Germany

If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.

Pragmatic solutions are called for to ensure that German medical device manufacturing and innovation remain competitive in global terms, federal health minister Nina Warken told a hearing of medtech industry leaders.

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.

Deal gives NTC exclusive rights to commercialize Formycon and Klinge’s Baiama aflibercept biosimilar in Italy, expanding Formycon’s growing network of European ophthalmology partners.

As Formycon’s fourth-quarter sales and a key pembrolizumab biosimilar deal become critical to guidance, management hinted that deeper organizational changes may be required.

Inaugural cabinet office dialog session leaves German medtech optimistic about increasing central government support in the coming months, say trade associations in Medica preview.

The German group is looking at ‘single digit billion’ opportunities, chief financial officer Helene von Roeder tells Scrip.

Capital tightening and shifting US regulations slowed contract manufacturing orders in Q3, though Richter sees normalization ahead as new European clients come online.

Fresenius has acknowledged that the FDA’s draft guidance could shorten approval timelines and cut trial costs for biosimilars, even though it “may have not fundamentally changed the existing framework.”

Hikma has started searching for a new Injectables head after Bill Larkins stepped down, at the same time as the firm has begun a reorganization of its R&D operations. Meanwhile, Stada has named a new head of Germany and Viatris has promoted a key executive in Europe.

Fines are a fact of life when it comes to manufacturers’ compliance with EU rules on persons responsible for regulatory compliance. But Italy’s stance adds pressure on individuals appointed to the role.

Parliament will debate the KHAG hospital reform adjustment law proposal in November, but opinion is split over the value of the new delivery model for German inpatient care.