At the beginning of this month the FDA released its much anticipated final guidance for companion diagnostics tests. It recognizes that those tests are evolving as essential components in order for new innovative therapies to be targeted to patients who will benefit the most.
The Jumpstart Our Business Startups (JOBS) Act has had an extremely positive influence on the growth prospects for emerging biotechnology companies since it came into being in 2012. In fact, there has been a tidal wave of companies who have successfully completed their initial public offerings (IPOs) since its introduction.
Several big pharma companies still have to face the pain of significant revenue erosion over the next couple of years as their blockbuster products lose patent protection and endure the prospects of generic competition. However, by and large most have managed to navigate themselves beyond this tough terrain thanks to creative business strategies designed to secure consistent future growth.
Any notions that the pace of dealmaking would ease off in 2014 after the record number of M&A and licensing transactions that were completed last year, will be quickly dispelled following the release of the Thomson Reuters Recap half-year analysis.
The general markets headed south on the last day of the month with the Dow Jones Industrial Average dropping more than 300 points in value Thursday, which served to drag biotech's blue chip biotech companies with it. The drop wiped out all the Dow's gains for the year.
Any notions that the pace of dealmaking would ease off in 2014 after the record number of M&A and licensing transactions that were completed last year, will be quickly dispelled following the release of the Thomson Reuters Recap half-year analysis.
Reporting after the markets closed Tuesday, the industry's second largest biotech company by market cap, Amgen Inc., not only provided exceptionally strong second quarter financial results but also revealed its plans for significant corporate changes. The Thousand Oaks, Calif.-based company said it will shed approximately 12 percent to 15 percent of its global work force.
No discussion focused on the future of health care would be complete without considering how the field of personalized medicine will help shape medical innovation and the delivery of next-generation therapies.
Back in March, Rep. Henry Waxman (D-Calif.) and several Democratic colleagues in Congress, wrote to Gilead Sciences Inc. requesting a briefing to answer questions about the pricing of the company's hepatitis C drug Sovaldi (sofosbuvir). The Waxman letter got a lot of play in the media, triggering a massive sell-off in the biotechnology sector with investors worrying about a possible impending full court press on the costs of innovative new medicines by politicians, regulators and payers alike. (See BioWorld Insight, March 31, 2014.)
