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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

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

Halozyme can resume PEGPH20 clinical program in pancreatic cancer

Halozyme can resume PEGPH20 clinical program in pancreatic cancer

05-06-2014

US biotech firm Halozyme Therapeutics saw its shares rise after revealing that the US Food and Drug Administration…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

Merck and Endocyte pull CMA for vintafolide and companion imaging component in EU

20-05-2014

US pharma giant Merck & Co and Endocyte have withdrawn their conditional marketing authorization applications…

EndocyteEuropeMerck & CoOncologyPharmaceuticalRegulationResearchvintafolide

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

07-03-2014

Swiss pharma major Novartis today announced positive results from a pivotal Phase III trial of Jakavi…

IncyteJakaviNovartisOncologyPharmaceuticalRare diseasesRegulationResearch

Following talks with FDA, Sanofi drops fedratinib development

Following talks with FDA, Sanofi drops fedratinib development

18-11-2013

French drug major Sanofi this morning revealed its decision to halt all clinical trials and cancel plans…

fedratinibOncologyPharmaceuticalRegulationResearchSanofi

Curis plunges on negative CUCD-427 news; 3rd-qtr loss down

07-11-2013

Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of…

BiotechnologyCUCD-427CurisFinancialNorth AmericaOncologyRegulationResearch

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo

29-10-2013

Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning…

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Ariad stops Ph III Iclusing trial on blood clot woes

18-10-2013

US biotech firm Ariad Pharmaceuticals’took another tumble, falling 35% to $2.91, as the company said…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

FDA clinical hold on Iclusig sees Ariad stock go into free-fall

FDA clinical hold on Iclusig sees Ariad stock go into free-fall

10-10-2013

US drugmaker Ariad Pharmaceuticals saw its shares plunge 59% to $6.99 yesterday, wiping $2 billion off…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

US orphan designation for defactinib in mesothelioma

25-07-2013

US cancer drug developer Verastem (Nasdaq: VSTM) says that its lead cancer stem cell inhibitor, VS-6063…

BiotechnologydefactinibOncologyPharmaceuticalRegulationResearchVerastem

Celgene gets negative NICE view on Revlimid in rare blood cancer; presents new data in newly-diagnosed MM

11-07-2013

US biotech firm Celgene (Nasdaq: CELG) today (July 11) expressed disappointment at the preliminary decision…

BiotechnologyCelgeneEuropeOncologyPricingRare diseasesRegulationResearchRevlimid

US FDA puts partial clinical hold on Cell Thera's blood cancer drug tosedostat trial

25-06-2013

US biotech firm Cell Therapeutics (Nasdaq: CTIC) revealed this week in a filing with the Securities Exchange…

BiotechnologyCell TherapeuticsNorth AmericaOncologyRegulationResearchtosedostat

Sanofi prepares for regulatory filing of MF candidate on positive JAKARTA study results

17-05-2013

French drug major Sanofi (Euronext: SAN) and NYSE: SNY) this morning (May 17) revealed that the pivotal…

OncologyPharmaceuticalRegulationResearchSanofiSAR302503

Lilly drops enzastaurin development; Remoxy future viewed by Pfizer and partners

10-05-2013

US drug major Eli Lilly (NYSE: LLY) revealed that Phase III clinical trial results from enzastaurin's…

DurectEli LillyenzastaurinNeurologicalOncologyPain TherapeuticsPfizerPharmaceuticalRegulationRemoxyResearch

Clinical success rates for new cancer drugs doubled from the mid-1990s to early-2000s, says Tufts CSDD

08-05-2013

Clinical success rates for new cancer drugs doubled between the mid-1990s to the early 2000s, while the…

BiotechnologyNorth AmericaOncologyPharmaceuticalRegulationResearch

Pharmacyclics and Janssen gain third FDA "Breakthrough" designation for ibrutinib; new Ph II data

09-04-2013

Pharmacyclics (Nasdaq: PCYC) saw its shares gain 4.5% to $78.96 in early trading Monday, after it revealed…

ibrutinibJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

US FDA grants "breakthrough" status for Janssen and Pharmacyclics ibrutinib

14-02-2013

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, says that…

BiotechnologyibrutinibJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

Kyowa Hakko set to file for pegfilgrastim approval in Japan following strong Ph III data

28-01-2013

Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) on Friday released positive top-line results…

Asia-PacificBiotechnologyKyowa Hakko KirinOncologypegfilgrastimPharmaceuticalRegulationResearch

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