Generics News
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Eli Lilly to invest more in new medicines and drive growth
Generics | News | 0 Comment | 08 Sep, 2017
Eli Lilly and Company has decided to streamline operations to more efficiently focus resources on developing new medicines and to improve its cost structure. Global workforce reductions, in...Read more
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Lupin launches generic Benicar tablets in the US
Generics | News | 0 Comment | 04 Sep, 2017
Pharma company Lupin Limited has announced the launch of its Olmesartan Medoxomil tablets, 5 mg, 20 mg and 40 mg having received an approval from the United States Food and Drug Administrat...Read more
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U.S. FDA approves chemo group's benznidazole to treat children with Chagas disease
Generics | News | 0 Comment | 01 Sep, 2017
Singapore – The U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the first drug ever approved by the FDA to treat...Read more
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Battlefield Acupuncture (BFA): New pain management process for the military
Generics | News | 0 Comment | 27 Aug, 2017
Singapore - With the pressing need for more efficient and agile pain management practices for military service personnel, Dr. Richard C. Neimtzow of Andrews Air force base d...Read more
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Victoza indicated to reduce the risk of three major adverse cardiovascular events
Generics | News | 0 Comment | 26 Aug, 2017
The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke...Read more
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Generic Seroquel XR tablets launched by Lupin in USA
Generics | News | 0 Comment | 24 Aug, 2017
Lupin Limited has announced the launch of its Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. The tablet was approval from the United States Food an...Read more
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Generics | News | 0 Comment | 21 Aug, 2017
Singapore – US FDA has granted two orphan drug designations (ODD) for T cell therapy products to Singapore-based biotech company, Lion TCR Pte Ltd, for the treatment of hepatocel...Read more
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FDA provides new tools for tests to detect Zika virus infection
Generics | News | 0 Comment | 18 Aug, 2017
Singapore- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid ...Read more
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Bruker announces US FDA clearance of expanded 3rd claim for MALDI Biotyper
Generics | News | 0 Comment | 01 Aug, 2017
Singapore – Bruker, a US based manufacturing company of scientific instruments announced that it has received US Food & Drug Administration (FDA) clearance for its third, further ...Read more
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LEO Pharma gets EC nod for its first and only biologic Kyntheum that targets the IL-17 receptor
Generics | News | 0 Comment | 26 Jul, 2017
LEO Pharma announced that the European Commission has granted marketing authorization for Kyntheum (brodalumab), a new biologic for the treatment of moderate-to-severe plaque psoriasis in a...Read more
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Merck wins tentative U.S. FDA approval for Lusduna
Generics | News | 0 Comment | 26 Jul, 2017
Merck announced in a press release that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA Nexvue (insulin glargine injection) 100 units/mL, a ...Read more
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Study suggests positive airway pressure therapy could reduce COPD patient hospitalizations
Generics | News | 1 Comment | 11 Jul, 2017
Singapore - COPD hospitalizations are at an all-time high. The 30-day readmission rate for patients ranges from 20-39 percent, with related healthcare costs at an estimated $50 billion...Read more
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Japanese regulators grant additional approval for the sale of Ipsen's rare cancer drug in Japan
Generics | News | 1 Comment | 04 Jul, 2017
Bringing in much needed relief for millions of gastroenteropancreatic neuroendocrine cancer patients, the Japanese regulators have approved the sale of the drug Somatuline by Teijin pharma ...Read more
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Taiwan Pharma Association opens new office in Malaysia
Generics | News | 0 Comment | 09 Jun, 2017
Singpaore: In a bid to strengthen trade between two countries, the Taiwan Pharmaceutical Manufacturer’s Association has opened a New Southbound office in Kuala Lumpur, Malaysia. The a...Read more
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Astellas prostrate cancer drug gets EU nod
Generics | News | By BioSpectrum Bureau | 0 Comment | 25 Jun, 2013
Singapore: The European Commission has approved Xtandi (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer, whose disease has progressed on...Read more
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Sanofi, Carlyle to buy Elder Pharma for $450 mn
Generics | News | By BioSpectrum Bureau | 0 Comment | 25 Jul, 2013
Singapore: Sanofi's India unit and Carlyle group are in talks to buy the domestic drug formulation business of Indian drug major Elder Pharmaceuticals in a deal worth $400-to-450 million, a...Read more
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Gilead's cancer drug under FDA scrutiny
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 15 Mar, 2016
Singapore: US Food and Drug Administration has raised alarm for Gilead Science's cancer medicine Zydelig (idelalisib) due to incoming reports of an increased rate of adverse events, includi...Read more
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US FDA seeks inputs on its generic drug amendments
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 04 Sep, 2012
Singapore: On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was enacted by the US. The Food and Drug Administration (FDA) has now called for an industry meet to gather ...Read more
