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US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

UK NICE backs Janssen’s Velcade for multiple myeloma

UK NICE backs Janssen’s Velcade for multiple myeloma

21-03-2014

In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence…

JanssenJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

Brazil Senate discusses pathways for advancement of clinical research

Brazil Senate discusses pathways for advancement of clinical research

20-03-2014

The Brazilian Senate's Social Affairs Committee (CAS) held a hearing on March 18 to debate the progress…

BrazilPharmaceuticalRegulationResearch

FDA approves Impavido to treat tropical disease leishmaniasis

FDA approves Impavido to treat tropical disease leishmaniasis

20-03-2014

The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine)…

Endo Health SolutionsImpavidoNorth AmericaPaladin LabsPharmaceuticalRegulationUSA

EMA to focus on pharmacovigilance and supporting development in 2014

EMA to focus on pharmacovigilance and supporting development in 2014

19-03-2014

The European Medicines Agency has published its work program for 2014 with a focus on legislative developments.

EuropeLegalPharmaceuticalRegulation

Pan-European survey calls for a shift in policy for biosimilars

Pan-European survey calls for a shift in policy for biosimilars

19-03-2014

This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European…

BiosimilarsBiotechnologyEuropeHealthcareRegulation

EGA calls for removal of barriers to competition and free trade for generics

EGA calls for removal of barriers to competition and free trade for generics

19-03-2014

The European Union must remove barriers to competition and free trade by introducing common sense reforms…

BiosimilarsEuropeGenericsMarkets & MarketingPatentsRegulation

Astellas and Medivation file sNDA for new Xtandi indication

Astellas and Medivation file sNDA for new Xtandi indication

18-03-2014

Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application…

Astellas PharmaMedivationNorth AmericaOncologyPharmaceuticalRegulationUSAXtandi

FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

18-03-2014

Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration…

DermatologicalsHemangeolNorth AmericaPharmaceuticalPierre FabreRegulationUSA

Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab

18-03-2014

Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma…

Asia-PacificAustraliaBiogen IdecBiotechnologyNatalizumabNeurologicalRegulationTysabri

Additional indication in Japan for Kyowa Hakko’s Poteligeo

Additional indication in Japan for Kyowa Hakko’s Poteligeo

18-03-2014

Japanese drugmaker Kyowa Hakko Kirin has received approval for additional indication for relapsed or…

Kyowa Hakko KirinOncologyPharmaceuticalPoteligeoRegulation

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

17-03-2014

UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new…

Boehringer IngelheimGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

Undervaluing new medicines threatens patient wellbeing and economic growth; report

Undervaluing new medicines threatens patient wellbeing and economic growth; report

14-03-2014

Innovative medicines and other new therapies have extended life expectancy by some 10 years since the…

HealthcareNorthern EuropePharmaceuticalPricingRegulationUK

UK plans for early access to medicines scheme

UK plans for early access to medicines scheme

14-03-2014

Severely ill patients in the UK, and those with rare debilitating conditions, could be given new medicines…

HealthcareNorthern EuropePharmaceuticalRegulationUK

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

14-03-2014

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration…

Asia-PacificGenericsIndiaProductionRegulation

NICE says better information needed on Celgene’s MM drug

NICE says better information needed on Celgene’s MM drug

14-03-2014

The UK drugs watchdog, the National Institute for Health and care Excellence (NICE) says that, based…

BiotechnologyCelgeneNorthern EuropeOncologyPricingRegulationRevlimidUK

Taiwan’s TaiGen Biotech receives domestic marketing approval for Taigexyn

13-03-2014

Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration has…

Antibiotics and Infectious diseasesAsia-PacificBiotechnologyRegulationTaiGen BiotechTaigexyn

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

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