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Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

19-12-2014

Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine…

ADI-PEG 20OncologyPharmaceuticalPolaris GroupRegulation

CSL Behring files BLA for hemophilia B agent

CSL Behring files BLA for hemophilia B agent

18-12-2014

USA-based CSL Behring, a unit of Australia’s CSL Ltd, has submitted a biologics license application…

CSL BehringCSL LimitedHematologyPharmaceuticalRegulationUSA

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

18-12-2014

US pharma company Pozen has received a second complete response letter from the US Food and Drug Administration…

Cardio-vascularPharmaceuticalPozenRegulationUSAYosprala 325/40Yosprala 81/40

European Commission grants marketing authorization to AstraZeneca's Lynparza

European Commission grants marketing authorization to AstraZeneca's Lynparza

18-12-2014

Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission…

AstraZenecaLynparzaOncologyPharmaceuticalRegulation

FDA approves Alcon’s Xtoro to treat swimmer’s ear

FDA approves Alcon’s Xtoro to treat swimmer’s ear

18-12-2014

The US Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used…

Acute otitis externaAlcon LaboratoriesAntibiotics and Infectious diseasesHealthNovartisPharmaceuticalRegulationUSAXtoro

Eisai's Halaven now available in Russia for advanced breast cancer

Eisai's Halaven now available in Russia for advanced breast cancer

18-12-2014

Halaven (eribulin) manufactured by Japanese drug major Eisai is now available in Russia.

EisaiHalavenOncologyPharmaceuticalRegulationRussia

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

17-12-2014

The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

NICE backs Pradaxa for treating and preventing potentially fatal blood clots

NICE backs Pradaxa for treating and preventing potentially fatal blood clots

17-12-2014

In final guidance published today, UK health cost watchdog the National Institute for Health and Care…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulationUK

Trade groups call for integrated life science strategy ahead of European Commission Work Program

Trade groups call for integrated life science strategy ahead of European Commission Work Program

16-12-2014

European research and generic/biosimilar industry associatins have called for an integrated life science…

Advocacy groupsCompetitivenessEuropePharmaceuticalRegulation

Novartis gains US FDA approval of Signifor for acromegaly

Novartis gains US FDA approval of Signifor for acromegaly

16-12-2014

The US Food and Drug Administration has approved Swiss pharma giant Novartis’ Signifor (pasireotide)…

NovartisPharmaceuticalRare diseasesRegulationSigniforUSA

UK’s NICE recommends Pfizer’s Inlyta for kidney cancer

UK’s NICE recommends Pfizer’s Inlyta for kidney cancer

16-12-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new…

InlytaOncologyPfizerPharmaceuticalPricingRegulationUK

Added benefit of Eylea over Lucentis in DME not proven, says IQWiG

Added benefit of Eylea over Lucentis in DME not proven, says IQWiG

16-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has compared trial data on German…

BayerEyleaGermanyLucentisNovartisOphthalmicsPharmaceuticalPricingRegulationRoche

UK NICE partially backs Bayer’s Xofigo in preliminary assessment

UK NICE partially backs Bayer’s Xofigo in preliminary assessment

15-12-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) have recommended…

BayerOncologyPharmaceuticalPricingRegulationUKXofigo

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

15-12-2014

Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application…

BiotechnologycobimetinibExelixisGenentechOncologyRegulationRocheUSAZelboraf

India’s National Pharmaceutical Pricing Authority caps price of 52 more drugs

India’s National Pharmaceutical Pricing Authority caps price of 52 more drugs

15-12-2014

The National Pharmaceutical Pricing Authority (NPPA) of India has issued a notice capping prices of 52…

BaxterGlaxoSmithKlineIndiaPharmaceuticalPricingRegulationWockhardt

Australian mid-year economic and fiscal outlook does not show cost increases for PBS

Australian mid-year economic and fiscal outlook does not show cost increases for PBS

15-12-2014

The Mid-Year Economic and Fiscal Outlook released by the Australian government did not indicate any cost…

AustraliaHealthcare in AustraliaMedicines AustraliaPharmaceuticalRegulation

FDA approves third indication for Lilly’s Cyramza

FDA approves third indication for Lilly’s Cyramza

13-12-2014

The US Food and Drug Administration on Friday expanded the approved use of pharma major Eli Lilly’s…

CyramzaEli LillyOncologyPharmaceuticalRegulationUSA

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

13-12-2014

French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food…

Anti-viralsFluzonePharmaceuticalRegulationSanofiSanofi PasteurUSAVaccines

FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

12-12-2014

The US Food and Drug Administration has so far approved 35 novel drugs this year, compared to 27 last…

BlincytoHarvoniPharmaceuticalRegulationUSA

US FDA issues warning on Pfizer’s Geodon

US FDA issues warning on Pfizer’s Geodon

11-12-2014

The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under…

GeodonNeurologicalPfizerPharmaceuticalRegulationUSAZiprasidone

UK industry makes third quarter PPRS payment, Department of Health sets 2015 percentage at 10.36%

UK industry makes third quarter PPRS payment, Department of Health sets 2015 percentage at 10.36%

11-12-2014

The UK pharma industry has made its third quarter payment to underwrite the growth of the medicines bill…

ABPIDepartment of HealthPharmaceuticalRegulationUK

GlaxoSmithKline files for EU extended indication for Volibris in PAH

GlaxoSmithKline files for EU extended indication for Volibris in PAH

11-12-2014

UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency…

EuropeGilead SciencesGlaxoSmithKlineLetairisPharmaceuticalRegulationRespiratory and PulmonaryVolibris

US generic trade group supports compromise legislation for biosimilars

US generic trade group supports compromise legislation for biosimilars

11-12-2014

The USA's Generic Pharmaceutical Association (GPhA) has agreed to support compromise automatic substitution…

BiosimilarsGenericsLegalRegulationUSA

1 to 25 of 2712 results

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