pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

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XTalks

MAY 17, 2024

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.” If you want your company to be featured on Xtalks.com, please email ayeshar@xtalks.com.

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Pharma in Brief

OCTOBER 29, 2020

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

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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.

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FDA Law Blog

SEPTEMBER 26, 2023

HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Hyman, Phelps & McNamara, P.C. (HP&M),

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Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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pharmaphorum

JANUARY 10, 2023

Data is transforming life sciences, but many organisations are not using its full potential. Life sciences and the pharmaceutical industry are awash with data. The combination of health and data, he passionately believes, will transform life sciences. And he has a unique view of how data and health combine.

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Pharma in Brief

AUGUST 24, 2022

Importantly, the ONCA decision reaffirms that innovators are not liable beyond damages available under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) for the legitimate exercise of their rights under the Patent Act and the Regulations. Background. Eli Lilly Canada Inc.

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XTalks

MARCH 1, 2021

Anti-inflammatory drugs like Restasis and Xiidra are popular treatment options for the condition, but will the emergence of mask-associated dry eye bolster their sales? But if you thought the growing number of patients presenting with mask-associated dry eye would mean higher sales for Restasis, think again.

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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.

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Pharma Business Blog

MAY 10, 2021

Until 25th May 2021 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU. Furthermore ,the new regulations define the implementation of a European centralised database by the regulatory authorities where all relevant data related to the sale of Medtech products have to be filed electronically.

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pharmaphorum

JUNE 10, 2021

The latest version of the PRISYM 360 cloud-based labeling solution has achieved certification for the GS1 standards utilized by the medical device and life science industries. GS1 oversees a system of globally recognized open standards for unique identifiers that can be used throughout the supply chain to enhance traceability.

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pharmaphorum

SEPTEMBER 7, 2020

Wokingham, United Kingdom —4 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Robert Bowdish as Director of Clinical Trials Sales for North America. Robert has wide-ranging healthcare industry sales experience.

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XTalks

APRIL 3, 2024

billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. In 2023, its second year on the market, the drug earned $91 million in sales. According to Jefferies analyst Peter Welford, Voydeya’s peak annual worldwide sales in PNH could hit $759 million.

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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. We reported on the IO and the government’s consultation regarding its transition plan last year.

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Pharma in Brief

MARCH 21, 2022

3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 3 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders. Interim Order No. 1 and IO No. 2 was set to expire on March 1, 2022. Links: Interim Orders.

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XTalks

AUGUST 3, 2023

While most post-marketing activities are typically oriented towards marketing, sales, and commercialization of the drug, pharmacovigilance is fundamentally patient-centric, focusing on the safety and efficacy of pharmaceutical products once they reach the market.

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pharmaphorum

DECEMBER 15, 2022

of total sales – under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) introduced in 2019. “The life sciences industry has the potential to be the wind in the sails of a UK innovation-led recovery, but in the face of this storm risks blowing us backwards. Returns have risen sharply from £0.6

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pharmaphorum

FEBRUARY 25, 2022

The past two years have shone a spotlight on the UK life sciences industry. These efforts, as Nadhim Zahawi rightly said when he was Vaccines Minister, have led to the life sciences and pharma industry becoming a UK national treasure. An industry that will forever play a greater role in our everyday lives.

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Pharma in Brief

NOVEMBER 20, 2023

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. Natural health product vs. regulated drug In Winning Combination Inc. In its August 16, 2023 decision in Le-Vel Brands, LLC v.

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pharmaphorum

NOVEMBER 30, 2022

Veeva Systems invited pharmaphorum to attend its industry summit in Madrid this week, a huge event that gathered together over 1,000 individuals from life sciences and pharma. The question is, how can the journey there be accelerated, when on the horizon awaits a life sciences future very much immersed in speciality medicine?

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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.

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Pharma in Brief

JANUARY 19, 2023

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments ). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1 , is open until March 27, 2023. We previously reported on the IO here.

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XTalks

JANUARY 26, 2023

BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells. BTK is expressed in many B cell malignancies and inhibiting its activity has produced anti-tumor effects.

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XTalks

DECEMBER 19, 2023

As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. From life-saving cancer medications to treatments for chronic conditions, these top-selling drugs underscore the industry’s focus areas and innovation trajectories. billion in sales in 2022.

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Pharma Business Blog

MAY 10, 2020

Animal nutrition company BIOMIN America was fined by more than $250’000 for coordinating sales of agricultural commodities to a company in Cuba without authorization from OFAC (US Office of Foreign Assets Controls). BIOMIN identified this structure as being consistent with the US sanctions regulations. Sandra / Christine.

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pharmaphorum

OCTOBER 19, 2022

Emma Hyland, VP strategy, commercial content at Veeva Systems, tells us modular content is the most significant wave of innovation hitting the content world in life sciences, and rightly so because HCPs’ needs and expectations have changed. “There isn’t a one-size-fits-all for how the life sciences industry creates content.

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Pharma in Brief

APRIL 1, 2021

The first new order extends interim authorizations for COVID-19 medical devices until transition regulations can be passed. The new IOs will expire on March 1, 2022, unless they are repealed or superseded by regulations. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

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Pharmaceutical Technology

JULY 8, 2022

VDRs may be used for asset sales, audit tenders, bankruptcies, due diligence processes, mergers & acquisitions, public and private debt and equity capital raising, clinical trials, and organisational restructuring. Regulations protecting everything are made more robust. Privacy and security. Security is made more secure.

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XTalks

JANUARY 29, 2021

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. Keytruda (Pembrolizumab) and Opdivo (Nivolumab).

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XTalks

JANUARY 25, 2023

XTALKS WEBINAR: Review of Key Trends for Life Science Commercial Teams in 2023 Register for this free on-demand webinar to learn about the latest trends in sales and marketing campaigns that could help bolster commercial success for life science companies this year.

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Pharma in Brief

JULY 22, 2021

2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 1 to facilitate expedited evaluations by Health Canada of abbreviated applications for the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Medical Device Regulations , SOR/98-282.

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XTalks

DECEMBER 12, 2023

Analysts at Jefferies predict iptacopan’s peak sales potential to be $3.6 Fabhalta is a factor B inhibitor that regulates the destruction of red blood cells, developed for diseases like PNH that are driven by dysregulation of the immune complement system.

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Pharma Business Blog

JULY 27, 2021

Until 25 May 2021, all MedTech products that were admitted in Switzerland for sale could also be distributed in the EU and vice versa. Dr. Sandra Ragaz , Partner Leader Pharma & Life Science VAT Switzerland Tel: +41 58 792 44 69 sandra.ragaz@pwc.ch. David Bundi, lic.

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Pharma in Brief

SEPTEMBER 22, 2020

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order ) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada.

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pharmaphorum

NOVEMBER 23, 2022

A director in life sciences consulting for EY, she works within the commercial space for such companies, as well as their clients. “My EY was also running demos of EY’s Smart Reviewer, a transformational approach to reviewing promotional materials of life sciences companies. Innovative offerings around market access.

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pharmaphorum

JUNE 20, 2022

Evaluate provides commercial intelligence to the pharma and life sciences sectors through annual publications. We have a lot of data about pharmaceutical pipelines, sales in the market, and, crucially, about the forecasts and how the market might evolve, which is all derived from sell-side equity analysts,” Verdin states.

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