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Orexigen has another go at FDA approval of obesity drug Contrave

Orexigen has another go at FDA approval of obesity drug Contrave


US biopharma company Orexigen Therapeutics is having another stab at gaining approved for its weight-loss…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulation

Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin

Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin


In an 11 to one vote yesterday, the US Food and Drug Administration’s Endocrinologic and Metabolic…

AstraZenecaBristol-Myers SquibbMetabolicsmetreleptinNorth AmericaPharmaceuticalRare diseasesRegulation

Orexigen to resubmit US NDA for obesity drug Contrave


Along with presenting new data for its weight loss drug candidate Contrave (naltrexone SR and bupropion…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

Sanofi reaches deal in rimonabant lawsuit

Sanofi reaches deal in rimonabant lawsuit


French drug major Sanofi (Euronext; SAN) has reached a $40 million settlement in a US lawsuit accusing…

MetabolicsNorth AmericaRegulationSanofi

It's official: "obesity is a disease," says AMA


The American Medical Association at its annual meeting this week adopted a policy that recognizes obesity…

Arena PharmaceuticalsBelviqEisaiMarkets & MarketingMetabolicsNorth AmericaPharmaceuticalQsymiaRegulationVivus

Briefs: Depomed drops Sefelsa after CRL: Sun Pharma stalking Meda?


US specialty drugmaker Depomed (Nasdaq: DEPO) says that Food and Drug Administration issued a complete…

DepomedMedaMergers & AcquisitionsMetabolicsNorth AmericaPharmaceuticalRegulationResearchSefelsaSun Pharmaceutical Industries

Arena and Eisai finally get DEA scheduling for obesity drug Belviq


The long wait to get obesity drug Belviq (lorcaserin) to the US market, where it was approved by the…

Arena PharmaceuticalsBelviqEisaiMetabolicsNorth AmericaPharmaceuticalRegulation

Vivus rises as FDA eases restrictions on diet pill Qsymia


USA drugmaker Vivus' (Nasdaq: VVUS) shares rose as much as 11% by traded up 5% at $11.69, after the company…

MetabolicsNorth AmericaPharmaceuticalQsymiaRegulationVivus

FDA advisory gives thumbs down for Zogenix' Zohydro for chronic pain; EU label extension for Genzyme's Thyrogen


Shares of USA-based Zogenix (Nasdaq: ZGNX) plummeted 33.5% to $1.57 in after-hours trading on Friday…

BiotechnologyEuropeGenzymeMetabolicsNeurologicalNorth AmericaPharmaceuticalRegulationSanofiThyrogenZogenixZohydro

Orexigen gets FDA dispute response supportive of faster path to Contrave review


The USA's Orexigen Therapeutics (Nasdaq: OREX) saw its shares jump 9.3% in early trading yesterday, after…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearch

New approaches for evaluating benefits and risks of obesity drugs from QW


The USA's George Washington University School of Public Health and Health Services (GW) has released…

HealthcareMetabolicsNorth AmericaPharmaceuticalRegulationResearch

US FDA approves second diet pill, Vivus' Qsymia


In a much anticipated but largely expected decision, the US Food and Drug Administration yesterday approved…

MetabolicsNorth AmericaPharmaceuticalQnexaQsymiaRegulationVivus

Eureka moment: US FDA approves first new obesity drug in 13 years


After several years of investigation, and a rejection by the US regulator, the Food and Drug Administration…

Arena PharmaceuticalsBelviqEisailorcaserinMetabolicsNorth AmericaPharmaceuticalRegulation

Arena Pharma gets positive FDA panel vote for obesity drug; prophylactic Truvada backed


USA-based Arena Pharmaceuticals (Nasdaq: ARNA) and Japanese licensing partner Eisai (TYO: 4523) got a…

Anti-viralsArena PharmaceuticalsBiotechnologyEisaiGilead ScienceslorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulationTruvada

Vivus says FDA has delayed Qnexa PDUFA date


The US Food and Drug Administration has advised informed USA-based rug developer Vivus (Nasdaq: VVUS)…

MetabolicsNorth AmericaPharmaceuticalQnexaRegulationVivus

Arena Pharma updates on lorcaserin filings in EU and USA


San Diego, USA-based Arena Pharmaceuticals (Nasdaq: ARNA) revealed yesterday that the European Medicines…

Arena PharmaceuticalsEisaiEuropelorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulation

Boca generic version of Tapazole cleared by FDA


Florida, USA-based privately-held Boca Pharmacal said on Friday that it has received approval from the…

Boca PharmacalGenericsKing PharmaceuticalsMetabolicsNorth AmericaRegulationTapazole

FDA advisory panel backs approval of Qnexa


At last there was finally some good news for drug developer Vivus (Nasdaq: VVUS) - and Americans with…

MetabolicsNorth AmericaPharmaceuticalQnexaRegulationVivus

Another FDA hurdle for Orexigen obesity drug candidate


It might seem to some that the US Food and Drug Administration has no intentions of approving any new…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

FDA updates on obesity drug candidates


There have been two pieces of positive news coming out of the US Food and Drug Administration this week…

Arena PharmaceuticalsEisailorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalQnexaRegulationVivus

Arena files complete response on lorcaserin


In another attempt to gain approval for its obesity drug candidate that was turned down by US regulators…

Arena PharmaceuticalsEisailorcaserinLorquessMetabolicsNorth AmericaPharmaceuticalRegulationResearch

Vivus findings show greater risk of birth defects with Qnexa ingredient


USA-based drug developer Vivus (Nasdaq: VVUS) has released top-line preliminary results from its retrospective…

MetabolicsNorth AmericaPharmaceuticalQnexaRegulationResearchtopiramateVivus

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