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NICE backs Merck & Co hep C drug Victrelis


UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has today (March 9)…

Anti-viralsEuropeMerck & CoPharmaceuticalPricingRegulationVictrelis

Australia latest to approve Bayer's Eylea


The Australian Therapeutic Goods Administration (TGA) has approved Eylea (aflibercept) Injection for…


US FDA delays Eisai's Dacogen for AML; accepts perampanel NDA


The US Food and Drug Administration has issued a Complete Response Letter to Japanese drug major Eisai…

Astex PharmaceuticalsDacogenEisaiNeurologicalNorth AmericaOncologyperampanelPharmaceuticalRegulation

Gilead's Quad non-inferior to Atripla for HIV; Truvada objections


US biotech firm Gilead Sciences (Nasdaq: GILD) yesterday announced full Phase III clinical trial results…

Anti-viralsAtriplaBiotechnologyGilead SciencesNorth AmericaQuadRegulationResearchTruvada

FDA nod for Discovery Labs Surfaxin for RDS


US specialty drugmaker Discovery Laboratories (Nasdaq: DSCO) saw its shares rocker 30% to $4.88 in after-hours…

Discovery LaboratoriesNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxin

Aegerion files for lomitapide approval in USA and Europe


Emerging US biotech firm Aegerion Pharmaceuticals (Nasdaq: AEGR) has submitted a New Drug Application…

Aegerion PharmaceuticalsBiotechnologyEuropelomitapideNorth AmericaRare diseasesRegulation

CNS disease therapies take 35% longer to develop than other drugs, says Tufts CSDD


Drugs developed to treat central nervous system (CNS) diseases take 35% longer to complete clinical trials…


US House Bill will establish inspection parity, improve US drug supply


Ranking US Congress Member Henry Waxman, Health Subcommittee Ranking Member Frank Pallone, Representative…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

New Zealand to fund new cancer drugs Tykerb and Votrient


The Pharmaceutical Management Agency of New Zealand, PHARMAC, says it is funding two new targeted cancer…


EMA updates market authorization holder requirements


Pharmaceutical regulator the European Medicines Agency said yesterday that it has published an updated…


EU Commission proposes faster access to medicines for patients


With the intention of getting new medicines to the market faster, the European Commission yesterday proposed…

EuropeGenericsMarkets & MarketingPharmaceuticalPricingRegulation

EU Commission finds no evidence against AstraZeneca and Nycomed


The European Commission said yesterday that it has ceased its antitrust investigation into the pharmaceutical…

AstraZenecaEuropeLegalNycomedPatentsPharmaceuticalRegulationTakeda Pharmaceuticals

US FDA delays Eliquis decision; Pristiq dropped for menopause


USA drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) say that the US Food and…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalPristiqRegulationWomen's Health

Biogen Idec files oral MS candidate in USA


US biotech firm Biogen Idec (Nadaq: BIIB) has submitted its orally-active drug for relapsing-remitting…

Biogen IdecBiotechnologyNeurologicalRegulation

EMA increases public information on conflicts of interest of experts and management


The European Medicines Agency this week updated its list of European experts to display each expert's…


Hi-Tech and Mylan update on generics


US generic drugmaker Hi-Tech Pharmacal (Nasdaq: HITK) says that the US Food and Drug Administration has…

GenericsMarkets & MarketingNeurologicalNorth AmericaRegulation

FDA OKs first quadrivalent flu vaccine; and lower dose Angeliq


Anglo-Swedish drug major AstraZeneca (LSE: AZN) US unit MedImmune's FluMist Quadrivalent, a vaccine to…

Anti-viralsNorth AmericaPharmaceuticalRegulationVaccinesWomen's Health

FDA expands on cholesterol-lowering drug risks


Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins…

AstraZenecaCardio-vascularCrestorLipitorMerck & CoNorth AmericaPfizerPharmaceuticalRegulationZocor

Bayer and J&J’s Xarelto gets US Priority Review for new indication


The US Food and Drug Administration has granted Priority Review designation to the supplemental New Drug…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Frontage and Fanghui Pharma launch $10 million collaboration


Emerging Chinese pharmaceutical company Luohe Fanghui Pharmaceutical has launched a new globalization…

Asia-PacificFanghui PharmaceuticalsFinancialFrontage LaboratoriesGenericsNorth AmericaRegulation

Merck warned for not carrying out post-approval sitagliptin study


The US Food and Drug Administration (FDA) has sent a warning letter to Merck & Co for failing to carry…

DiabetesJanumetJanuviaMerck & CoPharmaceuticalRegulationsitagliptinSitagliptin Metformin HCL

GSK boss accuses UK government of blocking new drugs to save money


The chief executive of the UK’s largest pharmaceutical company, GlaxoSmithKline (LSE: GSK) has accused…

EuropeGlaxoSmithKlineMarkets & MarketingPharmaceuticalPricingRegulation

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