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UK NICE partially backs Bayer’s Xofigo in preliminary assessment

UK NICE partially backs Bayer’s Xofigo in preliminary assessment

15-12-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) have recommended…

BayerOncologyPharmaceuticalPricingRegulationUKXofigo

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

15-12-2014

Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application…

BiotechnologycobimetinibExelixisGenentechOncologyRegulationRocheUSAZelboraf

India’s National Pharmaceutical Pricing Authority caps price of 52 more drugs

India’s National Pharmaceutical Pricing Authority caps price of 52 more drugs

15-12-2014

The National Pharmaceutical Pricing Authority (NPPA) of India has issued a notice capping prices of 52…

BaxterGlaxoSmithKlineIndiaPharmaceuticalPricingRegulationWockhardt

Australian mid-year economic and fiscal outlook does not show cost increases for PBS

Australian mid-year economic and fiscal outlook does not show cost increases for PBS

15-12-2014

The Mid-Year Economic and Fiscal Outlook released by the Australian government did not indicate any cost…

AustraliaHealthcare in AustraliaMedicines AustraliaPharmaceuticalRegulation

FDA approves third indication for Lilly’s Cyramza

FDA approves third indication for Lilly’s Cyramza

13-12-2014

The US Food and Drug Administration on Friday expanded the approved use of pharma major Eli Lilly’s…

CyramzaEli LillyOncologyPharmaceuticalRegulationUSA

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

13-12-2014

French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food…

Anti-viralsFluzonePharmaceuticalRegulationSanofiSanofi PasteurUSAVaccines

FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

12-12-2014

The US Food and Drug Administration has so far approved 35 novel drugs this year, compared to 27 last…

BlincytoHarvoniPharmaceuticalRegulationUSA

US FDA issues warning on Pfizer’s Geodon

US FDA issues warning on Pfizer’s Geodon

11-12-2014

The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under…

GeodonNeurologicalPfizerPharmaceuticalRegulationUSAZiprasidone

UK industry makes third quarter PPRS payment, Department of Health sets 2015 percentage at 10.36%

UK industry makes third quarter PPRS payment, Department of Health sets 2015 percentage at 10.36%

11-12-2014

The UK pharma industry has made its third quarter payment to underwrite the growth of the medicines bill…

ABPIDepartment of HealthPharmaceuticalRegulationUK

GlaxoSmithKline files for EU extended indication for Volibris in PAH

GlaxoSmithKline files for EU extended indication for Volibris in PAH

11-12-2014

UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency…

EuropeGilead SciencesGlaxoSmithKlineLetairisPharmaceuticalRegulationRespiratory and PulmonaryVolibris

US generic trade group supports compromise legislation for biosimilars

US generic trade group supports compromise legislation for biosimilars

11-12-2014

The USA's Generic Pharmaceutical Association (GPhA) has agreed to support compromise automatic substitution…

BiosimilarsGenericsLegalRegulationUSA

Merck’s new Gardasil 9 gains backing from US FDA

Merck’s new Gardasil 9 gains backing from US FDA

11-12-2014

The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent…

Gardasil 9Merck & CoOncologyPharmaceuticalRegulationUSAVaccines

FDA Focus: Life-threatening disease and the benefit-risk of treatment options

FDA Focus: Life-threatening disease and the benefit-risk of treatment options

10-12-2014

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

ChemistryFDAPharmaceuticalRegulationUSA

Supernus notified of Par Pharma ANDA filing for Trokendi XR generic

09-12-2014

US drugmaker Supernus Pharmaceuticals says that it has received a Paragraph IV Notice Letter from privately-held…

GenericsNeurologicalPar PharmaceuticalsPatentsRegulationSupernus PharmaceuticalsTrokendi XRUSA

AstraZeneca’s Moventig gains EU approval for OIC

09-12-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaEuropeGastro-intestinalsMoventigNektar TherapeuticsPharmaceuticalRegulation

China’s new regulatory process could cause delays, RDPAC warns

China’s new regulatory process could cause delays, RDPAC warns

09-12-2014

Concerns have been raised in China that regulatory delays could defer the introduction of new drugs into…

BloombergChinaPharmaceuticalR&D-Based Pharmaceutical Association CommitteeRegulation

NICE now proposes to recommend Stelara for psoriatic arthritis

NICE now proposes to recommend Stelara for psoriatic arthritis

09-12-2014

UK health cost watchdog, the National Institute for Health and Care Excellence (NICE) has opened a consultation…

Anti-Arthritics/RheumaticsBiotechnologyInflammatory diseasesJanssenJohnson & JohnsonPricingRegulationStelaraUK

FDA approves new indication for Amgen's Xgeva

FDA approves new indication for Amgen's Xgeva

08-12-2014

USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab),…

AmgenBiotechnologyOncologyRare diseasesRegulationUSAXgeva

EFPIA responds to European Commission's patent settlement report with own transparency proposal

EFPIA responds to European Commission's patent settlement report with own transparency proposal

08-12-2014

The European Commission has published its fifth Monitoring Report of Patent Settlements in the pharma…

EuropeEuropean CommissionLegalPharmaceuticalRegulation

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

08-12-2014

The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured…

AdempasBayerCardio-vascularGazyvaroOncologyPharmaceuticalRegulationRoche

A top-20 pharma to utilize Xyntek-Antares serializing for China

A top-20 pharma to utilize Xyntek-Antares serializing for China

08-12-2014

A top 20 multi-national pharmaceutical research and manufacturer is utilizing the Xyntek-Antares solution…

ChinaPharmaceuticalProductionRegulationXyntek

Labeling update of Lundbeck and Otsuka’s Abilify Maintena approved by FDA

08-12-2014

The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for…

Abilify MaintenaLundbeckNeurologicalOtsuka PharmaceuticalPharmaceuticalRegulationUSA

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