The day started with a 5 o’clock alarm call and me feeling remarkably fresh to begin my journey to Frankfurt for this year’s CPhI Worldwide event. Unfortunately, the idea of a smooth journey was thwarted fairly quickly with the news at Crewe that the 06:33 train to Manchester airport was canceled. Bad start. Read more »

Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche’s strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines. Read more »

In a ruling issued this week concerning the patent rights of research universities, the US Supreme Court ruled in favor of Roche in a long-standing patent dispute the company had with Stanford University regarding patent rights to technology to detect HIV blood levels using polymerase chain reaction (PCR) technology. The ruling is significant in that it provides clarity in this particular case to technology transfer and related rights between universities using federal funding and private companies. Read more »

Roche (Basel, Switzerland) announced last week that it signed a drug-development deal worth up to $1.1 billion with the biopharmaceutical company Aileron Therapeutics (Cambridge, MA) to discover, develop, and commercialize “stapled peptides,” or drug candidates that use peptide-stabilization technology to enhance potency and cell permeability. So are stapled peptides a potential magic bullet in biopharmaceutical development? Read more »

In a speech last week to the City Club of San Diego, John Lechleiter, chairman and chief executive officer of Eli Lilly, offered very candid remarks about the state of innovation in the pharmaceutical industry, saying that the engine of biopharmaceutical innovation is “broken.” His comments may be a bitter pill to swallow in light of escalating investment in research and development (R&D), but his frankness may just be the remedy the industry needs to reinvent itself. 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 »

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced this week that it is creating a new committee of its board of directors dedicated to small biopharmaceutical companies. The committee will be composed of full and research associate members. In a separate item, late last month, Roche confirmed that it was leaving PhRMA to join the Biotechnology Industry Organization (BIO), the US-based trade group representing the biotechnology industry, in the wake of Roche’s recent acquisition of Genentech. Taken on one level, these moves simply reflect an organizational change by a well-established association to better serve and broaden its membership and the strategic shift of one member company. On another level, however, these moves reveal broader dynamics shaping the focus of the pharmaceutical industry. Read more »

Driving to the office today, I heard a talk by Bob Franks, president of the Healthcare Institute of New Jersey, on the local radio station 101.5FM. Although New Jersey spent $7 billion on R&D in 2008, said Franks, the state stands a chance of losing its stance as the pharma capital of the US—and really of the world—in the coming years. Not only are China, Singapore, and Ireland taking R&D as well as manufacturing dollars out of the state, but New Jersey-based pharmaceutical and biotechnology companies also face stiff competition close to home. Read more »

In response to the swine-flu outbreak, the European Medicines Agency (EMEA) last week authorized the use of Tamiflu (oseltamivir) capsules up to two years after the drug’s prescribed expiration dates. EMEA’s Committee for Medicinal Products for Human Use (CHMP) specifically extended the shelf-life of Tamiflu 75 mg, 45 mg, and 30 mg hard capsules from 5 to 7 years. Read more »