Everyone loved my grandmother. That's why they were rather relieved to hear she had died. My grandmother spritely went about her business against the grain of at least six diseases and with the help of four surgeries, six prescription drugs and four medical devices after becoming a nonagenarian, but she also was mentally prepared for death, mainly because her joints, organs, bones, cells and her five senses were either abandoning or mocking her with frustrating and tormenting bouts of blindness, forgetfulness, ignored nerve center commands and pain . . . especially pain. She was putting up with a lot for...

Biopharma is often the scapegoat for the escalating cost of healthcare, especially when it comes to the price of brand drugs. But since it’s hard to put a price on health and a long life, what gets lost in this focus on the bottom line is the public return on investment (ROI). National Institutes of Health (NIH) Director Francis Collins made that case last week when he testified before a Senate appropriations subcommittee. “Due in large measure to NIH research [and better treatment], our nation has gained about one year of longevity every six years since 1990,” he said. But...

Big pharma has been none too shy about backing away from biotech deals lately, as the likes of Rigel Pharmaceuticals Inc., Targacept Inc., Metabolex Inc., S*BIO Pte Ltd., Portola Pharmaceuticals Inc., Renovo plc, Arena Pharmaceuticals Inc., Adolor Corp. and others can attest. BioWorld Insight contributing writer Brian Orelli did some analysis and found 13 terminated pharma-biotech agreements so far this year, compared to eight terminations in the same period last year. What’s the big deal? Chris Dokomajilar, senior biotech analyst at Deloitte Recap LLC, says it’s partially a numbers game: more deal-making activity means more deals that fail. Also to...

Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news. Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial.” Not until the second paragraph did readers find out the most important tid-bit: that the FDA had denied their appeal regarding the cancer drug, which received a complete response letter last year. Meanwhile, Vivus Inc. issued first quarter earnings late Monday, but the piece of news everyone was most interested in – the path forward...

Recruiting subjects for ongoing Phase III hepatitis C virus (HCV) trials just got a lot harder. Even if the FDA doesn’t step in and force a change in the standard-of-care control arms after last week’s Antiviral Drugs Advisory Committee meetings, companies testing their experimental drugs in conjunction with pegylated interferon and rebavirin (PR) vs. PR alone may find enrollment and retention challenging, especially for treatment-naïve subjects. In a three-arm study that includes PR alone, patients would be signing up for a 33 percent chance of a year of flu-like symptoms with a cure rate of about 45 percent, at best....

When it comes to making biotechs toe the line on drug promotion, public guilt and humiliation aren’t working. Neither are multimillion-dollar corporate fines. They’re just the cost of doing business these days. And yanking an offending company’s Medicare participation hurts the patients whose health depends on the firm’s drugs. So how’s the government to keep biopharma on the straight and narrow? Make CEOs pay for the sins of their companies. In recent months, the FDA and the Departments of Justice and Health and Human Services have held corporate officers to the fire, banning them from the industry, imposing hefty personal...

Remember when the promise of biotech was a mere twinkle of innovation in some researcher’s eyes? An investor’s long-term bet? Depending on how you label a biotech company, Amgen Inc.’s first-ever payment of a quarterly dividend last week marks an important step in the growth of the world’s largest biotech and the industry as a whole. How many other pure-play biotechs have reported the same news? None. It wasn’t a surprise. The big biotech has about $15 billion in cash and has been criticized by some for not returning money to its shareholders. Still, I was surprised at the lack...

Marriage is both heaven and hell. So it goes with people and so it goes with biotech firms racing to bring new drugs to market. Faced with up to $1 billion to bring a drug from idea to patient, funding more than a decade of work is a complicated affair, especially amid these weak market conditions. Just as people enter courtships and marriages with different hopes and long-term game plans, biotechs hope for long honeymoons, but are smacked with real-life challenges. BioWorld Today relays news of countless deals gone sour, mostly when drugs don’t pass muster. But sometimes it’s because...