Pharmaceutical companies can no longer take strong growth for granted, and CEOs and shareholders are lowering their expectations about future performance. The industry’s global sales growth likely will be limited to 1.3% until 2015, according to Joe Dixon, a spokesperson for Datamonitor. Compare this anemic figure to the 7.1% growth rate that manufacturers enjoyed from 2003 to 2009, and you’ll see little reason for joy in drugville. Read more »

Earlier this week I took a trip to Liverpool (UK) to the Downstream Processing Day hosted by SAFC and Sartorius Stedim Biotech. A lot of interesting topics were discussed, including vaccine manufacture, which is a particularly hot issue both inside and outside of the industry at the moment. Read more »

On Jan. 4, President Obama signed the FDA Food Safety Modernization Act. The bill expands FDA’s oversight of the food industry and grants the agency, among other things, the authority to issue mandatory food recalls (see back story).

PharmTech is asking readers in our current poll whether FDA should have the same power over pharmaceutical recalls. Right now, nearly 90% of respondents have said  “Yes.” Read more »

At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »

Innovative research is constantly being carried out in the pharma industry so it’s easy to start letting your eyes glide over some of the developments taking place. This week though a lot of eyes have been pulled to a study involving magnetically controlled pills. Many people would rather take drugs orally than via injection, but tablets do not always dissolve at exactly the right site in the gastrointestinal (GI) tract for absorption into the bloodstream. Magnetically-controlled pills, however, enable a tablet to be held in place at the correct site in the GI tract to optimize absorption. Read more »

The Federal Trade Commission opposes them. Lawmakers have tried and failed to abolish them. Soon, the US Supreme Court may rule on their legality. The future of pay-for-delay agreements, which pharmaceutical companies use to postpone the introduction of generic drugs to the market, could hang in the balance. Read more »

Guest blogger: Kiran Mazumdar Shaw, Chairman & Managing Director, Biocon, Ltd.

Biotechnology holds the promise for our future, be it food, healthcare, environmental sustainability, and even renewable energy. It is critically important for Indian biotechnology to be recognized on the world stage, and indeed our ascendance in this industry is promising. Read more »

Buying a new company isn’t an easy process, as clearly shown by one of the industry’s most talked about potential mergers: Sanofi and Genzyme have been talking for months now, but there’s still no indication that a deal will take place. Sanofi made a tender offer last year to acquire the company at $69 per share, but had to extend the original December 2010 deadline to 21 Janaury 2011 after less than 1% of shares were tendered. The tender offer is still open, but there’s no indication that the result will be favorable to Sanofi. Read more »

Only a few weeks into the new year, biosimilars or follow-on biologics already are occupying a prominent space in public policy and business developments. Following hearings in November 2010, FDA will continue to pave a regulatory pathway for biosimilars in the United States. On the other side of the Atlantic, the six-month consultation period on the draft guidelines issued by the European Medicines Agency on biosimilar monoclonal antibodies will end in May 2011. As these key regulatory matters are considered, both large and small bio/pharmaceutical companies are positioning themselves in the biosimilars market. Read more »

The confetti from the New Year’s celebrations has settled, and drugmakers are busy planning their activities for 2011. Some people make New Year’s resolutions in hopes of bettering themselves or adopting good habits. After its recent disappointments, the pharmaceutical industry likely will resolve to improve its research and development (R&D) efforts. Read more »