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Oxygen Biotherapeutics signs agreement to acquire Phase III cardiac drug from Phyxius Pharma

22-10-2013

US drug developer Oxygen Biotherapeutics has signed a Definitive Agreement to acquire certain assets…

Cardio-vascularLevosimendanLicensingMergers & AcquisitionsNorth AmericaOxygen BiotherapeuticsPharmaceutical

Genentech’s SC Actemra approved by US FDA for severe RA

Genentech’s SC Actemra approved by US FDA for severe RA

22-10-2013

Genentech has announced that the US Food and Drug Administration has approved a subcutaneous formulation…

ActemraAnti-Arthritics/RheumaticsGenentechNorth AmericaPharmaceuticalRegulationRoche

Iroko’s pain relief drug effective at low doses

Iroko’s pain relief drug effective at low doses

22-10-2013

Iroko Pharmaceuticals has announced that the US Food and Drug Administration has approved Zorvolex capsules…

AnalgesiaIrokoNorth AmericaPharmaceuticalRegulationZorvolex

PDL BioPharma secures royalties on diabetes products in $240m deal

PDL BioPharma secures royalties on diabetes products in $240m deal

22-10-2013

PDL BioPharma has acquired the rights to receive royalties and milestones payable on sales of Type 2…

DepomedDiabetesFinancialGlumetzaInvokanaJanumetLicensingmetforminNorth AmericaPDL BioPharmaPharmaceutical

Novartis third quarter results driven by strong sales despite generic competition

Novartis third quarter results driven by strong sales despite generic competition

22-10-2013

Novartis has announced strong sales performance in its third quarter results, released today.

DiovanEuropeFinancialNorth AmericaNovartisPharmaceuticalSandozZometa

Regeneron reports positive Phase III data for Eylea

Regeneron reports positive Phase III data for Eylea

22-10-2013

Regeneron Pharmaceuticals has announced positive results for Eylea Injection from the Phase III VIBRANT…

EyleaNorth AmericaOphthalmicsPharmaceuticalRegeneronResearch

Canada welcomes Comprehensive Economic and Trade Agreement with Europe

21-10-2013

Canada’s Research-Based Pharmaceutical Companies (Rx&D) group has welcomed the Canadian Government’s…

EuropeNorth AmericaPharmaceuticalPolitics

Mixed results for Pfizer’s two Lyrica Phase IIIb studies

Mixed results for Pfizer’s two Lyrica Phase IIIb studies

21-10-2013

Pfizer has announced mixed results from two Phase IIIb studies of Lyrica capsules CV in patients with…

AnalgesiaLyricaNorth AmericaPfizerPharmaceuticalResearch

FDA calls for new trial before it can approve Alimera’s Iluvien

FDA calls for new trial before it can approve Alimera’s Iluvien

18-10-2013

USA-based ophthalmic biopharma specialist Alimera Sciences says that it has received a third Complete…

Alimera SciencesIluvienNorth AmericaOphthalmicsPharmaceuticalpSividaRegulation

Anacor Pharma awarded $100 million damages

18-10-2013

Anacor Pharmaceuticals says that the arbitrator appointed to resolve its dispute with Canada-based Valeant…

Anacor PharmaceuticalsLegalNorth AmericaPharmaceuticalValeant Pharmaceuticals

Abraxane shows increased survival in metastatic pancreatic cancer

Abraxane shows increased survival in metastatic pancreatic cancer

17-10-2013

Celgene International, a wholly-owned subsidiary of Celgene Corp, has announced the results of the MPACT…

AbraxaneCelgeneNorth AmericaOncologyPharmaceuticalResearch

US FDA approved Novo Nordisk hemophilia A drug

US FDA approved Novo Nordisk hemophilia A drug

16-10-2013

Novo Nordisk revealed this morning that the US Food and Drug Administration has approved its Biologics…

HematologyNorth AmericaNovo NordiskNovoEightPharmaceuticalRegulationturoctocog alfa

Eisai to double Belviq sales force by December

Eisai to double Belviq sales force by December

15-10-2013

Eisai’s US subsidiary will increase its force for the obesity drug Belviq to around 400 representatives…

Arena PharmaceuticalsBelviqEisaiManagementMarkets & MarketingMetabolicsNorth AmericaPharmaceutical

FDA clears Eisai Zonegran facility in UK for US exports

FDA clears Eisai Zonegran facility in UK for US exports

15-10-2013

Eisai says the US Food and Drug Administration has approved the US supply of the epilepsy drug Zonegran…

EisaiEuropeNeurologicalNorth AmericaPharmaceuticalProductionRegulationZonegran

Coronado reports disappointing results from its Crohn’s disease trial

15-10-2013

Coronado Biosciences has announced that TSO (Trichuris suis ova or CNDO-201) did not meet its primary…

Coronado BiosciencesGastro-intestinalsNorth AmericaPharmaceuticalResearch

US FDA investigating stricken Ariad over Iclusig safety concerns

US FDA investigating stricken Ariad over Iclusig safety concerns

14-10-2013

The US FDA is investigating an increasing frequency of reports of serious and life-threatening blood…

Ariad PharmaceuticalsIclusigNorth AmericaOncologyPharmaceuticalRegulation

FDA allows OTC of Sanofi’s Nasacort

FDA allows OTC of Sanofi’s Nasacort

13-10-2013

The US Food and Drug Administration has approved Sanofi’s Nasacort Allergy 24HR nasal spray as an over-the-counter…

ChattemNasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofi

Opioid-induced constipation market expected to see rapid growth by 2017

Opioid-induced constipation market expected to see rapid growth by 2017

13-10-2013

The global market for opioid-induced constipation will increase significantly from $144.42 million in…

AstraZenecabevenopranCubist PharmaceuticalsEuropeGastro-intestinalsMarkets & MarketingnaloxegolNorth AmericaPharmaceuticalRelistorSalix Pharmaceuticals

Auxilium gains rights to Vivus ED drug for USA and Canada

11-10-2013

Auxilium Pharmaceuticals has signed an agreement with fellow USA-based Vivus providing Auxilium with…

Auxilium PharmaceuticalsLicensingMen's HealthNorth AmericaPharmaceuticalStendraVivus

Pfizer sees mixed top-line results in the first two of five phase III clinical trials of tofacitinib

Pfizer sees mixed top-line results in the first two of five phase III clinical trials of tofacitinib

09-10-2013

Pfizer has announced mixed top-line results from two Phase III clinical trials of tofacitinib for the…

DermatologicalsNorth AmericaPfizerPharmaceuticalResearchtofacitinibXeljanz

CSL settles US antitrust class action litigation

CSL settles US antitrust class action litigation

09-10-2013

Australian blood products and vaccine maker CSL has signed an agreement to settle the US antitrust class…

CSL LimitedFinancialHematologyLegalNorth AmericaPharmaceutical

US infectious disease specialists’ prescribing choices for GNIs

US infectious disease specialists’ prescribing choices for GNIs

09-10-2013

A majority of US surveyed infectious disease specialists are willing to prescribe novel antibiotics if…

Antibiotics and Infectious diseasesMarkets & MarketingNorth AmericaPharmaceuticalPricing

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

Update on US FDA activities in ongoing govt shutdown

08-10-2013

We are now entering the second week of the shutdown of the US federal government (or “the lapse period”…

North AmericaPharmaceuticalPoliticsRegulation

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