Generics Bulletin Managing Editor Dave Wallace has nearly 10 years experience of reporting on the global generic, biosimilar, value-added and OTC medicines industries. 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 judges the annual Global Generics & Biosimilars Awards. A French speaker, Dave enjoys music - with a love of the piano - and visual arts.
Latest From David Wallace
Pfizer has received an endorsement for a pan-European marketing authorization for its Nyvepria pegfilgrastim biosimilar from the EMA’s CHMP. However, the company would not be drawn on commercialization plans amid competition from numerous other approved versions.
Fresenius Kabi must pay Eli Lilly €28m in damages after a French court of first instance found that the generics firm’s pemetrexed infringed intellectual property protecting the Alimta chemotherapy brand. The German firm has commented on possible next steps.
Mylan has celebrated a reversal from the European Patent Office that has seen a key patent protecting Teva’s higher-strength 40mg/ml thrice-weekly version of Copaxone deemed invalid and revoked across Europe. Meanwhile, Teva has commented on the possibility of an appeal.
Merck, Sharp & Dohme’s Brenzys biosimilar version of Amgen’s Enbrel has received four new indications in Canada, bringing it in line with Sandoz’ rival biosimilar, Erelzi.
Accord is kicking off plans to launch a number of addiction treatments by partnering with Molteni Farmaceutici on distributing its Sixmo six-month buprenorphine implant in Europe.
Neuraxpharm says a deal with Takeda to acquire the only buccal midazolam approved across Europe, Buccolam, not only gives the CNS specialist a strong asset but also offers the opportunity to expand its commercial footprint into the Nordics and Ireland.