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. Continued authorization for COVID-19 drugs.

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The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies.

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Pharma in Brief

JANUARY 7, 2024

Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. As we reported , the export regulations first issued as an interim order in November 2020, in response to the FDA publishing the US Importation Rule in October 2020. 01.014.13).

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Drug Discovery World

JULY 16, 2024

As life sciences companies’ investments in regulatory data capture, enrichment and exchange continue to rise in line with agency mandates, the potential scope for artificial intelligence (AI) and generative AI seems limitless in its promise to transform labour-intensive processes while maintaining high accuracy. But where to start?

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Pharma in Brief

SEPTEMBER 5, 2023

If classified instead as edible cannabis, Jolts would exceed the THC content per immediate container permitted by the Cannabis Regulations. After initial exchanges, on January 3, 2023, Health Canada issued a Notice of Non-Compliance ( NNC ) with respect to the Jolts line of cannabis products.

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Pharma in Brief

JANUARY 24, 2021

The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. The year saw the first trials and decisions in actions under the new Patented Medicines (Notice of Compliance) Regulations ( PM(NOC) Regulations ). Introduction. a) COVID-19.

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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. Subsection 5(1) is DIN-specific.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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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). the Plaintiffs ) are involved in litigation under the Regulations against Sandoz Canada Inc. of the Regulations.

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XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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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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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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Pharma in Brief

JUNE 9, 2021

The Federal Court has quashed a notice of compliance ( NOC ) issued to Médunik Canada ( Médunik ) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. of the Food and Drug Regulations (the Data Protection Provisions ). Background.

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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. It implored state and federal regulators to take action and “punish compounding pharmacies, counterfeiters and others who put patients at risk by selling unsafe products claiming to be tirzepatide.”

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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. Janssen and Actelion Pharmaceuticals Ltd.

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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 ). As a consequence, the Court’s recent decision of December 4, 2023 does not concern the Regulations , but rather parallel actions brought under the Patent Act.

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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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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 ). In reaching its decision, the Court provided substantive guidance on hearsay evidence in infringement actions under the Regulations.

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The Pharma Data

FEBRUARY 22, 2021

It will be applied broadly, fairly and in compliance with all applicable employment laws and regulations worldwide and across all management teams in Bayer.”. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. About Bayer. Capital expenditures amounted to 2.9

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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 ). Background. Janssen Inc. markets OPSUMIT® (macitentan) to treat patients afflicted with pulmonary arterial hypertension ( PAH ).

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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.

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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. Dr. Shamiram R.

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Pharma in Brief

MARCH 23, 2022

of the Food and Drug Regulations in a case involving new drug submissions ( NDSs ) for two different amifampridine products. This is the second time that the FC has set aside a decision to issue a notice of compliance ( NOC ) for the product in question on data protection grounds. The Applicants are Catalyst Pharmaceuticals Inc.

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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. Recent advancements in autonomic regulation therapy have introduced electrical devices designed to restore the autonomic nervous system’s balance.

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The Pharma Data

NOVEMBER 4, 2020

His broad leadership experience in the pharmaceutical industry, from intellectual property and regulatory compliance to product manufacturing and distribution, presents an exciting opportunity for XPhyto,” said Hugh Rogers, CEO of XPhyto. Thoresen is an important addition to XPhyto’s board of directors. Forward looking statements.

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The Pharma Data

JANUARY 9, 2021

RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations.

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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 ). The actions. Anticipation.

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XTalks

FEBRUARY 4, 2021

She says dynamics with respect to research goals, priorities and regulations have changed over the past decade. Some of the challenges are with respect to new General Data Protection Regulation (GDPR) regulations in the EU. New regulations in different regions can introduce challenges for international collaborative groups.

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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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