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The FDA should innovate to respond to new health economy, says PwC survey

The FDA should innovate to respond to new health economy, says PwC survey

27-01-2015

Health care product manufacturers are now much more willing to have their products judged based on economic…

FDAFood and Drug AdministrationPharmaceuticalPwCRegulationUSA

Hybrigenics extends its partnership with Servier

27-01-2015

French biopharma company Hybrigenics says it has extended its partnership with France’s leading independent…

HybrigenicsOncologyPharmaceuticalResearchServier

Otsuka opens subsidiary in Australia

27-01-2015

Japanese drugmaker Otsuka Pharmaceutical has established a direct presence in Australia. A new office…

AustraliaManagementMarkets & MarketingNeurologicalOtsuka PharmaceuticalPharmaceutical

Novartis sees negative currency impact in 4th-qtr 2014; gives positive 2015 guidance

Novartis sees negative currency impact in 4th-qtr 2014; gives positive 2015 guidance

27-01-2015

Swiss pharma major Novartis, now the world’s largest drugmaker by sales, this morning posted financial…

FinancialNovartisPharmaceutical

Aspen buys rights to an anti-coagulant product from Novartis

26-01-2015

Aspen Global Inc, a wholly-owned subsidiary of South Africa’s Aspen Holdings, has entered into an agreement…

Aspen Global IncAspen HoldingsHematologyMergers & AcquisitionsMono-EmbolexNovartisPharmaceutical

Rockwell's Triferic cleared for marketing by US FDA

26-01-2015

The US Food and Drug Administration has approved US biopharma company Rockwell Medical’s Triferic (ferric…

Nephrology and HepatologyPharmaceuticalRegulationRockwell MedicalTrifericUSA

CIPA and KEFEA discuss initiatives to improve Cyprus’ pharma investment climate

26-01-2015

The potential to attract investments in the pharmaceutical industry and develop joint initiatives to…

FinancialHealthcarePharmaceuticalRest of the World

Nicox holds successful pre-NDA meeting with FDA for AC-170

Nicox holds successful pre-NDA meeting with FDA for AC-170

26-01-2015

French ophthalmics company Nicox has held a positive pre-New Drug Application meeting with the US Food…

AC-170NicOxOphthalmicsPharmaceuticalRegulationUSA

ALK's partner Torii submits NDA in Japan for house dust mite sublingual tablet

ALK's partner Torii submits NDA in Japan for house dust mite sublingual tablet

26-01-2015

Denmark-based allergy specialist ALK Abello’s Japanese partner, Torii Pharmaceutical, has submitted…

ALK AbelloImmunologicalsJapanPharmaceuticalRegulationSLIT-tabletTorii Pharma

Ipsen's Dysport gives positive results in adult and pediatric lower limb spasticity

Ipsen's Dysport gives positive results in adult and pediatric lower limb spasticity

26-01-2015

French drugmaker Ipsen has announced top line results from two double-blind Phase III trials of Dysport…

CNS DiseasesDysportFranceIpsenPharmaceuticalResearch

Indonesia pharma market forecast to grow in 2015

Indonesia pharma market forecast to grow in 2015

26-01-2015

Today, Indonesia’s pharmaceutical market value is estimated at $6.24 billion, reflecting pharmaceutical…

IndonesiaMarkets & MarketingPharmaceuticalPharmaceutical industryProduction

Novartis’ meningitis B vaccine Bexsero approved by US FDA

Novartis’ meningitis B vaccine Bexsero approved by US FDA

24-01-2015

On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’…

BexseroNovartisPharmaceuticalRegulationUSAVaccines

EMA recommends suspending medicines over flawed studies at GVK Biosciences

EMA recommends suspending medicines over flawed studies at GVK Biosciences

23-01-2015

A number of medicines for which authorization in the European Union was primarily based on clinical studies…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

US Senator plans legislation to advance medical research

23-01-2015

In remarks at the Families USA Health Action Conference in Washington DC on January 22, US Senator Elizabeth…

FinancialLegalPharmaceuticalResearchUSA

Array acquires worldwide rights to encorafenib from Novartis

Array acquires worldwide rights to encorafenib from Novartis

23-01-2015

Oncology specialist Array Biopharma has reached an agreement with Swiss drug major Novartis to acquire…

Array BioPharmaencorafenibLicensingNovartisOncologyPharmaceutical

More EMA/CHMP recommendations

23-01-2015

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

Anti-viralsAntibiotics and Infectious diseasesCubistDutrebisEuropeIkervisMerck & CoOphthalmicsPharmaceuticalSanten PharmaceuticalsSivextro

Eric Halioua steps down as chief executive of Promethera Biosciences

Eric Halioua steps down as chief executive of Promethera Biosciences

23-01-2015

Belgian pharma company Promethera Biosciences has announced the resignation of its chief executive Eric…

BelgiumBoardroomEric HaliouaPharmaceuticalPromethera Biosciences

FDA's anti-infective committee recommends Astellas' Cresemba

FDA's anti-infective committee recommends Astellas' Cresemba

23-01-2015

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has voted unanimously…

Antibiotics and Infectious diseasesAstellasCresembaPharmaceuticalRegulationUSA

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

23-01-2015

The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese…

EisaiGermanyHalavenOncologyPharmaceuticalRegulation

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

23-01-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive…

PfizerPharmaceuticalPrevenarRegulationRespiratory and Pulmonary

High hopes for President Obama’s Indian visit for pharma

High hopes for President Obama’s Indian visit for pharma

23-01-2015

This January 26, India's Republic Day is set to be a momentous one with the country hosting the US President…

IndiaPatentsPharmaceuticalPoliticsUSA

Milestone for GSK/NIH candidate Ebola vaccine as first doses shipped for Phase III trial

Milestone for GSK/NIH candidate Ebola vaccine as first doses shipped for Phase III trial

23-01-2015

UK pharma major GlaxoSmithKline said this morning that the first batch of its candidate Ebola vaccine…

EbolaGlaxoSmithKlinePharmaceuticalResearchUKVaccines

Leading Russian drug producers call for state support measures

Leading Russian drug producers call for state support measures

23-01-2015

Leading Russian drug producers have called on the national parliament (State Duma) for a complex of measures…

BiotecFinancialPharmaceuticalPolisanPricingProductionRussia

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