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US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

17-06-2014

USA-based Mirati Therapeutics has been granted Orphan Drug designation by the US Food and Drug Administration…

BiotechnologyOncologyRare diseasesRegulation

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

Novartis files for US approval of meningitis B vaccine Bexsero

Novartis files for US approval of meningitis B vaccine Bexsero

17-06-2014

Swiss pharma major Novartis has submitted a Biologic License Application to the US Food and Drug Administration…

BexseroBiotechnologyNovartisRegulationUSAVaccines

Actelion shares leap on positive Ph III data with selexipag

Actelion shares leap on positive Ph III data with selexipag

16-06-2014

Shares of Switzerland-based Actelion, Europe’s largest biotech firm, gained 15.1% to 104.70 Swiss francs…

ActelionBiotechnologyResearchRespiratory and Pulmonaryselexipag

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

16-06-2014

In draft recommendations published today, UK health care watchdog the National Institute for Health and…

Anti-viralsBiotechnologyGilead SciencesPricingRegulationSovaldiUK

Doomed future for Tykerb in breast cancer arena, says analyst

Doomed future for Tykerb in breast cancer arena, says analyst

16-06-2014

The future of Tykerb (lapatinib) in the breast cancer market looks bleak, after the combination of GlaxoSmithKline’s…

BiotechnologyGlaxoSmithKlineMarkets & MarketingNovartisOncologyResearchTykerb

Takeda to withdraw NDA as Omontys pact with Affymax ends

Takeda to withdraw NDA as Omontys pact with Affymax ends

15-06-2014

USA-based Affymax and Japan's Takeda Pharmaceutical revealed on Friday that they have terminated their…

AffymaxBiotechnologyLicensingOmontysOncologyRegulationTakeda Pharmaceutical

Geron leaps as FDA lifts partial hold on imetelstat trial

Geron leaps as FDA lifts partial hold on imetelstat trial

13-06-2014

US biotech Geron Corp's shares jumped around 27% to $3.31 in early afternoon trading yesterday after…

BiotechnologyGeron CorpHematologyimetelstatOncologyRegulationUSA

Immunotherapies show promise for non-small cell lung cancer market

Immunotherapies show promise for non-small cell lung cancer market

13-06-2014

Immunotherapies have huge potential for the treatment of non-small cell lung cancer (NSCLC), with three…

BiotechnologyBristol-Myers SquibbMarkets & MarketingMerck & ConivolumabOncologypembrolizumabResearchRoche

EULAR: Positive Ph III sarilumab data in RA from Sanofi and Regeneron

EULAR: Positive Ph III sarilumab data in RA from Sanofi and Regeneron

12-06-2014

French drug major Sanofi and partner US biotech firm Regeneron Pharmaceuticals have presented positive…

Anti-Arthritics/RheumaticsBiotechnologyRegeneronResearchSanofisarilumab

EULAR: Sustained outcomes with UCB’s Cimzia in spondyloarthritis

EULAR: Sustained outcomes with UCB’s Cimzia in spondyloarthritis

12-06-2014

Belgium’s leading drugmaker UCB today presented new long-term data on Cimzia (certolizumab pegol) in…

Anti-Arthritics/RheumaticsBiotechnologyCimziaResearchUCB

EULAR: High rates of DAS-defined remission with Bristol-Myers’ Orencia in early RA

EULAR: High rates of DAS-defined remission with Bristol-Myers’ Orencia in early RA

12-06-2014

US drug major Bristol-Myers Squibb has released new data from a Phase IIIb RA trial showing that the…

Anti-Arthritics/RheumaticsBiotechnologyBristol-Myers SquibbOrenciaResearch

ScinoPharm to provide API for TaiGen’s novel stem cell drug burixafor

ScinoPharm to provide API for TaiGen’s novel stem cell drug burixafor

11-06-2014

Taiwanese drugmaker ScinoPharm Taiwan and Taiwan-based drug developer TaiGen Biotechnology have signed…

BiotechnologyLicensingOncologyProduction

Lucrative biosimilars space to erode biologics market from 2019

Lucrative biosimilars space to erode biologics market from 2019

11-06-2014

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market…

BiosimilarsBiotechnologyGlobalMarkets & MarketingRegulation

Lonza invests in clinical antibody drug conjugate manufacturing

Lonza invests in clinical antibody drug conjugate manufacturing

11-06-2014

Swiss chemical supplier Lonza has announced plans for investment for technology and facility improvements…

BiotechnologyLonzaProduction

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

10-06-2014

US drugmaker Achillion has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for…

ACH-3422AchillionAnti-viralsBiotechnologyRegulationResearchsovaprevir

arGEN-X partners on ARGX-110 for Waldenstrom’s macroglobulinemia

arGEN-X partners on ARGX-110 for Waldenstrom’s macroglobulinemia

10-06-2014

Dutch/Belgian preclinical stage biotech company arGEN-X, has entered into a partnership with The Leukemia…

arGEN-XARGX-110BiotechnologyHematologyOncologyResearch

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

10-06-2014

US biotech firm Immunomedics says that IMMU-132, its antibody-drug conjugate (ADC) for solid cancer therapy,…

BiotechnologyIMMU-132ImmunomedicsOncologyRegulationResearchUSA

Dendreon chief to step down for personal reasons

Dendreon chief to step down for personal reasons

10-06-2014

US biotech firm Dendreon revealed last evening that John Johnson plans to step down as president and…

BiotechnologyBoardroomDendreonManagementProvenge

Israel’s OphthaliX updates on clinical developments and strategic plans

09-06-2014

Israel-based OphthaliX, a majority-owned subsidiary of biotech firm Can-Fite BioPharma focussed on ophthalmic…

BiotechnologyCan-Fite BioPharmaLicensingOphthaliXOphthalmicsResearch

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