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Responsibilities of the Marketing Authorisation Holder

    Responsibilities of the Marketing Authorisation Holder

Marketing Authorisation Holder: EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime in relation to its safety, quality and efficacy, lies with

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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 a biosimilar version, the industry has argued. In its submission

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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 production of the formulated bulk substance (N-acetylgalactosamine 6-sulfatase (GALNS) used

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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 in Ireland over the next three years bolsters the country’s

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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 an agreement in January this year to acquire Actelion, which develops

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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 addition of 20 new jobs to help spearhead its expansion

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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 biological medicines that are highly similar in all essential aspects

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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 return to the UK because their right to healthcare in

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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 treatment administration. This decision means that ticagrelor will become the

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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 higher in the UK than anywhere else in the region,

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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 as biosimilar rivals came to market. The Competition and Markets

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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 part of the agency’s collaboration with African regulators. The meeting

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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 in vitro diagnostic devices. Taking place on 4 – 5

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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 next 18 months, but will counterbalance that with 350 new

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EMA Launch of New EudraVigilance System Moves Forward

    EMA Launch of New EudraVigilance System Moves Forward

On May 22, 2017, the European Medicines Agency (EMA) announced that its Pharmacovigilance Risk Assessment Committee has completed an audit and evaluation of the new EudraVigilance information system for tracking

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European countries offer goodies in bid to win EMA after Brexit

    European countries offer goodies in bid to win EMA after Brexit

Even before European officials present the groundwork for relocating the bloc’s drug regulator, a fight has emerged between countries vying for the economic lift and status that come with hosting the

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Global European Rights to AstraZeneca’s Heart Failure Treatment Acquired by Recordati for $300M

    Global European Rights to AstraZeneca’s Heart Failure Treatment Acquired by Recordati for $300M

Recordati announced that it has entered into an agreement with AstraZeneca for the acquisition of the rights to Seloken®/Seloken® ZOK (metoprolol succinate) and associated Logimax® fixed dose combination (metoprolol succinate

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Irish Biotech developing New Antibiotics attracts €58M in Series B Round

    Irish Biotech developing New Antibiotics attracts €58M in Series B Round

Iterum Therapeutics has raised €58M to fund Phase III and bring a new antibiotic to a market where innovation is lacking. Iterum Therapeutics is a biotech based in Dublin that

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Final deadline to notify hazardous mixtures with Spanish poison centre

    Final deadline to notify hazardous mixtures with Spanish poison centre

Business placing products on the market in Spain must notify their products ahead of 1 June 2017 or risk enforcement by the Spanish Authorities Businesses that place mixtures with a

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2021 Forecast: Germany Pharma Market to Reach $86B

    2021 Forecast: Germany Pharma Market to Reach $86B

  The German pharmaceuticals market is set to rise from $67.9 billion (€52.9 billion) in 2016 to around $86.3 billion (€67.2 billion) in 2021, representing a compound annual growth rate

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European Medicines Agency’s 2016 annual report published

    European Medicines Agency’s 2016 annual report published

The European Medicines Agency’s (EMA) 2016 annual report focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and

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Ireland reiterates bid to host the European Medicines Agency post-Brexit

    Ireland reiterates bid to host the European Medicines Agency post-Brexit

Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past

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Five new global experts ‘on board’ to advise CPhI Worldwide

    Five new global experts ‘on board’ to advise CPhI Worldwide

This year’s advisory board for CPhI Worldwide has been announced by organiser, UBM EMEA. Featuring five new global experts, the

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Ashfield Healthcare Communications expands across the UK and Europe

Ashfield Healthcare Communications, a global healthcare communications agency, announces significant growth across the UK and Europe. Ashfield Healthcare Communications has

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Diamond BioPharm’s Response to the United Kingdom’s Withdrawal from the European Union

On May 2, 2017, the EMA and European Commission published a notice alerting Marketing Authorization Holders of centrally authorized medicines

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Ready, steady, go: Tightened EU medical device regulations are here

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR). The

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Spanish Pharma Market Shows Signs of Stability

Spain’s pharmaceutical market set to show signs of stability, surpassing $25 billion by 2021, says GlobalData. The Spanish pharmaceutical market

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French Biotech Could Be Taking its Diabetes Drug to Phase III on its own

Poxel was able to score positive results for its type 2 diabetes drug in a Phase IIb study in Japan, preparing the company

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EMA and EU Member States Begin Brexit Discussions

The agency met with EU National Competent Authorities to begin making plans for the distribution of workload because of the

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Dublin-based drugs firm Icon reports rise in revenues

Dublin-headquartered drugs group Icon, which employs more than 1,000 people in Ireland, reported a record number of business wins in

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United Drug announces €40m investment at headquarters

Pharmaceutical wholesaler United Drug has announced a €40 million investment in technology and innovation at its headquarters at Citywest in

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Inoviem Scientific raises €750k of funds

Inoviem Scientific, a contract research biotech (CRB), has secured funding of €750k from existing financial partners to support the company’s

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Fujifilm Increases Production Capacity in the US and UK

On April 18, 2017 Fujifilm announced the completion of a $93-million cGMP production facility in Texas. The facility expansion is

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Medtec Europe 2017 reports record attendance and reveals industry trends

This year’s Medtec Europe showed a record attendance with a 7% increase in overall visits. The event attracted 6,816 attendees

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Irish medtech company Diaceutics to recruit 30 people

Irish medtech firm Diaceutics is set to add 30 jobs to its workforce in the coming year, as the company

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What is driving success in corporate Ireland?

With Brexit centre stage, there is a temptation for all attention in Ireland to focus on two topics: how much

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UK digital health companies generate over £1bn turnover in 2016

A new government report shows that digital health companies in the UK generated a turnover of over £1 billion in

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Amryt posts €1.35m sales as pipeline drugs advanced

Amryt Pharma, the orphan drug development company that was subject to a reverse takeover of former oil and gas group

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Article 50: what does it mean for the UK’s medtech sector?

Now that the die has been cast, it’s time for the deal-making process to begin – if indeed a deal

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Sharp Announces Major Investment in Pharma Manufacturing Facility

Sharp Clinical Services, part of UDG Healthcare plc, has announced a £9 million ($11.2 million) investment to fund a new multiple-phase pharmaceutical

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Brexit: The Luck of the Irish?

The move by Great Britain to step away from the European Union may be sending chills of uncertainty to many

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Merck Accelerator hits new peak of applications

Merck, a leading science and technology company, announced today the new startups participating in its Accelerator programs in Darmstadt, Germany

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Eurofins Scientific Invests in New UK Facility

Eurofins Scientific announced on March 20, 2017 that it will be establishing a new pharmaceutical chemistry and microbiology facility in

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Oneview Healthcare wins new hospital contract in US

Irish hospital software group Oneview Healthcare has secured another contract in the United States. The listed company will roll out

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Scottish gov to stream extra £71m into general practice

General practice in Scotland will benefit from an extra £250 million a year by 2021 under wider plans to raise

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European experts meet with African regulators to discuss collaboration

Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve

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University of Cambridge fosters industry-academia collaborations in therapeutics

Cambridge Academy of Therapeutic Sciences aims to create world-leading industry-academia collaborations with new initiative The Cambridge Academy of Therapeutic Sciences

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Coping mechanism: How businesses can deal with Brexit

Frost & Sullivan, Gary Jeffery comments on the implications of Brexit for businesses both in and out of the UK.

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J&J to shutter West Lothian plant

Healthcare giant Johnson & Johnson is planning to close its medical manufacturing plant in West Lothian, Scotland, potentially affecting around

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Collaboration tackles respiratory irritancy hazard

SenzaGen and AstraZeneca will develop a new genomic signature to distinguish allergens from irritants in the respiratory tract Swedish in

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Pro-Samsung U.K. court ruling hurts AbbVie’s defense against Humira biosims

Score one for Samsung Bioepis in its quest to bring a biosimilar version of AbbVie’s anti-inflammatory behemoth Humira to market in

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The potential consequences for cancer care and cancer research of Brexit

In an editorial published in the journal ecancermedicalscience, leading academics from across the UK explore the risks facing cancer care,

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Price drops make more cancer drugs routinely available

The National Institute for Health and Care Excellence (NICE) is half way through a review of drugs approved and still

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Johnson and Johnson “most admired” pharma company

A survey conducted by Fortune determined that the company are most admired by peers out of all the pharma companies

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