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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

FDA advisory panel votes to approve Merck & Co’s vorapaxar

FDA advisory panel votes to approve Merck & Co’s vorapaxar

16-01-2014

There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationUSAvorapaxarZontivity

MegaPharm receives marketing and reimbursement approval for Ruconest in Israel

15-01-2014

Privately-owned Israeli pharmaceutical company MegaPharm, partner of Dutch biotech company Pharming Group…

Cardio-vascularMegapharmPharmaceuticalPharmingRegulationRuconest

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

Surprise FDA advisory panel backing for Chelsea’s Northera

Surprise FDA advisory panel backing for Chelsea’s Northera

15-01-2014

A US Food and Drug Administration advisory panel has voted 16-one to recommend approval of US biotech…

BiotechnologyCardio-vascularChelsea TherapeuticsNorth AmericaNortheraRegulationUSA

Actavis restructures, appointing industry veterans to lead US Specialty Brands business units

Actavis restructures, appointing industry veterans to lead US Specialty Brands business units

14-01-2014

US generics and specialty drugmaker Actavis has announced an updated business structure for its US Specialty…

ActavisBoardroomGenericsManagement

Amneal appoints former Warner Chilcott senior VP Rochelle Fuhrmann as CFO

14-01-2014

Privately-held US generics drugmaker Amneal has announced Rochelle Fuhrmann has joined the company as…

Amneal PharmaBoardroomGenericsUSAWarner Chilcott

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

Hint of minor added benefit for Bayer’s Stivarga seen by IQWiG

Hint of minor added benefit for Bayer’s Stivarga seen by IQWiG

13-01-2014

There was a hint of positive news for German drug major Bayer, when the German Institute for Quality…

BayerGermanyNorthern EuropeOncologyPharmaceuticalPricingRegulationStivarga

EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

10-01-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended…

Anti-Arthritics/RheumaticsEuropeOsseorPharmaceuticalProtelosRegulationServierWomen's Health

US drug approvals lower than previously reported; new study

10-01-2014

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearchUSA

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

09-01-2014

Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition…

BiosimilarsGenericsJanssenJohnson & JohnsonNorth AmericaRegulationUSA

Allergan closes $65 million deal with Medytox

Allergan closes $65 million deal with Medytox

09-01-2014

This week US drugmaker Allergan (NYSE: AGN) announced that it has closed a $65 million license agreement…

AllerganAsia-PacificBotoxDermatologicalsLicensingMedytoxPharmaceuticalRegulationUKUSA

Teva confirms appointment of Erez Vigodman as president and CEO

Teva confirms appointment of Erez Vigodman as president and CEO

09-01-2014

Somewhat sooner than expected, Isael’s Teva Pharmaceutical Industries, the world’s largest generics…

BoardroomGenericsManagementTeva Pharmaceutical Industries

Report: India’s strong commercial opportunities hampered by bureaucracy and poor policy planning

Report: India’s strong commercial opportunities hampered by bureaucracy and poor policy planning

09-01-2014

Due to its large population and substantial unmet medical needs, India represents a market with strong…

Asia-PacificIndiaMarkets & MarketingPharmaceuticalPricingRegulation

GSK gains accelerated FDA approval for combination use of Mekinist and Tafinlar

GSK gains accelerated FDA approval for combination use of Mekinist and Tafinlar

09-01-2014

GlaxoSmithKline (LSE: GSK) says that the US Food and Drug Administration has approved Mekinist (trametinib)…

GlaxoSmithKlineMekinistOncologyPharmaceuticalRegulationTafinlarUKUSA

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

09-01-2014

Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesFarxigaNorth AmericaPharmaceuticalRegulationUSA

Added benefit of Sanofi’s Aubagio not proven, says IQWiG

Added benefit of Sanofi’s Aubagio not proven, says IQWiG

08-01-2014

In yet another negative opinion from the German Institute for Quality and Efficiency in Health Care (IQWiG)…

AubagioGermanyNeurologicalNorthern EuropePharmaceuticalPricingRegulationSanofi

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

08-01-2014

Japanese drug major Daiichi Sankyo (TYO: 4568) has submitted a Marketing Authorization Application to…

Asia-PacificCardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulation

Ranbaxy cleared to market branded generic of Aricept in Canada

Ranbaxy cleared to market branded generic of Aricept in Canada

08-01-2014

The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil…

AriceptCanadaDaiichi SankyoEisaiGenericsNeurologicalNorth AmericaRAN-DonepezilRanbaxy LaboratoriesRegulation

Added benefit of Bayer’s Eylea again not proven, says IQWiG

Added benefit of Bayer’s Eylea again not proven, says IQWiG

08-01-2014

For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG)…

BayerEyleaGermanyNorthern EuropeOphthalmicsPharmaceuticalPricingRegulation

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