Germany

Teva’s subsidiary in Germany plans to begin rolling out a biosimilar to Stelara in the third quarter of this year after shaking hands on a distribution agreement with manufacturer Formycon.

Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

A German biotech has solved a fundamental physics problem that has limited mRNA therapeutics to injectable vaccines. Its breakthrough stabilizer technology allows mRNA particles to survive the mechanical stress of inhalation delivery, opening the door to treating chronic respiratory diseases.

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

The German biotech has been forced into insolvency and NASDAQ suspension.

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.

Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.