API Warning Letters Each spring, the FDA publishes data on its website related to Form 483 inspection observations and warning letters issued
Breaking News
- Brexit – Implications For the Pharma Industry in Ireland The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland,...
- 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...
- 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...
- Brexit – Key Issues For the Pharmaceutical Industry Brexit – the stark reality is that the UK’s EU membership and the application of all EU legislation in the UK ends automatically at midnight on 30th March 2019! Current understanding...
- 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,...
Standard operating procedures (SOP’s) define the essential steps, their order and the instructions necessary to formally repeat a quality performance.
Public Health England has launched a major new campaign designed to further reign in inappropriate use of antibiotics, as estimates
The FDA has approved Bydureon BCise for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines.
The Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing, announced it has begun the first
In a decades-long game of hide and seek, scientists from Sydney’s Westmead Institute for Medical Research have confirmed for the
Eli Lilly has signed up CureVac to develop cancer vaccines based on its mRNA technology, in a deal that could
Gilead’s Yescarta – recently acquired through its purchase of Kite Pharma -has become the second gene therapy to be approved
AventaMed, a Cork-based medtech firm focused on simplifying surgical procedures, has secured a €1.8 million investment to enable the company
More than 70 Irish medical technology companies will seek investment from 300 international blue-chip company buyers from 42 countries on
Visterra and Vir Biotechnology have entered into a research collaboration, exclusive licence and option agreement for the development and commercialisation
Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer. AstraZeneca and Merck &
Plasticell, a biotechnology company specialising in stem cell screening and cell therapy development, has entered into a collaboration with GSK
A specialist in therapeutic approaches to treat resistant bacterial infections, Mutabilis has been selected to join the European consortium ENABLE
The FDA has approved an expanded indication for Stelara for the treatment of adolescents with moderate plaque psoriasis. Janssen Biotech,
Titan Pharmaceuticals has announced that the first patient has been treated in a Phase I/II trial of its ropinirole subdermal
SGS announced it has entered into collaboration with Bavarian Nordic A/S, an international biotechnology company specialising in vaccines, to develop
The NIH and 11 leading biopharmaceutical companies have launched the Partnership for Accelerating Cancer Therapies (PACT), totalling $215m as part
The European Patent Office has issued a new patent to biotechnology company, CEL-SCI, for its lead investigational immunotherapy, which is
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