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Australian government U-turn on PBS listing of drugs


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


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


Astellas drops development of blood thinner darexaban


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


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


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


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”


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


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


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


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


Medicines Australia starts new Code of Conduct review


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


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


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


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


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


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


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

HealthcareMarkets & MarketingPharmaceuticalRegulation

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