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EMA to Work With Stakeholders to Improve Product Information For EU Medicines

    EMA to Work With Stakeholders to Improve Product Information For EU Medicines

The European Medicines Agency (EMA) has published an action plan to improve the product information (PI) for EU medicines, an information package for patients and healthcare professionals that accompanies every single medicine authorised in

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New Precision Medicine Centre of Excellence Will Improve Patient Treatment

    New Precision Medicine Centre of Excellence Will Improve Patient Treatment

A £10 million Centre of Excellence in Precision Medicine has been launched by Invest Northern Ireland and Queen’s University Belfast. The Centre of Excellence in Precision Medicine will develop an

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Diaceutics Wins at Export Industry Awards

    Diaceutics Wins at Export Industry Awards

Diaceutics, the Irish data insights and solutions company helping patients receive potentially lifesaving medicine through better testing, won the Small & Emerging Exporter of the Year Award at the recent Export

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European Commission Diagnoses the State of Health in the EU

    European Commission Diagnoses the State of Health in the EU

Only by rethinking our health systems can we ensure that they remain fit-for-purpose and provide patient-centred care. This is what the 28 Country Health Profiles recently published by the Commission,

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Biopharma firm Regeneron to create 300 jobs in Limerick

    Biopharma firm Regeneron to create 300 jobs in Limerick

US biopharma company Regeneron Pharmaceuticals is to create 300 new jobs in Ireland as part of a new $100 million investment. The company has announced a further expansion of its

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Reduce SOP Complexity – Top 10 Tips

    Reduce SOP Complexity – Top 10 Tips

Standard operating procedures (SOP’s) define the essential steps, their order and the instructions necessary to formally repeat a quality performance. SOPs essentially are a blue print for risk mitigation. Industry

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PHE launches campaign to reign in use of antibiotics

    PHE launches campaign to reign in use of antibiotics

Public Health England has launched a major new campaign designed to further reign in inappropriate use of antibiotics, as estimates show that around 5,000 people in England alone die every

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FDA approves Bydureon BCise for patients with type-2 diabetes

    FDA approves Bydureon BCise for patients with type-2 diabetes

The FDA has approved Bydureon BCise for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines. AstraZeneca has announced that the US Food and Drug Administration

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US approves second CAR-T therapy

    US approves second CAR-T therapy

Gilead’s Yescarta – recently acquired through its purchase of Kite Pharma -has become the second gene therapy to be approved by the US Food and Drug Administration, offering a new

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Cork-based AventaMed eyes FDA approval after raising €1.8m

    Cork-based AventaMed eyes FDA approval after raising €1.8m

AventaMed, a Cork-based medtech firm focused on simplifying surgical procedures, has secured a €1.8 million investment to enable the company to attain FDA approval and go to market in the

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More than 70 medtech companies to vie for investment

    More than 70 medtech companies to vie for investment

More than 70 Irish medical technology companies will seek investment from 300 international blue-chip company buyers from 42 countries on Thursday. Enterprise Ireland’s bi-annual Med in Ireland event at the RDS is

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Future quality of NHS and social care is “precarious”, says CQC

    Future quality of NHS and social care is “precarious”, says CQC

The future of the health and social care system is in peril as it struggles to cope with the increasingly complex needs of a 21st century population, the Care Quality

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Synthetic biologists can now create novel vector constructs

    Synthetic biologists can now create novel vector constructs

Double Helix Technologies (Doulix) announced it will collaborate with Agilent Technologies to promote Agilent’s SureVector next-generation cloning kits through Doulix’s web platform. Through this partnership, synthetic biologists will be able to

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Researchers Help Develop New Antifungal Drug

    Researchers Help Develop New Antifungal Drug

University of Liverpool researchers, working with F2G Limited (Eccles, Manchester), have developed a new antifungal drug to help in the treatment of life threatening invasive fungal infections such as invasive aspergillosis.

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Tjoapack invests in bottle packing capabilities

    Tjoapack invests in bottle packing capabilities

Tjoapack, a Dutch contract packaging organisation (CPO), has added an additional bottling line to its facility in Etten-Leur, the Netherlands, to meet growing demand for this service, particularly from generics

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Most approved oncology drugs do not offer better survival rate or quality of life, say researchers

    Most approved oncology drugs do not offer better survival rate or quality of life, say researchers

A retrospective cohort study, published in the British Medical Journal, has found no conclusive evidence that most oncology treatments approved for use by the European Medicines Agency (EMA) offered survival

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GE Healthcare opens its first Eu 3D printing and design centre

    GE Healthcare opens its first Eu 3D printing and design centre

A 3D printed part can combine 20 parts into a single part and improve performance, reducing parts in a manufacturing process could benefit the biomanufacturing industry where processes and equipment

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Partnership formed for regenerative medicines

    Partnership formed for regenerative medicines

The Cell and Gene Therapy Catapult (CGT Catapult) has signed a Memorandum of Understanding (MoU) with the Forum for Innovative Regenerative Medicine (FIRM) in Japan, demonstrating a shared ambition to

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PCI acquires Dublin-based contract packaging services provider

    PCI acquires Dublin-based contract packaging services provider

Pharmaceutical outsourcing provider, PCI Pharma Services, has acquired Dublin-based pharmaceutical and healthcare contract packaging services provider, Millmount Healthcare. “We are very excited to welcome the Millmount team to PCI,” commented

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Strategic alliance formed between Sygnature and ApconiX

    Strategic alliance formed between Sygnature and ApconiX

A strategic alliance between Sygnature Discovery, provider of integrated drug discovery resource and expertise, and ApconiX, non-clinical safety strategies and ion channel screening experts, has been announced. The partnership will

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MHRA continues to promote #FakeMeds campaign to protect new students

    MHRA continues to promote #FakeMeds campaign to protect new students

As the new academic year begins, the Medicines & Healthcare products Regulatory Agency (MHRA) is campaigning to students about the risks of self-prescribing and self-medicating with medicines purchased online. Buying

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Commission not ranking preferences for key EU agencies post-Brexit

    Commission not ranking preferences for key EU agencies post-Brexit

The publication on Saturday of the EU Commission’s unranked and unshortlisted assessment of the 27 bids from member states to host the London-based European Banking Authority (EBA) and the European

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European Medicines Agency fears losing staff after it leaves London

    European Medicines Agency fears losing staff after it leaves London

Losing valuable staff is the major concern in the impending relocation of the European Medicines Agency. The agency which is

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FDA Requires Opioid Makers to Develop Doctor Training

    FDA Requires Opioid Makers to Develop Doctor Training

The Food and Drug Administration is requiring manufacturers of the most widely prescribed painkillers to provide extensive training to doctors

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Brexit move creates EMA risk: report

    Brexit move creates EMA risk: report

The Brexit-inspired need to move the London HQ of the European Medicines Agency will throw up two major risks when

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Exclusive access to Cancer Research UK’s inhibitor payload granted to Glythera

    Exclusive access to Cancer Research UK’s inhibitor payload granted to Glythera

The antibody drug conjugate (ADC) development company, Glythera, has been granted exclusive, worldwide rights to Cancer Research UK’s novel CDK11

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MGC Pharmaceuticals to sponsor first medical cannabis conference in London

    MGC Pharmaceuticals to sponsor first medical cannabis conference in London

Australian-based medical grade cannabis company, MGC Pharmaceuticals, will sponsor and speak at the first conference on medical cannabis in the

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Single-tablet regimen for HIV-1 approved by European Commission

    Single-tablet regimen for HIV-1 approved by European Commission

Janssen has announced that the European Commission (EC) has approved its darunavir-based single-tablet regimen (STR), Symtuza▼, for the treatment of

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Partnership formed to combat pharmaceutical counterfeiting

    Partnership formed to combat pharmaceutical counterfeiting

Bio/pharmaceutical analytical and bioanalytical contract solutions provider, SGS, has entered into a partnership with Nature’s Fingerprint, which specialises in product

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BBC releases app to help stop future flu pandemics

    BBC releases app to help stop future flu pandemics

If you’ve ever wanted to contribute to a science event that could potentially help save lives then a new app

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UCB receives EU approval for paediatric anti-epileptic drug

    UCB receives EU approval for paediatric anti-epileptic drug

UCB has announced that the European Commission (EC) has approved expanding the use of its anti-epileptic drug (AED) Vimpat (lacosamide)

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Doctors should ‘control biosimilar drug regimes’

    Doctors should ‘control biosimilar drug regimes’

Doctors and not pharmacies should retain control of any decision to switch a patient from a modern biologic medicine to

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Kymab antibody could be used to treat leukemia

    Kymab antibody could be used to treat leukemia

Kymab, an emerging biopharmaceutical company focused on the discovery and development of fully human monoclonal antibody drugs, announced new data

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Amryt boost as epidermolysis bullosa drug rival fails

    Amryt boost as epidermolysis bullosa drug rival fails

Irish woundcare group Amryt has become the front-runner in the race to find a treatment for epidermolysis bullosa (EB), known

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Out with the old and in with the new — EU project launched for renewable solvents

    Out with the old and in with the new — EU project launched for renewable solvents

ReSolve — ‘Renewable solvents with high performance in applications and improved toxicity profiles’ — is set to last three years

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FDA approves BioMarin’s manufacturing facility in Cork, Ireland

    FDA approves BioMarin’s manufacturing facility in Cork, Ireland

The Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for

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British manufacturing industry calls on government to rethink Brexit strategy

    British manufacturing industry calls on government to rethink Brexit strategy

British manufacturers are asking the government to negotiate access to the single market and a form of customs union along

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UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

    UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

The UK National Institute for Health and Care Excellence (NICE) has granted approval for Roche’s breast cancer drug Kadcyla for

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MSD investment confirms thriving biopharmaceutical hub

    MSD investment confirms thriving biopharmaceutical hub

BioPharmaChem Ireland, the Ibec group that represents business in the sector, said the announcement of MSD to invest €280 million

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Novo Nordisk wins European approval for Refixia

    Novo Nordisk wins European approval for Refixia

Novo Nordisk has won EU approval for its new haemophilia drug Reflixia and is planning its first European launches in

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EMA to Evaluate Liver Problems Linked to Zinbryta

    EMA to Evaluate Liver Problems Linked to Zinbryta

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed the safety reviews of a variety of medications during its

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EC approves Johnson & Johnson’s $30bn acquisition of Actelion

    EC approves Johnson & Johnson’s $30bn acquisition of Actelion

The European Commission (EC) has approved Johnson & Johnson’s proposed $30bn acquisition of Actelion Pharmaceuticals, subject to conditions J&J signed

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Health Beacon to hire 20 new staff in Dublin

    Health Beacon to hire 20 new staff in Dublin

Medtech firm Health Beacon, whose backers include Bill McCabe’s Oyster Capital, will more than double its Dublin workforce with the

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New EMA guidelines on biosimilar medicines

    New EMA guidelines on biosimilar medicines

The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are

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Expats returning post Brexit could cost NHS £500m

    Expats returning post Brexit could cost NHS £500m

The NHS could be faced with having to pay nearly half a billion pounds more if British expats decide to

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Three new apprenticeship schemes seek to plug skills gap

    Three new apprenticeship schemes seek to plug skills gap

Three new apprenticeship schemes have been introduced in the medtech sector as part of Government attempts to plug the skills

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Cambrex announces investment and expansion in Sweden

    Cambrex announces investment and expansion in Sweden

Cambrex, manufacturer of small molecule active pharmaceutical ingredients (APIs), has announced it is investing in new capacity and continuous flow

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Brilique (ticagrelor) new formulation gains European approval

    Brilique (ticagrelor) new formulation gains European approval

The European Commission (EC) has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new method of

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Isolated Greek villages reveal genetic secrets that protect against heart disease

    Isolated Greek villages reveal genetic secrets that protect against heart disease

A genetic variant that protects the heart against cardiovascular disease has been discovered by researchers at the Wellcome Trust Sanger

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UK biotech takes pole position in Europe

    UK biotech takes pole position in Europe

The UK has the strongest and most robust clinical pipeline in Europe, with the number of drug products in development

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MSD probed by UK for blocking Remicade biosimilars

    MSD probed by UK for blocking Remicade biosimilars

The UK government says Merck Sharp & Dohme (MSD) broke competition laws by lowering the price of its Remicade drug

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EMA Builds Collaboration with African Regulators

    EMA Builds Collaboration with African Regulators

The European Medicines Agency (EMA) met with a delegation from the East African Community (EAC) from May 18–19, 2017 as

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Industry experts to deliver workshop on medical device regulation

    Industry experts to deliver workshop on medical device regulation

The Regulatory Affairs Professionals Society (RAPS) is hosting a dedicated workshop on the new EU regulations for medical devices and

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Novartis’ Swiss head of operations reveals job cuts

    Novartis’ Swiss head of operations reveals job cuts

Novartis has revealed that up to 500 positions in Switzerland will be eliminated or transferred to other areas over the

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