compliance 105

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?

Vaccine 92

Vaccine Vaccination Antibody Life Science 92