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- PMLiVE

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- PMLiVE

Pharma companies back Rare Disease Day

Genzyme, Shire and more hold global campaigns today

- PMLiVE

AZ gets limited approval for metreleptin in US

First FDA-backed treatment for rare disease lipodystrophy

Bristol-Myers Squibb (BMS) building

BMS’ oral hepatitis C regimen gets breakthrough status

Combines daclatasvir and asunepravir

- PMLiVE

FDA expands efforts to test quality of generics

Monitoring programme to ensure drug copies are equivalent to branded medicines

The distressing impact of rare diseases

Much more needs to be done to address the problem of effective communications with stakeholders and adequate information for patients affected

- PMLiVE

EMA and FDA create pharmacovigilance ‘cluster’

Monthly meetings to discuss key issues in medicines safety

- PMLiVE

FDA mulls use of side effect voiceover in TV advertising

Agency considers updating how drug risks are communicated

- PMLiVE

FDA approves Chelsea’s rare blood pressure drug

US biopharma company gets green light in US for Northera

- PMLiVE

US and Indian regulators forge closer ties

FDA signs new agreement with India's Ministry of Health and Family Welfare

Define the patient burden in rare diseases

Putting patients and carers at the heart of the value demonstration equation in orphan drugs is key

- PMLiVE

FDA backs BioMarin drug for rare enzyme disorder

Vimizim is first drug approved in US under rare paediatric disease priority review

- PMLiVE

FDA knocks back J&J and Bayer’s Xarelto in ACS

Follows unanimous negative committee vote

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