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Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

Aspen Will Pay UK's NHS £8m In Landmark Deal Following Competition Probe

Aspen has agreed to pay the National Health Service £8m following an investigation by the Competition and Markets Authority.

Compliance Legal Issues

Dr Reddy's Is Knocked Back On US NuvaRing And Copaxone Rivals

Dr Reddy’s has received a further CRL from the US Food and Drug Administration over its application for a generic rival to Merck Sharp & Dohme’s NuvaRing contraceptive, along with a CRL for its version of Teva’s Copaxone.

Regulation United States

Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating

Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.

Value-Added Medicines FDA
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Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

Generics Players Dominating New OTC Launches In Germany

An analysis by Sempora Consulting of the German OTC market in 2018 shows that generic products dominate new OTC product launches.
Health OTC Drugs

Industry Pact Aligns Canadian Prices To International Levels

An agreement between industry and authorities in effect from April last year is already having a major effect in ensuring Canadian generics prices are similar to those in other developed markets, an official report shows.

Canada Pricing Debate

Teligent Prepares For Injectables Filings With Strengthened Team

As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions. 

United States Business Strategies
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Intellectual Property Explore this Topic

Set Alert for Intellectual Property

Generics Players Dominating New OTC Launches In Germany

An analysis by Sempora Consulting of the German OTC market in 2018 shows that generic products dominate new OTC product launches.
Health OTC Drugs

Industry Pact Aligns Canadian Prices To International Levels

An agreement between industry and authorities in effect from April last year is already having a major effect in ensuring Canadian generics prices are similar to those in other developed markets, an official report shows.

Canada Pricing Debate

Teligent Prepares For Injectables Filings With Strengthened Team

As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions. 

United States Business Strategies
See All

Market Intelligence Explore this Topic

Set Alert for Market Intelligence

Generics Players Dominating New OTC Launches In Germany

An analysis by Sempora Consulting of the German OTC market in 2018 shows that generic products dominate new OTC product launches.
Health OTC Drugs

Industry Pact Aligns Canadian Prices To International Levels

An agreement between industry and authorities in effect from April last year is already having a major effect in ensuring Canadian generics prices are similar to those in other developed markets, an official report shows.

Canada Pricing Debate

Teligent Prepares For Injectables Filings With Strengthened Team

As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions. 

United States Business Strategies
See All
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