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French regulators push for huge cut in hypnotic benzodiazepine reimbursement

French regulators push for huge cut in hypnotic benzodiazepine reimbursement

01-08-2014

French regulators are attempting to discourage the over-consumption and misuse of hypnotic benzodiazepines…

diazepamFranceFrench governmentNeurologicalPharmaceuticalRegulation

USA’s 340B Drug Discount Program “needs more oversight,” says BIO

USA’s 340B Drug Discount Program “needs more oversight,” says BIO

01-08-2014

The US Biotechnology Industry Organization’s (BIO) Laurel Todd shared concerns that the 340B program…

BiotechnologyFinancialHealthcareRegulationUSA

Kyowa Hakko Kirin files for KW-3357 approval in Japan

Kyowa Hakko Kirin files for KW-3357 approval in Japan

01-08-2014

Japanese drugmaker Kyowa Hakko Kirin has filed an application for marketing approval with the Ministry…

HematologyJapanKW-3357Kyowa Hakko KirinPharmaceuticalRare diseasesRegulationThrombus

FDA approves Boehringer’s Striverdi Respimat for COPD

FDA approves Boehringer’s Striverdi Respimat for COPD

01-08-2014

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

Boehringer IngelheimPharmaceuticalPulmonologyRegulationRespiratory and PulmonaryStriverdi RespimatUSA

Harlan aims to provide expertise for biologics and biosimilars

31-07-2014

Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology…

BiosimilarsBiotechnologyContract research servicesHarlanRegulationResearchSwitzerlandToxicology services

NICE consulting again on Celgene's Revlimid for multiple myeloma

NICE consulting again on Celgene's Revlimid for multiple myeloma

31-07-2014

The UK clinical guidance body, the National Institute for Health and Care Excellence (NICE), is again…

Celgene Corp.ImmunosuppressantslenalidomideOncologyPharmaceuticalRegulationRevlimidUK

Regeneron’s Eylea gains FDA approval for DME

Regeneron’s Eylea gains FDA approval for DME

30-07-2014

The Food and Drug Administration has approved US biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneronRegulationUSA

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

30-07-2014

The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban)…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

FDA performs inspection of Impax's Taiwan facility

FDA performs inspection of Impax's Taiwan facility

30-07-2014

The US Food and Drug Administration has performed a general Good Manufacturing Practices (GMP) inspection…

Impax LaboratoriesNeurologicalPharmaceuticalRegulationRytaryUSA

Canada’s Health Minister moves on safe prescribing practices for drugs prone to abuse

Canada’s Health Minister moves on safe prescribing practices for drugs prone to abuse

29-07-2014

Canada’s Minister of Health, Rona Ambrose, has issued a national Call for Proposals to improve the…

CanadaNeurologicalPharmaceuticalRegulation

pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal

pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal

29-07-2014

Eye disease specialist pSivida has been granted marketing authorization in Norway for its treatment Iluvien,…

IluvienNorwayOphthalmicsPharmaceuticalPortugalpSividaRegulation

Antiviral gel in condoms to kill HIV approved in Australia

Antiviral gel in condoms to kill HIV approved in Australia

28-07-2014

Australian biotech firm Starpharma says it has achieved a major milestone with the receipt of Conformity…

AnsellAnti-viralsAntibiotics and Infectious diseasesAustraliaBiotechnologyRegulationStarpharmaVivaGel

Alcon’s Simbrinza approved for glaucoma in the EU

Alcon’s Simbrinza approved for glaucoma in the EU

28-07-2014

Eyecare specialist Alcon, a division of Swiss drug major Novartis, says its Simbrinza eye drops suspension…

AlconEuropeEuropean CommissionGlaucomaOphthalmicsPharmaceuticalRegulationSimbrinza

AcelRx Pharma’s Zalviso approval delayed by FDA

AcelRx Pharma’s Zalviso approval delayed by FDA

28-07-2014

USA-based specialty pharma firm AcelRx Pharmaceuticals says that the US Food and Drug Administration…

AcelRxFood and Drug AdministrationNeurologicalPharmaceuticalRegulationUSAZalviso

1 to 25 of 2549 results

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