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US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Almirall gains European rights to InDex Pharma’s Kappaproct

07-04-2014

Sweden’s InDex Pharmaceuticals and Spain’s largest drugmaker Almirall have signed a license agreement…

AlmirallEuropeGastro-intestinalsInDex PharmaceuticalsKappaproctLicensingPharmaceutical

Safinamide marketing application submitted to Swissmedic

07-04-2014

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

Markets & MarketingNeurologicalNewron PharmaNorthern EuropePharmaceuticalRegulationsafinamideZambon

Abilify Maintena cuts hospitalization rates for patients with schizophrenia vs oral antipsychotics

07-04-2014

Danish CNS drug specialist Lundbeck and partner Japanese drugmaker Otsuka Pharmaceutical today announced…

Abilify MaintenaLundbeckNeurologicalOtsukaPharmaceuticalResearch

EMA and Australia’s TGA collaborate in the area of orphan medicines

EMA and Australia’s TGA collaborate in the area of orphan medicines

07-04-2014

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi,…

AustraliaEuropePharmaceuticalRare diseasesRegulation

Ph III data shows Pacira’ Exparel good as femoral nerve block in knee arthroplasty

06-04-2014

US drugmaker Pacira Pharmaceuticals has released additional Phase III data supporting the efficacy and…

ExparelNeurologicalPacira PharmaceuticalsPharmaceuticalResearch

Brazil’s CMED approves price adjustment of medicines to 3.35%

04-04-2014

Brazil's National Health Surveillance Agency ANVISA’s office of pharmaceutical drug market regulation…

BrazilPharmaceuticalPricingSouth America

EMA confirms AbbVie’s withdrawal of court cases on access to clinical-trial data

04-04-2014

The European Medicines Agency confirms that US drugmaker AbbVie has withdrawn both its court cases brought…

AbbVieEuropeLegalPharmaceuticalResearch

Pharmaceutical companies to benefit from new blood cancer drugs

04-04-2014

Blood cancer drugs represent a growth opportunity for the pharmaceutical industry over the next few years,…

AmgenCelgeneGilead SciencesJohnson & JohnsonMarkets & MarketingOncologyPharmaceuticalRoche

UK’s NICE reverses negative decision on Roche’s Tarceva for NSCLC

04-04-2014

Following a consultation period, the UK drug watchdog the National Institute for Health and Care Excellence…

Northern EuropeOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

Merck Serono in deal with Auxogyn to advance fertility research

03-04-2014

USA-based Auxogyn, a company dedicated to advancing women’s reproductive health, has entered into an…

AuxogynLicensingMerck KGaAMerck SeronoPharmaceuticalReproductive

Astellas files for wider use of prostate cancer drug Xtandi in Europe

03-04-2014

Japanese drug major Astellas Pharma has submitted a variation to amend the Marketing Authorization Application…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalRegulationXtandi

UCB enters strategic alliance with Weill-Cornell in three discovery projects

03-04-2014

Belgian drugmaker UCB has launched a major, three-year strategic research alliance with Weill-Cornell…

MetabolicsPharmaceuticalRare diseasesResearchUCB

UK Pharma moves on transparency of financial relationships with health professionals

03-04-2014

The UK’s pharmaceutical industry today announced another step towards greater transparency by revealing…

FinancialNorthern EuropePharmaceuticalResearchUK

Aqua’s acquisition to push Almirall in US dermatology market

03-04-2014

Spain’s largest drugmaker, Almirall (ALM: MC), announced at the end of last year the acquisition of…

AlmirallAqua PharmaceuticalsDermatologicalsMergers & AcquisitionsPharmaceutical

MEPs vote for more transparent and simpler European clinical trial rules

03-04-2014

Pharmaceutical companies and academic researchers will have to post the results of all their European…

EuropePharmaceuticalRegulationResearch

Global Fund taps pharmaceutical expertise in China

02-04-2014

The Global Fund is deepening its partnership with China by tapping the expertise of Chinese pharmaceutical…

Anti-viralsAntibiotics and Infectious diseasesChinaGlobalMarkets & MarketingPharmaceuticalProductionRegulation

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