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FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

22-09-2014

US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

European Commission approves Gilead’s Zydelig for blood cancer

European Commission approves Gilead’s Zydelig for blood cancer

19-09-2014

The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig…

BiotechnologyEuropeGilead SciencesLymphomaMedicineOncologyRegulationZydelig

Bill to increase competition for generic drugs introduced in USA

Bill to increase competition for generic drugs introduced in USA

19-09-2014

US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined…

GenericsLegalPoliticsRegulationUSA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

Orphan status for Navidea’s Lymphoseek in head and neck cancers

Orphan status for Navidea’s Lymphoseek in head and neck cancers

19-09-2014

US biotech company Navidea Biopharmaceuticals that its Lymphoseek (technetium Tc 99m tilmanocept) Injection…

BiotechnologyLymphoseekNavidea BiopharmaceuticalsOncologyRegulationUSA

FDA approves Lilly’s Trulicity to treat type 2 diabetes

FDA approves Lilly’s Trulicity to treat type 2 diabetes

19-09-2014

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide),…

BydureonDiabetesdulaglutideEli LillyPharmaceuticalRegulationTanzeumTrulicityUSAVictoza

First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

EuropaBio calls for EMA action on labeling of biosimilars

18-09-2014

EuropaBio has published a statement giving the perspective of the health care biotechnology industry…

BiosimilarsBiotechnologyEuropeRegulation

GPhA calls for feedback and dialogue on US generic legislation

GPhA calls for feedback and dialogue on US generic legislation

18-09-2014

The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User…

GenericsGPhALegalRegulationUSA

UK NICE consults on draft guidance for hepatitis C drug Olysio

UK NICE consults on draft guidance for hepatitis C drug Olysio

18-09-2014

In draft guidance published today UK drugs watchdog the National Institute for Health and Care Excellence…

Anti-viralsJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulationUK

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

18-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft…

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationRocheTafinlarUKZelboraf

First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

17-09-2014

The UK’s Department of Health announced that DCVax-L, the dendritic cell-based vaccine from US company…

BiotechnologyDCVaxNorthwest BiotherapeuticsOncologyRegulationUK

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

16-09-2014

US biotech firm Regeneron Pharmaceuticals says that the US Food and Drug Administration has granted Eylea…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

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

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

FDA approves Baxter/Halozyme’s HyQvia

FDA approves Baxter/Halozyme’s HyQvia

14-09-2014

The US Food and Drug Administration on Friday approved Baxter International’s and Halozyme Therapeutics’…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUSA

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