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New blood cancer injection given green light by UK regulators

New blood cancer injection given green light by UK regulators

05-08-2014

Patients in the UK with one of the most common forms of blood cancer can now benefit from a new injection.…

Andrew DaviesLymphomaMabTheraNHSOncologyPharmaceuticalRegulationRituximabRocheUK

Chiesi and uniQure delay Glybera launch to add data

Chiesi and uniQure delay Glybera launch to add data

04-08-2014

Netherlands-based venture capital backed human gene therapy firm uniQure and privately-held Italian drugmaker…

BiotechnologyChiesi FarmaceuticiEuropeGlyberaOrphan disease lipoprotein lipase deficiencyPricingRare diseasesRegulationuniQure

Eisai's Fycompa launches in Belgium for partial-onset seizures

Eisai's Fycompa launches in Belgium for partial-onset seizures

04-08-2014

Fycompa (perampanel), an epilepsy drug developed by Japanese dug major Eisai, launches today in Belgium.

BelgiumCentral nervous systemEisaiEpilepsyFycompaJapanNeurologicalPharmaceuticalRegulation

FDA expands approval of Genzyme’s Lumizyme to treat Pompe disease

FDA expands approval of Genzyme’s Lumizyme to treat Pompe disease

02-08-2014

The US Food and Drug Administration on Friday approved Lumizyme (alglucosidase alfa) for treatment of…

BiotechnologyGenzymeLumizymeMyozymeRare diseasesRegulationSanofiUSA

US FDA approves Jardiance for adults with type 2 diabetes

US FDA approves Jardiance for adults with type 2 diabetes

02-08-2014

The US Food and Drug Administration on Friday approved Jardiance (empagliflozin) tablets as an adjunct…

Boehringer IngelheimDiabetesEli LillyEuropeGermanyJardiancePharmaceuticalRegulationUSA

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

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