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


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


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


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

Orexigen resubmits obesity drug application in Europe

Orexigen resubmits obesity drug application in Europe


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


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


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


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

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


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


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


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


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

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


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


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

Arena Pharma files for Swiss approval of lorcaserin for weight control


USA-based Arena Pharmaceuticals (Nasdaq: ARNA) this week filed with the Swiss health authority, Swissmedic,…

Arena PharmaceuticalsEuropelorcaserinMetabolicsPharmaceuticalRegulation

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