Generics - North America, Regulation

Filter

Current filters:

North AmericaRegulation

Popular Filters

1 to 25 of 3999 results

GSK confirms further misconduct allegations, now in Jordan and Lebanon

17-04-2014

There has been recent publicity on cases of alleged misconduct by UK Pharma giant GlaxoSmithKline employees…

GlaxoSmithKlineJordanMarkets & MarketingPharmaceuticalRegulationRest of the World

Teva and Pfizer settle patent litigation over Celebrex

17-04-2014

Israel-based Teva Pharmaceutical Industries says that its US subsidiary has settled a law suit with US…

Anti-Arthritics/RheumaticsCelebrexGenericsNorth AmericaPatentsPfizerTeva Pharmaceutical IndustriesUSA

Astellas settles with US DoJ over Mycamine marketing

Astellas settles with US DoJ over Mycamine marketing

17-04-2014

The US subsidiary of Japanese drug major Astellas Pharma will pay $7.3 million to resolve allegations…

Antibiotics and Infectious diseasesAstellas PharmaLegalMarkets & MarketingMycamineNorth AmericaPharmaceuticalUSA

EMA says that vials of falsified Herceptin have been identified

EMA says that vials of falsified Herceptin have been identified

16-04-2014

The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster…

EuropeHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

Prosonix and Mylan in deal for Flixotide and Flovent generics

15-04-2014

Prosonix, a UK-based company which is developing a portfolio of inhaled “Respiratory Medicines by Design,”…

FloventGenericsGlaxoSmithKlineGlobalLicensingMylan LaboratoriesProsonixRespiratory and Pulmonary

FTC imposes conditions on Akorn’s proposed buy of Hi-Tech Pharmacal

15-04-2014

In order to consummate the proposed $640 million acquisition of Hi-Tech Pharmacal by fellow USA-based…

ActavisAkornGenericsHi-Tech PharmacalMergers & AcquisitionsNorth AmericaUSA

Depomed settlements with two Gralise ANDA filers

15-04-2014

US specialty drugmaker Depomed has entered into settlement agreements with two of the three defendants…

DepomedGenericsGraliseIncepta PharmaceuticalsLegalNeurologicalNorth AmericaPatentsUSAZydus Cadila

Total spending growth returns for US medicines, reports IMS Health

Total spending growth returns for US medicines, reports IMS Health

15-04-2014

Total spending on US medicines increased 1.0% on a real per capita basis in 2013, while the use of health…

FinancialHealthcareMarkets & MarketingNorth AmericaPharmaceuticalUSA

EMA concludes inquiry into Roche infringement procedure

EMA concludes inquiry into Roche infringement procedure

14-04-2014

The European Medicines Agency says it has concluded its inquiry into alleged non-compliance with pharmacovigilance…

EuropePharmaceuticalRegulationRoche

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

Extended US market exclusivity for BioMarin's rare disease drug Kuvan

14-04-2014

US drugmaker BioMarin Pharmaceutical says that the Food and Drug Administration has granted Kuvan (sapropterin…

BioMarin PharmaceuticalKuvanNorth AmericaPharmaceuticalRare diseasesRegulationUSA

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

Indian govt plans to support a competitive pharma sector, especially for SMEs

Indian govt plans to support a competitive pharma sector, especially for SMEs

14-04-2014

In a bid to strengthen the existing infrastructure facilities and to enable the Indian pharmaceutical…

Asia-PacificGenericsIndiaMarkets & MarketingPoliticsProduction

Sylvia Mathews Burwell nominated as next US HHS Secretary as Sebelius quits

Sylvia Mathews Burwell nominated as next US HHS Secretary as Sebelius quits

14-04-2014

On Friday in a Rose Garden ceremony, US President Barack Obama announced that Sylvia Mathews Burwell,…

ManagementNorth AmericaPharmaceuticalPoliticsUSA

Impax Pharma resubmits NDA for Rytary

Impax Pharma resubmits NDA for Rytary

11-04-2014

Impax Laboratories’ branded products division has resubmitted the New Drug Application for Rytary (carbidopa…

Impax LaboratoriesNeurologicalNorth AmericaPharmaceuticalRegulationRytaryUSA

US Judge enforces settlement deal between Mylan and Endo over generic Frova

US Judge enforces settlement deal between Mylan and Endo over generic Frova

11-04-2014

US generic major Mylan today confirmed that a federal district court has granted its request to enforce…

Endo Health SolutionsEndo PharmaceuticalsFrovaGenericsLegalMylan LaboratoriesNeurologicalNorth AmericaPatentsUSA

1 to 25 of 3999 results

Company Spotlight

Fibrotech

Fibrotech

Back to top