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US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

30-01-2014

US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee,…

GenericsNorth AmericaPoliticsRegulationUSA

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

10 billion real to be invested in Brazil’s production of biotech drugs by 2016

10 billion real to be invested in Brazil’s production of biotech drugs by 2016

27-01-2014

Brazil's Development Bank (BNDS) plans to invest up to 10 billion real ($4.2 billion) in the production…

BiotechnologyBrazilFinancialGenericsHypermarcasMarkets & MarketingProductionSanofiSouth America

Actavis to shed another business, its Actavis Foshan unit in China

Actavis to shed another business, its Actavis Foshan unit in China

26-01-2014

US generics major Actavis revealed a second divestiture this month, saying it has signed and completed…

ActavisAsia-PacificChinaGenericsMergers & AcquisitionsZhejiang Chiral

Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility

24-01-2014

As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

23-01-2014

The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

Actavis confirms challenge to Allergan’s Restasis

22-01-2014

Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated…

ActavisAllerganGenericsNorth AmericaOphthalmicsPatentsRegulationRestasisUSAWatson Pharmaceuticals

Par Pharmaceutical to acquire JHP Pharmaceutical

21-01-2014

US privately-held Par Pharmaceutical has entered into a definitive agreement to acquire JHP Group Holdings,…

GenericsJHP PharmaceuticalsMergers & AcquisitionsPar Pharmaceutical

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

20-01-2014

US emerging biotech firm Aegerion Pharmaceuticals says that the Mexican Federal Commission for the Protection…

Aegerion PharmaceuticalsJuxtapidMexicoPharmaceuticalRare diseasesRegulationSouth America

Actavis to divest certain European operations to Aurobindo

Actavis to divest certain European operations to Aurobindo

18-01-2014

US generics major Actavis plans to enter into an agreement with India’s Aurobindo Pharma for the latter…

ActavisAurobindo PharmaEuropeGenericsMergers & Acquisitions

Brazil initiates public consultation on interchangeability of biosimilar drugs

Brazil initiates public consultation on interchangeability of biosimilar drugs

17-01-2014

Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference…

BiosimilarsBrazilPharmaceuticalRegulationSouth America

Alvogen takes 67% stake in Lotus Pharma

17-01-2014

Privately-owned US generics firm Alvogen revealed that, last month, it agreed to become the majority…

AlvogenAsia-PacificGenericsLotus PharmaceuticalsMergers & Acquisitions

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea

16-01-2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

Brazil to produce atazanavir to supply SUS demand; strong pharma growth forecast for 2014

15-01-2014

Following the Official Gazette market application filling for the drug atazanavir sulfate, an HIV protease…

Anti-viralsatazanavirBrazilBristol-Myers SquibbFiocruzGenericsMarkets & MarketingPharmaceuticalProductionSouth America

Actavis restructures, appointing industry veterans to lead US Specialty Brands business units

Actavis restructures, appointing industry veterans to lead US Specialty Brands business units

14-01-2014

US generics and specialty drugmaker Actavis has announced an updated business structure for its US Specialty…

ActavisBoardroomGenericsManagement

Biotoscana to buy United Medical to create regional specialty pharma group in South America

14-01-2014

Colombia-based Grupo Biotoscana has signed an agreement to acquire Brazilian drugmaker United Medical…

Grupo BiotoscanaMergers & AcquisitionsPharmaceuticalSouth AmericaUnited Medical

Amneal appoints former Warner Chilcott senior VP Rochelle Fuhrmann as CFO

14-01-2014

Privately-held US generics drugmaker Amneal has announced Rochelle Fuhrmann has joined the company as…

Amneal PharmaBoardroomGenericsUSAWarner Chilcott

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

09-01-2014

Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition…

BiosimilarsGenericsJanssenJohnson & JohnsonNorth AmericaRegulationUSA

Teva confirms appointment of Erez Vigodman as president and CEO

Teva confirms appointment of Erez Vigodman as president and CEO

09-01-2014

Somewhat sooner than expected, Isael’s Teva Pharmaceutical Industries, the world’s largest generics…

BoardroomGenericsManagementTeva Pharmaceutical Industries

Ranbaxy cleared to market branded generic of Aricept in Canada

Ranbaxy cleared to market branded generic of Aricept in Canada

08-01-2014

The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil…

AriceptCanadaDaiichi SankyoEisaiGenericsNeurologicalNorth AmericaRAN-DonepezilRanbaxy LaboratoriesRegulation

US national health spending growth remains low for 4th consecutive year

07-01-2014

Overall national health expenditures in the USA grew at an annual rate of 3.7% in 2012, marking the fourth…

FinancialGenericsHealthcareNorth AmericaPharmaceuticalUSA

Teva looks set to name Erez Vigodman as new CEO

Teva looks set to name Erez Vigodman as new CEO

07-01-2014

Speculation is mounting that Israel’s Teva Pharmaceutical Industries is about to appoint a new chief…

BoardroomGenericsManagementPharmaceuticalTeva Pharmaceutical Industries

Amneal debuts generic Esomeprazole strontium in USA

07-01-2014

Privately-held US generics drugmaker Amneal Pharmaceuticals has announced the launch of generic esomeprazole…

Amneal PharmaAstraZenecaEsomeprazole MagnesiumGastro-intestinalsGenericsMarkets & MarketingNexiumNorth AmericaUSA

moksha8 files Viibryd and Colobreathe in Brazil; amends Forest alliance

06-01-2014

Brazil-based pharma firm moksha8 has filed applications with the Brazilian regulatory authority, ANVISA,…

BrazilColoBreatheForest LaboratoriesLicensingMerck SeronoMoksha8NeurologicalPharmaceuticalRare diseasesRegulationSouth AmericaViibryd

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