Category Archives: Biotech

Global Gaps in Standards Threaten Biosimilar Development

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
Also posted in Europe, FDA, Global, Regulatory | Tagged , , , , , , | Leave a comment

Healthcare Reform in China: A Doubled-Edge Sword for Foreign Firms?

The Chinese market is attractive to foreign investors for many reasons. It is the world’s third largest market for pharmaceuticals with annual sale of US$71 billion.  In fact, it is poised to become the second largest market in 2015 given that its annual growth rate of sales is between 15 and 20%, according to Yanzhong […]
Also posted in Emerging Markets, Global, Guest Blog, healthcare, Regulatory | Tagged , | Leave a comment

The Nordic Region’s “Star” Companies

Three companies were crowned the Nordic region’s “shining examples of innovative life science companies” in Stockholm, Sweden, this week.  Nordic Life Science Days, the region’s largest partnering conference, gave its annual Nordic Star Awards to Bone Index (Kuopio, Finland), Lytix Biopharma (Oslo, Norway) and PledPharma (Stockholm, Sweden). Bone Index was noted for its osteoporosis diagnostic, Bindex, while Lytix Biopharma […]
Also posted in Europe | Tagged , , , | Leave a comment

EuropaBio’s Most Innovative Biotechs 2014

EuropaBio, the European Association for Bioindustries, has announced its “top five biotech SMEs in Europe”. The companies will compete to win the 5th annual Most Innovative EU Biotech SME Award, to be awarded during European Biotech Week (October 8) in Brussels, Belgium. Shortlisted are: 
Also posted in Europe, Events | Tagged , , , | Leave a comment

Sponsor–CMO Relationships: Critical Issues

Eric Langer assesses the results of a recent survey of what biopharm companies want from CMOs. Contract manufacturing organizations (CMOs) should have the technical expertise to be considered by clients for partnerships. It’s no longer enough for them to lay claim to technology, regulatory compliance, and IP protection expertise, as these increasingly become non-negotiable issues, according […]
Posted in Biotech | Tagged , , | Leave a comment
  • Categories

  • Meta