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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

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

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

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

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

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

FDA approves Impavido to treat tropical disease leishmaniasis

FDA approves Impavido to treat tropical disease leishmaniasis

20-03-2014

The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine)…

Endo Health SolutionsImpavidoNorth AmericaPaladin LabsPharmaceuticalRegulationUSA

Astellas and Medivation file sNDA for new Xtandi indication

Astellas and Medivation file sNDA for new Xtandi indication

18-03-2014

Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application…

Astellas PharmaMedivationNorth AmericaOncologyPharmaceuticalRegulationUSAXtandi

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

18-03-2014

Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration…

DermatologicalsHemangeolNorth AmericaPharmaceuticalPierre FabreRegulationUSA

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

Generic drugs slow pharma spending growth in Canada

Generic drugs slow pharma spending growth in Canada

13-03-2014

Last year, C$29.3 billion ($26.47 billion) was spent on prescription drugs in Canada, but the annual…

CanadaFinancialGenericsMarkets & MarketingNorth AmericaPharmaceutical

PhRMA links up on national campaign to help increase clinical trials diversity

PhRMA links up on national campaign to help increase clinical trials diversity

13-03-2014

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum…

North AmericaPharmaceuticalResearchUSA

Pfizer to appeal Court decision on Celebrex reissue patent

Pfizer to appeal Court decision on Celebrex reissue patent

13-03-2014

US pharma behemoth Pfizer confirmed today that the US District Court for the Eastern District of Virginia…

Anti-Arthritics/RheumaticsCelebrexLegalNorth AmericaPatentsPfizerPharmaceuticalUSA

USA’s HHS establishes new network to perform clinical studies

USA’s HHS establishes new network to perform clinical studies

13-03-2014

The USA’s Department of Health and Human Services has established a network of five clinical research…

HealthcareNorth AmericaPharmaceuticalResearchUSA

Mallinckrodt gains FDA approval for Xartemis XR

Mallinckrodt gains FDA approval for Xartemis XR

12-03-2014

The US Food and Drug Administration has approved Ireland-headquartered specially drugmaker Mallinckrodt’s…

DepomedMallinckrodtNeurologicalNorth AmericaPharmaceuticalRegulationUSAXartemis XR

US CMS withdraws contentious Medicare Part D proposals

11-03-2014

The US Centers for Medicare & Medicaid Services (CMS) has halted movement on several proposals in its…

HealthcareNorth AmericaPharmaceuticalPoliticsUSA

KYTHERA regains rights to ATX-101 outside USA and Canada from Bayer

KYTHERA regains rights to ATX-101 outside USA and Canada from Bayer

11-03-2014

US biotech firm KYTHERA Biopharmaceuticals says it has re-acquired all rights outside of the USA and…

ATX-101BayerDermatologicalsKYTHERA BiopharmaceuticalsLicensingNorth AmericaPharmaceutical

FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine

10-03-2014

The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

US researchers report blood test that can predict Alzheimer’s

10-03-2014

A blood test that can accurately predict the onset of Alzheimer's disease has been reported by, US researchers.…

NeurologicalNorth AmericaPharmaceuticalResearchUSA

Severe diarrheal illness in children linked to antibiotics prescribed in US doctor’s offices; study

10-03-2014

The majority of pediatric Clostridium difficile infections, which are bacterial infections that cause…

Antibiotics and Infectious diseasesHealthcareNorth AmericaPharmaceutical

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