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China SFDA approves new production line for NeoStem’s Suzhau Erye

14-06-2011

There was good news for USA-based NeoStem (NYSE Amex: NBS) yesterday, as China’s medicines regulator…

Asia-PacificBiotechnologyFinancialNeoStemRegulation

Towards updating Israel’s “basket” of health services in 2012

14-06-2011

Towards updating Israel’s “basket” of health services in 2010

HealthcarePharmaceuticalRegulationRest of the World

US FDA warns on risk of more serious forms of prostate cancer with 5-ARI drugs

13-06-2011

The US Food and Drug Administration has warned that the labeling for drugs used to treat enlarged prostate…

AvodartGlaxoSmithKlineMerck & CoNorth AmericaOncologyPharmaceuticalProscarRegulation

GlaxoSmithKline and Valeant get FDA approval for epilepsy drug Potiga

13-06-2011

Following backing from a US Food and Drug Administration advisory panel last summer (The Pharma Letter…

GlaxoSmithKlineNeurologicalNorth AmericaPharmaceuticalPotigaRegulationTrobaltValeant Pharmaceuticals

US FDA working to lessen drug shortage impact

11-06-2011

Last year, the number of drug shortages in the USA reached a record high, and medicine scarcities have…

Markets & MarketingNorth AmericaPharmaceuticalRegulation

France suspends sales of Takeda’s Actos on cancer risk concerns

10-06-2011

Sales of blockbuster diabetes drug Actos (pioglitazone), from Japan’s leading drugmaker Takeda Pharmaceuticals…

ActosDiabetesEli LillyEuropePharmaceuticalRegulationTakeda Pharmaceuticals

European Medicines Agency nominates Guido Rasi as new head; sets up geriatric expert group

10-06-2011

The European Medicines Agency’s management board has nominated Guido Rasi as new Executive Director…

EuropeManagementPharmaceuticalRegulation

German regulator raises questions on Allergy Thera’s Pollinex Quattro MAA

10-06-2011

Allergy Therapeutics (AIM: AGY), a UK-based specialty pharmaceutical company specializing in allergy…

Allergy TherapeuticsEuropePharmaceuticalPollinex QuattroRegulationRespiratory and Pulmonary

Concerns about pharmaceutical safety testing cause clinicians to appeal to UK PM and Health Sec

10-06-2011

A group of eminent UK clinicians and scientists who have written an open letter to Prime Minister David…

CyprotexEuropePharmaceuticalRegulationResearch

Changing of the Guard begins in biotech sector

08-06-2011

The biotechnology sector is bracing for change this year as a flurry of "biosimilar" or "biogeneric"…

BiotechnologyGenericsMarkets & MarketingNorth AmericaRegulation

Russia should boost innovation to drive economic growth, says OECD

07-06-2011

Russia should increase protection of intellectual property, strengthen competition and invest more in…

EuropePatentsPharmaceuticalRegulationResearch

FDA accepts ciclesonide NDA from Nycomed partner Sunovion

07-06-2011

Swiss drugmaker Nycomed, the subject of a $13.7 billion takeover bid from Japan’s Takeda (TYO:4502;…

Ciclesonide Inhalation AerosolNorth AmericaNycomedPharmaceuticalRegulationRespiratory and PulmonarySunovion

Blow for Orexigen as regulatory demands see firm put obesity drug Contrave on hold

06-06-2011

Shares of US biotech firm Orexigen Therapeutics (Nasdaq: OREX) plunged 33% to $2.13 by afternoon trading…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulation

Good news for RVO suffers as EU approves Novartis’ Lucentis and NICE backs Allergan’s Ozurdex

06-06-2011

The European Commission has granted Novartis a new indication for Swiss drug major Novartis’ (NOVN:…

AllerganEuropeLucentisNovartisOphthalmicsOzurdexPharmaceuticalRegulation

UK Pharma group ABPI has qualms about GMC proposal

06-06-2011

Responding to the UK General Medical Council (GMC) consultation on “Good practice in prescribing…

EuropePharmaceuticalRegulation

US FDA says use of ARBs for hypertension does not increase risk of cancer

03-06-2011

The US Food and Drug Administration stated yesterday that a group of drugs used to control high blood…

Cardio-vascularNorth AmericaPharmaceuticalRegulation

CROMA and B&L’s eye drug Yellox approved by the European Commission

03-06-2011

Austria-based CROMA Pharma GmbH, a private global specialty pharmaceutical and surgical company, and…

Bausch & LombCROMA PharmaEuropeOphthalmicsPharmaceuticalRegulationYellox

Pfizer files for EU approval of axitinib in advanced kidney cancer

02-06-2011

The European Medicines Agency (EMA) has accepted US drugs behemoth Pfizer’s (NYSE: PFE) filing for…

axitinibEuropeOncologyPfizerPharmaceuticalRegulation

European Medicines Agency and HMA propose measures on dossier transparency

02-06-2011

A guidance document on the identification of commercially confidential information and protection of…

EuropePharmaceuticalRegulationResearch

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