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., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product (“ CRP ”).

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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

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. 3d) 209 (FCA), at paras. 5] Merck Frosst Canada Inc.

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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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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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Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry.

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XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). The approved drugs contain the base form of semaglutide. Instead, they may contain compounded semaglutide in salt forms, which could pose health risks.

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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 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. Catalyst ) filed an NDS for FIRDAPSE, which contains amifampridine. On November 16, 2019, Catalyst Pharmaceuticals, Inc.

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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

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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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. “People are always at the center of this journey. About Bayer.

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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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XTalks

NOVEMBER 6, 2020

Symvivo CEO and founder Alexander Graves told CTV News that the vaccine candidate has a scientific and compliance benefit. The gene therapy-based vaccine targets mucosal tissues in the gastrointestinal tract, allowing for greater selectivity and targeted delivery compared to traditional vaccines. BacTRL Gene Therapy Platform.

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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

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

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

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

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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The Pharma Data

DECEMBER 27, 2020

The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures. Cowen served as the sole placement agent for each of the PIPE financings.

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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 ). It was not sufficient that the product containing macitentan (claims 1–5) or medicament containing macitentan (claims 10–20) was “for use in combination” with a PDE5-I.

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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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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

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

JANUARY 7, 2024

Before Florida can import and distribute Canadian drugs, it must first: submit a Pre-Import Request to the FDA for each eligible prescription drug to be imported; ensure that the drugs have been tested for, among other things, authenticity and compliance with FDA specifications and standards; and relabel the drugs with FDA-approved labels.

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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

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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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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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.

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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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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. In HFpEF patients, stimulating the greater splanchnic nerve increases cardiac preload and afterload, leading to elevated cardiopulmonary pressure.

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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 ). The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No. A-203-22).

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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

NOVEMBER 15, 2020

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. Before joining Acorda, Ms. He received a JD from Harvard Law School and a BA from Yale University.

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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 ). Anticipation.

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XTalks

FEBRUARY 4, 2021

Biobanks contain a wealth of information, ready to be extracted, analyzed and purposed for gaining insights into disease biology and development of therapies. Dr. Lowery agrees with this, saying that GDPR has been interpreted in every European country somewhat differently, making it difficult to know the GDPR compliance.

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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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