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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

India revisits plans for free generic medicines, drug price fixing

India revisits plans for free generic medicines, drug price fixing

11-12-2014

Government hospitals in India that lack medicines, are overcrowded and understaffed, may soon be a thing…

FinancialGenericsHealthcareIndiaPharmaceuticalPoliticsPricing

Russia’s R-Pharm to invest $50 million in development of new drugs and vaccines

Russia’s R-Pharm to invest $50 million in development of new drugs and vaccines

11-12-2014

R-Pharm, one of Russia’s largest pharmaceutical producers, together with Russian Venture Company (RVC)…

FinancialPharmaceuticalPharmstandardR-PharmResearchRussia

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

Shire exercises option on candidates from arGEN-X collaboration

Shire exercises option on candidates from arGEN-X collaboration

11-12-2014

Ireland-headquartered drugmaker Shire has exercised the option to advance into preclinical development…

arGEN-XLicensingPharmaceuticalResearchShire

Africa will be hardest hit region of anti-microbial resistance, warns report

Africa will be hardest hit region of anti-microbial resistance, warns report

11-12-2014

Low income countries are likely to suffer the greatest loss of population and economic output if anti-microbial…

Antibiotics and Infectious diseasesFinancialPharmaceuticalResearchRest of the WorldSub-Saharan Africa

2015 will see blockbuster drug launches and more big M&A deals, report predicts

2015 will see blockbuster drug launches and more big M&A deals, report predicts

11-12-2014

Innovation will continue to drive the pharma and biotech sectors in 2015, according to EP Vantage’s…

GlobalHarvoniLCZ696Markets & MarketingPharmaceutical

Merck presents early data on Keytruda in advanced triple-negative breast cancer

Merck presents early data on Keytruda in advanced triple-negative breast cancer

11-12-2014

Pharma giant Merck & Co says Keytruda (pembrolizumab) has achieved an overall response rate of 18.5%…

KeytrudaMerck & CoOncologyPharmaceuticalResearchUSA

Vectura achieves positive results in Phase IIb/III trial of VR475 drug-device hybrid for asthma

Vectura achieves positive results in Phase IIb/III trial of VR475 drug-device hybrid for asthma

11-12-2014

Respiratory specialist Vectura says VR475 has met the primary endpoint in its Phase IIb/III trial of…

HealthHealth Medical PharmaPharmaceuticalVecturaVR475VR475 drug

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

New EU Internal Market and Industry Commissioner says parallel trade is lawful

New EU Internal Market and Industry Commissioner says parallel trade is lawful

10-12-2014

In September Enrico Gasbarra, a newly-elected Italian Member of the European Parliament (BEP) from the…

EuropeMarkets & MarketingPharmaceuticalPharmaceutical sciencesPolitics

Russian Ministry of Health reveals new classification of drugs for domestic market

Russian Ministry of Health reveals new classification of drugs for domestic market

10-12-2014

The Russian Ministry of Health has designed a new classification of drugs for the domestic pharmaceutical…

FinancialHealthcarePharmaceuticalPharmacologyRussia

Genesis One Nucleus 2014: personalized medicine and big data

Genesis One Nucleus 2014: personalized medicine and big data

10-12-2014

In the opening sessions at the Genesis One Nucleus 2014 conference in London yesterday, the main themes…

Evidence-based medicineHealth Medical PharmaInterviewsJohnson & JohnsonPharmaceuticalResearch

Takeda partners with Monash University on gastrointestinal research

Takeda partners with Monash University on gastrointestinal research

10-12-2014

Japan’s largest drugmaker Takeda has entered into a research partnership with the Monash Institute…

AustraliaGastro-intestinalsPharmaceuticalResearchTakeda Pharmaceuticals

Shire's guanfacine hydrochloride extended release reduces core ADHD symptoms in Phase III trial

Shire's guanfacine hydrochloride extended release reduces core ADHD symptoms in Phase III trial

10-12-2014

Ireland-headquartered drugmaker Shire has achieved positive results in a Phase III trial of guanfacine…

Guanfacine HydrochlorideIrelandNeurologicalPharmaceuticalResearchShire

Lundbeck and Otsuka present Phase III results of brexpiprazole in major depressive disorder

Lundbeck and Otsuka present Phase III results of brexpiprazole in major depressive disorder

10-12-2014

Japanese drug maker Otsuka and Danish CNS specialist Lundbeck have announced Phase III study results…

brexpiprazoleLundbeckNeurologicalOtsukaPharmaceuticalResearchUSA

Medical burden still heavy for Chinese

10-12-2014

Chinese medical reform fiscal measures have lined the pockets of hospitals and companies but not done…

ChinaFinancialHealthcarePharmaceutical

Medicines Australia welcomes new report on Australian pharma industry

Medicines Australia welcomes new report on Australian pharma industry

10-12-2014

A new report has found that the pharmaceutical and medical technology industries in Australia produce…

AustraliaFinancialMedicines AustraliaPharmaceuticalPharmaceuticals policy

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

ASH 2014: Gilead announces good response rates for Zydelig in non-Hodgkin lymphoma

ASH 2014: Gilead announces good response rates for Zydelig in non-Hodgkin lymphoma

09-12-2014

US biotech major Gilead Sciences has announced long-term follow-up results from the registration studies…

Gilead SciencesOncologyPharmaceuticalResearchUSAZydelig

Bayer collaborates with DNDi on novel, oral human river blindness treatment

09-12-2014

German pharma major Bayer and the Drugs for Neglected Diseases initiative (DNDi) have signed an agreement…

Astellas PharmaBayeremodepsidePharmaceuticalResearchTropical diseases

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