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Novo Nordisk’s Tresiba shows long-term efficacy and safety in diabetic children and adolescents

Novo Nordisk’s Tresiba shows long-term efficacy and safety in diabetic children and adolescents

16-09-2014

Danish diabetes care giant Novo Nordisk announced positive new data from the BEGIN YOUNG 1 trial today,…

DiabetesNovo NordiskPharmaceuticalResearchTresiba

Nicox acquires ophthalmic company Doliage and Carragelose eyedrops from Marinomed

Nicox acquires ophthalmic company Doliage and Carragelose eyedrops from Marinomed

16-09-2014

French ophthalmic company Nicox has advanced its strategy of building an international business by acquiring…

CarrageloseEuropeMarinomed BiotechnologiesMergers & AcquisitionsNicOxOphthalmicsPharmaceutical

Merck’s odanacatib succeeds in Ph III osteoporosis trial

Merck’s odanacatib succeeds in Ph III osteoporosis trial

16-09-2014

US pharma giant Merck & Co has announced positive data from the pivotal Phase III fracture outcomes study…

Anti-Arthritics/RheumaticsMerck & CoodanacatibPharmaceuticalResearchWomen's Health

Empagliflozin/linagliptin combo shows sustained reduction in blood glucose in Ph III

16-09-2014

Family-owned German pharma major Boehringer Ingelheim and US partner Eli Lilly have presented results…

Boehringer IngelheimDiabetesEli LillyempagliflozinlinagliptinPharmaceuticalResearch

Lundbeck launches Brintellix in Denmark

Lundbeck launches Brintellix in Denmark

16-09-2014

Danish CNS drug specialist Lundbeck is debutting its new antidepressant Brintellix (vortioxetine) in…

BrintellixCNS DiseasesDenmarkLundbeckMarkets & MarketingPharmaceutical

Avanir shares jump 85% on positive AVP-923 clinical trial results

Avanir shares jump 85% on positive AVP-923 clinical trial results

16-09-2014

US CNS specialist Avanir Pharmaceuticals has announced positive results from the Phase II clinical trial…

AvanirAVP-923CNS DiseasesPharmaceuticalResearchUSA

Plethora signs licensing agreement with Recordati for premature ejaculation drug

Plethora signs licensing agreement with Recordati for premature ejaculation drug

16-09-2014

Urological specialist Plethora Solutions has signed a licensing agreement with international pharma group…

EuropeLicensingMen's HealthPharmaceuticalPlethoraPSD502Recordati

Lilly to pay up to $500 million for AstraZeneca Alzheimer’s candidate

Lilly to pay up to $500 million for AstraZeneca Alzheimer’s candidate

16-09-2014

Anglo-Swedish pharma major AstraZeneca and US peer Eli Lilly have entered an agreement to jointly develop…

AstraZenecaAZD3293Eli LillyLicensingNeurologicalPharmaceuticalResearchUKUSA

UK M&A regulator consults on more stringent regulations

UK M&A regulator consults on more stringent regulations

16-09-2014

Partly in response to the recent (failed, thus far) attempt by US pharma giant Pfizer to acquire Anglo-Swedish…

LegalMergers & AcquisitionsPfizerPharmaceuticalUK

to-BBB appoints Anders Harfstrand as chief executive

to-BBB appoints Anders Harfstrand as chief executive

15-09-2014

Dutch biopharma company specializing in brain diseases, to-BBB, has appointed Anders Harfstrand as chief…

Anders HarfstrandBoardroomNetherlandsNeurologicalPharmaceutical

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

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