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FDA at last approves Genzyme’s Lemtrada

FDA at last approves Genzyme’s Lemtrada

15-11-2014

The US Food and Drug Administration on Friday approved French pharma major Sanofi subsidiary Genzyme’s…

BayerBiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

ABPI speaks out against changes to UK Cancer Drugs Fund medicines list

ABPI speaks out against changes to UK Cancer Drugs Fund medicines list

14-11-2014

The Association of the British Pharmaceutical Industry has spoken out against imminent changes to how…

NHSOncologyPharmaceuticalRegulationUK

Ethical business practices promoted by Medicines Australia singled out in APEC Declaration

Ethical business practices promoted by Medicines Australia singled out in APEC Declaration

14-11-2014

Ethical business practices promoted by industry representative Medicines Australia in Asia Pacific are…

Asia-PacificAustraliaMedicines AustraliaPharmaceuticalRegulation

EMA responds to Ombudsman questioning of AbbVie trial redactions

13-11-2014

The European Medicines Agency says it has taken note of the European Ombudsman’s recent remarks on…

AbbVieAnti-Arthritics/RheumaticsEuropeHumiraPharmaceuticalRegulationResearch

UK Cancer Drugs Fund to re-assess procedure and currently-approved drugs

UK Cancer Drugs Fund to re-assess procedure and currently-approved drugs

13-11-2014

The UK’s National Health Service has updated its procedure for evaluating drugs in the Cancer Drugs…

AvastinKadcylaOncologyPharmaceuticalRegulationSprycelUK

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

13-11-2014

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationUSA

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

13-11-2014

Ireland-headquartered generics major Actavis has had its Supplemental New Drug Application for Saphris…

ActavisIrelandNeurologicalPharmaceuticalRegulationSaphris

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

13-11-2014

Generic and branded specialty pharma company Par Pharmaceuticals has received approval for its New Drug…

HematologyPar PharmaceuticalsPharmaceuticalRegulationUSAVasostrict

SMC accepts Eylea and Onglyza for use in NHS Scotland

SMC accepts Eylea and Onglyza for use in NHS Scotland

13-11-2014

The Scottish Medicines Consortium (SMC) has accepted German drugmaker Bayer’s Eylea (aflibercept solution…

AstraZenecaBayerDiabetesEyleaOnglyzaPharmaceuticalRegulationUK

GlaxoSmithKline files for added Revolade indication in EU

12-11-2014

UK pharma major GlaxoSmithKline has filed an application with the European Medicines Agency for a variation…

EuropeGlaxoSmithKlineLigand PharmaceuticalsOncologyPharmaceuticalPromactaRare diseasesRegulationRevolade

Polyphor’s POL7080 receives QIDP designation from the FDA

12-11-2014

Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated…

Antibiotics and Infectious diseasesPharmaceuticalPOL7080PolyphorRegulationRocheUSA

Durect to ‘refine the path’ of Posidur program

Durect to ‘refine the path’ of Posidur program

12-11-2014

US drugmaker Durect Corporation says that it has received meeting minutes from its face-to-face meeting…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

Canada passes Vanessa's Law on unsafe medicines

Canada passes Vanessa's Law on unsafe medicines

11-11-2014

New legislation known as Vanessa’s Law (Bill C 17; the Protecting Canadians from Unsafe Drugs Act)…

CanadaMinister of HealthPharmaceuticalPoliticsRegulation

India takes action on spurious and sub-standard drugs

India takes action on spurious and sub-standard drugs

10-11-2014

An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals…

GenericsIndiaMarkets & MarketingPharmaceuticalPoliticsRegulation

Two Bristol-Myers Squibb drugs approved by Scottish Medicines Consortium

Two Bristol-Myers Squibb drugs approved by Scottish Medicines Consortium

10-11-2014

The Scottish Medicines Consortium has approved two new treatments today, one for skin cancer and one…

Bristol-Myers SquibbDaklinzaNephrology and HepatologyOncologyPharmaceuticalRegulationUKYervoy

Scottish backing for Novartis’ Afinitor for kidney cancer patients

Scottish backing for Novartis’ Afinitor for kidney cancer patients

10-11-2014

The Scottish Medicines Consortium has issued a positive recommendation for Swiss pharma major Novartis’…

AfinitorClinical pharmacologyHealthHealth Medical PharmaNHSNovartisOncologyPharmaceuticalPricingRegulationUK

FDA Focus: The Sherley Amendment

FDA Focus: The Sherley Amendment

10-11-2014

In the fourth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

Food and Drug AdministrationPharmaceuticalRegulationUnited StatesUSA

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

10-11-2014

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have…

OncologyPerjetapertuzumabPharmaceuticalRegulationRocheUSA

Highlights of EMA Pharmacovigilance unit meeting

09-11-2014

At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee…

BayerBiogen IdecCSL BehringEuropeHelixateHematologyKogenateNeurologicalPharmaceuticalRegulationTecfidera

EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine

09-11-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a…

AmgenCardio-vascularEuropeivabradinePharmaceuticalProcoralanRegulationServier

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

07-11-2014

The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé…

AvastinFranceOphthalmicsPharmaceuticalRegulationRoche

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

07-11-2014

The UK’s National Institute for Health and Care Excellence is consulting on provisional recommendations…

Anti-Arthritics/RheumaticsPfizerPharmaceuticalRegulationUKXiapex

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