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US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

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

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