European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

FDA 85

FDA 85

European Pharmaceutical Review

JUNE 26, 2023

The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. The review summarised what the organisation has learned from conducting real-world data (RWD) regulator-led studies from September 2021 to February 2023.

Medical Records 78

Medical Records Clinic Management 78

STAT

MARCH 14, 2024

We hope you have a smashing day and conquer the world. European Union lawmakers proposed a compromise on exclusivity periods for new drugs in the biggest overhaul of pharmaceutical rules in 20 years , Reuters reports. So far, our choice today is peppermint mocha. Please do join us. And as always, we hope you keep in touch.

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STAT

JULY 12, 2023

Hope you conquer the world and, as always, do keep in touch … Supplies are running out for a key antidote for life-threatening lead poisoning , The Wall Street Journal says. Our choice today is gingerbread, for those tracking this sort of thing. declared bankruptcy in February.  Illumina said it would appeal the decision.

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Hospitals 96

pharmaphorum

NOVEMBER 9, 2022

It goes without saying that The Economist’s 8th Annual World Cancer Series congress was well-attended in Brussels this week, the unofficial capital of the European Union. The keynote address of the event entire came from Stella Kyriakides, commissioner for health and food safety at the European Commission. Her opener?

Insurance 97

Insurance 97

Hospital Pharmacy Europe

JANUARY 18, 2024

Subcutaneous atezolizumab (brand name Tecentriq SC) has been granted marketing authorisation by the European Commission (EC) for multiple cancer types, its manufacturer Roche has announced. The post European approval of SC atezolizumab offers quicker and more flexible cancer treatment appeared first on Hospital Pharmacy Europe.

Hospitals 101

Hospitals 101

pharmaphorum

NOVEMBER 25, 2022

The European Commission has provided around €7 million ($7.2 million) in funding to a new project that aims to boost the ability of hospitals within the EU to collect real-world data (RWD) to gauge the effectiveness of novel cancer therapies.

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Hospitals 90

pharmaphorum

DECEMBER 13, 2022

A new initiative to boost research and development into rare and paediatric diseases launched last week, on Thursday 8 th December, at the European Health Summit. Last month, the European Commission provided around €7 million ($7.2 Last month, the European Commission provided around €7 million ($7.2

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Hospitals 97

European Pharmaceutical Review

APRIL 13, 2023

Given that the World Health Organization estimates that one in eight people globally live with a mental disorder , 4 developing these new treatments would be life-changing for millions of people, especially given that some are being investigated for treating conditions in groups where traditional treatments have failed.

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Pharmaceutical Companies Pharmaceutical Companies FDA 116

STAT

SEPTEMBER 6, 2022

The world, such as it is, continues to spin, no matter how we try to slow it down. … Illumina will have to divest Grail after the European Union vetoed the $7.1 The European Commission, which acts as the competition enforcer in the 27-country bloc, said that Illumina’s remedies did not adequately address its concerns.

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European Pharmaceutical Review

AUGUST 2, 2023

The European Commission (EC) approved AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442) antibody combination in September 2022 as a treatment for COVID-19 patients in the EU. In a clinical trial, this vaccine was shown to faciliate a strong immune response against the Omicron BA.1

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Vaccines Immunization 97

European Pharmaceutical Review

NOVEMBER 17, 2023

The European Commission has approved Ebglyss (lebrikizumab) for atopic dermatitis patients 12 years and older with a body weight of at least 40kg, who are candidates for systemic therapy. The company said it will launch lebrikizumab in Germany, with further European rollout planned throughout 2024.

Hospitals 83

Hospitals 83

European Pharmaceutical Review

FEBRUARY 7, 2023

Forxiga (dapagliflozin) has been approved in the European Union for heart failure (HF) with reduced ejection fraction (HFrEF) across the full spectrum of left ventricular ejection fraction (LVEF). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) in December 2022.

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Pharmaceutical Technology

MAY 5, 2023

The European Medicines Agency’s (EMA) committee for medicinal products for human use (CHMP) has recommended full marketing authorisation (MA) for Gilead Sciences ’ Hepcludex (bulevirtide) to treat chronic hepatitis delta virus (HDV) and compensated liver disease in adult patients.

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pharmaphorum

JUNE 18, 2021

A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer than the amount sought by the European Commission. “All other measures sought by the European Commission have been dismissed,” said the company.

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Vaccines 59

Pharmaceutical Technology

JULY 14, 2022

The Novavax COVID-19 vaccine has also received conditional authorization to be used in people aged 18 years and above, from multiple regulatory agencies across the globe, including the European Commission (EC), and the World Health Organization (WHO) emergency use listing.

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Vaccines FDA 64

Pharmaceutical Technology

JUNE 14, 2023

The Council of the EU has adopted recommendations proposed by the European Commission (EC) to combat antimicrobial resistance (AMR), setting targets for reduced antimicrobial use and increased surveillance. According to the announcement, AMR causes over 35,000 deaths each year in the wider European Economic Area.

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Long-Term Care Facilities Documentation Hospitals 52

pharmaphorum

APRIL 28, 2021

The European Commission has officially begun legal proceedings against AstraZeneca over supplies of COVID vaccines. Under pressure to roll out vaccinations, the European Commission has accused AZ of failing to live up to a contract to produce 300 million doses of the vaccine it developed with Oxford University.

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Vaccines 52

European Pharmaceutical Review

NOVEMBER 28, 2022

The data-driven technology platform will be able to re-use and cross-reference data with information contained in other repositories, including real world evidence (RWE) data captured across multiple settings and devices. ” The post Framework to enable re-use of patient clinical data appeared first on European Pharmaceutical Review.

Hospitals 93

Hospitals 93

European Pharmaceutical Review

APRIL 28, 2023

The European Commission ’s (EC’s) reform of the EU pharmaceutical legislation published on 26 April 2023, adopted a proposal for a new Directive and a new Regulation. He summarised that the revision “weakens the attractiveness for investment in innovation and hampers European science, research and development.”

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Communication 86

Hospital Pharmacy Europe

FEBRUARY 16, 2024

The NextGen project will be delivered by a 21-member consortium of academic, clinical, technical and commercial partners from across Europe and the US, including the European Society for Cardiology, and led by University Medical Center (UMC) Utrecht and Queen Mary University of London.

Hospitals 52

Hospitals 52

pharmaphorum

DECEMBER 16, 2022

CSL’s gene therapy for haemophilia B has been recommended for approval by the EMA’s human medicine committee, setting up a decision by the European Commission early next year. million – making it the most expensive medicine in the world – which was above the $2.9

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FDA 124

Pharmaceutical Technology

MAY 24, 2023

Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). The latest designation comes after the European committee for orphan medicinal products provided a positive opinion on the company’s application for the therapy.

FDA 52

FDA 52

Pharmaceutical Technology

MAY 11, 2023

The European Commission (EC) has granted approval for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients. The therapy’s safety and tolerability were found to be consistent with that observed in previous clinical trials and real-world use.

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Labelling Immunization 52

Pharmaceutical Technology

APRIL 4, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

Immunization 52

Immunization 52

European Pharmaceutical Review

JANUARY 31, 2023

The European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE). The post First medicine approved in EU for eosinophilic esophagitis appeared first on European Pharmaceutical Review.

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pharmaphorum

MARCH 26, 2021

The European Union has stopped short of export controls on vaccines after leaders met at a summit to discuss the issue of shortfalls in supply. At the meeting of the European Council leaders said that toughening export controls was an option but a post-summit statement emphasised the importance of global supply chains to produce vaccines.

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Vaccines Compounding 59

pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. It will be provided on a no-profit basis while the pandemic is ongoing.

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Vaccines Immunization 111

European Pharmaceutical Review

AUGUST 3, 2022

The European Pharmacopoeia (Ph. Commission has established the mRNAVAC Working Party to begin working on quality standards to support the emerging field of messenger RNA (mRNA) vaccines. The GBT assesses regulatory functions against a set of more than 260 indicators.

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Vaccines 93

pharmaphorum

MAY 26, 2021

Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious” failure to meet the terms of its contract to supply COVID-19 vaccines to the EU. Last week, the Commission signed a third contract with the two companies covering an additional 1.8

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Vaccines 76

Pharmaceutical Technology

AUGUST 1, 2022

1 Omicron strain, which could be of benefit as observed by the World Health Organization (WHO). In June, the company and the European Commission (EC) signed an agreement to amend their previously agreed contractual supply schedules for the former’s Covid-19 vaccine booster product (Spikevax, mRNA-1273) or updated booster vaccine candidate.

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Vaccines FDA 115

Pharmaceutical Technology

MAY 25, 2023

It is already the first proposed high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar in the world to receive marketing authorisation from the European Commission. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody.

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FDA Packaging Patient Care 52

European Pharmaceutical Review

APRIL 21, 2023

The leaked draft of the European pharmaceutical package is promising on this point as it states that marketing authorisation may be refused if the ERA is not completed or risk mitigation measures are insufficient, and that an ERA programme should be set up for medicines that were authorised before the introduction of the ERA.

Pharmaceutical Companies 83

Pharmaceutical Companies Pharmaceutical Companies Packaging 83

Pharmaceutical Technology

DECEMBER 27, 2022

In a recap of this eventful year, we take a moment to look at some of our biggest stories that relied on data and experts to inform our audience about the latest developments in the world of pharma, medical devices, and clinical trial operations. Tracking the news. Tracking drug development.

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Vaccines 122

pharmaphorum

SEPTEMBER 29, 2020

UK Prime Minister Boris Johnson has told the UN General Assembly that the UK will donate £571 million ($735 million) to the COVAX scheme aimed at distributing COVID-19 vaccines fairly around the world. All participating countries, regardless of income levels, will have equal access to these vaccines once they are developed, it pledges.

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Vaccines 116

pharmaphorum

DECEMBER 7, 2021

The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours of a recommendation from its advisory committee. The Commission is however thought to be the first regulator to award full regulatory approval to the IL-6 inhibitor.

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pharmaphorum

AUGUST 21, 2020

There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp. This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic.

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Vaccines 105