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Australian government U-turn on PBS listing of drugs

03-10-2011

More than 160,000 Australians per year will benefit from the Australian Government’s decision to…

Asia-PacificBoehringer IngelheimPharmaceuticalPradaxaPricingRegulation

New EMA database gives access to declarations of interests of all experts

02-10-2011

Coinciding with the entry into force of new rules on how to handle conflicts of interests of scientific…

BiotechnologyEuropePharmaceuticalRegulation

Astellas drops development of blood thinner darexaban

29-09-2011

Japanese drug major Astellas Pharma (TYO: 4503) says it has decided to discontinue the global development…

Astellas PharmaCardio-vasculardarexabanPharmaceuticalRegulationResearch

Takeda and Pronova file for triglyceride lowererTAK-085 approval in Japan

29-09-2011

Norway-based lipid therapies specialist Pronova BioPharma says that its partner, Takeda Pharmaceutical…

Asia-PacificCardio-vascularPharmaceuticalRegulationTakeda Pharmaceuticals

Onyx Pharma files NDA for multiple myeloma drug carfilzomib

29-09-2011

California, USA-based Onyx Pharmaceuticals (Nasdaq: ONXX) says it has completed the New Drug Application…

carfilzomibNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Off-label use of antipsychotics for some conditions not supported by evidence, says US govt agency

28-09-2011

There is little evidence to support the use of atypical antipsychotic drugs for some treatments other…

NeurologicalNorth AmericaPharmaceuticalRegulation

GPhA joins in US drug shortages challenge, urging “unprecedented multi-stakeholder collaboration”

28-09-2011

With shortages of prescription drugs continuing in the USA, the country’s Generic Pharmaceutical…

GenericsMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Novo Nordisk files for EU approval of ultra-long-acting insulins Degludec and DegludecPlus

28-09-2011

Danish insulin giant Novo Nordisk NVO: N) has made the first regulatory approval submissions, to the…

DegludecDiabetesEuropeNovo NordiskPharmaceuticalRegulation

US FDA communicates concern about drospirenone-containing birth control pills

27-09-2011

The US Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion,…

BayerDrospirenone and Ethinyl EstradiolNorth AmericaPharmaceuticalRegulationReproductiveYasminYaz

HRT therapy appears to increase risk of hospitalization from severe asthma attacks

27-09-2011

Women taking postmenopausal hormone replacement therapy (HRT) may have an increased risk of severe asthma…

PharmaceuticalRegulationReproductiveResearch

Medicines Australia starts new Code of Conduct review

26-09-2011

Pharma trade group Medicines Australia has commenced a Review of its Code of Conduct and invites public…

Asia-PacificGlaxoSmithKlineMarkets & MarketingPharmaceuticalRegulation

EMA advisory panel backs Bayer’s Xarelto for AF-related stroke prevention and DVT

26-09-2011

There was more good news for Bayer HealthCare, the pharma unit of Germany’s Bayer AG (BAY: DE),…

BayerCardio-vascularEuropePharmaceuticalRegulationXarelto

USA’s GPhA calls on “Super Committee” to pursue policies encouraging use of generic drugs

25-09-2011

The US Generic Pharmaceutical Association (GPhA) says it has sent a letter to Co-Chairs Senator Patty…

GenericsNorth AmericaPoliticsRegulation

EMA recommends restricting use of Sanofi AF drug Multaq, but sees positive benefit-risk in some patients

23-09-2011

There was mixed news for French drug major Sanofi (Euronext: SAN) yesterday, when the European Medicines…

Cardio-vascularEuropeMultaqPharmaceuticalRegulationSanofi

European action needed to protect patients from unlicensed/off-label medicines, say patient groups

22-09-2011

Four European patient organizations have published a consensus statement raising concerns about the unlicensed…

HealthcareMarkets & MarketingPharmaceuticalRegulation

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