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US FDA warns on over-prescribing of testosterone products

US FDA warns on over-prescribing of testosterone products

04-03-2015

The US Food and Drug Administration is requiring that the manufacturers of all approved prescription…

AbbVieAndroGelAxironEli LillyMen's HealthPharmaceuticalRegulationUSA

Patent reform bill to protect innovation, confront abuse introduced in USA

Patent reform bill to protect innovation, confront abuse introduced in USA

04-03-2015

US Senators Chris Coons (Democrat, Delaware) and Dick Durbin (Democrat, Illinois), members of the Senate…

LegalPatentsPharmaceuticalPoliticsUSA

Orexigen shares jump on Contrave trial interim data but FDA orders more cardio studies

Orexigen shares jump on Contrave trial interim data but FDA orders more cardio studies

04-03-2015

The US Food and Drug Administration has said it is “disappointed” by Orexigen Therapeutics’ decision…

ContraveMetabolicsNeurologicalOrexigen TherapeuticsPharmaceuticalRegulationUSA

Lilly licenses pomaglumetad methionil to Denovo as potential schizophrenia therapy

Lilly licenses pomaglumetad methionil to Denovo as potential schizophrenia therapy

03-03-2015

US drug major Eli Lilly has licensed late-stage neuroscience drug pomaglumetad methionil (mGlu2/3 receptor…

Eli LillyLicensingNeurologicalPharmaceuticalpomaglumetad methionilUSA

FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia

FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia

03-03-2015

The US Food and Drug Administration has declined to expand the approval of Exparel (bupivacaine), manufactured…

AnalgesiaExparelPacira PharmaceuticalsPharmaceuticalRegulationUSA

Teva to sell Sellersville, PA, manufacturing facility to G&W Laboratories

Teva to sell Sellersville, PA, manufacturing facility to G&W Laboratories

03-03-2015

Israel-based Teva Pharmaceutical Industries is to sell its manufacturing facility in Sellersville, Pennsylvania,…

PharmaceuticalProductionTevaTeva Pharmaceutical IndustriesUSA

Endo to divest its American Medical Systems men's and prostate businesses to Boston Scientific

Endo to divest its American Medical Systems men's and prostate businesses to Boston Scientific

03-03-2015

Ireland-headquartered Endo International has entered into a definitive agreement with Boston Scientific…

EndoLicensingMen's HealthPharmaceuticalUSA

2015 outlook for US and EU pharma; report

2015 outlook for US and EU pharma; report

27-02-2015

According to this Global Pharma US & EU Outlook 2015 report, strategy diversification stays divested…

EuropeManagementMarkets & MarketingMergers & AcquisitionsPatentsPharmaceuticalUSA

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

26-02-2015

The US Food and Drug Administration has approved French pharma major Sanofi’s Toujeo (insulin glargine…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

US FDA approves new antibacterial drug Avycaz

US FDA approves new antibacterial drug Avycaz

26-02-2015

The US Food and Drug Administration has approved antibacterial drug Avycaz (ceftazidime-avibactam) to…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamForest PharmaceuticalsPharmaceuticalRegulationUSA

Pfizer reports positive top-line data for Trumenba Phase II study in adolescents

Pfizer reports positive top-line data for Trumenba Phase II study in adolescents

24-02-2015

US pharma giant Pfizer has announced positive top-line results of a Phase II study of Trumenba (meningococcal…

Antibiotics and Infectious diseasesPfizerPharmaceuticalResearchTrumenbaUSA

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

24-02-2015

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat,…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Eli Lilly delays US and Europe filings for new diabetes agent peglispro

23-02-2015

US pharma major Eli Lilly says it is delaying the submission of its basal insulin peglispro (BIL) to…

DiabetesEli LillyEuropepeglisproPharmaceuticalRegulationUSA

Astellas announces reorganization of its North American operation and business development

Astellas announces reorganization of its North American operation and business development

20-02-2015

Japanese drug major Astellas Pharma is to make organizational and personnel changes in the Americas,…

AstellasAstellas Pharma Canada IncBoardroomPharmaceuticalUSA

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

20-02-2015

Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted…

cobimetinibGenentechOncologyPharmaceuticalRegulationRocheUSA

Lilly accepts committee recommendation to extend evacetrapib study by six months

Lilly accepts committee recommendation to extend evacetrapib study by six months

20-02-2015

US drug major Eli Lilly has accepted the recommendation of the ACCELERATE study academic executive committee…

Cardio-vascularEli LillyevacetrapibPharmaceuticalResearchUSA

UPDATE: New study shows Regeneron’s Eylea is superior to rivals in DME

UPDATE: New study shows Regeneron’s Eylea is superior to rivals in DME

19-02-2015

US biotech Regeneron Pharmaceuticals today announced results from a study which show Eylea (aflibercept)…

AvastinEyleaLucentisOphthalmicsPharmaceuticalRegeneron PharmaceuticalsResearchUSA

Actavis’ fourth-qtr 2014 beats expectations

Actavis’ fourth-qtr 2014 beats expectations

18-02-2015

Ireland-headquartered generics major Actavis posted better-than-expected fourth-quarter and full-year…

AccountancyActavisAllerganFinancialForest LaboratoriesGenericsPharmaceuticalThomson ReutersUSA

Former pharma execs set up financing strategy partnership

Former pharma execs set up financing strategy partnership

18-02-2015

Three former pharma and health care executives have formed a new partnership to provide strategic support…

Business FinanceFinancialnext20PharmaceuticalUSA

Use of generics key to glaucoma medicine adherence, study says

Use of generics key to glaucoma medicine adherence, study says

18-02-2015

A potential solution to resolve patient non-adherence in glaucoma treatment is switching to generic drugs,…

Bimatoprost Ophthalmic Solution 0.03% for GlaLatanoprost OphthalmicOphthalmicsPharmaceuticalPricingResearchUSA

FDA issues new draft documents related to compounding of human drugs

FDA issues new draft documents related to compounding of human drugs

17-02-2015

The US Food and Drug Administration issued five draft documents related to drug compounding and repackaging…

FDAHealthPharmaceuticalPharmaceutical sciencesPharmacologyRegulationSterile compounded drug productsUSA

Sprout Pharmaceuticals resubmits flibanserin to the FDA for women's hypoactive sexual desire disorder

Sprout Pharmaceuticals resubmits flibanserin to the FDA for women's hypoactive sexual desire disorder

17-02-2015

Privately-held US sexual health specialists Sprout Pharmaceuticals has resubmitted its New Drug Application…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

17-02-2015

In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks the…

FDAPharmaceuticalPharmacologyRegulationUSA

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