Biopharma Business

Regulation

Brexit – Implications For the Pharma Industry in Ireland

    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,

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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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Brexit – Key Issues For the Pharmaceutical Industry

    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

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Ireland and the Life Science Industry – 2017

    Ireland and the Life Science Industry – 2017

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

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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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FDA Acts to Eencourage Generic Competition for Complex Drugs

    FDA Acts to Eencourage Generic Competition for Complex Drugs

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

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Extractables and leachables in pharmaceutical packaging

    Extractables and leachables in pharmaceutical packaging

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

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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 with suitable transition period. The call comes from EEF, the

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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 the fourth quarter. The European Commission marketing authorisation comes one

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EU review for Sandoz’ Humira, Remicade biosimilars

    EU review for Sandoz’ Humira, Remicade biosimilars

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

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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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EMA approves once-daily therapy for partial-onset epilepsy

    EMA approves once-daily therapy for partial-onset epilepsy

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

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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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Aspen Pharmacare hit by EU antitrust cancer drug price probe

    Aspen Pharmacare hit by EU antitrust cancer drug price probe

  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

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A Spanish Biosimilar of Amgen’s Blockbuster gets Ready for EU Approval

    A Spanish Biosimilar of Amgen’s Blockbuster gets Ready for EU Approval

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

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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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Abbott announces CE Mark and first use of the world’s first smartphone compatible insertable cardiac monitor

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

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EMA Promotes Understanding and Use of Biosimilars

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

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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 of their obligations in relation to Brexit. Although the final

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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 next step is a transition period of three years for

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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 UK’s departure from the EU. On April 28, 2017, the

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May the fourth be with you: IVD Symposium to take place in Dublin

On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on

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EU expands use of Janssen’s Darzalex

EU regulators have expanded the scope of Janssen’s Darzalex to include patients with multiple myeloma who have received at least

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Intuitive Surgical gets CE mark for robot-assisted device

Intuitive Surgical has bagged a CE mark for the latest product in its da Vinci series of robot-assisted surgical systems.

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Impax Launches Generic Version of Vytorin

Impax Laboratories, Inc., a specialty pharmaceutical company, announced it has received final U.S. Food and Drug Administration (FDA) approval for a

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Solidsoft Reply to operate the Irish National Medicine Verification System

After Danish and Swedish, Solidsoft Reply, the Reply group company specialising in enterprise strength solutions on the Microsoft Azure cloud

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Industry response to new EU laws on medical devices

The medtech sector has welcomed the vote from the European Parliament to endorse new regulations on in vitro diagnostic medical

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FDA Approves More Drugs, and Faster, than Europe, Study Says

Contrary to some political claims, the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than

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BTG receives CE mark certification for radiopaque drug-eluting bead

BTG, a global specialist healthcare company, has received Class III CE Mark certification for DC Bead LUMI, the first commercially

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Novartis’ lung cancer drug combination receives EU approval

The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF

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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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Pfizer’s Xeljanz Authorized for Marketing in the European Union

Xeljanz (tofacitinib citrate) receives marketing authorization in the European Union for the treatment of moderate to severe active rheumatoid arthritis

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EMA Recommends Approval of New Treatment for Brain Cancer

Apeiron Biologics has announced that the EMA’s CHMP has recommended the approval of APN311 for immunotherapy of high risk neuroblastoma.

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EMA Suspends Drugs Associated with Micro Therapeutic Research Labs

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic

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