UN pledges to eradicate drug-resistant infections | EMA panel backs approval of 11 new drugs | Janssen's Crohn's disease drug gains EMA panel endorsement
September 22, 2016
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UN pledges to eradicate drug-resistant infections
In response to growing concerns about the threat of treatment-resistant infections, member countries of the United Nations will sign a historic declaration that aims to eradicate drug-resistant infections around the globe. Health experts consider the declaration a key turning point for globally coordinated action that could save 700,000 lives a year.
BBC (9/21),  Vox (9/21) 
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10 Questions to ask before choosing a cloud-based ERP solution
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EMA panel backs approval of 11 new drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of 11 new treatments including cancer drugs such as Takeda's Ninlaro for multiple myeloma and Eli Lilly and Co.'s Lartruvo for advanced soft tissue sarcoma. Recommendations were also given for drugs that treat type 2 diabetes, HIV infections, pulmonary arterial hypertension, angina pectoris and heart failure, and gastroenteropancreatic neuroendocrine tumors, among others.
PharmaTimes (U.K.) (9/19) 
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Janssen's Crohn's disease drug gains EMA panel endorsement
The European Medicines Agency's Committee for Medicinal Products for Human Use has endorsed the approval of Janssen's Stelara, or ustekinumab, an interleukin-12/23 inhibitor. The treatment is recommended for moderate to severe active Crohn's disease in adults who are intolerant to, no longer respond to or did not have an adequate response to a tumor necrosis factor alpha antagonist or conventional therapy, or for those cannot take such treatments because of medical contraindications.
PharmaTimes (U.K.) (9/20) 
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White paper: Create effective enterprise training programs
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Asia Pacific
Takeda partners with Zydus on chikungunya vaccine
Takeda Pharmaceutical has entered into a broad-based partnership agreement with Zydus Cadila to develop a vaccine for the chikungunya virus. Financial terms of the agreement, which covers development of the vaccine from Phase I studies through final marketing, were not disclosed.
Business Standard (India)/Asian News International (9/20) 
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API from Laxachem Organics banned in US
The US FDA has banned imports from Indian API maker Laxachem Organics after the agency traced an outbreak of Burkholderia cepacia to contaminated docusate sodium produced by the company. Laxachem will remain on import alert until it passes an FDA inspection.
The Economic Times (India) (9/20) 
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North America
Sarepta's DMD treatment approved by FDA
The FDA has granted accelerated approval to Sarepta Therapeutics' Duchenne muscular dystrophy treatment Exondys 51, or eteplirsen, despite an advisory committee's prior decision that data was insufficient to support approval of the drug. In a letter, Janet Woodcock, the agency's Center for Drug Evaluation and Research director, said the decision "reflects FDA's ability to apply flexibility to address challenges we often see with rare, life-threatening diseases."
MedPage Today (free registration) (9/19),  The Wall Street Journal (tiered subscription model) (9/19),  Reuters (9/19) 
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Oversight of biomedical research threatened by personnel conflict
The Office of Research Integrity, which investigates scientific falsification and error at the nation's biomedical labs, is in unrest after clashes between the staff and its new director. Six investigators said in a letter to HHS Acting Assistant Secretary for Health Karen DeSalvo that they may leave, putting at risk the office's capacity to review billions of dollars in biomedical grants to universities and other research institutions.
The Washington Post (tiered subscription model) (9/20) 
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Latin America
Better US-Cuba relations open door to pharma companies
More US pharmaceutical and biologic firms are expected to bring new products as well as generics to Cuba as diplomatic relations normalize between the two countries, said Rafael Perez Cristia, director-general of Cuba's Center for State Control of Drugs, Medical Devices. Cristia also said negotiations are underway to hold clinical trials on lung cancer and diabetic foot ulcer treatments developed in Cuba.
Regulatory Focus (9/20) 
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AbbVie partners with BioArctic to develop antibodies for Parkinson's
BioArctic has entered into a collaboration with AbbVie for the development and marketing of its portfolio of antibodies targeting alpha-synuclein to treat potential indications including Parkinson's disease. Financial terms of the deal were not disclosed.
Genetic Engineering & Biotechnology News (9/20) 
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MEDX Ventures opens medtech incubator in Israel
Investment firm MEDX Ventures, along with partners that include Boston Scientific and Intellectual Ventures, has launched the MEDX incubator for companies developing medical devices, particularly noninvasive ones, in Israel. The incubator, which intends to eventually include digital health and make investments in 40 ventures within eight years, is evaluating up to six companies and is looking to propose to the Israel Innovation Authority up to four projects in the next several months, said MEDX Ventures CEO Harel Gadot.
Globes (Israel) (9/20) 
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