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Takeda gains approval for Takecab in Japan; files MS drug NDA

Takeda gains approval for Takecab in Japan; files MS drug NDA

29-12-2014

Japan’s largest drugmaker Takeda Pharmaceutical and partner Otsuka Pharmaceuticals have been granted…

Gastro-intestinalsGlatiramer AcetateJapanNeurologicalOtsuka PharmaceuticalsPharmaceuticalRegulationTakecabTakeda PharmaceuticalTeva Pharmaceuticals Industriesvonoprazan

Torrent enters exclusive licensing deal with Reliance Life Sciences for three biosimilars

Torrent enters exclusive licensing deal with Reliance Life Sciences for three biosimilars

29-12-2014

Ahmedabad, India-based Torrent Pharmaceuticals last week entered into an exclusive licensing agreement…

adalimumabAnti-Arthritics/RheumaticsBiosimilarscetuximabGenericsIndiaLicensingMarkets & MarketingOncologyrituximabTorrent Pharmaceuticals

Newron and Zambon re-submit NDA for safinamide following Refusal to File

Newron and Zambon re-submit NDA for safinamide following Refusal to File

29-12-2014

Clinical-stage biopharma company Newron and its commercial development partner, fellow Italy-based pharma…

NeurologicalNewron PharmaPharmaceuticalRegulationsafinamideUSAZambon

Chugai wins first round of patent infringement law suit for Oxarol ointment

Chugai wins first round of patent infringement law suit for Oxarol ointment

29-12-2014

Japanese drugmaker Chugai Pharmaceutical says that, on December 24, the Tokyo District Court granted…

Cerbios-PharmaChugai PharmaceuticalDermatologicalsDKSHGenericsIwaki SeiyakuJapanLegalOxarolPatentsPola PharmaRocheTakata Seiyaku

Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

29-12-2014

Swiss drug major Roche has received Emergency Use Authorization for its LightMix Ebola Zaire rRT-PCR…

Anti-viralsPharmaceuticalRegulationRocheWest Africa

Sumitomo Dainippon to halve its Japanese production sites

Sumitomo Dainippon to halve its Japanese production sites

29-12-2014

Japanese pharma company Sumitomo Dainippon is to reduce its four production sites in Japan to just two.

Dainippon Sumitomo PharmaJapanPharmaceuticalProductionSumitomo

First ever regulatory approval of Novartis' Cosentyx in Japan

First ever regulatory approval of Novartis' Cosentyx in Japan

26-12-2014

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma giant Novartis’…

Anti-Arthritics/RheumaticsBiotechnologyCosentyxDermatologicalsJapanNovartisRegulation

FDA backs Actavis’ Namzaric, but issues CRL on nebivolol/valsartan combo

FDA backs Actavis’ Namzaric, but issues CRL on nebivolol/valsartan combo

26-12-2014

The US Food and Drug Administration has approved the New Drug Application for Namzaric (formerly known…

ActavisAdamas PharmaceuticalsCardio-vasculardonepezilMemantine HCLNamzaricnebivololNeurologicalPharmaceuticalRegulationUSAvalsartan

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