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

31-12-2013

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

18-11-2013

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

11-11-2013

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

01-11-2013

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

18-07-2013

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

26-06-2013

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

20-06-2013

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

06-06-2013

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

15-04-2013

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

02-04-2013

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

27-03-2013

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

25-02-2013

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

19-02-2013

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

28-01-2013

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

15-01-2013

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

16-12-2012

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

05-12-2012

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

29-10-2012

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

07-10-2012

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

07-10-2012

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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