Tuesday, 17 September 2019

Generics News

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Daiichi Sankyo's subsidiary launches four new generic drugs

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 18 Jun, 2015

    Daiichi Sankyo Company Limited has announced that on Friday, June 19, its generics subsidiary, Daiichi Sankyo Espha, will launch seven new generic drugs with four new active ingredients. T...Read more

  • US FDA extends timeline for generic drug approval

    Generics |  News | By BioSpectrum Bureau  | 0 Comment | 29 Oct, 2012

    Singapore: In a recent move, the US Food and Drug Administration (FDA) has decided to extend the timeline for granting tentative approval to generic drug applications. The timelines of appl...Read more

  • FDA approves generic versions of Plavix

    Generics |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 18 May, 2012

    Singapore: The US Food and Drug Administration has approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and strok...Read more



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