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. Health Canada has also updated its fee for CSP applications.

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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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Pharma in Brief

JUNE 20, 2023

The Patented Medicine Prices Review Board ( PMPRB ) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 ( Interim Guidance ). Currently, New Medicines are not subject to price review by Board Staff during the Interim Period.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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Drug Discovery World

FEBRUARY 1, 2023

Michael Sassano , CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area. The use of medicinal cannabis across much of the world is still in its infancy.

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The Pharma Data

AUGUST 17, 2020

The UK government is imposing stricter regulations on the sale of laxatives, to help prevent their misuse. But they should seek advice from a prescriber such as their GP if the child is younger than 12 or they are worried about their child’s health, the Medicines and Healthcare products Regulatory Agency (MHRA) says.

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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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Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. According to GlobalData’s patient-based forecast model, Stelara is anticipated to have US sales of $525.5m

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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? Like most areas of medicine today, clinicians take a personalized approach to treating each case of dry eye disease.

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Drug Discovery World

DECEMBER 21, 2023

Insilico Medicine has initiated the first-in-human study for ISM5411, a poly hydroxylase domain (PHD) 1/2 inhibitor for the treatment of inflammatory bowel disease (IBD) designed by its generative AI platform. Analysts GlobalData predict that the total sales of IBD drugs will reach approximately $10.2 billion in the US in 2023.

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Pharmaceutical Technology

NOVEMBER 21, 2022

billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio. Other reasons include lower sales demand and high investment costs. in 2022 to JPY9.498 trillion ($68.08

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Pharmaceutical Technology

MAY 3, 2023

CBMG will receive $245m in an upfront payment and will also be entitled to potential development, regulatory filing, commercialisation and sales milestones along with tiered royalty payments on net trade sales. The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL).

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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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pharmaphorum

OCTOBER 24, 2022

Companies who are thinking about seeking funding via England’s new Innovative Medicines Fund (IMF) need to think through all the commercial implications, including whether spending in the IMF counts towards rebates made against sales through the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).

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Pharma in Brief

SEPTEMBER 28, 2023

The Patented Medicine Prices Review Board ( PMPRB ) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP ).

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Pharmaceutical Technology

OCTOBER 13, 2022

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). In 1995, the UK government classified it as a medicine making its over-the-counter sale illegal.

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The Pharma Data

MARCH 23, 2021

Privately held, fully integrated Italian multinational company, with R&D, manufacturing, marketing and sales capabilities. Commercial terms of the agreement will not be disclosed. About Fidia Farmaceutici. The Company was founded in 1946 and is headquartered in Abano Terme (a short distance from Venice).

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The Pharma Data

MAY 8, 2021

The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably. Our ambition is to be the world’s leading and most valued generics company.

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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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Pharmaceutical Technology

NOVEMBER 21, 2022

billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio. Other reasons include lower sales demand and high investment costs. in 2022 to JPY9.498 trillion ($68.08

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Pharmaceutical Technology

JANUARY 2, 2023

The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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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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Pharmacy Checkers

JULY 2, 2019

One of the Sustainable Development Goals, 3.8 , created under UN auspices is: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” as it applies to access to affordable medicine.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Increasing medicine sales through e-pharmacies and the growing adoption of advanced packaging solutions are projected to drive the demand for contract commercial packaging in the pharmaceutical sector. Finding the best commercial packaging suppliers in contract marketing. Trends in pharmaceutical contract packaging.

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pharmaphorum

OCTOBER 12, 2021

Sales were $20 million and $0.5 Gocovri could see its sales momentum rise following its approval for a second indication by the FDA earlier this year. per share subject to Gocovri meeting sales targets. per share subject to Gocovri meeting sales targets. million, respectively, in the second quarter of this year.

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pharmaphorum

JULY 28, 2022

Opdualag – a fixed-dose combination of LAG-3 inhibitor relatlimab and BMS’ PD-1 inhibitor Opdivo (nivolumab) – was approved as a first-line therapy for unresectable or metastatic melanoma by the FDA in March, and garnered $58 million in sales in the second quarter. Overall, BMS reported a 2% rise in second-quarter revenues to $11.9

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The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . This is because they did not have access to essential medicines needed for treatment.

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pharmaphorum

JANUARY 24, 2023

Given the funding environment for innovative medicines that is faced by all pharma, large or small, once assets are approved, however, this 2023 reset seems a necessary response. Medicines manufacturing is energy intensive. Medicines distribution and supply is also an energy intensive and regulated business.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1.

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pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. It has drawn up the guidance with the help of the companies, the ABPI, and UK regulator the MHRA.

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pharmaphorum

DECEMBER 15, 2022

The Association of the British Pharmaceutical Industry (ABPI) said today that in 2023 manufacturers of branded medicines will have to return almost £3.3 of total sales – under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) introduced in 2019. billion (around $4 billion) in revenue to the government – 26.5%

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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. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

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pharmaphorum

MAY 5, 2021

Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines. . The sales forecast for 2021 is based on contracts to deliver 1.6 The vaccine made $3.5 The vaccine made $3.5

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pharmaphorum

APRIL 30, 2021

Savana’s Dr Ignacio Medrano explains how natural language processing technology is opening up huge amounts of previously-inaccessible real-world evidence for pharma and regulators. From representation to empowerment: Putting patients at the centre of medicine reimbursement . A year on: pandemic driven trends in HCP Engagement.

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pharmaphorum

FEBRUARY 5, 2021

The US regulator slapped a black box warning on the 10mg dose, although that doesn’t appear to have applied much of a brake on sales in it approved indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and juvenile idiopathic arthritis. First approved in 2o12, Xeljanz brought in sales of more than $1.7

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pharmaphorum

JANUARY 29, 2023

The EMA’s human medicines committee has started a review of Novartis’ sickle cell disease (SCD) therapy Adakveo, shortly after the company reported that it failed to show efficacy in a phase 3 trial. The post EMA reviewing Novartis’ Adakveo after phase 3 miss appeared first on.

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