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FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Akashi gets rights to novel DMD treatment from Tonus

Akashi gets rights to novel DMD treatment from Tonus

15-09-2014

US clinical-stage biopharma firm Akashi Therapeutics has acquired global rights to GsMTx-4, a small molecule…

Akashi TherapeuticsGlobalGsMTx-4LicensingPharmaceuticalRare diseasesTonus Therapeutics

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

15-09-2014

Ireland-headquartered drugmaker Shire has received acceptance for its filing with priority review for…

AbbVieIrelandNeurologicalPharmaceuticalRegulationShireVyvanse

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

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

PharmaceuticalPharmacologyRegulationResearchUSA

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

15-09-2014

The pan-European medicines verification system that the European Federation of Pharmaceutical Industries…

EuropeLegitimate supply chainMarkets & MarketingPharmaceuticalRegulation

Allergan says Pershing’s additional requests for meeting is not “meaningful development”

Allergan says Pershing’s additional requests for meeting is not “meaningful development”

15-09-2014

Hostile takeover target Allergan has said that value is what “really matters” in response to Pershing…

AllerganCanadaFinancialLegalPharmaceuticalUSAValeant Pharmaceuticals International

Canadian government commits funding to innovative brain research projects

Canadian government commits funding to innovative brain research projects

15-09-2014

Innovative research projects have been given new funding under the Canada Brain Research Fund, announced…

Brain Canada FoundationCanadaCanada Brain Research FundPharmaceuticalResearch

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

14-09-2014

Shares of US biotech firm Amarin Corp tanked 23.7% to $1.38 on Friday in heavy trading, when the company…

AmarinCardio-vascularGlaxoSmithKlineLovazaPharmaceuticalRegulationVascepa

Lilly’s Cyramza meets endpoints in Ph III colorectal cancer trial

Lilly’s Cyramza meets endpoints in Ph III colorectal cancer trial

14-09-2014

US pharma major Eli Lilly says that the RAISE trial, a Phase III study of ramucirumab (already marketed…

CyramzaEli LillyOncologyPharmaceuticalResearch

EMA’s PRAC concludes review of Valdoxan/Thymanax

EMA’s PRAC concludes review of Valdoxan/Thymanax

14-09-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded its regular…

EuropeNeurologicalPharmaceuticalRegulationServierThymanaxValdoxan

Novartis shows leadership in ophthalmology at EURETINA

Novartis shows leadership in ophthalmology at EURETINA

14-09-2014

New data on Swiss pharma major Novartis’ ophthalmic drugs Lucentis (ranibizumab) and Jetrea (ocriplasmin)…

JetreaLucentisNovartisOphthalmicsPharmaceuticalResearch

Further guidance on adaptive licensing pilot project available from EMA

12-09-2014

Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines…

EuropePharmaceuticalRegulation

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

Russia does not plan to ban drug imports from Western countries

12-09-2014

The Russian government has no plans to impose a ban on the pharmaceutical imports from the European Union…

Markets & MarketingPharmaceuticalPoliticsRussia

Ukraine takes measures to solve problem of drug shortages

12-09-2014

Ukraine is experiencing a shortage of pharmaceutical products, as the country’s government does not…

HealthcareMarkets & MarketingPharmaceuticalUkraine

ABPI and Department of Health announce second PPRS payment

ABPI and Department of Health announce second PPRS payment

12-09-2014

The Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health have announced…

Association of the British Pharmaceutical IndustryNHS EnglandPharmaceuticalRegulationUK

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

12-09-2014

There was good news for Danish diabetes care giant Novo Nordisk yesterday, when the US Food and drug…

liraglutideMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

Palatin licenses certain rights to Richter for bremelanotide

11-09-2014

USA-based Palatin Technologies and Hungary’s largest drugmaker Gedeon Richter have entered into a collaboration…

EuropeGedeon RichterLicensingPalatin TechnologiesPharmaceuticalWomen's Health

US Pharma now developing 44 drugs/vaccines for HIV/AIDS

11-09-2014

The USA’s biopharmaceutical research companies are currently developing 44 medicines and vaccines for…

Anti-viralsPharmaceuticalResearchUSAVaccines

Norgine sells certain rights for Camcolit and Somnite to Essential Pharma

11-09-2014

Netherlands-headquartered independent drugmaker Norgine has agreed to sell all rights in the UK for Somnite…

Essential PharmaIrelandLicensingNeurologicalNorginePharmaceuticalUK

Positive new data for AbbVie’s Humira in HS

Positive new data for AbbVie’s Humira in HS

11-09-2014

US pharma group AbbVie has released results from a Phase III pivotal study demonstrating that its blockbuster…

AbbVieAnti-Arthritics/RheumaticsDermatologicalsHumiraPharmaceuticalResearch

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