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Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

US CMS ensures higher value and quality for Medicare health and drug plans

08-04-2014

The US Centers for Medicare & Medicaid Services (CMS) issued the 2015 rate announcement and final call…

FinancialHealthcareNorth AmericaPharmaceuticalUSA

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

Sunovion’s once-daily epilepsy drug Aptiom debuts in USA

08-04-2014

USA-based Sunovion Pharmaceuticals, a subsidiary of Japanese drug major Dainippon Sumitomo, has launched…

AptiomDainippon Sumitomo PharmaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalSunovionUSA

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Prasco to market the authorized generic of Lilly’s Evista in USA

01-04-2014

Privately-held US generics firm Prasco has signed a further deal with US pharma major Eli Lilly to market…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsMarkets & MarketingNorth AmericaPrasco LaboratoriesUSA

Amarin and Kowa Pharma to co-promote Vascepa in USA

01-04-2014

US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an…

AmarinBiotechnologyCardio-vascularKowa PharmaceuticalsMarkets & MarketingNorth AmericaUSAVascepa

Lilly's Alimta patent upheld through 2022

Lilly's Alimta patent upheld through 2022

01-04-2014

US pharma major Eli Lilly says that the US District Court for the Southern District of Indiana has ruled…

AlimtaEli LillyLegalNorth AmericaOncologyPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

US Supreme Court agrees to hear Teva’s Copaxone patent appeal

US Supreme Court agrees to hear Teva’s Copaxone patent appeal

01-04-2014

Israel’s Teva Pharmaceutical Industries, the world largest generic drugmaker, says that the US Supreme…

CopaxoneLegalNeurologicalNorth AmericaPatentsPharmaceuticalTeva Pharmaceutical IndustriesUSA

Actavis prevails in Lialda patent dispute in USA

Actavis prevails in Lialda patent dispute in USA

31-03-2014

US generics major Actavis says that the US Court of Appeals for the Federal Circuit has reversed a lower…

ActavisGastro-intestinalsGenericsLegalLialdaNorth AmericaPatentsShireUSA

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

Regional differences in health care private equity investment

Regional differences in health care private equity investment

28-03-2014

As the global investment community continues its recovery from the 2008 financial crisis, the total value…

Asia-PacificEuropeFinancialNorth AmericaPharmaceutical

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

Proposed new bill would create new patent term extension for certain biologics patents in USA

Proposed new bill would create new patent term extension for certain biologics patents in USA

26-03-2014

Earlier this week in the USA, legislation was introduced allowing new sponsors to gain intellectual property…

BiotechnologyLegalNorth AmericaPatentsPoliticsUSA

37 new medicines in development for Parkinson’s disease by PhRMA firms

25-03-2014

The USA’s biopharmaceutical research companies currently are developing 37 innovative new medicines…

NeurologicalNorth AmericaPharmaceuticalResearchUSA

US District Court upholds Mylan's US patents on Perforomist Inhalation Solution

25-03-2014

US generics major Mylan says the US District Court for the Northern District of West Virginia issued…

GenericsLegalMylan LaboratoriesNorth AmericaPatentsPerforomistRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

Patent lawyer seeking US Senate seat proposes patent reform to lower Rx drug costs

25-03-2014

Republican Art Gardner, a patent attorney seeking election to the US Senate in Georgia, has issued a…

North AmericaPatentsPharmaceuticalPoliticsPricingUSA

Medimetriks licenses ozenoxacin, a novel antibacterial, from Ferrer

24-03-2014

US specialty drug firm Medimetriks Pharmaceuticals has entered into a licensing agreement with Ferrer,…

Antibiotics and Infectious diseasesFerrer InternacionalLicensingMedimetriks PharmaceuticalsNorth AmericaOzenoxacinPharmaceuticalUSA

Lupin launches generic Niaspan in USA

24-03-2014

Indian drugmaker Lupin says that its US subsidiary has launched its niacin extended-release tablets USP,…

AbbVieCardio-vascularGenericsLupinMarkets & MarketingNiaspanNorth AmericaUSA

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