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EC grants marketing authorisation for Gilead Sciences’ Descovy F/TAFThe European Commission (EC) has granted marketing authorisation to biopharmaceutical company Gilead Sciences, for two doses of Descovy (emtricitabine and tenofovir alafenamide 200/10mg and 200/25mg;2016/4/28
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Ireland’s Allergan acquires US manufacturer Topokine TherapeuticsIrish pharmaceutical giant Allergan has acquired Topokine Therapeutics, a US-based manufacturer of topical medicines for fat reduction, in a deal valued at $85m. The deal value includes Topokine's de2016/4/28
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Lannett and YiChang to develop generic insulin product for US marketGeneric pharmaceutical products developer and distributor Lannett Company has planned to develop a generic insulin pharmaceutical product for the US market. The product is now at its late stage devel2016/4/27
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Merck's Keytruda gets FDA breakthrough therapy designation for cHLMerck, commonly known as MSD, has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) to treat patients with relapsed or refractor2016/4/27
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NICE recommends PTC's Translarna to treat Duchenne muscular dystrophyThe UK's National Institute for Health and Care Excellence (NICE) has recommended PTC Therapeutics' Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD) caused by a nonsense mu2016/4/26
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EC grants approval for Bristol-Myers' Opdivo to treat renal cell carcinomaBristol-Myers Squibb has obtained approval from the European Commission (EC) for its Opdivo (nivolumab) for previously treated advanced renal cell carcinoma (RCC). RCC is the most common type of kidn2016/4/26
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Catalent plant gets 14 observations from FDAMiami-based Opko was caught off guard last month when the FDA cited concerns over a Catalent ($CTLT) plant in Florida that is producing its drug candidate as the reason the agency was putting off its2016/4/25
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China FDA slams 3 drugmakers on manufacturing lapsesChina FDA has ordered 3 drugmakers to recall certain products off the shelf in the latest effort to enforce good manufacturing practices (GMP) on the firms suspected of sending medicines to the market2016/4/25
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Merck's Keytruda gets FDA breakthrough therapy designation for cHLMerck, commonly known as MSD, has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) to treat patients with relapsed or refractor2016/4/22
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US firm Protein Sciences and partners to develop new Zika virus vaccineUS-based vaccine development firm Protein Sciences has reached an agreement with Sinergium Biotech and Mundo Sano to co-develop a new vaccine against the Zika virus. Through using Protein Sciences' p2016/4/22