Regulation

Filter

Current filters:

None

Popular Filters

1 to 25 of 2743 results

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NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C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

India plans to impose price controls on medical device makers and distributors

India plans to impose price controls on medical device makers and distributors

27-02-2015

In a major crackdown, India's drug regulator the National Pharmaceutical Pricing Authority has come down…

IndiaPharmaceuticalPricingRegulation

EC approves Zambon and Newron’s Xadago for late-stage PD patients

EC approves Zambon and Newron’s Xadago for late-stage PD patients

27-02-2015

Zambon and its partner, fellow Italy-based Newron Pharmaceuticals, have received approval from the European…

EuropeNeurologicalNewron PharmaceuticalsPharmaceuticalRegulationXadagoZambon

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

27-02-2015

The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib)…

AmgenEuropeKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Chiesi found to have breached ABPI Code

Chiesi found to have breached ABPI Code

27-02-2015

Privately-held Italian drugmaker Chiesi Farmaceutici has been publicly reprimanded for providing inaccurate…

Chiesi FarmaceuticiFostairLegalPharmaceuticalRegulationUK

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

26-02-2015

The US Food and Drug Administration has approved French pharma major Sanofi’s Toujeo (insulin glargine…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

US FDA approves new antibacterial drug Avycaz

US FDA approves new antibacterial drug Avycaz

26-02-2015

The US Food and Drug Administration has approved antibacterial drug Avycaz (ceftazidime-avibactam) to…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamForest PharmaceuticalsPharmaceuticalRegulationUSA

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

26-02-2015

Although there is widespread optimism around the first biosimilars being launched in the USA, a new report…

BiosimilarsProductionRegulationUnited StatesUSA

NICE recommends Sovaldi and Olysio for hepatitis C

NICE recommends Sovaldi and Olysio for hepatitis C

25-02-2015

The UK’s National Institute for Health and Care Excellence (NICE) has published final guidance recommending…

Anti-viralsGilead SciencesJanssenOlysioPharmaceuticalRegulationSovaldiUK

1 to 25 of 2743 results

COMPANY SPOTLIGHT

Menarini

Back to top