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,
Regulation
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
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
The Life Science Industry The manufacturing industry in Ireland is now enjoying a renewed period of growth on the back of increased consumer demand in both Irish and overseas markets. This
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
The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines. Complex drugs
The potential for harmful chemicals to be extracted from packaging materials that pose a risk to patients has spurred regulatory authorities to establish guidelines for extractable and leachable (E&L) testing
British manufacturers are asking the government to negotiate access to the single market and a form of customs union along with suitable transition period. The call comes from EEF, the
Novo Nordisk has won EU approval for its new haemophilia drug Reflixia and is planning its first European launches in the fourth quarter. The European Commission marketing authorisation comes one
European regulators have accepted for review Sandoz’ marketing applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab). The company is seeking approval for its biosimilars for use 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 European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. It is already indicated in Europe as an
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
Aspen Pharmacare is under investigation by the European Commission over its pricing practices for five cancer medicines. EU antitrust regulators will investigate whether the South African generics firm abused
Cinfa Biotech announced trial results for a biosimilar of Amgen’s Neulasta, a multi-billion blockbuster to treat chemotherapy-induced neutropenia. Cinfa Biotech is a Spanish company specialized in developing biosimilars. The biotech
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
Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world’s first smartphone compatible ICM that will help physicians identify
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference. In an effort to provide healthcare professionals with information on the science
On May 2, 2017, the EMA and European Commission published a notice alerting Marketing Authorization Holders of centrally authorized medicines of their obligations in relation to Brexit. Although the final
The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR). The next step is a transition period of three years for
On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on
EU regulators have expanded the scope of Janssen’s Darzalex to include patients with multiple myeloma who have received at least
Intuitive Surgical has bagged a CE mark for the latest product in its da Vinci series of robot-assisted surgical systems.
Impax Laboratories, Inc., a specialty pharmaceutical company, announced it has received final U.S. Food and Drug Administration (FDA) approval for a
After Danish and Swedish, Solidsoft Reply, the Reply group company specialising in enterprise strength solutions on the Microsoft Azure cloud
The medtech sector has welcomed the vote from the European Parliament to endorse new regulations on in vitro diagnostic medical
Contrary to some political claims, the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than
BTG, a global specialist healthcare company, has received Class III CE Mark certification for DC Bead LUMI, the first commercially
The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF
Now that the die has been cast, it’s time for the deal-making process to begin – if indeed a deal
Xeljanz (tofacitinib citrate) receives marketing authorization in the European Union for the treatment of moderate to severe active rheumatoid arthritis
Apeiron Biologics has announced that the EMA’s CHMP has recommended the approval of APN311 for immunotherapy of high risk neuroblastoma.
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic
Advertisements
