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NICE backs Merck & Co hep C drug Victrelis

09-03-2012

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

08-03-2012

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

Asia-PacificBayerEyleaOphthalmicsPharmaceuticalRegeneronRegulation

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

08-03-2012

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

08-03-2012

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

07-03-2012

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

07-03-2012

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

06-03-2012

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

NeurologicalPharmaceuticalRegulationResearch

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

06-03-2012

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

05-03-2012

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

Asia-PacificGlaxoSmithKlineOncologyPharmaceuticalPricingRegulationTykerbVotrient

EMA updates market authorization holder requirements

05-03-2012

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

BiotechnologyEuropePharmaceuticalRegulation

EU Commission proposes faster access to medicines for patients

02-03-2012

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

02-03-2012

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

02-03-2012

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

01-03-2012

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

01-03-2012

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

EuropeManagementPharmaceuticalRegulation

Hi-Tech and Mylan update on generics

01-03-2012

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

01-03-2012

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

29-02-2012

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

29-02-2012

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

28-02-2012

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

28-02-2012

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

27-02-2012

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

EuropeGlaxoSmithKlineMarkets & MarketingPharmaceuticalPricingRegulation

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