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FDA backs added use for UCB’s Vimpat

01-09-2014

Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a…

NeurologicalPharmaceuticalRegulationUCBUSAVimpat

Takeda and Lilly fail to overturn $9 billion award for hiding cancer risk of Actos

Takeda and Lilly fail to overturn $9 billion award for hiding cancer risk of Actos

31-08-2014

Japan’s largest drugmaker Takeda Pharmaceutical and US pharma major Eli Lilly have failed in their…

ActosDiabetesEli LillyFinancialLegalPharmaceuticalTakeda PharmaceuticalUSA

FTC puts conditions on acquisition of Insight Pharma by Prestige Brands

29-08-2014

US firm Prestige Brands Holdings, the maker of Dramamine (dimenhydrinate), has agreed to divest assets…

Insight PharmaceuticalsMergers & AcquisitionsPharmaceuticalPrestige BrandsRegulationUSA

FDA approves Elelyso for pediatric use in Gaucher disease

FDA approves Elelyso for pediatric use in Gaucher disease

29-08-2014

The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa)…

ElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationUSA

Colorectal cancer market will remain steady at $7.7 billion by 2023; report

29-08-2014

The market for colorectal cancer (CRC) therapies will remain constant, at around $7.7 billion by 2023…

EuropeJapanMarkets & MarketingOncologyPharmaceuticalUSA

Curious resilience of the $50,000-per-QALY threshold

28-08-2014

For more than two decades, the ratio of $50,000 per quality-adjusted life-year (QALY) gained by using…

HealthcarePharmaceuticalPricingRegulationUSA

USIBC concludes successful pharmaceutical mission to India

USIBC concludes successful pharmaceutical mission to India

28-08-2014

The US-India Business Council (USIBC) has concluded its Pharmaceutical Executive Mission to Delhi, India.…

IndiaPatentsPharmaceuticalPricingUSA

Novo Nordisk buys production plant in New Hampshire

Novo Nordisk buys production plant in New Hampshire

27-08-2014

Danish diabetes care giant Novo Nordisk (NOV: N) said today that it has acquired a manufacturing facility…

Mergers & AcquisitionsNovo NordiskOlympus BiotechPharmaceuticalProductionUSA

FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

Vivus acquires topiramate patents from Janssen

Vivus acquires topiramate patents from Janssen

26-08-2014

USA-based pharma company Vivus has acquired a group of patents from Johnson & Johnson’s Janssen Pharmaceuticals…

AnorecticsEuropean Medicines AgencyJanssen PharmaceuticaLicensingObesityPharmaceuticalPhentermine/topiramateQsymiaTopiramateUSAVivus

US Administration to ensure women’s continued access to contraception coverage, while respecting religious-based objections

US Administration to ensure women’s continued access to contraception coverage, while respecting religious-based objections

25-08-2014

On Friday, the Obama Administration in the USA took several steps to help ensure women, whose coverage…

FinancialPharmaceuticalRegulationReproductiveUSA

ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

ADHD treatment market set to reach $9.9 billion by 2020

ADHD treatment market set to reach $9.9 billion by 2020

22-08-2014

The attention-deficit hyperactivity disorder (ADHD) therapeutics market value will rise from $6.9 billion…

ADHDEuropeJapanNeurologicalPharmaceuticalPsychiatryUSA

US DEA publishes final rule to reschedule hydrocodone combination products

US DEA publishes final rule to reschedule hydrocodone combination products

22-08-2014

The US Drug Enforcement Administration (DEA) has today published in the Federal Register the Final Rule…

AnalgesiaPharmaceuticalRegulationUS Drug Enforcement AdministrationUSA

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

Public Citizen expert slams aspects of FDA draft drug labeling guidance

Public Citizen expert slams aspects of FDA draft drug labeling guidance

21-08-2014

The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical…

PharmaceuticalRegulationUSA

US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

21-08-2014

A judge in US federal court has issued a temporary restraining order following the US Food & Drug Administration’s…

Food and Drug AdministrationHospiraMylanNeurologicalPharmaceuticalPrecedexUSA

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

21-08-2014

UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has…

Arnuity ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUSA

Depomed prevails in Gralise ANDA litigation with Actavis

Depomed prevails in Gralise ANDA litigation with Actavis

20-08-2014

US drug maker Depomed saw its shares climb more than 12% to $14.76 on Tuesday, on the news that the firm…

ActavisDepomedGraliseLegalNeurologicalPatentsPharmaceuticalUSA

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