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FDA at last approves weight-management drug Contrave

FDA at last approves weight-management drug Contrave

11-09-2014

After considerable delay, the US Food and Drug Administration late yesterday finally granted approval…

Arena PharmaceuticalsBelviqContraveMetabolicsOrexigen TherapeuticsPharmaceuticalQnexaRegulationTakeda PharmaceuticalsUSAVivus

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

21-07-2014

USA-based Arena Pharmaceuticals has entered into an exclusive marketing and supply agreement for its…

AbicArena PharmaceuticalsBelviqLicensingMetabolicsObesityPharmaceuticalRegulationRest of the WorldTeva Pharmaceutical Industries

Vivus says Actavis has filed ANDA for generic Qsymia

Vivus says Actavis has filed ANDA for generic Qsymia

10-05-2014

US drug developer Vivus disclosed on Friday that the company had received notice from generics major…

ActavisGenericsMetabolicsPatentsQsymiaRegulationUSAVivus

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

Novo Nordisk files for approval of high strength liraglutide for obesity

Novo Nordisk files for approval of high strength liraglutide for obesity

22-12-2013

Danish insulin giant Novo Nordisk has filed separate regulatory submissions with the US Food and Drug…

DiabetesEuropeliraglutideMetabolicsNorth AmericaNovo NordiskPharmaceuticalRegulationVictoza

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

Orexigen resubmits obesity drug application in Europe

Orexigen resubmits obesity drug application in Europe

04-10-2013

Having experienced significant delays in gaining approval for its weight-loss drug, Orexigen Therapeutics…

ContraveEuropeMetabolicsOrexigen TherapeuticsPharmaceuticalRegulation

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

Orexigen updates on obesity drug filing plans

08-08-2013

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) yesterday (August 7) announced its plan to…

BiotechnologyContraveEuropeFinancialMetabolicsOrexigen TherapeuticsPharmaceuticalRegulation

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

Arena Pharma pulls EU application for Belviq; posts 1st-qtr results

06-05-2013

As part of an update on its activities and first-quarter financial results report, USA-based Arena Pharmaceutical…

Arena PharmaceuticalsBelviqEisaiEuropeFinancialMetabolicsPharmaceuticalRegulation

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

EMA confirms negative view on Vivus' obesity drug Qsiva after appeal

22-02-2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dealt a blow to…

EuropeMetabolicsPharmaceuticalQsivaQsymiaRegulationVivus

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

Vivus gets formal "No" from EMA panel on obesity drug

19-10-2012

US drugmaker Vivus (Nasdaq: VVUS) revealed yesterday that is has received the formal opinion from the…

EuropeMetabolicsPharmaceuticalQsivaRegulationVivus

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

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