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EMA backs record number of drugs for rare diseases in 2014

EMA backs record number of drugs for rare diseases in 2014

11-01-2015

The European Medicines Agency recommended the highest number of orphan designated medicines for marketing…

CyramzaEuropeGazyvaroHoloclarImbruvicaMekinistPharmaceuticalRegulationScenesseTranslarna

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

01-12-2014

US health care giant Johnson & Johnson’s Belgium-based subsidiary Janssen-Cilag International has submitted…

EuropeImbruvicaJanssen-CilagOncologyPharmaceuticalPharmacyclicsRegulation

Non-Hodgkin lymphoma market to grow to $9.2 billion

Non-Hodgkin lymphoma market to grow to $9.2 billion

29-10-2014

The non-Hodgkin lymphoma (NHL) market will be worth $9.2 billion by 2020, according to new research.

Celgene Corp.EuropeGilead SciencesImbruvicaJanssen BiotechJohnson & JohnsonMabTheraOncologyPharmaceuticalPharmacyclicsResearchRevlimidRocheUSAVelcadeZydelig

Pharmacyclics files Imbruvica sNDA for Waldenstrom’s macroglobulinemia

20-10-2014

US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug…

ImbruvicaJanssen BiotechJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulationUSA

Pharmacyclics’ Imbruvica gains EU approval for two blood cancers

17-10-2014

US drugmaker Pharmacyclics has received marketing approval from the European Commission for Imbruvica…

EuropeImbruvicaJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulation

Pharmacyclics and Roche research Imbruvica and Gazyva

Pharmacyclics and Roche research Imbruvica and Gazyva

17-10-2014

USA-based biopharma company Pharmacyclics has entered into a master clinical drug supply agreement with…

GazyvaImbruvicaOncologyPharmaceuticalPharmacyclicsResearchRocheUSA

AACR report calls for US cancer funding to be a national priority

AACR report calls for US cancer funding to be a national priority

18-09-2014

Declining budgets have slowed the pace of research into cancer, according to a new report from the American…

AbraxaneCyramzaFinancialGazyvaImbruvicaNexavarOncologyPharmaceuticalResearchTafinlarUSAZydelig

US FDA grants approval for Imbruvica for chronic lymphocytic leukemia

US FDA grants approval for Imbruvica for chronic lymphocytic leukemia

29-07-2014

The US Food and Drug Administration has granted USA-based Pharmacyclics approval for Imbruvica (ibrutinib)…

B-cell chronic lymphocytic leukemiaChronic lymphocytic leukemiaDanelle JamesImbruvicaJanssen BiotechOncologyPharmaceuticalPharmacyclicsRegulationUSA

New entrants in chronic lymphocytic leukemia will raise market value to $3.3 billion by 2018

New entrants in chronic lymphocytic leukemia will raise market value to $3.3 billion by 2018

02-07-2014

The introduction of several new drugs will accelerate growth in the chronic lymphocytic leukemia treatment…

EuropeidelalisibImbruvicaMarkets & MarketingOncologyPharmaceuticalUSA

US FDA approves sNDAs for Imbruvica and Azilect

US FDA approves sNDAs for Imbruvica and Azilect

09-06-2014

USA-based Pharmacyclics says that the US Food and Drug Administration has accepted for filing its supplemental…

AzilectImbruvicaNeurologicalOncologyPharmaceuticalPharmacyclicsRegulationTeva Pharmaceutical IndustriesUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

Pharmacyclics signs deal with Lonza to support manufacturing of Imbruvica

Pharmacyclics signs deal with Lonza to support manufacturing of Imbruvica

13-01-2014

USA-based Pharmacyclics has signed a deal with Swiss chemical supplier Lonza for the commercial and clinical…

ImbruvicaLonzaOncologyPharmaceuticalPharmacyclicsProductionUSA

Janssen and Pharmacyclics’ Imbruvica meets key endpoints early in Phase III leukemia trial

Janssen and Pharmacyclics’ Imbruvica meets key endpoints early in Phase III leukemia trial

08-01-2014

USA-based Pharmacyclics and co-developer Janssen Biotech have announced that an Independent Data Monitoring…

ImbruvicaJanssen BiotechOncologyPharmaceuticalPharmacyclicsResearchUSA

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

14-11-2013

The US Food and Drug Administration yesterday approved US health care giant Johnson & Johnson’s Imbruvica…

ibrutinibImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclics

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