Generics Bulletin Executive Editor Dave Wallace has more than 10 years' experience of reporting on the global generics, biosimilars and value-added medicines industries. Having begun his career in the European chemicals industry, Dave has now spent over a decade with Generics Bulletin, becoming editor from 2018. Bringing his background and education in law to bear on industry litigation as well as national legislative and regulatory affairs, he also keeps a close eye on corporate strategy, personnel moves, and product pipelines. A regular delegate to industry events and conferences, he has a particular interest in local market developments, maintaining close links with national industry representatives. He also organizes and acts as a judge for the annual Global Generics & Biosimilars Award.
Latest From David Wallace
The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.
Teva is expecting to have a new CEO by the end of next year, after current leader Kåre Schultz indicated that he was unlikely to renew his contract. The president and chief executive has overseen an eventful and transformative period for the Israeli firm.
Coherus has revealed further details of the firm’s plans for its Cimerli interchangeable biosimilar rival to Lucentis in the US, including a launch date and pricing information.
Sun’s rival to Forsteo, Accord and Mylan’s versions of Aubagio and Accord’s Nexavar generic were all endorsed by the European Medicines Agency at the CHMP’s September meeting.
Following a review of an earlier decision, the European Medicines Agency has confirmed its recommendation to suspend marketing authorizations for dozens of medicines with bioequivalence studies conducted by Synchron Research Services. However, eight products have been spared after alternative supporting data was identified.