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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

12-12-2013

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

12-12-2013

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

26-11-2013

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

23-09-2013

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

20-06-2013

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?

03-06-2013

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

08-05-2013

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

17-04-2013

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

10-12-2012

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

22-10-2012

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

20-08-2012

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

18-07-2012

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

28-06-2012

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

11-05-2012

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

10-04-2012

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

MetabolicsNorth AmericaPharmaceuticalQnexaRegulationVivus

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