Study: New HIV cases could be cut significantly in US by 2025 | Boehringer Ingelheim to partner with Peking University on drug research | EU OKs Shockwave Medical's Coronary Lithoplasty System
May 18, 2017
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Study: New HIV cases could be cut significantly in US by 2025
The HIV epidemic in the US could be over within the next decade, if key milestones including decreasing the number of annual new cases to 12,000 by 2025 are reached, according to a study in the American Journal of Preventive Medicine. "While these targets are ambitious, they could be achieved with an intensified and sustained national commitment over the next decade," study co-author David Holtgrave said.
Specialty Pharmacy Times (5/16) 
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Europe
Boehringer Ingelheim to partner with Peking University on drug research
Boehringer Ingelheim has agreed to work with Peking University to identify targets and develop medicines for cancer, cancer immunology and immune modulation, respiratory conditions and cardiometabolic and central nervous system diseases, as well as gene therapies and regenerative drugs.
BioCentury (5/16) 
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EU OKs Shockwave Medical's Coronary Lithoplasty System
European regulators have given Shockwave Medical CE mark approval for its Coronary Lithoplasty system for use in combination with stenting to treat coronary artery disease patients with calcified plaque. The system allows integration of angioplasty balloon catheter devices with lithotripsy, which creates calcium-disrupting sonic pressure waves.
FDAnews (5/16) 
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Asia Pacific
US FDA approves sale of Jubilant Pharma hypertension drug in US
Jubilant Pharma has received US FDA approval of its hypertension drug amlodipine and olmesartan medoxomil, the firm's parent company, Jubilant Life Sciences, announced. The drug, a generic version of Daiichi Sankyo's Azor, will be sold in tablet form in assorted dosages.
The Economic Times (India)/Press Trust of India (5/17) 
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Pharmadax's generic version of Seroquel XR wins FDA nod
Taiwan-based Pharmadax has received FDA approval for its generic version of AstraZeneca's antidepressant Seroquel XR, or quetiapine fumarate.
Seeking Alpha (free registration) (5/16) 
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Wuhan rice albumin approved by China FDA for clinical trial
Wuhan Healthgen Biotechnology received approval from the China Food and Drug Administration's Center for Drug Evaluation for its rice-derived human albumin to be used in clinical trials, potentially leading to mass production of plasma. Clinical trials could begin in August, and the product might be introduced in the market within five years.
ChinaView.cn/Xinhua News Agency (China) (5/17) 
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North America
Comments on device test labs accreditation pilot program sought by FDA
The FDA has issued a request for comments on its planned Accreditation Scheme for Conformity Assessment Pilot Program, which aims to accredit medical device test laboratories for manufacturers' conformity to consensus standards recognized by the agency to support premarket review. The program comes as part of the agency's MDUFA IV agreement with the industry and is expected to pilot by the end of fiscal 2020.
Regulatory Focus (5/16) 
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Sangamo's hemophilia A drug gets FDA fast-track status
The FDA has granted fast-track status to Sangamo Therapeutics' investigational gene therapy SB-525, which has an ongoing early-stage trial of the treatment in adult patients with hemophilia A. The company anticipates data from the study before the end of the year or early next year.
Reuters (5/16) 
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Latin America
Drug for Alzheimer's indication to be developed in Cuba
The Center of Molecular Immunology in Cuba said it will conduct clinical trials of NeuroEpo for Alzheimer's disease indication pending approval from the Center for State Control of Drugs, Equipment and Medical Devices.
Pharmafile (UK) (5/16) 
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