Generics - North America, Eastern Europe

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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

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

Ukraine drug imports halted due to VAT confusion

Ukraine drug imports halted due to VAT confusion

15-04-2014

Imports of medicines into Ukraine have completely stopped, due to current confusions regarding the value-added…

Eastern EuropeFinancialMarkets & MarketingPharmaceuticalUkraine

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

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

Russia may tighten criteria for the patentability of drugs

Russia may tighten criteria for the patentability of drugs

14-04-2014

The Russian Federal Anti-Monopoly Service is considering tightening the criteria of patentability, in…

Eastern EuropePatentsPharmaceuticalPoliticsRussia

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

Potential growth trajectories for the US biopharmaceutical sector

Potential growth trajectories for the US biopharmaceutical sector

11-04-2014

The Pharmaceutical Research and Manufacturers of America (PhRMA) yesterday released a report that outlines…

North AmericaPharmaceuticalPoliticsResearchUSA

Despite focus on generics, South Korean pharma market to reach $24.3 billion by 2020

Despite focus on generics, South Korean pharma market to reach $24.3 billion by 2020

10-04-2014

As a result of a high level of access to health care insurance and reimbursement, coupled with increasing…

Asia-PacificGenericsMarkets & MarketingPolitics

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

09-04-2014

US drugmaker Forest Laboratories and partner Almirall, Spain’s largest pharma company, say they have…

aclidiniumAlmirallForest LaboratoriesformoterolNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryUSA

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