pharmaphorum

NOVEMBER 24, 2022

The Data Analysis and Real World Interrogation Network (DARWIN) EU platform aims to create a network of databases of verified, quality, and secure content that can be used to support “scientific evaluations and regulatory decision making” with reliable evidence from healthcare practice.

Documentation 52

Documentation Insurance Hospitals 52

Hospital Pharmacy Europe

JULY 13, 2023

Pharmacists and other healthcare professionals from the EU can continue to join the NHS workforce for the next five years without taking additional tests, following a recent UK Government review. A version of this story was originally published by our sister publication Pulse.

Hospitals 96

Hospitals 96

European Pharmaceutical Review

AUGUST 1, 2022

The workplan lays out deliverables and timelines including: More than one hundred studies annually by 2025 for the EMA’s network of data and services in Europe for a better use of real-world evidence when assessing medicines: Data Analysis and Real World Interrogation Network (DARWIN EU).

Documentation 92

Documentation 92

European Pharmaceutical Review

NOVEMBER 20, 2023

On World Antibiotic Awareness Week (WAAW), 18-24 November 2023, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted the importance of efficient legislation for determining the EU’s future actions in the challenge to overcome antimicrobial resistance (AMR).

Vaccines 77

Vaccines 77

Fierce Pharma

AUGUST 1, 2023

TG Therapeutics is preparing to debut its multiple sclerosis antibody on the world stage. million upon Briumvi’s first EU launch—to chip in on commercialization of TG’s CD20-targeting drug outside the U.S. Eight months after Briumvi’s initial green light in the U.S., Under the deal, TG is eligible to receive another $492.5

Pharmaceutical Companies 76

Pharmaceutical Companies Pharmaceutical Companies 76

European Pharmaceutical Review

OCTOBER 17, 2022

This recommendation marks the first time the CHMP has simultaneously reviewed applications for EU-aimed medicine under both the centralised procedure and the EMA’s ‘EU-Medicines for all’ (EU-M4all) programme for non-EU countries. TAK-003 has not yet been approved anywhere else in the world. About dengue.

Vaccines 91

Vaccines 91

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. Specifically, the overall EU sales of antimicrobials used in farm animals and aquaculture should be reduced by 50% by the same year.

Long-Term Care Facilities 52

Long-Term Care Facilities Documentation Hospitals 52

pharmaphorum

NOVEMBER 12, 2021

The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to be backed for full approval in the EU. The post COVID antibodies from Roche, Celltrion backed for approval in EU appeared first on.

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pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

FDA 124

FDA 124

pharmaphorum

OCTOBER 14, 2022

.” The programme has been set up to develop four devices – an e-paper label, smart wearable sensor, smart pill box, and endo-cutter used in surgical procedures – with funding from the EU’s Horizon Europe programme and support from the Waste Electrical and Electronic Equipment (WEEE) Forum.

Labelling 124

Labelling 124

STAT

SEPTEMBER 6, 2022

The world, such as it is, continues to spin, no matter how we try to slow it down. Illumina completed the deal in August last year ahead of EU regulatory approval, resulting in an EU order to keep Grail separate and appoint independent managers to run the company until the investigation was concluded.

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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.

Pharmaceutical Companies 116

Pharmaceutical Companies Pharmaceutical Companies FDA 116

Policy Prescription

AUGUST 25, 2022

Burr had fallen asleep over 20 years ago and woke up believing that nothing had changed in the world of drug regulation. His essential focus was that the EU does not have the same strong pharmaceutical regulations as the U.S. could harmonize drug regulatory standards with the EU. Then the “rest of the world.”

FDA 89

FDA 89

STAT

NOVEMBER 6, 2023

The world, such as it is, continues to spin. The European Federation of Pharmaceutical Industries and Associations says the commission has not conducted a competitiveness impact assessment and if the new rules become law, they would accelerate the negative innovation trend in the EU and hit small and medium-sized enterprises the hardest.

FDA 88

FDA 88

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. EU is at a xroads: will it choose 2 #closethegap with US or become reliant on the rest of the world?

Communication 86

Communication 86

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. Seeking EU-wide excellence. What will then be provided will be personalised cancer care for EU patients. The essential aim?

Insurance 97

Insurance 97

Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). These antibodies are obtained from B-cells of convalescent Covid-19 patients. 5 variant, the company noted.

Dosage 111

Dosage Vaccines Immunization 111

European Pharmaceutical Review

NOVEMBER 28, 2022

Part of a four-year project, aided by 27 partners from both EU and non-EU Member States, the framework will help develop technological solutions to support the sharing and re-use of the data. Permit informed workable aligned positions for EU researchers. Improve future research in the pharmaceutical industry.

Hospitals 93

Hospitals 93

pharmaphorum

AUGUST 16, 2020

The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine. Reuters says that the Commission has “urged EU states to shun the WHO-led initiative because it sees it as too expensive and slow.”. The post EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine appeared first on.

Vaccines 111

Vaccines Immunization 111

European Pharmaceutical Review

JUNE 27, 2023

This data was presented at the 2023 Fetal Medicine Foundation (FMF) World Congress in Spain. If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the EU.

Immunization 84

Immunization 84

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 CHMP looked at data from other studies, a managed access programme and real‑world data.

FDA 85

FDA 85

NICE

JANUARY 24, 2023

Real-world evidence has the potential to transform current models of evidence generation. Here at NICE, we want to use real-world data to resolve gaps in knowledge. In June 2022, we published our real-world evidence framework. It allows us to better substantiate the benefit of a medical intervention outside clinical trials.

Hospitals 52

Hospitals 52

pharmaphorum

NOVEMBER 10, 2022

To continue with pharmaphorum’s coverage of Day One of The Economist’s 8th Annual World Cancer Series congress in Brussels, Belgium this week – where the foci were “innovation, equity, and excellence” – after the opening addresses came a panel on the priorities for innovation and excellence in cancer care within Europe.

Vaccines 92

Vaccines Pharmaceutical Companies Pharmaceutical Companies Labelling 92

pharmaphorum

APRIL 14, 2021

A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data. The authors said there was a “statutory conflict between EU fundamental rights and other countries’ regulation”. Click here to read the full report.

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pharmaphorum

MARCH 26, 2021

However the EU ordered its doses three months later than the UK and the issue has been compounded by low yields from AZ’s EU manufacturing network. The EU now wants AZ to catch up on deliveries to the EU before exporting doses elsewhere.

Vaccines 59

Vaccines Compounding 59

STAT

MARCH 14, 2024

We hope you have a smashing day and conquer the world. years with one extra year of incentives if a drug meets “unmet medical needs” and if studies are held in the EU. So far, our choice today is peppermint mocha. Please do join us. Meanwhile, here are few items of interest for you to peruse.

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Pharmaceutical Technology

MAY 24, 2023

This makes INO-3107 the first RRP product candidate to receive designations from both the EU and the US regulatory agencies. This is yet another important step forward for our development process and for the RRP patients around the world who could benefit from a potentially game-changing therapy.”

FDA 52

FDA 52

European Pharmaceutical Review

JANUARY 18, 2023

Pfizer has announced it is expanding its ‘An Accord for a Healthier World’ initiative, to include its full portfolio of medicines and vaccines for which Pfizer has global rights. The initial not-for-profit offering provided access to all its patented medicines and vaccines available in the US or European Union (EU) to 1.2

Vaccines 81

Vaccines Chemotherapy Communication 81

pharmaphorum

SEPTEMBER 26, 2022

The Economist ’s 8th Annual World Cancer Series: Europe convenes a wide range of stakeholders critical to effective cancer care, to drive innovation, equity and excellence in cancer control across Europe. The post 8th annual World Cancer Series Europe appeared first on. Learn more: [link].

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52

Hospital Pharmacy Europe

AUGUST 23, 2023

Pancreatic ductal adenocarcinoma (PDAC) is known to be the fourth-leading cause of cancer related mortality in the world and has a poor prognosis, with a five-year survival rate of below 5%. The EMA orphan drug designation follows a similar approval by the FDA in May 2023.

Chemotherapy 98

Chemotherapy Immunization Hospitals FDA 98

European Pharmaceutical Review

AUGUST 15, 2023

Italy is one of Europe’s largest producers and exporters of ingredients – exporting around 85 percent to North America, the EU and Japan, according to CPHI research. The Milan region is at the centre of Italy’s pharmaceutical base, with over 50 facilities in the Lombardy region alone.

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Packaging Dosage 90

European Pharmaceutical Review

FEBRUARY 7, 2023

Forxiga (dapagliflozin) Forxiga is approved for type-2 diabetes (T2D), HFrEF and chronic kidney disease (CKD) in more than 100 countries around the world including the US, the EU, China and Japan. The post Forxiga approved in EU for chronic heart failure appeared first on European Pharmaceutical Review.

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pharmaphorum

SEPTEMBER 8, 2021

The UK could end up facing “either long delays in approving new medicines or that the MHRA will be reduced to effectively ‘rubber stamping’ EU regulatory decisions,” according to the unions. ” The letter argues however that any change must be evidence-based, and not simply led by financial considerations.

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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). Dupixent as a subcutaneously administered injection is now an option for the approximately 50,000 patients with uncontrolled EoE in the EU.

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Pharmaceutical Technology

APRIL 4, 2023

If approved, it is expected to become the first and only long-acting C5 complement inhibitor to receive approval in the European Union (EU) for this indication. In Japan, EU, and the US, the medication received approval to treat generalised myasthenia gravis in certain adults. “For

Immunization 52

Immunization 52

pharmaphorum

OCTOBER 17, 2022

It is the first time that the CHMP has reviewed a medicinal product for the EU market under a centralised procedure simultaneously with a medicinal product for non-EU countries under the ‘Eu-Medicines for all’ programme (EU-M4all). Approval from the EMA is expected within months.

Vaccines 52

Vaccines Generic Medicine 52

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. The EU also wants the balance of 180 million doses from the contact to be delivered no later than the end of September.

Vaccines 76

Vaccines 76