Regulation

Filter

Current filters:

None

Popular Filters

2370 to 2394 of 2709 results

US House of Reps Passes FDA Reform Act

01-06-2012

Just days after the US Senate overwhelming approved the Food and Drug Administration Safety and Innovation…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

EMA boosts EU transparency with on-line publication of suspected side effect reports

31-05-2012

The European Medicines Agency yesterday began publishing suspected side effect reports for medicines…

BiotechnologyEuropePharmaceuticalRegulation

NZ's PHARMAC consults on funding for Iressa and Tarceva

31-05-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to:

Asia-PacificAstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarceva

BioAlliance's Sitavig NDA "receivable" by US FDA

30-05-2012

French biotech firm BioAlliance Pharma (Euronext Paris: BIO) has announced the receivability of its Sitavig…

Anti-viralsBioAlliance PharmaBiotechnologyNorth AmericaRegulationSitavigSitavir

Expanded Access Program for enzalutamide agreed with US FDA

30-05-2012

The US Food and Drug Administration agreed that Medivation (Nasdaq: MDVN) and Japanese drug major Astellas…

Astellas PharmaBiotechnologyenzalutamideMDV3100MedivationNorth AmericaOncologyPharmaceuticalRegulation

US legislation could block public access to drug safety information, claim consumer groups

30-05-2012

A provision in the Food and Drug Administration Reform Act that would block public access to potentially…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulation

Ranbaxy gains US FDA approval for Absorica

29-05-2012

India's largest drugmaker Ranbaxy Laboratories (AB: BO) has received approval from the US Food and Drug…

AbsoricaCipher PharmaceuticalsDermatologicalsIsotretinoinNorth AmericaPharmaceuticalRanbaxy LaboratoriesRegulation

UK health and life sciences group agrees new clinical trials transparency principles

28-05-2012

The Ethical Standards in Health and Life Sciences Group (ESHLSG), a partnership including the Association…

BiotechnologyEuropePharmaceuticalRegulationResearch

EMA orphan drug committee makes 16 recommendations at May meeting

28-05-2012

The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) adopted a total of 16…

Alexion PharmaceuticalsBiotechnologyeculizumabEuropePharmaceuticalRare diseasesRegulation

EMA recommends approval of Vertex' CF drug Kalydeco

28-05-2012

European Medicines Agency last Friday recommended approval of Kalydeco (ivacaftor), an orphan-designated…

EuropeKalydecoPharmaceuticalRare diseasesRegulationRespiratory and PulmonaryVertex

US Senate passing of FDA Safety and Innovation Act lauded by biotech and pharma industry

28-05-2012

The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalPoliticsRegulation

EMA unit backs approval of Jentadueto; Agency updates on Pradaxa

28-05-2012

Independent German drug major Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) have received…

Boehringer IngelheimCardio-vascularDiabetesEli LillyEuropeJentaduetoPharmaceuticalPradaxaRegulation

EMA confirms Roche's MabThera made at Vacaville site poses no health risk

28-05-2012

Following a quality review of the genetically engineered monoclonal antibody MabThera, the European Medicines…

Anti-Arthritics/RheumaticsBiotechnologyMabTheraOncologyPharmaceuticalRegulationRoche

FDA advisory panel gives mixed views on Pfizer's tafamidis

25-05-2012

The US Food and Drug Administration's peripheral and Central Nervous System Drugs Advisory Committee…

North AmericaPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

Australia's TGA launches consultation on better medicines labeling

24-05-2012

Australia's medicine's regulator, the Therapeutic Goods Administration, has this week released a consultation…

Asia-PacificBiotechnologyGenericsPharmaceuticalRegulation

US FDA advisory panel votes against added indication for Bayer's Xarelto

24-05-2012

Despite relatively positive briefing papers earlier this week (The Pharma Letter May 22), the US Food…

BayerCardio-vascularJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

EMA accepts Takeda's submission of diabetes drug alogliptin

24-05-2012

Japan's largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), says its European subsidiary has received…

alogliptinDiabetesEuropeFuriex PharmaceuticalsPharmaceuticalRegulationTakeda Pharmaceuticals

News briefs: GlaxoSmithKline and Bayer

24-05-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) has said it would not proceed with its $2.59 billion hostile…

Antibiotics and Infectious diseasesBayerGlaxoSmithKlineMergers & AcquisitionsOncologyPharmaceuticalregorafenibRegulationResearch

FDA expands Levemir use to young children; negative on tafamidis

23-05-2012

Denmark-based global insulin giant Novo Nordisk (NOV: N) says that the US Food and Drug Administration…

DiabetesLevemirNorth AmericaNovo NordiskPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

"NICE" news for Bayer, as UK watchdog backs Xarelto for AF

23-05-2012

There was good news today (May 23) for German drug major Bayer (BAYN: DE), when the UK's drug watchdog,…

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

2370 to 2394 of 2709 results

COMPANY SPOTLIGHT

Parexel

Parexel

Back to top