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FDA proposed rule to change label requirements would cause dangerous confusion, raise costs

24-02-2014

The Food and Drug Administration’s Proposed Rule to change prescription drug label requirements risks…

GenericsNorth AmericaRegulationUSA

MSF warns of impact of proposed EU trade mark infringement measures

24-02-2014

Ahead of a vote tomorrow in the European Parliament on proposed strengthened EU enforcement of European…

EuropeGenericsPatents & Trade marks

Indian drugmakers readying for next “Patent cliff”

24-02-2014

The strategic drug reviews, as well as mergers and acquisitions – such as Actavis buying out Forest…

Asia-PacificGenericsIndiaMergers & AcquisitionsPatentsPharmaceuticalRegulation

Positive CHMP opinion for Teva’s DuoResp Spiromax for asthma and COPD

22-02-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

AstraZenecaDuoResp SpiromaxPharmaceuticalRegulationRespiratory and PulmonarySymbicortTeva Pharmaceutical Industries

US GPhA member support for GDUFA promise and progress

US GPhA member support for GDUFA promise and progress

21-02-2014

The US Food and Drug Administration’ Office of Generic Drugs acting director Kathleen Uhl, highlighted…

GenericsNorth AmericaRegulationUSA

Setting the record straight: Australia’s PBS expenditure is in decline

21-02-2014

Comments made this week by Australia’s federal Health Minister, Peter Dutton MP, about expenditure…

Asia-PacificAustraliaFinancialGenericsHealthcarePharmaceutical

Actavis net revenue rise 59% beats forecasts; non-GAAP EPS rises 99%

Actavis net revenue rise 59% beats forecasts; non-GAAP EPS rises 99%

20-02-2014

Acquisitive Ireland-headquartered generics major Actavis says that net revenue leapt 59% to $2.779 billion…

ActavisFinancialGenerics

Actavis confirms plan to acquire Forest Labs for about $25 billion

Actavis confirms plan to acquire Forest Labs for about $25 billion

18-02-2014

After a morning of speculation and rumors, generics drug major Actavis today confirmed that it has reached…

ActavisForest LaboratoriesGenericsMergers & AcquisitionsPharmaceutical

NZ’s PHARMAC tender reveals vibrant market for pharmaceuticals

NZ’s PHARMAC tender reveals vibrant market for pharmaceuticals

12-02-2014

The number of companies bidding to be suppliers through PHARMAC, New Zealand’s Pharmaceutical Management…

Asia-PacificGenericsHealthcarePricing

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

Dr Reddy’s sees generics soar due to limited competition

Dr Reddy’s sees generics soar due to limited competition

11-02-2014

India’s second-largest drugmaker Dr Reddy's Laboratories has reported strong third quarter sales of…

Dr Reddy's LaboratoriesFinancialGenericsIndiaPharmaceutical

Cadila net profit up by 82% in third-quarter

07-02-2014

Indian drugmaker Cadila Healthcare posted a net profit of 1.86 billion rupees ($29.7 million), for the…

BiosimilarsCadila PharmaceuticalsFinancialGenericsResearchZydus Cadila

Teva’s full year results steady led by Copaxone sales up 8%

Teva’s full year results steady led by Copaxone sales up 8%

07-02-2014

Israel-based Teva Pharmaceutical Industries has released its full year results for 2014 showing that…

CopaxoneEastern EuropeFinancialGenericsPharmaceuticalTeva Pharmaceutical Industries

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

AstraZeneca 4th-qtr profits plunge 26% on generic woes

AstraZeneca 4th-qtr profits plunge 26% on generic woes

06-02-2014

Increasing generic competition took its toll on Anglo-Swedish drug major AstraZeneca, which this morning…

AstraZenecaFinancialPharmaceutical

Ranbaxy rises on 4th-qtr performance, but can this continue?

Ranbaxy rises on 4th-qtr performance, but can this continue?

05-02-2014

Ranbaxy Laboratories, India’s largest generic drugmaker by sales, saw its shares rise 5.6% to 340 rupees…

Daiichi SankyoFinancialGenericsRanbaxy Laboratories

Spain continues reduction of pharma spending and starts adopting value based pricing

04-02-2014

The Spanish Ministry of Health last week announced pharmaceutical spending data, which showed a new drop…

EuropeFinancialGenericsHealthcarePharmaceuticalPricingSpain

US health advocacy groups state case on biosimilars naming policy

04-02-2014

In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health…

BiosimilarsGenericsNorth AmericaRegulationUSA

Actavis confirms generic Treanda patent challenge

Actavis confirms generic Treanda patent challenge

04-02-2014

US generics drug major Actavis confirms that it has filed an Abbreviated New Drug Application with the…

ActavisCephalonGenericsNorth AmericaOncologyPatentsTeva Pharmaceutical IndustriesTreandaUSA

UK’s NICE consults on updating guidance for Tarceva and Iressa

UK’s NICE consults on updating guidance for Tarceva and Iressa

04-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) said this morning that it is reviewing…

AstraZenecadocetaxelIressaOncologyPharmaceuticalRegulationRocheTarcevaUK

US generics lobby group, GPhA, sets out 2014 priorities

US generics lobby group, GPhA, sets out 2014 priorities

04-02-2014

The US trade group the Generic Pharmaceutical Association (GPhA) has identified its key priorities for…

BiosimilarsGenericsHealthcareNorth AmericaRegulationUSA

Mylan debuts Hertraz, first Herceptin biosimilar, in India

Mylan debuts Hertraz, first Herceptin biosimilar, in India

03-02-2014

US generics major Mylan has launched the world's first trastuzumab biosimilar in India. The product,…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazIndiaMarkets & MarketingMylan LaboratoriesOncologyRoche

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