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Dendreon seeks a buyer as it files for bankruptcy

Dendreon seeks a buyer as it files for bankruptcy

10-11-2014

US biotech firm Dendreon has filed voluntary petitions under Chapter 11 of the Bankruptcy Code in the…

DendreonFinancialOncologyPharmaceuticalProvengeUSA

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

Almirall profits leap in first nine months of 2014

Almirall profits leap in first nine months of 2014

10-11-2014

Almirall, Spain’s largest drugmaker, has reported strong financial results for the first-three quarters…

AlmirallAstraZenecaEkliraFinancialPharmaceuticalSpain

Eisai’s Zonegran safety in pediatric patients confirmed by pooled data analysis

Eisai’s Zonegran safety in pediatric patients confirmed by pooled data analysis

10-11-2014

The safety profile of adjunctive Japanese drugmaker Eisai’s Zonegran (zonisamide) in pediatric patients…

EisaiEuropeNeurologicalPharmaceuticalResearchZonegran

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

District Court sets accelerated date to resolve Takeda suit against FDA over Colcrys

District Court sets accelerated date to resolve Takeda suit against FDA over Colcrys

10-11-2014

The US District Court for the District of Columbia, presiding in a law suit between Japanese drugmaker…

ColcrysGastro-intestinalsHikmaLegalPharmaceuticalTakeda PharmaceuticalUSAWest-Ward

Salix shares slide on reports of wholesale stock backlog

Salix shares slide on reports of wholesale stock backlog

10-11-2014

Shares in Salix Pharmaceuticals fell nearly 36% after Thursday’s trading as the company cut its 2014…

FinancialPharmaceuticalRelistorRuconestSalix PharmaceuticalsUSA

Cut number of rheumatoid arthritis drugs and reduce side effects, says Belgian research

Cut number of rheumatoid arthritis drugs and reduce side effects, says Belgian research

10-11-2014

A two-year study into rheumatoid arthritis conducted at university hospitals in Belgium has shown that…

Anti-Arthritics/RheumaticsBelgiumLeflunomidemethotrexatePharmaceuticalResearch

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

Fresenius Kabi dumps planned Russian joint venture

09-11-2014

Fresenius Kabi and its partners Sistema JSFC and Zenitco Finance Management have mutually agreed to terminate…

BinnopharmFinancialFreseniusFresenius KabiMergers & AcquisitionsPharmaceuticalProductionRussia

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

Global Pharma may suspend production of vital drugs for Russia

07-11-2014

Global pharmaceutical producers are considering suspending of production of vital drugs for the Russian…

FinancialPharmaceuticalPricingProductionRussia

Vectura gets VR315 US development milestone

07-11-2014

UK inhaled therapies developer Vectura Group says that it has triggered a further milestone associated…

FinancialPharmaceuticalResearchRespiratory and PulmonaryVectura GroupVR315

AstraZeneca’s olaparib shows success in tumor response rate for patients with BRCA-related cancers

07-11-2014

Olaparib, an experimental twice-daily oral cancer drug, produces an overall tumor response rate of 26%…

AstraZenecaLynparzaolaparibOncologyPharmaceuticalResearch

Allergan is reportedly in takeover talks with Actavis

Allergan is reportedly in takeover talks with Actavis

07-11-2014

Botox maker Allergan is reportedly in merger talks with Ireland-headquartered generics major Actavis,…

ActavisAllerganMergers & AcquisitionsPharmaceuticalUSA

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

FDA advisory panel votes against approval of Novartis MM drug

07-11-2014

At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC)…

LBH589NovartisOncologypanobinostatPharmaceuticalRegulationUSA

FDA declines approval of Macrilen, issuing CRL

06-11-2014

Canadian biopharma firm AEterna Zentaris has received a Complete Response Letter from the US Food and…

Aeterna ZentarisMacrilenMetabolicsPharmaceuticalRegulationUSA

Eisai “dismayed” by G-BA decision on Fycompa

06-11-2014

Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee…

EisaiFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

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