PARIS – Dentressangle Initiative SAS, of Lyon, France, is in talks to buy a majority stake in Marle International Holding SAS, an orthopedic implant contract manufacturer. The acquisition is said to be worth $880 million, although Dentressangle has not confirmed this amount. “We are looking forward to supporting the management team in achieving its long-term goal for Marle, of offering higher value-added services to its clients and pursuing target acquisitions,” Thierry Coloigner, managing partner for mid and large cap at Dentressangle, told BioWorld MedTech.

LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.

HAMBURG, Germany – Monoclonal antibodies and their various derivatives now represent the biotechnology industry's dominant, incumbent technology. Six of the top 10 best-selling drugs are antibodies. Two more top 10 drugs are biologics based on fusion protein designs. In all, there are around a hundred antibodies on the market. Whether cell and gene therapy (CAGT) will ever attain that level of success was the subject of two lively panel discussions – on deal trends and valuation and on collaboration and integrated development of advanced therapies – which closed the 25th anniversary edition of BIO-Europe Wednesday.

HAMBURG, Germany – Despite the biotech industry's recent record-breaking run in terms of fundraising and new drug approvals, the ongoing drug pricing controversy is acting as a drag on biotechnology investment. Since the debate started to heat up about four years ago, the Nasdaq Biotechnology Index is down 14%, while the S&P 500 Index is up by 46% during the same period, David Thomas, vice president, industry research at the Biotechnology Innovation Organization (BIO), told delegates attending the opening plenary session at BIO-Europe. "Something is clearly holding back investors in our space," he said.