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FDA cites insufficient information in response to AMAG’s Feraheme application

FDA cites insufficient information in response to AMAG’s Feraheme application

23-01-2014

US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the…

AMAG PharmaceuticalsFerahemeHematologyNephrology and HepatologyPharmaceuticalRegulationUSA

Actavis confirms challenge to Allergan’s Restasis

22-01-2014

Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated…

ActavisAllerganGenericsNorth AmericaOphthalmicsPatentsRegulationRestasisUSAWatson Pharmaceuticals

Evidence used for FDA decisions “varies widely,” study claims

Evidence used for FDA decisions “varies widely,” study claims

22-01-2014

The quality of clinical trial evidence used by the US Food and Drug Administration as the basis for recent…

PharmaceuticalRegulationUSA

Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

22-01-2014

The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted…

amatuximabEisaiEuropePharmaceuticalRare diseasesRegulation

Lundbeck’s Brintellex available in US pharmacies for depression

Lundbeck’s Brintellex available in US pharmacies for depression

22-01-2014

Lundbeck (LUN: CO) and Takeda Pharmaceutical (TYO: 4502) jointly announced today that Brintellix (vortioxetine)…

BrintellixLundbeckMarkets & MarketingNeurologicalPharmaceuticalRegulationTakeda PharmaceuticalsUSA

AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

22-01-2014

The European Commission has approved Anglo-Swedish drug major AstraZeneca and soon to be ex-partner USA-based…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesPharmaceuticalRegulationXigduo

NICE recommends Sanofi’s Aubagio as new treatment option for MS

NICE recommends Sanofi’s Aubagio as new treatment option for MS

22-01-2014

In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

AubagioBiotechnologyGenzymeNeurologicalNorthern EuropePricingRegulationSanofiUK

Par Pharmaceutical to acquire JHP Pharmaceutical

21-01-2014

US privately-held Par Pharmaceutical has entered into a definitive agreement to acquire JHP Group Holdings,…

GenericsJHP PharmaceuticalsMergers & AcquisitionsPar Pharmaceutical

Norgine and Kissei’s Savene approved in Japan

21-01-2014

Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from…

Asia-PacificKissei PharmaceuticalNorgineOncologyPharmaceuticalRegulationSavene

New data reveals substantial variation in patients’ access to medicines across England

New data reveals substantial variation in patients’ access to medicines across England

21-01-2014

Analysis showing the extent to which the UK National Health Service (NHS) is prescribing National Institute…

HealthcarePharmaceuticalRegulationUK

Santhera's Raxone granted temporary use in France

21-01-2014

Switzerland-based Santhera Pharmaceuticals (SIX: SANN) announced today that the French National Agency…

FranceNeurologicalPharmaceuticalRaxoneRegulationSanthera Pharmaceuticals

81 European marketing authorization recommendations in 2013

81 European marketing authorization recommendations in 2013

21-01-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 81…

EuropePharmaceuticalRegulation

Japanese approval for Bayer’s riociguat for CTEPH

Japanese approval for Bayer’s riociguat for CTEPH

20-01-2014

German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare for riociguat,…

AdempasAsia-PacificBayerPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

20-01-2014

US emerging biotech firm Aegerion Pharmaceuticals says that the Mexican Federal Commission for the Protection…

Aegerion PharmaceuticalsJuxtapidMexicoPharmaceuticalRare diseasesRegulationSouth America

Astellas gains Japanese clearance for diabetes drug Suglat

Astellas gains Japanese clearance for diabetes drug Suglat

20-01-2014

Japanese drug major Astellas Pharma has obtained the marketing approval of selective SGLT2 inhibitor…

Asia-PacificAstellas PharmaDiabetesipragliflozinKotobuki PharmaceuticalMerck & CoPharmaceuticalRegulationSuglat

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

20-01-2014

US antivirals specialist Gilead Sciences has received marketing authorization from the European Commission…

Anti-viralsBiotechnologyEuropeGilead SciencesPricingRegulationSovaldi

Takeda's lymphoma drug Adcetris approved in Japan

Takeda's lymphoma drug Adcetris approved in Japan

18-01-2014

Japan’s largest drugmaker Takeda Pharmaceutical has received approval from the country’s Ministry…

AdcetrisFinancialOncologyPharmaceuticalRegulationSeattle GeneticsTakeda Pharmaceuticals

Actavis to divest certain European operations to Aurobindo

Actavis to divest certain European operations to Aurobindo

18-01-2014

US generics major Actavis plans to enter into an agreement with India’s Aurobindo Pharma for the latter…

ActavisAurobindo PharmaEuropeGenericsMergers & Acquisitions

Brazil initiates public consultation on interchangeability of biosimilar drugs

Brazil initiates public consultation on interchangeability of biosimilar drugs

17-01-2014

Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference…

BiosimilarsBrazilPharmaceuticalRegulationSouth America

Alvogen takes 67% stake in Lotus Pharma

17-01-2014

Privately-owned US generics firm Alvogen revealed that, last month, it agreed to become the majority…

AlvogenAsia-PacificGenericsLotus PharmaceuticalsMergers & Acquisitions

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea

16-01-2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

FDA recommends high-dose acetaminophen combo drugs be discontinued

FDA recommends high-dose acetaminophen combo drugs be discontinued

16-01-2014

The US Food and Drug Administration is recommending health care professionals discontinue prescribing…

NeurologicalNorth AmericaPharmaceuticalRegulationUSA

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