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US health advocacy groups state case on biosimilars naming policy

04-02-2014

In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health…

BiosimilarsGenericsNorth AmericaRegulationUSA

UK’s MHRA approves Botox for treatment of ankle disability in stroke survivors

04-02-2014

Allergan says that Botox has been approved by the UK’s Medicines and Healthcare Products Regulatory…

AllerganBotoxPharmaceuticalRegulationUK

Regulatory update on Indian clinical research approval timelines

04-02-2014

The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry…

Asia-PacificIndiaPharmaceuticalRegulationResearch

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

04-02-2014

GlaxoSmithKline’s Tafinlar (dabrafenib) is now available for metastatic melanoma patients in England…

FinancialGSKOncologyPharmaceuticalRegulationTafinlarUK

US FDA grants Edison’s EPI-743 orphan status for Friedreich's ataxia

US FDA grants Edison’s EPI-743 orphan status for Friedreich's ataxia

04-02-2014

Privately-held US pharma company Edison Pharmaceuticals has announced that the US Food and Drug Administration…

Edison PharmaceuticalsEPI-743PharmaceuticalRare diseasesRegulationUSA

UK’s NICE consults on updating guidance for Tarceva and Iressa

UK’s NICE consults on updating guidance for Tarceva and Iressa

04-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) said this morning that it is reviewing…

AstraZenecadocetaxelIressaOncologyPharmaceuticalRegulationRocheTarcevaUK

US generics lobby group, GPhA, sets out 2014 priorities

US generics lobby group, GPhA, sets out 2014 priorities

04-02-2014

The US trade group the Generic Pharmaceutical Association (GPhA) has identified its key priorities for…

BiosimilarsGenericsHealthcareNorth AmericaRegulationUSA

Biogen’s MS drug Tecfidera approved in EU

Biogen’s MS drug Tecfidera approved in EU

03-02-2014

US biotech firm Biogen Idec’s Tecfidera (dimethyl fumarate) has been approved by the European Commission…

Biogen IdecBiotechnologyEuropeNeurologicalRegulationTecfidera

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

03-02-2014

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for UK pharma…

GlaxoSmithKlinePharmaceuticalPromactaRare diseasesRegulationRevolade

SMEs, academia significant originators of innovative medicines in the EU

SMEs, academia significant originators of innovative medicines in the EU

03-02-2014

More than 40% of innovative medicines recommended for marketing authorization in the European Union between…

EuropePharmaceuticalRegulationResearch

FDA approves Hetlioz, first treatment for non-24 hour sleep-wake disorder in blind people

FDA approves Hetlioz, first treatment for non-24 hour sleep-wake disorder in blind people

03-02-2014

The US Food and Drug Administration on Friday approved US drugmaker Vanda Pharmaceutical's Hetlioz (tasimelteon),…

HetliozNeurologicalPharmaceuticalRare diseasesRegulationVanda Pharmaceuticals

Avanir Pharma files NDA for migraine drug AVP-825

30-01-2014

US drugmaker Avanir Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

Avanir PharmaceuticalsAVP-825NeurologicalNorth AmericaPharmaceuticalRegulationUSA

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

30-01-2014

US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee,…

GenericsNorth AmericaPoliticsRegulationUSA

Teva gets FDA approval of three-times-a-week Copaxone

Teva gets FDA approval of three-times-a-week Copaxone

29-01-2014

Israel’s Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved…

CopaxoneNeurologicalNorth AmericaPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

Chinese health professionals' conduct to be regulated

29-01-2014

China's National Health and Family Planning Commission this week issued a draft regulation on health…

Asia-PacificChinaPharmaceuticalRegulation

China’s pharma blacklist could be weakened by inconsistent enforcement

China’s pharma blacklist could be weakened by inconsistent enforcement

29-01-2014

Though Chinese regulators are pushing ahead with a blacklisting system to combat bribery in pharmaceutical…

ChinaLegalPharmaceuticalRegulation

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

28-01-2014

The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available…

Alk-AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

Heron Therapeutics says timeline for Sustol resubmission delayed

28-01-2014

US specialty pharma group Heron Therapeutics saw its shares plunge after the company revealed an around…

Heron TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationSustolUSA

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

28-01-2014

UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance…

Astellas PharmaEuropeOncologyPharmaceuticalPricingRegulationUKXtandi

European Commission approves Gedeon Richter’s Esmya type II Variation

European Commission approves Gedeon Richter’s Esmya type II Variation

27-01-2014

The European Commission has granted marketing authorization to extend the use of Esmya (ulipristal acetate)…

EsmyaEuropeGedeon RichterPharmaceuticalRegulationWomen's Health

NW Bio to expand manufacturing of DCVax products

27-01-2014

US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion…

BiotechnologyDCVaxEuropeNorth AmericaNorthwest BiotherapeuticsProductionRegulationUSA

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