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EMA plans targeted discussions on clinical trial data policy

EMA plans targeted discussions on clinical trial data policy

09-04-2014

The European Medicines Agency will launch a final round of targeted consultations with key stakeholders…

EuropePharmaceuticalRegulationResearch

Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

US/EU generic industries call for thoughtful changes to speed medicines to patients

US/EU generic industries call for thoughtful changes to speed medicines to patients

08-04-2014

In a joint letter sent to the European Commission and the Office of the US Trade Representative, the…

EuropeGenericsPoliticsRegulationUSA

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

GSK faces fresh allegations of “inproper conduct” in Iraq

GSK faces fresh allegations of “inproper conduct” in Iraq

08-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribery in Iraq, less than a year after the…

ChinaGlaxoSmithKlineGSKIraqMajorPharmaceuticalRegulationUK

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

07-04-2014

Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to…

BiosimilarsEuropeFilgrastimInterviewsMarkets & MarketingRegulationSandoz

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Safinamide marketing application submitted to Swissmedic

07-04-2014

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

Markets & MarketingNeurologicalNewron PharmaNorthern EuropePharmaceuticalRegulationsafinamideZambon

EMA and Australia’s TGA collaborate in the area of orphan medicines

EMA and Australia’s TGA collaborate in the area of orphan medicines

07-04-2014

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi,…

AustraliaEuropePharmaceuticalRare diseasesRegulation

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada

04-04-2014

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

BiotechnologyGenzymeLemtradaNeurologicalNorthern EuropeRegulationSanofiUK

UK’s NICE reverses negative decision on Roche’s Tarceva for NSCLC

04-04-2014

Following a consultation period, the UK drug watchdog the National Institute for Health and Care Excellence…

Northern EuropeOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

Astellas files for wider use of prostate cancer drug Xtandi in Europe

03-04-2014

Japanese drug major Astellas Pharma has submitted a variation to amend the Marketing Authorization Application…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalRegulationXtandi

MEPs vote for more transparent and simpler European clinical trial rules

03-04-2014

Pharmaceutical companies and academic researchers will have to post the results of all their European…

EuropePharmaceuticalRegulationResearch

Global Fund taps pharmaceutical expertise in China

02-04-2014

The Global Fund is deepening its partnership with China by tapping the expertise of Chinese pharmaceutical…

Anti-viralsAntibiotics and Infectious diseasesChinaGlobalMarkets & MarketingPharmaceuticalProductionRegulation

Hikma’s US facility back in compliance

Hikma’s US facility back in compliance

02-04-2014

Hikma Pharmaceuticals, Jordan's largest pharmaceutical company, has received a close-out letter from…

GenericsHikma PharmaceuticalsJordanPharmaceuticalRegulation

European generic drug makers sets out priorities for EU Trade Policy

European generic drug makers sets out priorities for EU Trade Policy

02-04-2014

European Generic Medicines Association (EGA) revealed this morning that its president, Nick Haggar, has…

EuropeGenericsPoliticsRegulationRest of the World

US FDA approves Stallergenes’ allergy tablet Oralair

US FDA approves Stallergenes’ allergy tablet Oralair

02-04-2014

The US Food and Drug Administration has approved Oralair immunotherapy tablet from French allergen specialist…

ImmunologicalsOralairPharmaceuticalRegulationStallergenesUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

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