Biography for Tracy Staton
Tracy Staton is the editor of FiercePharma. She has been a freelance writer for five years, but before that served as editor of the Dallas Business Journal, editor of Texas Business magazine, and a senior editor at American Way, the inflight magazine of American Airlines. She is based in Vermont, and can be reached at firstname.lastname@example.org or find her on LinkedIn.
Articles by Tracy Staton
Here's what a successful negotiation with a government payer will get you: An 18% hike in your earnings forecast, about $150 million in additional sales, and a quick spike in share price. That's what Alexion yielded from a new reimbursement deal with France on its pricey rare disease treatment Soliris.
New, long-acting clotting factors are on their way, with Biogen Idec's hemophilia B drug Alprolix first in line. The new treatments promise to prevent bleeding for up to two weeks, and that means today's injections will have to find a way to compete.
As the company points out, it's the only product cleared for patients whose chronic spontaneous urticaria haven't responded to antihistamines.
Merck KGaA's multiple sclerosis treatment Rebif is holding its own. Considering that the German drugmaker's flagship product faces some formidable new competitors--including Biogen Idec's brand-new powerhouse, Tecfidera--that's not too shabby.
Johnson & Johnson and AstraZeneca will just have to duke it out for share of the market for SGLT2 treatments for diabetes. A potential third competitor from Eli Lilly and Boehringer Ingelheim, empagliflozin, failed to win FDA approval, thanks to problems at a Boehringer manufacturing plant.
Eli Lilly is staring down the barrel of its Evista patent expiration. And Tuesday, Teva Pharmaceutical Industries won FDA approval to load the bullet. The company's generic version of Lilly's breast cancer and osteoporosis drug got the green light, and Teva says it will hit the U.S. market within a month.
It's fairly routine for the U.K.'s cost-effectiveness watchdogs to ask companies for more data to support approval for use by the country's National Health Service. Clinical data, price modeling, the works. But asking for information on R&D costs? That's something different altogether.
Drugmakers aren't spending as much on speaking fees these days. Some companies--namely Pfizer and Eli Lilly--have slashed physician payments by more than half.
The German government has decided to extend a drug-pricing freeze through 2017.
Pfizer's once-gargantuan statin drug Lipitor has been cut down to size by generic competition. But if the drugmaker's plan to win over-the-counter status for the drug succeeds, Pfizer could add up to $1 billion back into its Lipitor franchise.