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First Asian approval for ophthalmic drug Jetrea, in Malaysia

18-04-2014

Belgian biotech firm ThromboGenics NV revealed today that Jetrea (ocriplasmin) has been approved in Malaysia…

AlconAsia-PacificBiotechnologyJetreaMalaysiaNovartisOphthalmicsRegulationThromboGenics

EMA update on stolen vials of Herceptin

18-04-2014

The European Medicines Agency has provided an update on the latest information relating to the stolen…

AlimtaEuropeHealthcareHerceptinItalyPharmaceuticalRegulationRemicade

FDA approves Merck’s Ragwitek for short ragweed pollen allergies

18-04-2014

The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

Canadian approval for GSK’s Incruse Ellipta as a treatment for COPD

17-04-2014

UK pharma giant GlaxoSmithKline says that Incruse Ellipta (umeclidinium) has received market authorization…

CanadaGlaxoSmithKlineIncruse ElliptaNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

Jacques Servier, founder and president of Lab Servier, dies aged 92

17-04-2014

French independent drugmaker Laboratories Servier announced that its founder and president, Jacques Servier,…

BoardroomManagementPharmaceuticalServier

GSK confirms further misconduct allegations, now in Jordan and Lebanon

17-04-2014

There has been recent publicity on cases of alleged misconduct by UK Pharma giant GlaxoSmithKline employees…

GlaxoSmithKlineJordanMarkets & MarketingPharmaceuticalRegulationRest of the World

Lost sales could reach $32 billion by 2022 as cancer drugs hit patent cliff

Lost sales could reach $32 billion by 2022 as cancer drugs hit patent cliff

17-04-2014

Over $17 billion of sales will be at risk in 2018/19 as many of the top performing oncology drugs lose…

AlimtaCancerChemistryEli LillyFinancialFranceGenericsGermanyHealth Medical PharmaHerceptinItalyJapanJohnson & JohnsonOncologyPatentsPharmaceuticalPharmaceutical sciencesPharmacologyRocheSpainUKUSAVelcade

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

17-04-2014

The US Food and Drug Administration and the European Commission have granted German family-owned drug…

Boehringer IngelheimEuropeGermanyHealth Medical PharmaMajorMedicineOncologyPharmaceuticalPharmacologyRegulationUS Food and Drug AdministrationUSAvolasertib

Potential to fast-track drugs in new Cancer Research UK partnership with AstraZeneca and Pfizer

Potential to fast-track drugs in new Cancer Research UK partnership with AstraZeneca and Pfizer

17-04-2014

British charity Cancer Research UK has joined forces with Anglo-Swedish drug major AstraZeneca and US…

AstraZenecaCancerHealthMajorMedicineOncologyPfizerPharmaceuticalPharmacologyResearchUK

EMA says that vials of falsified Herceptin have been identified

EMA says that vials of falsified Herceptin have been identified

16-04-2014

The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster…

EuropeHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

Astellas US promotes Jeffrey Bloss to SVP of medical affairs for the Americas

Astellas US promotes Jeffrey Bloss to SVP of medical affairs for the Americas

16-04-2014

The US subsidiary of Japanese drug major Astellas Pharma announced that Jeffrey Bloss has been promoted…

Astellas PharmaBoardroomManagementPharmaceuticalUSA

EFPIA welcomes EU step towards Innovate Medicines Initiative launch

EFPIA welcomes EU step towards Innovate Medicines Initiative launch

16-04-2014

The European Parliament’s Industry, Research and Energy (ITRE) Committee voted in favor of the second…

EuropeEuropean Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and AssociationsFinancialHealth Medical PharmaHealthcarePharmaceuticalPharmaceutical sciencesRegulationTherapies for Alzheimer’s disease

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

US FDA approves ALK and Merck’s Grastek sublingual tablet for grass allergy

US FDA approves ALK and Merck’s Grastek sublingual tablet for grass allergy

15-04-2014

The US Food and Drug Administration has approved the Biologic License Application for Grastek (Timothy…

ALK AbelloAllergologyAllergy treatmentBiologyGrastekGrazaxImmunologicalsMerck & CoMerck Research LaboratoriesPharmaceuticalPresident and chief executiveRegulationUSA

NICE draft guidance recommends Ferring’s Firmagon for prostate cancer

NICE draft guidance recommends Ferring’s Firmagon for prostate cancer

15-04-2014

In final draft guidance published today, the UK’s National Institute for Health and Care Excellence…

AnatomyCare ExcellenceFerring PharmaceuticalsFirmagonHealth Medical PharmaMedicineOncologyPharmaceuticalRegulationUKUnited Kingdom

EMA concludes inquiry into Roche infringement procedure

EMA concludes inquiry into Roche infringement procedure

14-04-2014

The European Medicines Agency says it has concluded its inquiry into alleged non-compliance with pharmacovigilance…

EuropePharmaceuticalRegulationRoche

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

Extended US market exclusivity for BioMarin's rare disease drug Kuvan

14-04-2014

US drugmaker BioMarin Pharmaceutical says that the Food and Drug Administration has granted Kuvan (sapropterin…

BioMarin PharmaceuticalKuvanNorth AmericaPharmaceuticalRare diseasesRegulationUSA

GSK faces bribery allegations in Poland

GSK faces bribery allegations in Poland

14-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribing doctors in Poland, according to the…

BBCGlaxoSmithKlineGSK regional managerLegalMajorMedicinePharmaceuticalPolandPulmonologyRespiratory and PulmonarySeretideUK

Ukraine pharma trade group APRaD sets out priorities with Vice PM and Customs authority

Ukraine pharma trade group APRaD sets out priorities with Vice PM and Customs authority

14-04-2014

The Ukraine Association of Pharmaceutical Research and Development (APRaD) participated in a meeting…

Eastern EuropePharmaceuticalPoliticsPricingRegulationUkraine

Impax Pharma resubmits NDA for Rytary

Impax Pharma resubmits NDA for Rytary

11-04-2014

Impax Laboratories’ branded products division has resubmitted the New Drug Application for Rytary (carbidopa…

Impax LaboratoriesNeurologicalNorth AmericaPharmaceuticalRegulationRytaryUSA

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

11-04-2014

The US Food and Drug Administration’s recent approval of Johnson & Johnson subsidiary Janssen’s Topamax…

JanssenJohnson & JohnsonMarkets & MarketingNeurologicalPharmaceuticalRegulationTopamax

Chugai files NDA for vemurafenib for melanoma

Chugai files NDA for vemurafenib for melanoma

11-04-2014

Japanese drugmaker Chugai Pharmaceutical has filed a new drug application to the Ministry of Health,…

BRAFV600ChemistryChugai PharmaceuticalJapanJO28178OncologyOrganochloridesPharmaceuticalRegulationRoche Diagnosticsvemurafenib

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