- Genzyme clears way for MS drug Lemtrada by pulling Campath
Genzyme, a Sanofi unit, is withdrawing leukemia drug Campath in the U.S. and Europe in preparation for launching it as a multiple sclerosis treatment and as a different dose under brand name Lemtrada. The pullout is ongoing in some European countries and will take effect next month in the U.S. If approved, Lemtrada might enter the market next year. Reuters (8/20)        | Health Care & Policy |  |  | | - FDA pushes back decision on Pfizer's arthritis drug tofacitinib
The FDA pushed back its deadline by three months to Nov. 21 for completing the review of Pfizer's rheumatoid arthritis drug candidate tofacitinib, the first among a new class of drugs known as Janus kinase inhibitors. Pfizer had said previously that the FDA had asked for additional data analysis. Reuters (8/21) - Ipsen renegotiates hemophilia drug partnership with Inspiration
Ipsen and Inspiration Biopharmaceuticals renegotiated a development agreement covering the latter's recombinant hemophilia products. The revised agreement allows Ipsen to regain commercial rights to OBI-1, a recombinant porcine factor VIII, and obtain marketing rights to IB1001, a recombinant factor IX, in several regions. Aside from $30 million upfront, Inspiration could get $215 million in milestone payments and as much as $20 million in investment from Ipsen. Genetic Engineering & Biotechnology News (8/21) - Alzheimer's drug by Bristol works at lower doses in study
A midstage study found that Bristol-Myers Squibb's gamma secretase inhibitor avagacestat, or BMS-708163, was well tolerated by patients with mild to moderate Alzheimer's disease at 50 milligrams and 25 milligrams daily. However, researchers said the drug was "poorly tolerated with trends for cognitive worsening" at 125 milligrams and 100 milligrams. "Results from this trial will be used in conjunction with data from our ongoing Phase IIa study in pre-dementia to help define the overall development plan for this compound," Bristol Public Affairs Director Sonia Choi said. Medscape (free registration) (8/20) - Researchers test stem cell-derived organoid for intestinal research
Researchers at the Johns Hopkins University School of Medicine are testing an organoid made of stem cell-derived tissue that is intended to mimic the effect of diarrhea onset on the intestine. The organoid could speed the testing and development of treatments. Results of the study are set to be reported at a gastroenterological group's meeting next week. Bloomberg (8/20) - Topol: Revamp clinical trials to revolutionize medicine
 Advances in genomics will make recruiting for large, randomized, placebo-controlled clinical trials increasingly difficult, says Dr. Eric Topol, director of the Scripps Translational Science Institute. "We need to get to the real world and into this digital world where we would have electronic surveillance of every single patient who is admitted and enrolled in a trial" to establish safety, Topol says. "Why can't we have conditional approval for a new drug or device or even a diagnostic test, and then monitor that very carefully?"  Medscape (free registration) (8/20) | Company & Financial News | | | | - Relypsa raises $80M to advance hyperkalemia drug Patiromer
Relypsa pulled in $80 million in a Series C financing round. The biopharmaceutical firm will use the money to fund late-stage development, a new-drug application and commercial planning for Patiromer, or RLY5016, a non-absorbed oral potassium binder that treats hyperkalemia among patients with chronic kidney disease, heart failure or diabetes. MedCityNews.com (8/21)  | First class, non-stop, global connections.
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| Food & Agriculture | | | | | Industrial & Environmental | | | | - Opinion: Don't tamper with the renewable fuels standard
Issuing a temporary waiver of the Renewable Fuel Standard based solely on political expediency would be inappropriate and should be opposed, write former Reps. Stephanie Herseth Sandlin, D-S.D., and Tom Ewing, R-Ill. Ethanol production is not the primary driver of corn prices, Sandlin and Ewing write, and tampering with the RFS would further the country's dependence on foreign oil and discourage investment in advanced biofuels. Politico (Washington, D.C.) (8/21)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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