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Ukraine’s new Health Minister outlines priorities at meeting with APRAD

Ukraine’s new Health Minister outlines priorities at meeting with APRAD

22-12-2014

At the instance of Association of Pharmaceutical Research and Development (APRAD), the Ministry of Health…

PharmaceuticalPoliticsPricingRegulationUkraine

OPEN Act introduced in USA to repurpose drugs for rare diseases

OPEN Act introduced in USA to repurpose drugs for rare diseases

26-11-2014

Last week, US Representatives Gus Bilirakis (Republican, Florida) and G K Butterfield (Democrat, North…

PharmaceuticalPoliticsRare diseasesRegulationUSA

France negotiates lowest price in Europe for Gilead’s Sovaldi

France negotiates lowest price in Europe for Gilead’s Sovaldi

21-11-2014

The discount negotiated by the French government on hepatitis C drug Sovaldi (sofosbuvir), produced by…

FranceGilead SciencesNephrology and HepatologyPharmaceuticalPoliticsPricingRegulationSovaldi

UK government looks to speed up access to new medicines

UK government looks to speed up access to new medicines

20-11-2014

The UK government has announced a substantial investment package from industry, and that it is to carry…

BiotechnologyPoliticsRegulationUKUnited Kingdom

Canada passes Vanessa's Law on unsafe medicines

Canada passes Vanessa's Law on unsafe medicines

11-11-2014

New legislation known as Vanessa’s Law (Bill C 17; the Protecting Canadians from Unsafe Drugs Act)…

CanadaMinister of HealthPharmaceuticalPoliticsRegulation

India takes action on spurious and sub-standard drugs

India takes action on spurious and sub-standard drugs

10-11-2014

An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals…

GenericsIndiaMarkets & MarketingPharmaceuticalPoliticsRegulation

Russian Parliament to restrict imports of unregistered drugs

30-10-2014

The Russian National Parliament (State Duma) plans to impose a ban on the imports of unregistered drugs…

PharmaceuticalPoliticsRegulationRussia

European Commission abandons plan to transfer control of pharma products to Industry Commissioner

European Commission abandons plan to transfer control of pharma products to Industry Commissioner

14-10-2014

Jean-Claude Juncker, President-elect of the European Commission, has backtracked on his decision to return…

Clinical researchEuropePharmaceuticalPoliticsRegulation

Update: Negotiations on EU-Canada Free Trade Agreement concluded

Update: Negotiations on EU-Canada Free Trade Agreement concluded

29-09-2014

Canadian trade group Research-Based Pharmaceutical Companies (Rx&D) expressed its support to the government…

CanadaEuropeGenericsMarkets & MarketingPatentsPoliticsRegulation

Bill to increase competition for generic drugs introduced in USA

Bill to increase competition for generic drugs introduced in USA

19-09-2014

US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined…

GenericsLegalPoliticsRegulationUSA

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

Indian clinical trial rules counter-productive, says ASSOCHAM

Indian clinical trial rules counter-productive, says ASSOCHAM

10-09-2014

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback…

IndiaPharmaceuticalPoliticsRegulationResearch

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

Australian Health Ministers sign on to end HIV transmissions by 2020

Australian Health Ministers sign on to end HIV transmissions by 2020

21-07-2014

All Australian Health Ministers have committed to working towards the virtual elimination of new Australian…

AIDSAnti-viralsAustraliaHealthcareHIV/AIDSPharmaceuticalPoliticsRegulation

Congressional hearing in Brazil will discuss the efficacy of generic medicines

26-05-2014

The Brazilian Commission for Consumer Protection will soon hold a hearing to discuss the effectiveness…

BrazilGenericsPoliticsRegulation

Ukraine pharma trade group APRaD sets out priorities with Vice PM and Customs authority

Ukraine pharma trade group APRaD sets out priorities with Vice PM and Customs authority

14-04-2014

The Ukraine Association of Pharmaceutical Research and Development (APRaD) participated in a meeting…

Eastern EuropePharmaceuticalPoliticsPricingRegulationUkraine

US/EU generic industries call for thoughtful changes to speed medicines to patients

US/EU generic industries call for thoughtful changes to speed medicines to patients

08-04-2014

In a joint letter sent to the European Commission and the Office of the US Trade Representative, the…

EuropeGenericsPoliticsRegulationUSA

European generic drug makers sets out priorities for EU Trade Policy

European generic drug makers sets out priorities for EU Trade Policy

02-04-2014

European Generic Medicines Association (EGA) revealed this morning that its president, Nick Haggar, has…

EuropeGenericsPoliticsRegulationRest of the World

US lawmakers question price of Gilead’s Sovaldi

US lawmakers question price of Gilead’s Sovaldi

24-03-2014

Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPoliticsPricingRegulationSovaldiUSA

US FDA visit to India results in first Statement of Intent

US FDA visit to India results in first Statement of Intent

12-02-2014

A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family…

IndiaPharmaceuticalPoliticsRegulationUSA

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

30-01-2014

US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee,…

GenericsNorth AmericaPoliticsRegulationUSA

UK report on life sciences calls for greater freedoms for EU member states

UK report on life sciences calls for greater freedoms for EU member states

15-01-2014

A new UK report condemns the European Union’s “anti-biotech legislation” which is damaging Europe’s…

BiotechnologyEuropePoliticsRegulation

EMA guidance on publication and access to clinical trial data expected in 2014

EMA guidance on publication and access to clinical trial data expected in 2014

17-12-2013

Discussions on publication and access to clinical trial data are on schedule to be published in 2014…

EuropePharmaceuticalPoliticsRegulation

OncoMed CEO presses for better environment for biopharma innovation, at House hearings

13-12-2013

The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight…

BiotechnologyNorth AmericaOncoMed PharmaceuticalsPoliticsRegulationResearch

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