pharmaphorum

OCTOBER 12, 2022

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory. This need for data integrity facilitates and maintains trust between the regulators and the manufacturing organisations and, in turn, patients. As the industry increases the adoption of Pharma 4.0,

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XTalks

JULY 19, 2024

These advertisements, often found on social media platforms, search engines and various websites, frequently violate advertising guidelines and regulations. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.

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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

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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Drug Discovery World

JULY 16, 2024

As life sciences companies’ investments in regulatory data capture, enrichment and exchange continue to rise in line with agency mandates, the potential scope for artificial intelligence (AI) and generative AI seems limitless in its promise to transform labour-intensive processes while maintaining high accuracy. But where to start?

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XTalks

APRIL 3, 2024

While Soliris had its market launch 17 years ago with $3.2 Competitors in the PNH market include Novartis, which won approval for its factor B inhibitor Fabhalta (iptacopan), the first oral pill for PNH treatment, late last year. In 2023, its second year on the market, the drug earned $91 million in sales.

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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 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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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. This has been a real cause for concern for the industry, which is also facing growing competition in the investment market from big tech and AI.

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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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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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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. This rule applies across all sectors and enshrines the fundamental principle allowing goods that originate in one market to be exported to the other without tax, duty or quota. Medical devices do not feature at all.

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pharmaphorum

MAY 14, 2021

This article appears in our digital magazine, Deep Dive: Market Access 2021. Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA.

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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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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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pharmaphorum

MAY 17, 2021

This article appears in full in our digital magazine Deep Dive: Market Access 2021. Finally, the life sciences industry needs to be ensuring systematic patient involvement upfront in market and disease assessments, clinical trial design and throughout the medicines development process.

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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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Drug Discovery World

AUGUST 3, 2023

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. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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XTalks

MAY 28, 2024

Through their insights, we gain a clearer understanding of the strategic decisions that go into vaccine development and deployment, the anticipated impacts on the market and the ongoing efforts to enhance community health resilience against influenza.

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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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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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XTalks

APRIL 24, 2023

This is an increase from the EMA’s approval of two novel ATMPs with orphan designation in 2021 (although the marketing authorization for one of these ATMPs was withdrawn in the European Union in November 2021) and three novel ATMPs with orphan designation in 2020. As a result, there are several EU regulations and directives to follow.

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The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. NEW YORK, NY, Dec.

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The Pharma Data

NOVEMBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. NEW YORK, NY, Nov.

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Drug Discovery World

SEPTEMBER 26, 2022

A report by the medical charity LifeArc 1 puts the timeframe for a therapy brought to market through repurposing methods at anywhere from one to three years. This is a stark contrast to the often decade-long projects that pharmaceutical companies undertake to bring a drug to market.

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XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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Pharma in Brief

JANUARY 10, 2021

s ( Allergan ) silodosin capsules (marketed as RAPAFLO ® ) under an exclusive license in Canada granted by Kissei Pharmaceutical Co., The Court’s decision concerns Canadian Patent No. 2,507,002 ( 002 Patent ), which is listed on the patent register against Allergan Inc.’s Allergan brought an action against Sandoz Canada Inc.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. LONDON and BOSTON, Jan. LONDON and BOSTON, Jan.

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pharmaphorum

JANUARY 12, 2021

With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. The promise of faster market access . More change at NICE.

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XTalks

APRIL 2, 2021

Pfizer and German partner BioNTech are preparing to promptly submit the updated COVID-19 vaccine trial results to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2. “We

Vaccination 59

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pharmaphorum

OCTOBER 3, 2022

Healthcare coverage is heterogeneous across emerging markets, with public funding limited by budgetary constraints. It also would be in line with emerging markets’ ambitions to grant patients access to the latest, on-patent, innovative medicines. However, even then, challenges could remain. The power rests with Europe and the UK.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Cell culture challenges The viral vectors used in the gene therapies currently on the market are produced in adherent human embryonic HEK-293 cell culture. Another immediate benefit is improved batch-to-batch consistency — something regulators are expected to tighten the rules on in coming years.

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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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XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. The marketing rights to Thiola were acquired by Retrophin in 2014 from Mission Pharmacol.

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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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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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