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 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
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
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
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
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
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
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
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
This year’s advisory board for CPhI Worldwide has been announced by organiser, UBM EMEA. Featuring five new global experts, the
Ashfield Healthcare Communications, a global healthcare communications agency, announces significant growth across the UK and Europe. Ashfield Healthcare Communications has
On May 2, 2017, the EMA and European Commission published a notice alerting Marketing Authorization Holders of centrally authorized medicines
The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR). The
Spain’s pharmaceutical market set to show signs of stability, surpassing $25 billion by 2021, says GlobalData. The Spanish pharmaceutical market
Poxel was able to score positive results for its type 2 diabetes drug in a Phase IIb study in Japan, preparing the company
Pharmaceutical wholesaler United Drug has announced a €40 million investment in technology and innovation at its headquarters at Citywest in
Inoviem Scientific, a contract research biotech (CRB), has secured funding of €750k from existing financial partners to support the company’s
On April 18, 2017 Fujifilm announced the completion of a $93-million cGMP production facility in Texas. The facility expansion is
This year’s Medtec Europe showed a record attendance with a 7% increase in overall visits. The event attracted 6,816 attendees
Irish medtech firm Diaceutics is set to add 30 jobs to its workforce in the coming year, as the company
With Brexit centre stage, there is a temptation for all attention in Ireland to focus on two topics: how much
A new government report shows that digital health companies in the UK generated a turnover of over £1 billion in
Amryt Pharma, the orphan drug development company that was subject to a reverse takeover of former oil and gas group
Now that the die has been cast, it’s time for the deal-making process to begin – if indeed a deal
Sharp Clinical Services, part of UDG Healthcare plc, has announced a £9 million ($11.2 million) investment to fund a new multiple-phase pharmaceutical
The move by Great Britain to step away from the European Union may be sending chills of uncertainty to many
Merck, a leading science and technology company, announced today the new startups participating in its Accelerator programs in Darmstadt, Germany
Eurofins Scientific announced on March 20, 2017 that it will be establishing a new pharmaceutical chemistry and microbiology facility in
Irish hospital software group Oneview Healthcare has secured another contract in the United States. The listed company will roll out
General practice in Scotland will benefit from an extra £250 million a year by 2021 under wider plans to raise
Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve
Cambridge Academy of Therapeutic Sciences aims to create world-leading industry-academia collaborations with new initiative The Cambridge Academy of Therapeutic Sciences
Frost & Sullivan, Gary Jeffery comments on the implications of Brexit for businesses both in and out of the UK.
Healthcare giant Johnson & Johnson is planning to close its medical manufacturing plant in West Lothian, Scotland, potentially affecting around
SenzaGen and AstraZeneca will develop a new genomic signature to distinguish allergens from irritants in the respiratory tract Swedish in
Score one for Samsung Bioepis in its quest to bring a biosimilar version of AbbVie’s anti-inflammatory behemoth Humira to market in
In an editorial published in the journal ecancermedicalscience, leading academics from across the UK explore the risks facing cancer care,
The National Institute for Health and Care Excellence (NICE) is half way through a review of drugs approved and still
A survey conducted by Fortune determined that the company are most admired by peers out of all the pharma companies
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