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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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. Fellow GLP-1 maker over companies selling compounded versions of its semaglutide products, Ozempic and Wegovy, and using fraudulent marketing. The med spa has agreed to this requirement.

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Pharma in Brief

JANUARY 7, 2024

Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). According to the Export Guide, the regulations pertain to drugs intended for the Canadian market, namely, those having a drug identification number and a Canadian label.

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Pharma in Brief

MAY 29, 2023

Background A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. A CSP is intended to partly compensate innovators for time spent on research and on obtaining marketing authorization.

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Pharma in Brief

DECEMBER 17, 2023

However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not in the public interest to force patients to switch to another biosimilar product. Background In January 2022, JAMP Pharma Corporation ( JAMP ) was approved to market SIMLANDI, a biosimilar of HUMIRA (adalimumab).

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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. 2020 in the Courts.

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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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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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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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pharmaphorum

FEBRUARY 11, 2022

Sun says Komodo’s Healthcare Map has been built over the last seven and a half years and contains so much information that can help identify and treat patients with rare diseases. It’s our representation of tracking the deidentified, which is important from a privacy and compliance point of view,” Sun says. “It About the author.

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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 ). Janssen ) markets OPSUMIT® in Canada for the treatment of pulmonary arterial hypertension ( PAH ). OPSUMIT® is a tablet containing macitentan. Background.

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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 ). markets ACTONEL DR® in Canada for the treatment of osteoporosis. The Court also found that the patent contained sufficient detail to put the invention into practice.

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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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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 ). collectively, the Plaintiffs ). Knowledge of influence.

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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. The courts also had a busy year in 2021.

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Pharma in Brief

MARCH 23, 2022

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 and Médunik filed NDSs for drugs containing amifampridine. The Applicants are Catalyst Pharmaceuticals Inc. Catalyst ) and KYE Pharmaceuticals 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 ). markets JANUVIA® in Canada for the treatment of type 2 diabetes. markets JANUVIA® in Canada for the treatment of type 2 diabetes.

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Pharma in Brief

JANUARY 10, 2021

s ( Allergan ) silodosin capsules (marketed as RAPAFLO ® ) under an exclusive license in Canada granted by Kissei Pharmaceutical Co., The Court’s decision concerns Canadian Patent No. 2,507,002 ( 002 Patent ), which is listed on the patent register against Allergan Inc.’s Allergan brought an action against Sandoz Canada Inc.

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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. XPhyto Therapeutics Corp.

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XTalks

APRIL 25, 2024

BioVentrix markets the Revivent TC System in Europe but the device is currently only approved for investigational use in the US. 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.

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Pharmaceutical Technology

AUGUST 31, 2022

Forecasting, planning, procurement, stock levels, and marketing strategies are some of the areas that managers look at to overcome challenges with biopharmaceutical supply chains, and new innovations in the industry are revolutionising production methods. and Japanese Pharmacopoeia (JP).

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Mr. Shah is a seasoned executive, entrepreneur, and investor with more than 20 years of experience in building life science technology companies. She earned a BA from Durham University, U.K.,

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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 ). We previously reported on the first and second trial judgments.

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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. When new market disruptions occur, a transformational leadership style can be of great value.

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