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US biosimilar approvals poised to grow, but market uptake faces challenges, says Tufts CSDD

05-03-2015

Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns…

BiosimilarsBiotechnologyFinancialMarkets & MarketingRegulationUSA

European generics group launches Code of Conduct

05-03-2015

Following the adoption of the European Commission Guiding Principles Promoting Good Governance in the…

BiosimilarsEuropeGenericsMarkets & MarketingRegulation

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

05-03-2015

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers…

BiotechnologyBristol-Myers SquibbOncologyOpdivoRegulationUSA

Positive EMA/CHMP opinion for a label update of Brintellix

Positive EMA/CHMP opinion for a label update of Brintellix

05-03-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…

BrintellixEuropeLundbeckNeurologicalPharmaceuticalRegulation

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

04-03-2015

The US Food and Drug Administration has accepted German pharma major Bayer’s Biologics License Application…

BAY 81-8973BayerBiotechnologyHematologyKovaltryRegulationUSA

US FDA warns on over-prescribing of testosterone products

US FDA warns on over-prescribing of testosterone products

04-03-2015

The US Food and Drug Administration is requiring that the manufacturers of all approved prescription…

AbbVieAndroGelAxironEli LillyMen's HealthPharmaceuticalRegulationUSA

Orexigen shares jump on Contrave trial interim data but FDA orders more cardio studies

Orexigen shares jump on Contrave trial interim data but FDA orders more cardio studies

04-03-2015

The US Food and Drug Administration has said it is “disappointed” by Orexigen Therapeutics’ decision…

ContraveMetabolicsNeurologicalOrexigen TherapeuticsPharmaceuticalRegulationUSA

FDA formally accepts Actelion's NDA for Uptravi

FDA formally accepts Actelion's NDA for Uptravi

04-03-2015

Switzerland-based Actelion, Europe’s largest biotech company, says that the US Food and Drug Administration…

ActelionBiotechnologyRegulationRespiratory and PulmonaryselexipagUptraviUSA

Oncolytics Biotech gains third orphan status for Reolysin

Oncolytics Biotech gains third orphan status for Reolysin

03-03-2015

Canada’s Oncolytics Biotech revealed today that the US Food and Drug Administration has granted Orphan…

BiotechnologyOncologyOncolytics BiotechRare diseasesRegulationReolysinUSA

FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia

FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia

03-03-2015

The US Food and Drug Administration has declined to expand the approval of Exparel (bupivacaine), manufactured…

AnalgesiaExparelPacira PharmaceuticalsPharmaceuticalRegulationUSA

Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

03-03-2015

Belgian cell therapy specialist Cardio3 BioSciences has received a Pediatric Investigation Plan (PIP)…

BiotechnologyC-CureCardio-vascularCardio3 BioSciencesEuropeRegulation

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

03-03-2015

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England,…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationUK

Positive Ph III results for Portola’s Xarelto antidote andexanet alfa

02-03-2015

USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results…

andexanet alfaBayerBiotechnologyCardio-vascularPortola PharmaceuticalsRegulationResearchUSA

Boehringer Ingelheim files BLA with FDA for Pradaxa antidote idarucizumab

02-03-2015

German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA)…

BiotechnologyBoehringer IngelheimCardio-vascularidarucizumabPradaxaRegulationUSA

Shire files for US approval of Lifitegrast for dry eye disease

02-03-2015

Ireland-based drugmaker Shire has submitted a New Drug Application with the US Food and Drug Administration…

BiotechnologyEBI-005Eleven BiotherapeuticsLifitegrastOphthalmicsRegulationShireUSA

Celgene’s Abraxane gains new indication in Europe

02-03-2015

The European Commission has approved US biotech firm Celgene’s Abraxane (paclitaxel formulated as albumin-bound…

AbraxaneBiotechnologyCelgene CorpEuropeOncologyRegulation

Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

02-03-2015

Taiho Pharma Europe, a subsidiary of Japanese pharma company Otsuka (TYO: 4768), has submitted a marketing…

EuropeOncologyPharmaceuticalRegulationTaiho PharmaceuticalsTAS-102

Global drugmakers slam restrictions on state tendering in Russia

02-03-2015

Leading global pharmaceutical producers operating in the Russian market have criticized a recent decision…

PharmaceuticalPricingRegulationRussia

South Korea pharma news briefs

02-03-2015

News items, as posted by the Korean Research-based Pharmaceutical Industry Association (KRPIA) last month,…

FinancialPharmaceuticalPricingRegulationSouth Korea

Novartis hit with 15-day suspension over omission of adverse events reporting

Novartis hit with 15-day suspension over omission of adverse events reporting

02-03-2015

Swiss drug major Novartis has been ordered to suspend operations in Japan for 15 days as of March 5,…

JapanLegalNovartisPharmaceuticalRegulation

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

28-02-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

AvastinBiotechnologyEuropeOncologyRegulationRoche

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

28-02-2015

US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line…

AlprolixBiogen IdecBiotechnologyEuropeHematologyRegulationResearchSobiSwedish Orphan Biovitrum

Three new drugs recommended for approval by EMA/CHMP

Three new drugs recommended for approval by EMA/CHMP

27-02-2015

Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines…

AmgenEuropeJinarcNephrology and HepatologyNovartisOncologyOtsuka PharmaceuticalPharmaceuticalRegulationRistempaVectibixZykadia

1 to 25 of 2745 results

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