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Zonegran Russian approval prompts Eisai's expansion in that market

28-06-2012

Eisai (TYO: 4523), a leading Japanese drugmaker, says it plans to expand its operations into Russia,…

EisaiEuropeFycompaHalavenMarkets & MarketingNeurologicalPharmaceuticalRegulationZonegran

Astellas submits prostate cancer drug for EU approval

28-06-2012

Japanese drug major Astellas Pharma (TYO: 4503) yesterday filed a marketing authorization application…

Astellas PharmaenzalutamideEuropeMedivationOncologyPharmaceuticalRegulation

Tentative FDA approval for Supernus' Trokendi XR

27-06-2012

USA-based specialty drug firm Supernus Pharmaceuticals (Nasdaq: SUPN) says it has received a tentative…

GenericsNeurologicalNorth AmericaRegulationSupernus PharmaceuticalstopiramateTrokendi XRUpsher-Smith

Watson challenges Pfizer's Pristiq patent

26-06-2012

US generics drugmaker Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories,…

GenericsNeurologicalNorth AmericaPatentsPfizerPharmaceuticalPristiqRegulationWatson Pharmaceuticals

FDA again delays approval of Bristol-Myers and Pfizer's Eliquis

26-06-2012

A few days ahead of the expected decision date, the US Food and Drug Administration on Monday issued…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

Australian patients to benefit from new PBS listings; OTC reforms

26-06-2012

The listing of 11 prescription medicines on the Australian Pharmaceutical Benefits Scheme (PBS) has been…

Asia-PacificBiotechnologyHealthcarePharmaceuticalPricingRegulation

Alexza rockets on re-submission of Adasuve NDA

25-06-2012

USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) saw its shares soar 44.9% to close at $3.97 on Friday,…

AdasuveAlexza PharmaceuticalNeurologicalNorth AmericaPharmaceuticalRegulation

EMA calls for curbs on trimetazidine-containing and tolperisone medicines

24-06-2012

The European Medicines Agency on Friday recommended restricting the use of trimetazidine-containing medicines…

Cardio-vascularEuropeNeurologicalPharmaceuticalRegulationServiertolperisonetrimetazidineVestrel

EMA investigating deficiencies in Roche's drug safety reporting

22-06-2012

The European Medicines Agency revealed yesterday that it is working with national medicines agencies…

EuropePharmaceuticalRegulationRoche

Pfizer's Lyrica cleared for spinal cord injury pain in USA

22-06-2012

The US Food and Drug Administration has approved the use of Lyrica (pregabalin) capsules CV for the management…

LyricaNeurologicalNorth AmericaPfizerPharmaceuticalRegulation

Celgene slumps as it pulls new EU indication filing for Revlimid

22-06-2012

Celgene International, the European subsidiary of USA-based Celgene Corp (Nasdaq: CELG), has provided…

BiotechnologyCelgeneEuropeFinancialOncologyPharmaceuticalpomalidomideRegulationRevlimid

US House and Senate reconcile PDUFA reauthorization legislation

20-06-2012

The US Congress has released a reconciled Prescription Drug User Fee Act (PDUFA) reauthorization bill…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

US FDA calls for more efficacy data on Pfizer's tafamidis NDA

19-06-2012

The US Food and Drug Administration yesterday issued a complete response letter regarding drugs behemoth…

North AmericaPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

Issues to be navigated to unleash full potential of stem cell therapies

18-06-2012

Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research…

BiotechnologyPharmaceuticalPricingRegulationResearch

Prescription drug warning labels need to be more effective; MSU study

18-06-2012

Each year, an estimated 4 million Americans experience adverse reactions to prescription medications.…

North AmericaPharmaceuticalRegulation

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