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FDA FOCUS: FDA Regulations and Drug Shortages in America

FDA FOCUS: FDA Regulations and Drug Shortages in America

15-08-2014

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

FDAFood and Drug AdministrationPharmaceuticalPharmaceutical sciencesRegulationUSA

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

15-08-2014

USA-based Amgen initiated a voluntary recall on June 26 for nine packaged lots of anemia drug Aranesp…

AmgenAnemiaAranespBiotechnologyMarkets & MarketingOncologyRegulation

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

15-08-2014

Swiss drug major Roche has received approval from the US Food and Drug Administration for its drug Avastin…

AvastinCervical cancerOncologyPharmaceuticalRegulationRocheSwitzerland

Positive draft guidance for hep C drug Sovaldi from UK’s NICE

Positive draft guidance for hep C drug Sovaldi from UK’s NICE

15-08-2014

In further draft guidance published today, UK drugs watchdog the National Institute for Health and Care…

Anti-viralsBiotechnologyGilead SciencesHepatitis CPricingRegulationRibavirinSovaldiUK

NICE says benefit of prostate cancer drug Zytiga does not justify price

NICE says benefit of prostate cancer drug Zytiga does not justify price

15-08-2014

The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Zytiga (abiraterone)…

AbirateroneAndrew DillonJanssenOncologyPharmaceuticalRegulationUKZytiga

Alexza updates on the five post-EMA approval studies for Adasuve

Alexza updates on the five post-EMA approval studies for Adasuve

14-08-2014

US drugmaker Alexza Pharmaceuticals has provided an update on its European Medicines Agency post-approval…

AdasuveAlexza PharmaceuticalEuropeNeurologicalPharmaceuticalPiperazinesPsychiatryRegulationResearch

Merck’s Belsomra gets FDA approval for insomnia

Merck’s Belsomra gets FDA approval for insomnia

14-08-2014

Pharma giant Merck & Co has received US Food and Drug Administration approval for its insomnia treatment…

BelsomraMerck & CoNeurologicalPharmaceuticalRegulationSedativesUSA

Asia Healthcare Forum identifies challenges ahead for meetings in the sector

Asia Healthcare Forum identifies challenges ahead for meetings in the sector

13-08-2014

The inaugural Healthcare Meetings Forum Asia was over-subscribed on August 1 at Suntec Singapore, an…

Asia-PacificMarkets & MarketingPharmaceuticalRegulationSingapore

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

13-08-2014

“The National Institute for Health and Care Excellence’s recent rejection of Kadcyla, Roche’s latest…

KadcylaOncologyPharmaceuticalPricingRegulationRocheUK

Insys submits Dronabinol oral solution New Drug Application

Insys submits Dronabinol oral solution New Drug Application

13-08-2014

Supportive care specialist Insys Therapeutics has made a New Drug Application submission to the US Food…

CannabinoidsDronabinolEntheogensGastro-intestinalsInsys TherapeuticsPharmaceuticalRegulationTetrahydrocannabinolUSA

Medicines New Zealand updates its code of practice to cover social media

Medicines New Zealand updates its code of practice to cover social media

13-08-2014

New Zealand's pharmaceutical industry association, Medicines New Zealand, has updated its Code of Practice…

New ZealandPharmaceuticalPharmaceuticals policyPharmacologyRegulation

Belgian pharma trade body issues recommendations on domestic drug shortages

Belgian pharma trade body issues recommendations on domestic drug shortages

11-08-2014

Belgium’s pharmaceutical trade body, pharma.be, has issued a conclusion of its report on the shortage…

BelgiumMarkets & MarketingPharmaceuticalRegulation

Eylea approved for diabetic macular edema in Europe

Eylea approved for diabetic macular edema in Europe

11-08-2014

The European Commission has approved German pharma major Bayer’s Eylea (aflibercept) injection for…

BayerEuropeEyleaOphthalmicsOphthalmologyPharmaceuticalRegeneronRegulation

FDA issues new biosimilars guidance on exclusivity

FDA issues new biosimilars guidance on exclusivity

11-08-2014

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled…

BiosimilarsBiotechnologyFinancialRegulationUSA

Genentech files sBLA for Lucentis for diabetic retinopathy

09-08-2014

Genentech, the biotech subsidiary of Swiss pharma major Roche, has submitted a supplemental Biologics…

BiotechnologyGenentechLucentisOphthalmicsRegulationRocheUSA

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