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Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

16-10-2014

In preliminary draft guidance issued this morning the UK health costs watchdog the National Institute…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

Northwest Bio says DCVax-L hospital exemption program under way in Germany

Northwest Bio says DCVax-L hospital exemption program under way in Germany

15-10-2014

US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for…

BiotechnologyDCVax-LGermanyNorthwest BiotherapeuticsOncologyRegulationResearch

NICE preliminary guidance negative on Celgene’s pomalidomide for multiple myeloma

NICE preliminary guidance negative on Celgene’s pomalidomide for multiple myeloma

15-10-2014

UK medical costs watchdog the National Institute for Health and Care Excellence (NICE) has issued preliminary…

BiotechnologyCelgene Corp.ImnovidOncologyPricingRegulationUK

Janssen files for EU approval of Stelara in pediatric plaque psoriasis

13-10-2014

Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines…

BiotechnologyDermatologicalsEuropeInflammatory diseasesJanssen-CilagJohnson & JohnsonRegulationStelara

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

12-10-2014

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationSovaldiUSA

Biogen Idec files for Elocta approval in Europe

Biogen Idec files for Elocta approval in Europe

10-10-2014

US biotech firm Biogen Idec has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc;…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

09-10-2014

US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted…

BiotechnologyDNAtrixDNX-2401OncologyRegulationUSA

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

08-10-2014

One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive…

BiotechnologyLegalLicensingPatents & Trade marksProductionRegulationResearchSocial IssuesUK

US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

07-10-2014

The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm…

BiotechnologyBrainStorm Cell TherapeuticsNeurologicalNurOwnRegulationUSA

Regeneron gains further FDA indications for Eylea

Regeneron gains further FDA indications for Eylea

07-10-2014

The US Food and Drug Administration has approved biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

06-10-2014

When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar…

BiosimilarsBiotechnologyDenmarkPharmacologyRegulation

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

04-10-2014

The US Food and Drug Administration has granted orphan drug designation for Ireland-headquartered specialty…

ActimmuneBiotechnologyHorizon PharmaRare diseasesRegulationUSA

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

25-09-2014

Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene, say that…

AbraxaneBiotechnologyCelgene Corp.OncologyRegulationSwitzerland

Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24-09-2014

Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationsofosbuvir

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

24-09-2014

The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued…

BiotechnologyCelgene Corp.OncologyPricingRegulationRevlimidUK

FDA fast track designation for AstraZeneca’s MEDI3902

FDA fast track designation for AstraZeneca’s MEDI3902

24-09-2014

Anglo-Swedish pharma major AstraZeneca’s global biologics R&D arm, MedImmune has received fast track…

Antibiotics and Infectious diseasesAstraZenecaBiotechnologyMEDI3902MedImmuneRegulationUSA

Celgene’s psoriasis drug Otezla gains FDA approval

Celgene’s psoriasis drug Otezla gains FDA approval

24-09-2014

The US Food and Drug Administration has approved biotech major Celgene’s Otezla (apremilast), an oral,…

BiotechnologyCelgene Corp.DermatologicalsOtezlaRegulationUSA

Amgen files BLA for BiTE immunotherapy blinatumomab

Amgen files BLA for BiTE immunotherapy blinatumomab

22-09-2014

USA-based Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

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

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

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

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

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

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