pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Outsourcing Pharma

JANUARY 29, 2024

The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license.

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pharmaphorum

DECEMBER 9, 2021

If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments. The same principle applies to regulation,” she went on. ” Prerequisites for global competitiveness. .

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pharmaphorum

AUGUST 17, 2020

N o one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content. Engagement channels. Joanna Carlish.

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Outsourcing Pharma

MARCH 21, 2024

Merck set to invest over â300 million in new production center in South Korea.

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XTalks

JANUARY 4, 2023

In the era of increasing awareness of environmental, social and governance (ESG) policies, life science companies are starting to take notice of their benefits. ESG policies can be advantageous for small to mid-sized business-to-business (B2B) life science companies in a number of ways.

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XTalks

JANUARY 9, 2024

Swoop , a leader in healthcare marketing, recently introduced a groundbreaking portfolio of predictive AI targeting for pharmaceutical and life sciences advertisers. This capability will usher in a new era in healthcare marketing, moving beyond traditional methods that rely on past data to a future-focused approach.

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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 ). b) of the Regulations. Link: Health Canada, Notice: Application of the definition of Canadian Reference Product (January 26, 2024)

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Pharma in Brief

NOVEMBER 20, 2023

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.

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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. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

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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. Evolution of the Regulations Coming into force (1993–1997).

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Pharmaceutical Commerce

JULY 27, 2023

Drug safety database can now be used by life sciences organizations that are looking to develop, manufacture, and market regulated products in the country.

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XTalks

JULY 5, 2022

Employee retention and motivation is a challenge that all life science companies face. A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company.

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Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Drug Discovery World

NOVEMBER 27, 2023

By Anis H Khimani , PhD, Senior Strategy Leader, Life Sciences strategy group, Revvity, Inc. A complex journey Biotherapeutics discovery and development upstream encounters challenges in cell line development (CLD), clone screening and characterisation, scale up, and eventually production. This article is sponsored by Revvity.

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pharmaphorum

DECEMBER 14, 2021

The first publication focused on market and patient access, whereas the new report concentrates on the final part of the route to marketing authorisation: from the final scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) to the final decision of the European Commission (EC). Tide of change.

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pharmaphorum

OCTOBER 7, 2020

By having an effective complaint management system, life science organizations have a better chance to ward off inspections by using the appropriate guidelines and regulations. Monitoring complaint trends over time and having a complaint program improves the customer’s experience with your products.

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XTalks

MAY 11, 2023

Webinar hosts dedicate a lot of time and effort when creating webinar content, marketing it to potential attendees and practicing the delivery to ensure they convey their message to the audience in the best way possible. Xtalks is celebrating 20 years of offering best-in-class webinar production, marketing and content.

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Pharma in Brief

MAY 4, 2023

The Ontario Superior Court ( ONSC ) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) brought by Apotex Inc. Apotex ) for lost sales of its Apo-Atomoxetine product. Apotex filed an ANDS for its generic Apo-Atomoxetine product.

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BioPharma Reporter

AUGUST 14, 2023

Teknova, a producer of life science reagents, has opened a new GMP-certified production facility which it claims will enable bioprocessing and gene therapy companies to get into the clinic faster.

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XTalks

JANUARY 29, 2021

Oncology products monopolise the list of best-selling drugs. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products.

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BioPharma Reporter

JULY 3, 2023

Donaldson, a provider of filtration products and solutions, has acquired Univercells Technologies, a producer of biomanufacturing solutions for cell and gene therapy research, development, and commercial manufacturing, to broaden its life sciences reach.

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pharmaphorum

NOVEMBER 24, 2021

The public knows now more than ever that the Medicines and Healthcare products Regulatory Agency (MHRA) ensures the safety and quality of vaccines and medicines, and that evidence from clinical trials is required for any treatment to be approved. The new Life Sciences Vision details priority areas for enhancing regulation.

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Drug Discovery World

JULY 18, 2023

Chris Hughes, Managing Director North Europe, Revvity, said: “We are thrilled to be part of the UK’s life sciences industry through our Scientific Centre of Excellence and top expertise in Cambridge.

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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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. mL strength pre-filled syringe).

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pharmaphorum

SEPTEMBER 15, 2020

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. This is reinforced by web-focused marketing strategies that give them a highly-targeted approach when it comes to marketing execution.”. Be more agile .

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Pharma in Brief

DECEMBER 8, 2022

The New Mandatory Factors, which required the Board to consider pharmacoeconomic value, market size, and Gross Domestic Product when determining whether the price of a medicine was “excessive”. The FCA rejects a hyperdeferential standard of review for regulations. The FCA affirms statutory limits on the PMPRB.

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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 ). the PMS Product ). Background. collectively, the Plaintiffs ). In that case, Manson J.

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Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. The key challenge for all regulators next year is ensuring that they can keep up with the progress of the technology.”

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XTalks

AUGUST 3, 2023

Pharmacovigilance activities ensure optimal use of drugs, early detection of safety signals and inform updates to product labeling or regulatory status. Can you start by telling me about your background in post-marketing and pharmacovigilance? How is this shift affecting your post-marketing work?

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pharmaphorum

OCTOBER 12, 2022

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory. Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in.

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Pharma in Brief

NOVEMBER 16, 2020

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance ( NOC ) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. Fresenius Kabi Canada Ltd.

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Pharma in Brief

NOVEMBER 5, 2023

Background A manufacturer can apply to have a drug product listed on Ontario’s Formulary for coverage under the Ontario Drug Benefit ( ODB ) program. For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product.

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Drug Discovery World

MAY 6, 2024

Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany.

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Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Pharma in Brief

AUGUST 3, 2023

On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance ). Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ).

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