European Commission Archives - Medical Design Sourcing

European Commission sees potential antitrust activity in medtech

[Image courtesy of Google Satellite]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 of the company and the location or country of the inspection.

The news release added: “Unannounced inspections are a preliminary investigative step into suspected anticompetitive practices. The fact that the Commission carries out such inspections does not mean that the company in question is guilty of anti-competitive behavior, nor does it prejudge the outcome of the investigation itself.”

Antitrust regulation enforcement has increased in both the EU and the U.S. in recent years. In 2020, the Commission kicked off a co…

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 rules.

The rules require merging companies to wait until the Commission approves the deal before implementing it. European officials opened an investigation into Illumina’s acquisition of Grail in 2021 before blocking the transaction in 2022. They reasoned that the deal may have significant anticompetitive effects in the blood-based early cancer detection market.

In August 2021, amid the Commission’s review, Illumina publicly announced the completion of the $7.1 billion acquisition. The companies executed all necessary documents and Grail merged with t…

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 last week’s U.S. Federal Trade Commission ruling in favor of the acquisition moving forward. An administrative law judge in the U.S. rejected the FTC’s argument that the $8 billion acquisition of Grail is anti-competitive.

The much-scrutinized acquisition of Grail, a cancer detection technology developer, has met a series of roadblocks along the way. In September 2020, Illumina agreed to acquire Grail, a startup that initially spun out from the company in 2016.

Illumina completed the acquisition in August 2021. However, Illumina agreed to hold Grail as a separate company as the European Commission conducted a regulatory review. Illumina argued Grail has no business in Europe. The company said the…

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 (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Get the full story at our sister site, Drug Delivery Business News.

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 transaction’s completion, San Diego-based Illumina said that it will hold Grail as a separate company as the European Commission conducts an ongoing regulatory review. A decision from the EU regulators is anticipated after the deal expires, but Illumina has said Grail has no business in Europe, which leads company officials to believe the review is out of the European Commission’s jurisdiction.

A day after the announcement of the acquisition’s completion, the European Commission said in a news release that it would open an investigation to a…

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 has made in-person audits at manufacturers’ facilities difficult if not impossible.

Get the full story on our sister site, Medical Design & Outsourcing.