Regulation

Filter

Current filters:

None

Popular Filters

100 to 124 of 2523 results

Takeda to withdraw NDA as Omontys pact with Affymax ends

Takeda to withdraw NDA as Omontys pact with Affymax ends

15-06-2014

USA-based Affymax and Japan's Takeda Pharmaceutical revealed on Friday that they have terminated their…

AffymaxBiotechnologyLicensingOmontysOncologyRegulationTakeda Pharmaceutical

EMA agrees policy on publication of clinical trial data with more user-friendly amendments

EMA agrees policy on publication of clinical trial data with more user-friendly amendments

13-06-2014

The European Medicines Agency management board agreed the policy on publication of clinical trial data,…

EuropePharmaceuticalRegulationResearch

Geron leaps as FDA lifts partial hold on imetelstat trial

Geron leaps as FDA lifts partial hold on imetelstat trial

13-06-2014

US biotech Geron Corp's shares jumped around 27% to $3.31 in early afternoon trading yesterday after…

BiotechnologyGeron CorpHematologyimetelstatOncologyRegulationUSA

Pharma challenged by increasing global market access complexity

Pharma challenged by increasing global market access complexity

13-06-2014

New research indicates that global market access planning is growing in complexity as each country’s…

GlobalMarkets & MarketingPharmaceuticalRegulation

Study reveals factors supporting a sustainable European biosimilar medicines market

Study reveals factors supporting a sustainable European biosimilar medicines market

13-06-2014

Biosimilar medicines will deliver an opportunity for increased access to better healthcare for patients…

AvastinBiosimilarsEuropeHealthcareHerceptinHumiraRegulation

UK’s NICE says “Yes” to Bristol-Myers’ Yervoy

UK’s NICE says “Yes” to Bristol-Myers’ Yervoy

13-06-2014

People in England with advanced skin cancer should be able to receive ipilimumab as a first treatment…

Bristol-Myers SquibbOncologyPharmaceuticalPricingRegulationUKYervoy

Positive US FDA advisory panel view on PAMORAs

Positive US FDA advisory panel view on PAMORAs

13-06-2014

The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee…

AstraZenecaGastro-intestinalsMovantiknaloxegolPharmaceuticalRegulationUSA

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

12-06-2014

Ireland-headquartered drugmaker Shire says it has agreed to a written request by the US Food and Drug…

NeurologicalPharmaceuticalRegulationResearchShireUSAVyvanse

China’s FDA warns of on-line sales of fake cancer drug

China’s FDA warns of on-line sales of fake cancer drug

12-06-2014

China's drug administration on Wednesday warned consumers not to purchase illegally imported cancer drugs…

ChinaMarkets & MarketingOncologyPharmaceuticalRegulation

Bayer files for EMA approval of Eylea for macular edema secondary to BRVO

Bayer files for EMA approval of Eylea for macular edema secondary to BRVO

11-06-2014

German pharma major Bayer has submitted an application to the European Medicines Agency seeking marketing…

BayerEuropeEyleaOphthalmicsPharmaceuticalRegeneronRegulation

Lucrative biosimilars space to erode biologics market from 2019

Lucrative biosimilars space to erode biologics market from 2019

11-06-2014

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market…

BiosimilarsBiotechnologyGlobalMarkets & MarketingRegulation

US orphan status for EffRx’ EX404 for pediatric polycystic ovary syndrome

US orphan status for EffRx’ EX404 for pediatric polycystic ovary syndrome

11-06-2014

Swiss drug delivery specialist EffRx Pharmaceuticals says the US Food and Drug Administration has granted…

EffRx PharmaceuticalsEX404metforminPharmaceuticalRare diseasesRegulationUSAWomen's Health

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

10-06-2014

US drugmaker Achillion has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for…

ACH-3422AchillionAnti-viralsBiotechnologyRegulationResearchsovaprevir

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

10-06-2014

US biotech firm Immunomedics says that IMMU-132, its antibody-drug conjugate (ADC) for solid cancer therapy,…

BiotechnologyIMMU-132ImmunomedicsOncologyRegulationResearchUSA

US FDA issues guidance on new risk information dissemination

US FDA issues guidance on new risk information dissemination

09-06-2014

Late last Friday afternoon, the US Food and Drug Administration issued a new guidance document describing…

Markets & MarketingPharmaceuticalRegulationUSA

US FDA approves sNDAs for Imbruvica and Azilect

US FDA approves sNDAs for Imbruvica and Azilect

09-06-2014

USA-based Pharmacyclics says that the US Food and Drug Administration has accepted for filing its supplemental…

AzilectImbruvicaNeurologicalOncologyPharmaceuticalPharmacyclicsRegulationTeva Pharmaceutical IndustriesUSA

Mylan launches generic Paraplatin Injection in USA

Mylan launches generic Paraplatin Injection in USA

09-06-2014

US generics major Mylan has launched carboplatin injection, 50mg/5ml, in multi-dose vials, which is the…

Bristol-Myers SquibbGenericsMarkets & MarketingMylanOncologyParaplatinRegulationUSA

US FDA grants Valeant approval for Jublia NDA

US FDA grants Valeant approval for Jublia NDA

09-06-2014

Canadian drugmaker Valeant Pharmaceuticals International’s US subsidiary has received approval from…

CanadaDermatologicalsefinaconazoleJubliaPharmaceuticalRegulationUS Food and Drug AdministrationValeant Pharmaceuticals

Wider use of Novartis’ Gilenya approved in Europe

Wider use of Novartis’ Gilenya approved in Europe

09-06-2014

The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP)…

EuropeGilenyaNeurologicalNovartisPharmaceuticalRegulation

Orphan designation for Momenta Pharma’s necuparanib in pancreatic cancer

Orphan designation for Momenta Pharma’s necuparanib in pancreatic cancer

09-06-2014

USA-based Momenta Pharmaceuticals says that its novel oncology candidate, necuparanib (formerly M402),…

BiotechnologyMomenta PharmaceuticalsnecuparanibOncologyRegulationUSA

US FDA grants Edison Pharmaceuticals’ EPI-743 orphan status for Leigh Syndrome

US FDA grants Edison Pharmaceuticals’ EPI-743 orphan status for Leigh Syndrome

09-06-2014

The US Food and Drug Administration has granted orphan drug status to privately-held US pharma company…

CNS DiseasesEdison PharmaceuticalsEPI-743PharmaceuticalRegulationUSA

French Transparency agency backs Gilead’s new hepatitis C drug Sovaldi

French Transparency agency backs Gilead’s new hepatitis C drug Sovaldi

09-06-2014

There was good news for US antivirals major Gilead Sciences, when France’s health technology assessment…

Anti-viralsBiotechnologyFranceGilead SciencesPricingRegulationSovaldi

100 to 124 of 2523 results

Back to top