Regulation - Pharmaceutical, Patents


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Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity


Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

Indian drugmakers readying for next “Patent cliff”


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

Asia-PacificGenericsIndiaMergers & AcquisitionsPatentsPharmaceuticalRegulation

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP


Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

Indian pharmaceutical market to reach $56 billion by 2020, says GlobalData


Driven by the country’s growing economy and population income, the Indian pharmaceutical market will…

Asia-PacificMarkets & MarketingPatentsPharmaceuticalRegulation

Tightening health budgets on both sides of the Atlantic leading to crackdowns on patent settlements, says EIU analyst


Later this month, following an inquiry launched in 2009, the European Commission is expected to impose…

EuropeFinancialGenericsNorth AmericaPatentsPharmaceuticalPoliticsRegulation

Market access barriers for multinationals, but Argentina still offers attractive pharma opportunities


Several barriers impede market access but the regulatory landscape in Argentina is changing and attractive…

BiotechnologyMarkets & MarketingPatentsPharmaceuticalRegulationSouth America

Ahead of 2013 federal election, trade group makes plea for fixing Australia's PBS listing system


Pharma trade group Medicines Australia today (May 27) launched its 2013 Federal Election document, calling…


Argentina's pharma market to almost triple over one decade, says GlobalData


Argentina's pharmaceutical market is expected to grow from a value of around $5.6 billion in 2012 to…

GenericsMarkets & MarketingPatentsPharmaceuticalProductionRegulationSouth America

Europe falling behind USA and China as attractive for life sciences sector


Intellectual property specialists Marks & Clerk's latest Life Sciences Report unveils the changing landscape…


Briefs: Glenmark challenges Bayer patent; FDA delays Merck & Co's sugammadex


Indian drugmaker Glenmark Generics confirms that it seeking US Food and Drug Administration approval…

BayerBridionDermatologicalsFinacea GelGenericsGlenmark PharmaceuticalsMerck & CoNeurologicalNorth AmericaPatentsPharmaceuticalRegulationsugammadex

UK government moves to cut red tape to benefit R&D for new drugs


The UK government yesterday announced a change to the Patents Act which will help the UK's world class…


Regulatory news for Hyperion's Ravicti and Seattle Genetics' Adcetris


The US Food and Drug Administration on Friday approved Hyperion Therapeutics' (Nasdaq: HPTX) Ravicti…

AdcetrisBiotechnologyHyperion TherapeuticsNorth AmericaOncologyPatentsPharmaceuticalRare diseasesRavictiRegulationSeattle Genetics

EMA workshop on access to clinical-trial data and transparency kicks off process towards proactive publication of data


"The European Medicines Agency is committed to proactive publication of clinical-trial data, once the…


Saudi Arabia aims to improve national health care with patent and drug approval changes


Saudi Arabia is taking back control of its health care industry, states a new report by the business…

GenericsHealthcareMarkets & MarketingPatentsPharmaceuticalRegulationRest of the World

"New" CDER Exclusivity Board focuses on clarity and consistency of exclusivity decisions


The US Food and Drug Administration recently announced that the agency has established within the Center…

BiotechnologyLegalNorth AmericaPatentsPharmaceuticalRegulation

FDA approves Teva's Synribo for CML; Novartis plans for Tasigna switch


The US Food and Drug Administration on Friday approved Israel-headquartered Teva Pharmaceutical Industries'…

GleevecNorth AmericaNovartisOncologyPatentsPharmaceuticalRegulationResearchSynriboTasignaTeva Pharmaceutical Industries

UK govt sets out proposals to cut risks for pharmaceutical research


A new consultation launched yesterday by the Department for Business, Innovation & Skills (BIS) sets…


Shire's Dermagraft cleared in Canada; settles Intuniv litigation


Ireland headquartered Shire (LSE: SHP), NASDAQ: SHPG) says that its lead regenerative medicine product,…

Anchen PharmaceuticalsDermagraftDermatologicalsDiabetesGenericsIntunivNeurologicalNorth AmericaPatentsPharmaceuticalRegulationShireTWi Pharmaceuticals

Global pharmaceutical approvals moderate as patent cliff peaks, says Fitch


The Food and Drug Administration will approve fewer novel drugs in 2012 compared to 2011 while the industry…

BiotechnologyNorth AmericaPatentsPharmaceuticalRegulation

EU Parliament rejects ACTA by massive 478 vote from MEPs


The controversial Anti-Counterfeiting Trade Agreement (ACTA) was rejected by the European Parliament…


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