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Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Astellas’ Xtandi cleared in Japan for prostate cancer treatment

24-03-2014

Japanese drug major Astellas Pharma has obtained the marketing approval in Japan of its oral androgen…

Asia-PacificAstellas PharmaJapanMedivationOncologyPharmaceuticalRegulationXtandi

Positive CHMP opinion for Janssen’s simeprevir for chronic hepatitis C

24-03-2014

US health care giant Johnson & Johnson’s European subsidiary Janssen R&D Ireland has received a positive…

Anti-viralsEuropeJanssenJohnson & JohnsonMedivirOlysioPharmaceuticalRegulationsimeprevir

Japanese approval for Forxiga and Lonsurf

24-03-2014

Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

US lawmakers question price of Gilead’s Sovaldi

US lawmakers question price of Gilead’s Sovaldi

24-03-2014

Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPoliticsPricingRegulationSovaldiUSA

UK’s NICE unable to give the go ahead to new prostate cancer drug Xofigo

24-03-2014

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft…

BayerNorthern EuropeOncologyPharmaceuticalPricingRegulationUKXofigo

US FDA clears Xolair for chronic idiopathic urticaria

23-03-2014

Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for…

BiotechnologyDermatologicalsGenentechNorth AmericaNovartisRegulationRocheUSAXolair

EMA/CHMP recommends empagliflozin for approval for type 2 diabetes

23-03-2014

German family-owned drug major Boehringer Ingelheim and partner Eli Lilly of the USA have announce a…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

EMA/CHMP backs approval of Merck ovarian cancer drug Vynfinit and companion diagnostics

21-03-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

EndocyteEuropeFolcepriMerck & CoNeocepriOncologyPharmaceuticalRegulationVynfinit

Takeda gets positive CHMP opinion for Entyvio for UC and Crohn’s disease

21-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, today received a positive opinion form the European…

EntyvioEuropeGastro-intestinalsPharmaceuticalRegulationTakeda Pharmaceuticals

Label updates for Tresiba and Victoza backed by EMA committee

21-03-2014

The European Medicines agency’s Committee for Medicinal Products for Human Use has issued positive…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresibaVictoza

Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B

Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B

21-03-2014

US biotech firm Biogen Idec has announced that Health Canada has approved Alprolix for the control and…

AlprolixBiogen IdecCanadaHematologyPharmaceuticalRegulation

UK about turn, as JCVI now recommends meningitis B vaccination for infants

21-03-2014

The UK’s Joint Committee on Vaccination and Immunization has recommended that the meningitis B vaccine…

BexseroNorthern EuropeNovartisPharmaceuticalRegulationUKVaccines

US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

UK NICE backs Janssen’s Velcade for multiple myeloma

UK NICE backs Janssen’s Velcade for multiple myeloma

21-03-2014

In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence…

JanssenJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

Brazil Senate discusses pathways for advancement of clinical research

Brazil Senate discusses pathways for advancement of clinical research

20-03-2014

The Brazilian Senate's Social Affairs Committee (CAS) held a hearing on March 18 to debate the progress…

BrazilPharmaceuticalRegulationResearch

FDA approves Impavido to treat tropical disease leishmaniasis

FDA approves Impavido to treat tropical disease leishmaniasis

20-03-2014

The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine)…

Endo Health SolutionsImpavidoNorth AmericaPaladin LabsPharmaceuticalRegulationUSA

Promising mid-stage results for Prosensa’s drisapersen in DMD boys

19-03-2014

Shares of Dutch biotech firm Prosensa Holding rose 3.85% to $7.02 after the firm reported encouraging…

BiotechnologydrisapersenGlaxoSmithKlineProsensaRare diseasesResearch

EMA to focus on pharmacovigilance and supporting development in 2014

EMA to focus on pharmacovigilance and supporting development in 2014

19-03-2014

The European Medicines Agency has published its work program for 2014 with a focus on legislative developments.

EuropeLegalPharmaceuticalRegulation

Pan-European survey calls for a shift in policy for biosimilars

Pan-European survey calls for a shift in policy for biosimilars

19-03-2014

This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European…

BiosimilarsBiotechnologyEuropeHealthcareRegulation

EGA calls for removal of barriers to competition and free trade for generics

EGA calls for removal of barriers to competition and free trade for generics

19-03-2014

The European Union must remove barriers to competition and free trade by introducing common sense reforms…

BiosimilarsEuropeGenericsMarkets & MarketingPatentsRegulation

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