XTalks

MAY 17, 2024

The spa can obtain and distribute compounded tirzepatide products on the condition that they are produced in compliance with US federal law. The med spa has agreed to this requirement. Any adverse events linked to Totality’s compounded tirzepatide must be reported to the FDA.

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Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background.

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Pharma in Brief

MARCH 2, 2021

of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) is not subject to the 45-day limitation period familiar to patentees asserting infringement of listed patents under subsection 6(1). does not contain an express limitation period. Background. Merck Canada Inc. and Merck Sharp & Dohme Corp.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. He will be Chair of the Audit, Risk & Compliance Committee of Sandoz.

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Sales Production Doctors Doctor 40

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. The courts also had a busy year in 2021. b) Continued changes to the PMPRB.

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Pharma in Brief

JULY 5, 2021

The Federal Court of Appeal ( FCA ) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations , the “second person” ( i.e. , generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation ( NOA ).

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Regulation Compliance Containment Branding 52

Pharma in Brief

JUNE 14, 2022

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). OPSUMIT® is a tablet containing macitentan. Background. Janssen Inc. Janssen Inc. Sandoz Canada Inc. Sandoz ) sought approval for a generic macitentan product.

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Pharma in Brief

JULY 18, 2022

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product.

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Production Containment Regulation Compliance 52

Pharma in Brief

MARCH 9, 2022

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). ACTONEL DR® is an enteric-coated delayed release tablet containing risedronate and ethylene-daimine-tetraacetic acid ( EDTA ). Background. Allergan Inc.

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Production Regulation Containment Compliance 52

Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.

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Regulation Drugs Vaccination Vaccine 52

Pharma in Brief

DECEMBER 17, 2023

According to the Minister, JAMP’s new drug submission for SIMLANDI did not engage the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

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Antibody Production Regulation Marketing 52

Pharma in Brief

APRIL 19, 2022

The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). JANUVIA® is a tablet containing sitagliptin phosphate monohydrate. Background. Merck Canada Inc. Pharmascience Inc. (

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Regulation Production Compliance Containment 52

Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Knowledge of influence.

Regulation 52

Regulation Trials Production Compliance 52

Pharma in Brief

JANUARY 10, 2021

Sandoz ) under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) seeking a declaration that Sandoz’s generic alternative to RAPAFLO ® would infringe claims 1–3 and 6 of the 002 Patent. The Court’s decision concerns Canadian Patent No. Allergan brought an action against Sandoz Canada Inc.

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Manufacturing Regulation Compliance Licensing 52

XTalks

APRIL 25, 2024

This method preserves the intra-atrial septum for future interventions and potentially offers better accommodation of volume and pressure changes due to the compliance of the coronary sinus. Addressing this condition requires innovative treatments that go beyond traditional heart failure management strategies.

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Pharmaceutical Technology

AUGUST 31, 2022

ILC Dover, specialists in the innovative design of biopharmaceutical manufacturing solutions, continuously monitors the market in order to provide in-demand equipment such as flexible containment solutions that reduce bottlenecks by providing closed, Grade-A, aseptic environments for fill and finish activities.

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The Pharma Data

NOVEMBER 15, 2020

NASDAQ: ATHX), a clinical-stage regenerative medicine company, is pleased to announce that it has appointed Ms. a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004.

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Clinical Trials Clinical Trials Production Trials 40

XTalks

FEBRUARY 4, 2021

The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. This includes precision medicine strategies which can be effectively guided through high-level translational research led by clinical data.

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Research Biobanking Drugs Genome 98

Pharma in Brief

JUNE 1, 2020

The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), following a common trial on the validity of Canadian Patent No. 2,562,277 ( 277 Patent ). Anticipation.

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Trials Regulation Compliance Containment 40