According to reports, Edwards Lifesciences is the company under scrutiny in Europe for potential antitrust activity. Reuters reports that the company is working with EU antitrust regulators on the matter. The European Commission said last week that it conducted a surprise inspection at an undisclosed medtech company. It listed that company as active in the cardiovascular […]
European Commission
European Commission sees potential antitrust activity in medtech
The European Commission has conducted a surprise inspection at an undisclosed medtech company active in the cardiovascular space. The news release, posted yesterday on the Commission’s website, mentioned concerns that the inspected company may have violated EU antitrust rules that prohibit abuses of a dominant market position. Other details were not provided, including the identity […]
EU hits Illumina with $478M fine over Grail deal
The European Commission announced today that it issued significant fines to Illumina (Nasdaq:ILMN) and Grail as a result of their proposed merger. European authorities fined Illumina approximately $478.9 million (€432 million) and Grail $1,108 (€1,000). They claim the companies implemented their proposed merger before approval by the Commission. Such actions breach European Union merger control […]
European Commission blocks Illumina’s Grail acquisition, company to appeal
Illumina (Nasdaq:ILMN) announced today that the European Commission issued a decision prohibiting its planned acquisition of Grail. San Diego-based Illumina said it is reviewing the order and intends to appeal the decision. The new hurdle in Europe follows a recent ruling in the U.S. that favored the acquisition. An administrative law judge in the U.S. […]
AbbVie receives positive opinion from CHMP for injection that treats psoriatic arthritis
AbbVie (NYSE:ABBV) announced today that a European governing body recommended approval for its psoriatic arthritis treatment injection. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate […]
EU to investigate Illumina’s decision to close $8B Grail acquisition
The European Commission announced that it opened an investigation to assess Illumina’s (NSDQ:ILMN) recently completed acquisition of Grail. Last week, Illumina completed its long-awaited, highly-scrutinized acquisition of the cancer detection company that spun out from Illumina nearly five years ago. The $8 billion acquisition was initially announced in September 2020. Within the announcement of the […]
Europe approves Roche’s Enspryng subcutaneous NMOSD treatment
Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Get the full story at our sister site, Drug Delivery Business News.
EU allows remote audits for medical devices during pandemic
The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic […]
BREAKING: Pfizer’s COVID-19 vaccine receives European authorization
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received […]
MedTech Europe gives proposed European Health Union a partial nod
MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats. European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to lessons learned from […]
BREAKING: EU-MDR is postponed by 1 year due to coronavirus pandemic
The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply. EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve. Get the full […]
