Last week, I wrote that the increased attention to biological drugs, which are mostly taken through injections, was spurring interest in needle-free and implantable delivery methods for vaccines. Research into alternative delivery methods for vaccines could produce innovative ways of delivering other kinds of drugs as well, and I recently read about an inspired idea that a team of Boston researchers had for delivering intermittent doses of drugs. Read more »

Have you ever considered getting a flu shot but quailed at the sight of the needle? Lots of people hate getting injections, but this delivery method is still the predominant technique for administering biological drugs. Rising demand for vaccines and other biologicals is one factor spurring manufacturers to seek alternative delivery methods that could one day rescue the needlephobic. Read more »

Two announcements made on two consecutive days last week vividly showed that whether a thing is helpful or harmful often depends on how we use it. The announcements’ subject? Tobacco. Read more »

Last Thursday, the Biotechnology Industry Organization (BIO) weighed in on a patent issue that will soon be before the Supreme Court. In an amicus brief, BIO argued that the Court should overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involved Bernard L. Bilski’s method for hedging risks in commodities trading. Read more »

The Biotechnology Industry Organization (BIO) has won the latest battle over follow-on biologics. Last week, the House Energy and Commerce Committee approved Rep. Anna Eshoo’s (D-CA) amendment to the America’s Affordable Health Choices Act (H.R. 3200). The Eshoo amendment, a regulatory pathway for the approval of biosimilars, would grant about 12 years of market exclusivity to each new biological medicine. Read more »

Reading the news sometimes gives me a disorienting sense of déjà vu. I know I wrote that last week, but it’s true again for a different reason. Today, French heavyweight sanofi aventis (Paris) announced that it was acquiring a majority stake in Shantha Biotechnics (Hyderabad, India). This new development follows a now-familiar pattern. Read more »

To no one’s surprise, Wyeth shareholders approved yesterday the $68-billion merger agreement with Pfizer. The vote was overwhelming: 98% in favor. The final step is the approval by the Federal Trade Commission and international regulators. The mega deal, one in three this year (Merck and Schering Plough; and Roche and Genentech) emphasizes the bottom-line industry mantra: diversify to compete. Read more »

Congress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far. Read more »

Speakers’ comments at the Parenteral Drug Association’s Annual Meeting, held in Las Vegas on Apr. 20-24, 2009, reflected the crisis that pharmaceutical and biopharmaceutical industries face. Presenters alluded to a cloud of challenges (e.g., cost pressures, products that can be duplicated by competitors, and quality-control failures) that has been gathering for some time. Several speakers claimed that small- and large-molecule manufacturers must change now to survive in the short and long terms. But change how? Read more »

Pfizer announced this week that following a successful completion of its $68-billion acquisition of Wyeth, it will divide its research activities into two separate organizations, one for small molecules and one for biologics and vaccines. The reorganization is but a microcosm of Big Pharma’s larger strategic interest to strengthen its position in biologics with the hopes of improving its return on research and development (R&D). But is the calculus of intensifying R&D into biologics correct? Read more »