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Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

22-07-2014

In the latest in an ongoing takeover attempt of Allergan by Valeant, Valeant has contacted financial…

AllerganBausch & LombCanadaFinancialPharmaceuticalRegulationUSAValeant Pharmaceuticals

New Zealand proposes contestable fund for medicines for rare disorders

New Zealand proposes contestable fund for medicines for rare disorders

09-07-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC will be running a commercial process to fund…

FinancialNew ZealandPharmaceuticalRare diseasesRegulation

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

11-06-2014

The European Federation of Pharmaceutical Industries and Associations says it is concerned about a decision…

AvastinEuropeFinancialItalyNovartisOphthalmicsPharmaceuticalRegulationRoche

Bureaucratic delays hinder pharma investors in Zimbabwe

27-05-2014

Regulatory bureaucracy in the African state of Zimbabwe is a major deterrent to pharmaceutical investors…

FinancialPharmaceuticalRegulationRest of the World

Adamas Pharma gets $25 million milestone from Forest Labs

21-05-2014

Adamas Pharmaceuticals says it has received a $25 million milestone payment from Forest Laboratories…

Adamas PharmaceuticalsFinancialForest LaboratoriesMDX-8704NeurologicalPharmaceuticalRegulationUSA

New treatment funded for severe gout in New Zealand

21-05-2014

Patients with severe gout will soon have a new treatment option as New Zealand’s Pharmaceutical Management…

AdenuricAnti-Arthritics/RheumaticsfebuxostatFinancialMenariniNew ZealandPharmaceuticalRegulation

AbbVie files NDA for oral, interferon-free treatment of hepatitis C

22-04-2014

US drugmaker AbbVie has submitted its New Drug Application to the US Food and Drug Administration for…

AbbVieAnti-viralsEnanta PharmaceuticalsFinancialNorth AmericaPharmaceuticalRegulationUSA

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

New data shows FDA’s proposed generic labeling rules would add to health costs

New data shows FDA’s proposed generic labeling rules would add to health costs

06-02-2014

The US Food and Drug Administration’s Proposed Rule on prescription drug labeling would add $4 billion…

FinancialGenericsNorth AmericaRegulationUSA

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

04-02-2014

GlaxoSmithKline’s Tafinlar (dabrafenib) is now available for metastatic melanoma patients in England…

FinancialGSKOncologyPharmaceuticalRegulationTafinlarUK

Call for strategic regulatory rethink for EU generic medicines industry

Call for strategic regulatory rethink for EU generic medicines industry

27-01-2014

“It is vital that costs associated with regulatory processes do not become a barrier to developing…

EuropeFinancialGenericsRegulation

Takeda's lymphoma drug Adcetris approved in Japan

Takeda's lymphoma drug Adcetris approved in Japan

18-01-2014

Japan’s largest drugmaker Takeda Pharmaceutical has received approval from the country’s Ministry…

AdcetrisFinancialOncologyPharmaceuticalRegulationSeattle GeneticsTakeda Pharmaceuticals

US global share of biomedical research spending declines, as Asia gains

02-01-2014

The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while…

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

EMA Management Board endorses work program for 2014

EMA Management Board endorses work program for 2014

18-12-2013

The European Medicines Agency’s Management Board, at its meeting on December 11-12 adopted the Agency’s…

EuropeFinancialPharmaceuticalRegulation

2013 FDA approval rates suggest record year for post-launch success

14-11-2013

A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new…

Biogen IdecFinancialGilead SciencesNorth AmericaPharmaceuticalRegulationsofosbuvirTecfidera

Curis plunges on negative CUCD-427 news; 3rd-qtr loss down

07-11-2013

Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of…

BiotechnologyCUCD-427CurisFinancialNorth AmericaOncologyRegulationResearch

US FDA jacks up FY 2014 generic drug user fees

13-08-2013

In a Federal Register notice, the US Food and Drug Administration has announced the rate for the Abbreviated…

FinancialGenericsNorth AmericaRegulation

Latest developments in Japan pharma sector

12-08-2013

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) reported its self evaluation to the Ministry…

Asia-PacificFinancialMarkets & MarketingPharmaceuticalRegulation

Orexigen updates on obesity drug filing plans

08-08-2013

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) yesterday (August 7) announced its plan to…

BiotechnologyContraveEuropeFinancialMetabolicsOrexigen TherapeuticsPharmaceuticalRegulation

A third of pharma executives want to trial smartphone medication reminders, says KPMG

08-07-2013

Smartphone apps could be used to help patients stick to medication schedules, according to a report released…

FinancialGenericsRegulation

The case for Insmed's CF drug candidate Arikace; analysts' views

05-07-2013

The 16% decline in US biotech firm Insmed's (Nasdaq CM: INSM) stock is an overreaction to results from…

ArikaceBiotechnologyFinancialInsmedRare diseasesRegulationResearchRespiratory and Pulmonary

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