Generics News
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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
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Lupin gets FDA nod for generic Ortho Tri-cyclen Lo Tablets
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 05 Jul, 2012
Mumbai: Mumbai-based pharma major Lupin's subsidiary, Lupin Pharmaceuticals, has received approval for its Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, a...Read more
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FDA approves Sun Pharma's generic Prandin
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 12 Jul, 2013
Singapore: The US Food and Drug Administration (FDA) has given its finally approval to India's Sun Pharmaceutical Industries for releasing its diabetes generic Prandin. Making the announce...Read more
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Cipla, Alembic contest Indian drug pricing in court
Generics | News | By BioSpectrum Bureau | 0 Comment | 17 Jul, 2013
Singapore: Miffed at Indian government's move to slash prices of essential medicines through the new drug pricing policy, drug makers Cipla and Alembic have now moved court. The Indian gov...Read more
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Indian drug dealers worried about $1.69 bn old stocks
Generics | News | By BioSpectrum Bureau | 0 Comment | 02 Aug, 2013
New Delhi: Ahead of the Drug Price Control Order (DPCO) to revise drug prices that came into effect on July 29, medicine wholesalers and retailers have warned of many repercussions. The mos...Read more
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First generic versions of Cymbalta receive FDA nod
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 13 Dec, 2013
Singapore: US Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and ot...Read more
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Takeda close to releasing Norovirus vaccine
Generics | News | By BioSpectrum Bureau | 0 Comment | 08 Jul, 2013
Singapore: Japan's drug major Takeda Pharmaceutical has said that they are set to finish the early stage human studies on a vaccine against norovirus, by the end of this year. Takeda's vacc...Read more
