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FDA Approves Extended-Release, Single-Entity Hydrocodone ProductFDA has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternativ2013/10/29
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Japan's frustrated Eisai loses fight with DEARegulators sometimes are an irritation to drugmakers, andJapan'sEisaihas been really, really irritated as of late. The drugmaker, which this week lashed out at the U.K.'s cost watchdog as too restrict2013/10/28
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J&J gets FDA panel backing for simeprevir in hot race for hep C drugJohnson & Johnson ($JNJ) is out of the gate in the horse race that is shaping up aroundinterferon-free cocktails for treatinghepatitis C. An FDA panel voted 19-0 to recommend its simeprevir, an NS2013/10/28
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Capsugel Expands Global Manufacturing for Finished Dosage FormsMORRISTOWN, N.J. and BORNEM, Belgium, September 19, 2013 –Capsugel’s Dosage Form Solutions (DFS) business unit unveiled extensive upgrades and expansions to three of its manufacturing facilities in th2013/10/25
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BioLineRx signs licensing deal with Israeli institutions for type 1 diabetes treatmentBioLineRx has entered into an exclusive licensing agreement with three Israel-based institutions for the development and commercialisation of BL-9020 antibody treatment for patients with type 1 diabet2013/10/25
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CFDA Assistant Minister Sun Xianze meets Vice President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of PolandOn October 17, 2013, Sun Xianze, Assistant Minister of China Food and Drug Administration (CFDA), met with the delegation led by Mr. Marcin Kołakowski, Vice President of the Office for Registrati2013/10/24
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ViiV Healthcare files new drug application for three-drug HIV pill with US FDAViiV Healthcare, a joint venture involving GlaxoSmithKline (GSK), Pfizer and Shionogi, has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its investigational s2013/10/24
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Ablynx grants licence to Eddingpharm for anti-RANKL Nanobody development in Greater ChinaBelgian biotech firm Ablynx has granted a licence to a China-based Eddingpharm to develop and commercialise its anti-RANKL Nanobody, ALX-0141, in parts of South East Asia for conditions such as osteop2013/10/23
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Astellas' prostate-cancer prodigy Xtandi shines as pre-chemo treatmentSoon afterXtandihit the market last year, analysts were figuring that theprostate cancerdrug would help pump up that market to $9.1 billion by 2021. Already, the drug from Medivation ($MDVN) andAstell2013/10/23
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Health Canada Approves Levemir FlexTouch Prefilled Insulin Pen for the Treatment of Type 1 and Type 2 DiabetesNovo Nordiskhas announced thatHealth Canada has approved Levemir FlexTouch, a disposable prefilled insulin pen containing Levemir (insulin detemir). Levemir FlexTouch has been designed to improve ease2013/10/22