- Quicker approval of cancer drugs doesn't mean lower FDA standards
 The breakthrough designation, intended for cancer drugs and treatments of other life-threatening conditions, has transformed communication between the FDA and drugmakers, said Dr. Richard Pazdur, director of the FDA Office of Oncology and Hematology Products. Some applications have been rejected partly because drugmakers made a decision too soon based on just a small number of patients, Pazdur said. The review process helped speed up many approvals, but it doesn't mean that the agency's standards have fallen, Matthew Herper writes in this article. Forbes (6/23)        | Webcast: A Conversation with The Johns Hopkins Hospital on Lowering the Cost of Healthcare from Inside Out
Learn how The Johns Hopkins Hospital uses its Integrated Asset and Service Management solution to improve uptime to support patient care; control costs for procurement, maintenance, labor and materials; support regulatory compliance activities; and use workflow capabilities for internal controls. Watch the webcast. |
 | Health Care & Policy |  |  | | - Takeda submits IBD drug candidate for FDA approval
Takeda Pharmaceutical has filed a biologics license application with the FDA for approval to use its experimental monoclonal antibody drug vedolizumab as a treatment for moderately to severely active Crohn's disease and ulcerative colitis. The application was based on data from four late-stage international trials involving 2,700 patients. PharmaTimes (U.K.) (6/24) - Sandoz's biosimilar etanercept enters late-stage study
Novartis' generics unit Sandoz initiated a late-stage trial to confirm the biosimilarity of its version of etanercept with Amgen's Enbrel. The international trial will involve the treatment of moderate to severe chronic plaque-type psoriasis. Sandoz intends to use the results to support regulatory filings in the U.S. and Europe. Reuters (6/24), RTT News (6/24) - FDA places partial hold on experimental blood cancer drug
The FDA has asked for a review of all cardiac events in patients treated with Cell Therapeutics' experimental drug tosedostat following the myocarditis-related death of a patient, the company said. A partial hold has been placed on the blood cancer treatment, and new patients will not be enrolled in trials until the agency agrees recruitment can proceed. MedCityNews.com/Reuters (6/24) | Company & Financial News | | | | - BARDA contract worth up to $89M will support Basilea antibiotic
The Biomedical Advanced Research and Development Authority granted Basilea Pharmaceutica a six-year contract worth as much as $89 million to support development of its novel monosulfactam antibiotic BAL30072. The drug, which is under development for severe infections, was chosen because of its broad coverage against multidrug-resistant Gram-negative pathogens. Basilea initially will get $17 million over 22 months. RTT News (6/25) | Global Developments | | | | - EU OKs Astellas-Medivation's Xtandi capsules for prostate cancer
The European Commission granted Astellas Pharma and Medivation approval to market Xtandi, or enzalutamide, capsules as a treatment for metastatic castration-resistant prostate cancer after progression despite treatment with docetaxel. The drug was approved in the U.S. last year. The approval triggered the payment of a $15 million milestone fee from Astellas to Medivation. PharmaTimes (U.K.) (6/24) - Boehringer seeks expanded EU approval for anticoagulant
Boehringer Ingelheim filed an application with the European Medicines Agency seeking wider approval of its oral anticoagulant Pradaxa, or dabigatran. The firm wants the drug to be approved for treatment of deep vein thrombosis and pulmonary embolism, and for the prevention of recurrent DVT and PE. Reuters (6/24)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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- $10K reward offered for culprits in biotech sugar beet destruction
The FBI is looking into the destruction of fields of glyphosate-resistant biotech sugar beets grown by Syngenta in southern Oregon. "To my knowledge, this is the first time someone has deliberately taken the cowardly step of uprooting high value plants growing in our state. Regardless of how one feels about biotechnology, there is no justification for committing these crimes," Oregon Department of Agriculture Director Katy Coba said. A $10,000 reward is being offered to catch the culprits. Ag Professional online (6/24)  | Earn your MBA online from Northeastern University
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 | Industrial & Environmental | | | | - BP to focus advanced-biofuel work in the U.S., South America
BP is steering its advanced-biofuel investments to the U.S. and South America rather than the EU, where lack of predictable biofuel policy is bad for business, said BP Biofuels CEO Phil New. "At the moment, we are not contemplating investing in second-generation cellulosic [ethanol] in Europe simply for the reason that there is not enough certainty on what the market conditions will be like," New said. Reuters (6/21) | News from BIO | | | | - Secure document sharing services optimized for life science organizations
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