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US FTC rescheduled workshop on state regulations and naming conventions set for February


The US Federal Trade Commission announced its one-day public workshop on competition and follow-on biologics,…

BiosimilarsGenericsMarkets & MarketingNorth AmericaRegulationUSA

Teva updates on Lonquex and Granix launches

Teva updates on Lonquex and Granix launches


Israel-based Teva Pharmaceutical Industries announced two significant additions to its global oncology…

balugrastimBiosimilarsEuropeGenericsLonquexMarkets & MarketingNorth AmericaOncologyRegulationTeva Pharmaceutical Industries

FDA takes action to speed safety information updates on generic drugs

FDA takes action to speed safety information updates on generic drugs


A proposed US Food and Drug Administration rule would speed the dissemination of new safety information…

GenericsMarkets & MarketingNorth AmericaRegulation

Ariad Pharma “temporarily” suspends only marketed drug Iclusig in USA

Ariad Pharma “temporarily” suspends only marketed drug Iclusig in USA


US drugmaker Ariad Pharmaceutical says it temporarily suspending the marketing and commercial distribution…

Ariad PharmaceuticalsIclusigMarkets & MarketingNorth AmericaOncologyPharmaceuticalRegulation

US FDA fast-tracks Elan's Alzheimer's drug candidate


Ireland-based Elan Corp (NYSE: ELN) says that the US Food and Drug Administration has granted Fast Track…

ElanELND005GlobalMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulation

New Public Citizen report highlights need to allow generic drugmakers to update labeling as they learn of new risks


Many potential hazards are not discovered until years after drugs have been on the market, a new Public…

GenericsMarkets & MarketingNorth AmericaRegulation

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

New Florida law takes a major step in promoting access to biologic medicines


Legislation amending the US state of Florida's existing prescription drug substitution law has the potential…

BiotechnologyGenericsLegalMarkets & MarketingNorth AmericaRegulation

US FDA approves Lupin's generic version of Teva's Seasonique and Taro's Topicort


Indian drugmaker Lupin (BSE: 500257) saw its shares gain 2.3% to 659.65 rupees by close of trading on…

DayseeDermatologicalsGenericsLupinMarkets & MarketingNorth AmericaPharmaceuticalRegulationReproductiveSeasoniqueTaro PharmaceuticalsTeva Pharmaceutical IndustriesTopicort

Actavis wins generic Pulmicort Respules case; challenges AbbVie patent


US generic drugs maker Actavis (NYSE: ACT) has confirmed that the US District Court for the District…

AbbVieActavisAndroGelAstraZenecaGenericsMarkets & MarketingMen's HealthNorth AmericaPatentsPulmicort RespulesRegulationRespiratory and Pulmonary

BD to debut in pharma sector with new line of generic prefilled injectables


US medical technology firm Becton Dickinson (NYSE: BDX) is entering the pharmaceutical industry, with…

BD SimplistBecton DickinsonGenericsMarkets & MarketingNorth AmericaRegulation

Takeda and Affymax recall all lots of anemia drug Omontys


US drugmaker Affymax (Nasdaq: AFFY) and its licensee, Japan's Takeda Pharmaceutical (TYO: 4502), said…

AffymaxMarkets & MarketingNorth AmericaOmontysPharmaceuticalRegulationTakeda Pharmaceuticals

$30 billion of fresh opportunities for Rx-to-OTC switch in USA


The US Food and Drug Administration has recently created the Non-prescription Safe Use Regulatory Expansion…

LipitorMarkets & MarketingNorth AmericaPfizerPharmaceuticalRegulation

Genzyme says Lemtrada sBLA for MS accepted by FDA; reports on Aubagio


French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme says that the US Food and Drug…

AubagioBiotechnologyGenzymeLemtradaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

Pfizer's Quillivant XR oral suspension now available in USA; GlaxoSmithKline files BLA for albiglutide


Confirming expectations announced when Pfizer (NYSE: PFE) revealed its $680 million acquisition of NextWave…

albiglutideDiabetesGlaxoSmithKlineMarkets & MarketingNeurologicalNorth AmericaPfizerPharmaceuticalQuillivantRegulation

Regenstrief study finds that generic drugs often have incorrect safety labeling


Despite US Food and Drug Administration regulations requiring generic medicines to carry identical warnings…

GenericsMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Landmark US court ruling reverses conviction on off-label drug promotion


The US Court of Appeals for the Second Circuit (based in New York City) on December 3 issued a long-awaited…

Jazz PharmaceuticalsLegalMarkets & MarketingNorth AmericaPharmaceuticalRegulationXyrem

Novartis' flu vaccines suspended in several countries on suspected quality issues


A number of European Union member states have halted the use, as a precautionary measure, of some anti-influenza…

AgrifluAgrippalEuropeFluadMarkets & MarketingNorth AmericaNovartisPharmaceuticalRegulationVaccines

Bristol-Myers' subcutaneous Orencia OKed in EU; Biologics for RA


US drug major Bristol-Myers Squibb (NYSE: BMY) announced on Friday that the European Commission has granted…

Abbott LaboratoriesAmgenAnti-Arthritics/RheumaticsBiotechnologyBristol-Myers SquibbEnbrelEuropeHumiraMarkets & MarketingNorth AmericaOrenciaPfizerPharmaceuticalRegulation

Bayer's Stivarga races to FDA approval on the heels of Zaltrap


The earlier than expected US Food and Drug Administration approval of German drug major Bayer's (BAYN:…

BayerBiotechnologyMarkets & MarketingNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalregorafenibRegulationSanofiStivargaZaltrap

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