Pharma in Brief

DECEMBER 23, 2021

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. The amendments to the Regulations contain a number of changes affecting the PMPRB’s review of patented medicine prices. The amendments.

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Regulation Medicine Containment Drugs 72

Outsourcing Pharma

JANUARY 29, 2024

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

Life Science 98

Life Science Licensing Licensing Medicine 98

Pharmaceutical Technology

MAY 31, 2023

Policy and measurements had been established to minimise the negative influence of Brexit such as the EU–UK Trade and Cooperation Agreement (TCA), UK Medicines and Medical Devices Act, and the extended Horizon Europe Guarantee scheme to provide support to Horizon Europe applicants from the UK.

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Life Science Manufacturing Regulation Medicine 55

pharmaphorum

AUGUST 17, 2022

The latest life science competitiveness indicators (LSCIs) were published by the Office of Life Sciences (OLS) in July 2022. The life sciences ecosystem. Interest in indicators. If we aren’t already, we’re all likely to be patients one day, or caregivers of one at some point in the future.

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Life Science Medicine Marketing Regulation 59

pharmaphorum

JULY 19, 2021

A new report published by Medicines Discovery Catapult and CPI details the huge medical and market potential for complex medicines in the UK. A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route.

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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). Every day counts.

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pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. The Government has committed to relooking at regulation as it determines its own independent trading policy.

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Life Science Regulation Medicine Vaccine 98

pharmaphorum

MAY 17, 2021

Experts from Vynamic discuss their vision for a future where patients are at the heart of medicine reimbursement in Europe – and provide actionable steps for achieving this. There are different models, medicines are evaluated in different ways and the timelines for approval vary widely. However, much more needs to, and can, be done.

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Medicine Life Science Marketing Clinical Trials 93

XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

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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.

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Regulation Compliance Medicine Manufacturing 52

World of DTC Marketing

JUNE 22, 2022

Between 2019 and 2021, Alphabet’s venture-capital arms, Google Ventures, and Gradient Ventures, and its private-equity unit, CapitalG, made about 100 deals, a quarter of Alphabet’s combined total, in life sciences and health care. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm.

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pharmaphorum

MAY 6, 2022

The PING Conference 2022 is back in person this year, with opportunities to network face-to-face with people from right across the life sciences ecosystem. Hear about how the UK is leading the way in what has been described as the ‘Golden Age for Life Sciences Innovation’ and the opportunities arising from this from leading experts.

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pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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Pharma in Brief

JULY 7, 2021

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until January 1, 2022. The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices.

Regulation 52

Regulation Medicine Containment Life Science 52

pharmaphorum

MAY 5, 2021

It’s time to take what the UK has learnt about the “Holy Trinity” of government, academia, and industry and apply it to creating a “life sciences superpower”, says health secretary Matt Hancock. It’s about charting a new, better course… and transforming the UK into a life sciences superpower.

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Pharma in Brief

DECEMBER 8, 2022

On December 5, 2022, the Federal Court of Appeal ( FCA ) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board ( PMPRB ). The FCA rejects a hyperdeferential standard of review for regulations. The FCA affirms statutory limits on the PMPRB.

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Regulation Medicine Life Science Production 52

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

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Vaccine Vaccination Development Life Science 105

pharmaphorum

JANUARY 8, 2021

Six months after rebranding from BHE, Panalgo has won a contract to supply the European Medicines Agency (EMA) with its IHD data analytics platform, pledging to streamline its public health efforts. Most of Panalgo’s life sciences clients already rely on IHD to perform rapid analyses that support regulatory initiatives,” said Menzin.

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XTalks

APRIL 15, 2021

The decision in the EU was based on a report by the European Medicines Agency (EMA) published in the British Medical Journal ( BMJ ), in which the agency concluded that the AstraZeneca COVID-19 vaccine was not linked to an increased risk of blood clots and is both safe and effective as per an investigation it conducted.

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Vaccine Vaccination Regulation Drugs 98

pharmaphorum

NOVEMBER 26, 2020

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation. As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right.

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Vaccine Vaccination Life Science Regulation 105

XTalks

AUGUST 22, 2022

Blueprint Medicines announced top-line results from their clinical trial of Ayvakit (avapritinib) in patients with non-advanced systemic mastocytosis (SM) that showed clinically meaningful and highly significant improvements. Activating and inactivating KIT mutations result in increased mast cell signaling, leading to SM.

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Medicine Clinical Trials Clinical Trials Trials 98

pharmaphorum

SEPTEMBER 8, 2021

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. ” Fewer staff will therefore be asked to cover more ground with fewer resources, all whilst operating under a pay freeze, they claim. .”

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Regulation Life Science Medicine Production 105

pharmaphorum

OCTOBER 28, 2021

The Association of the British Pharmaceutical Industry (ABPI) and BioIndustry Association (BIA) both said that the increase acknowledges the enormous contribution made by the life sciences sector in helping to limit the impact of the pandemic through the rapid development of diagnostics, drugs and vaccines.

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Research Life Science Manufacturing Development 111

XTalks

DECEMBER 18, 2024

Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels. Trial data for both the pediatric and adult trials were published in The New England Journal of Medicine. Crenessity marks the third approved drug for Neurocrine.

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XTalks

NOVEMBER 15, 2024

Bexicaserin, an investigational oral therapy, works by activating specific brain receptors, notably the 5-HT2C receptor, which helps regulate neurological functions. With bexicaserin as the lead asset, Lundbeck gains a promising late-stage candidate for DEEs, including Dravet and Lennox-Gastaut syndromes.

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Trials Clinical Trials Clinical Trials Genetics 97

pharmaphorum

OCTOBER 12, 2022

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory. By remaining compliant, medicines are manufactured in line with their pre-defined and approved specifications, in order to ensure the delivery of safe and effective products to consumers. The dominion of data.

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Pharma in Brief

JUNE 21, 2021

A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations ) will soon require holders of Certificates of Supplementary Protection ( CSPs ) to report information to the Patented Medicine Prices Review Board ( PMPRB ) on substantially the same terms and conditions as would be reported by patentees.

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Medicine Regulation Life Science 52

XTalks

MAY 18, 2023

Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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Life Science Marketing Development Medicine 52

XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. This control plays a critical role in development and cellular function.

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Regulation Genetics Scientist RNA 52

pharmaphorum

DECEMBER 17, 2020

In the last few years, biopharma companies focusing on psychedelic medicines have been springing up like mushrooms – magic or otherwise – and venture capital money is starting to follow. In September, Compass became the first psychedelic medicine company to float on the Nasdaq, raising $127 million , and is now trading at a market cap of $1.98

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Medicine Life Science Marketing Regulation 104

Pharma in Brief

JANUARY 26, 2021

A defendant in a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations was allowed to amend its defence to include invalidity allegations not found in the Notice of Allegation. The proposed amendments are not prohibited by the Regulations. Background.

Regulation 52

Regulation Compliance Medicine Life Science 52

pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. The Medicinal Products Annex. Unfortunately, this is thin gruel.

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Production Medicine Marketing Regulation 119

Pharmaceutical Technology

NOVEMBER 29, 2022

In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. The Canadian company Awakn Life Sciences is focused on the drug’s use as an treatment of conditions like alcohol use disorder and and behavioral conditions such as addiction.

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pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. However, there is a general prohibition in the legislation of using celebrities to promote medicines.

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Life Science Medicine Regulation Compliance 98

pharmaphorum

DECEMBER 11, 2022

So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations. AI gets us closer to personalised medicine.”. Dr Yacine Hadjiat is global head of Biogen Digital Health Solutions. “We

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pharmaphorum

OCTOBER 7, 2020

“I encourage continued support of fundamental science as well as public discourse about the ethical uses and responsible regulation of CRISPR technology.”. In 2011, Emmanuelle Charpentier and Jennifer Doudna had no idea that their first meeting, in a café in Puerto Rico, would be life-changing. million) Nobel Prize award. “In

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pharmaphorum

FEBRUARY 9, 2021

In the final instalment of our series reviewing the t he 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), Leela Barham takes stock of the whole scheme after digging more deeply into its three objectives. The VPAS has set out objectives in three areas; for patients, for affordability and for the economy and innovation.

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