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Celgene’s Otezla is first oral therapy OKed by FDA for adults with active psoriatic arthritis

23-03-2014

The US Food and Drug Administration on Friday approved US biotech firm Celgene’s Otezla (apremilast),…

Anti-Arthritics/RheumaticsapremilastBiotechnologyCelgeneNorth AmericaOtezlaRegulationUSA

US FDA clears Xolair for chronic idiopathic urticaria

23-03-2014

Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for…

BiotechnologyDermatologicalsGenentechNorth AmericaNovartisRegulationRocheUSAXolair

US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

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

Actavis in Daytrana patent settlement

Actavis in Daytrana patent settlement

20-03-2014

Generic drugs major Actavis has entered into an agreement with Noven Pharmaceuticals, a subsidiary of…

ActavisDaytranaGenericsHisamitsu PharmaLegalNeurologicalNorth AmericaNoven PharmaceuticalsPatentsUSA

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

BioAlliance Pharma licenses Sitavig to Innocutis in North America

19-03-2014

French drug developer BioAlliance Pharma has executed a licensing accord with the USA’s Innocutis Holdings…

Anti-viralsBioAlliance PharmaBiotechnologyInnocutis HoldingsLicensingNorth AmericaSitavig

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

FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

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

US Court upholds damages award in Actelion/Asahi litigation

14-03-2014

Switzerland-based Actelion says that the California Supreme Court has denied the firm’ petition for…

ActelionAsahi KaseiBiotechnologyfasudilFinancialLegalNorth AmericaRespiratory and PulmonaryUSA

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

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

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

Teva agrees $27.6 million settlement with US Justice Dept

Teva agrees $27.6 million settlement with US Justice Dept

12-03-2014

US subsidiaries of Israeli generics giant Teva Pharmaceutical Industries have agreed to pay the US government…

ClozapineFinancialGenericsIvaxLegalNeurologicalNorth AmericaTeva Pharmaceutical IndustriesUSA

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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