pharmaphorum

NOVEMBER 24, 2021

The Government has committed to relooking at regulation as it determines its own independent trading policy. The new Life Sciences Vision details priority areas for enhancing regulation. Implementing the proposals on regulation within the Vision document will require collaboration. Conclusion.

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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

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. Drug establishment licensing.

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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. • What does it mean for you?

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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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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

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Pharma Business Blog

MAY 10, 2020

BIOMIN identified this structure as being consistent with the US sanctions regulations. Most probably they did not realize that the Cuban Assets Control Regulations (CACR) applies to US subsidiaries abroad the same way it does to US entities. – Subsidiary of ERBER Group, a “commercially sophisticated” company. Sandra / Christine.

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XTalks

DECEMBER 8, 2023

March-in rights is a measure to help agencies evaluate when it might be appropriate to relinquish patent licenses when products developed with federal funding aren’t readily accessible to the public. Exercising a march-in is another move the Biden administration could make in its goal to lower drug prices in the US.

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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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pharmaphorum

OCTOBER 3, 2022

At present many of the new disruptor PD-1/PD-L1 drugs only have trials conducted in China, which could raise concerns with local regulators that may wish to see more diverse, or locally representative, patient inclusion criteria. About CRA and the Life Sciences Practice. However, even then, challenges could remain.

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. In that time, we’ve gone from running 25 webinars each year to over 400, working with more than 800 expert speakers each year.

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Drug Discovery World

FEBRUARY 19, 2024

Financial landscape In 2023, life science companies experienced a significant decrease in funding, particularly seed funding for early-stage drug development. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year.

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Pharmaceutical Technology

FEBRUARY 3, 2023

This is really what has been very challenging for upscaling viral vector production and what leads some companies that have in-licensed projects with a huge amount of viral vector to slightly panic about future production,” she says. Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp.

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Pharma in Brief

MARCH 21, 2022

Also reported was Health Canada’s intention to introduce transition regulations, which would have ended the expedited IO authorization pathway but extended current IO authorizations so that industry could meet therequirements for converting their IO approvals to medical device licenses under the Medical Devices Regulations (the Regulations ).

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pharmaphorum

MARCH 24, 2021

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process. . In future, the hope is that it may encourage a higher level of patient involvement in its final assessment of whether clinical trials are approved or drugs are licensed.

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XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy. AstraZeneca is also venturing into cell therapy and genetic medicine.

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pharmaphorum

JUNE 8, 2022

The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport ‘, a designation designed to speed up NHS access to promising new medicines.

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pharmaphorum

AUGUST 19, 2021

The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license. Collective action.

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Drug Discovery World

AUGUST 1, 2023

Partnerships Earlier this year cell-engineering company MaxCyte signed a strategic platform license (SPL) with biotechnology company Catamaran Bio. In return MaxCyte will receive platform licensing fees and program-related revenue.

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XTalks

JULY 6, 2022

In working with sponsors, license holders, technology partners and regulators, Cogstate says its team has gained important perspectives on the successful implementation of remote COA administration in decentralized clinical trials.

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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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The Pharma Data

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

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XTalks

JANUARY 29, 2021

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. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g. Celltrion’s Herceptin biosimilar, Truxima).

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Pharma in Brief

JULY 22, 2021

2, along with all authorizations granted or extended under it, will expire on March 1, 2022, unless it is repealed or superseded by regulations sooner. Further information on obtaining such licences can be found in Health Canada’s guidance documents for medical device establishment licenses and medical device licences , respectively.

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XTalks

SEPTEMBER 9, 2022

Magnus Medical received exclusive licensing rights to commercialize the SAINT (Stanford Accelerated Intelligent Neuromodulation Therapy) technology from Stanford University. Related: Xtalks Voices: Magnus Medical CEO Dr. Brett Wingeier Talks About Neurostimulation for Depression – Xtalks Life Science Podcast Ep.

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Radiology Life Science Licensing Licensing 98

pharmaphorum

FEBRUARY 16, 2022

Will all the efforts to speed up market access and ensure that the UK remains attractive to the life sciences industry post-Brexit pay off in 2022? The 1 January 2021 saw the UK’s regulator, the MHRA, formally join Project Orbis. Innovative Licensing Access Pathway attracted a lot of interest in 2021, but not yet proven.

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pharmaphorum

MAY 17, 2021

Meanwhile, payers, regulators and policymakers need to advocate for changes in culture that ensure patient engagement is integrated at every step of the HTA process – as well as assessing alternative funding and reimbursement models to continue to improve patient access to licensed treatments.

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pharmaphorum

DECEMBER 16, 2022

There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations.

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Pharma in Brief

JANUARY 25, 2023

We also flag what to watch out for in 2023. The most significant legislative changes concerned the Patent Act and accompanying rules/regulations. Changes to how the PMPRB reviews prices In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ).

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pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. Digital technologies can cover a broad range of applications, and include mobile health (mHealth) tools (e.g.

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Pharma in Brief

FEBRUARY 5, 2024

The Federal Court of Appeal ( FCA ) has held that the sale of single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. Janssen commenced an infringement action under section 6 of the Patented Medicines (Notice of Compliance) Regulations. Pharmascience Inc. (

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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. Indeed, on 11 February the UK Government passed the Medicines and Medical Devices Act 2021, giving it sweeping powers to amend existing regulations. Medicinal products are mentioned only in passing.

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XTalks

MARCH 1, 2021

Bourla added that, “At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorization for an updated mRNA vaccine or booster if needed.”.

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XTalks

APRIL 24, 2023

Early and ongoing engagement with regulators greatly helps clinical development planning. Scientific advice meetings with regulators help ensure the trial design and gene therapy manufacturing will meet regulatory expectations. As a result, there are several EU regulations and directives to follow.

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XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

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