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GSK and Genmab file for Arzerra variation in Europe

04-10-2013

GlaxoSmithKline ) and partner Genmab have submitted a variation to the Marketing Authorization to the…

ArzerraBiotechnologyEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

Positive developments for GSK's Tafinlar/Mekinist and Arzerra

16-09-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has announced positive news relating to three of its drugs,…

ArzerraBiotechnologyGenmabGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlar

Approved cancer drug potentially could help treat diabetes, Stanford researchers find

16-09-2013

A pair of studies by researchers at the Stanford University School of Medicine has identified a molecular…

afliberceptBayerBiotechnologyDiabetesEyleaOncologyPharmaceuticalRegeneronResearchSanofiZaltrap

FDA advisory panel backs new indication for Genentech's Perjeta

13-09-2013

The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) yesterday (September…

BiotechnologyGenentechKadcylaNorth AmericaOncologyPerjetaPharmaceuticalRegulationRoche

SOBI restructures Kineret and Kepivance deals

09-09-2013

Swedish Orphan Biovitrum (STO: SOBI) said this morning that it has acquired the full rights to develop…

AmgenAnti-Arthritics/RheumaticsBiotechnologyKepivanceKineretLicensingOncologyPharmaceuticalRare diseasesSwedish Orphan Biovitrum

Otsuka confirms takeover bid for Astex Pharmaceuticals for $886 million

05-09-2013

Following heavy speculation on Wednesday (see The Pharma Letter story earlier today), this morning Japanese…

Astex PharmaceuticalsBiotechnologyMergers & AcquisitionsOncologyOtsukaPharmaceutical

GlaxoSmithKline's cancer drug candidate fails endpoint in melanoma

05-09-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and partner US biotech firm Agenus (Nasdaq: AGEN) this morning…

AgenusBiotechnologyGlaxoSmithKlineMAGE-A3OncologyPharmaceuticalResearchVaccines

Otsuka said to be buying Astex Pharma

05-09-2013

Japanese mid-size drugmaker Otsuka (TYO: 4768) is planning to acquire USA-based Astex Pharmaceuticals…

Astex PharmaceuticalsBiotechnologyMergers & AcquisitionsOncologyOtsukaPharmaceutical

Roche's new timesaving formulation of Herceptin approved in Europe

02-09-2013

Swiss pharma major Roche (ROG: SIX) revealed this morning (September 2) that a new injectable (subcutaneous)…

BiotechnologyEuropeHerceptinOncologyPharmaceuticalRegulationRoche

FDA acceptance of ibrutinib NDA triggers milestone for Pharmacyclics

30-08-2013

California, USA-based Pharmacyclics (Nasdaq: PCYC) said yesterday (August 29, 2013) that the US Food…

BiotechnologyibrutinibJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

Nexavar gains FDA priority review for thyroid cancer sNDA

27-08-2013

German drug major Bayer (BAYN: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX), which has just agreed…

BayerBiotechnologyNexavarNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

New therapies to spur acute myeloid leukemia market growth

27-08-2013

Driven by a boost in new therapies entering the market, as well as an increasing number of acute myeloid…

BiotechnologyCyclacel PharmaceuticalsMarkets & MarketingmidostaurinNovartisOncologyPharmaceuticalsapacitabineSunesis Pharmaceuticalsvosaroxin

AstraZeneca nabs Amplimmune for $500 million

27-08-2013

In a further bid to expand its ailing research portfolio, Anglo-Swedish drug major AstraZeneca (LSE:…

AmplimmuneAstraZenecaBiotechnologyMergers & AcquisitionsOncologyPharmaceutical

Bayer gets Japanese OK for GI stromal tumors drug

20-08-2013

German drug major Bayer (BAYN: DE) has received approval from the Ministry of Health, Labor and Welfare…

Asia-PacificBayerBiotechnologyOncologyPharmaceuticalRegulationStivarga

Eli Lilly's investigational sNSCLC drug meets Ph III endpoint

14-08-2013

US drug major Eli Lilly's (NYSE: LLY) shares rose nearly 4% to $56.21in pre-market trading when the company…

BiotechnologyBristol-Myers SquibbEli LillynecitumumabOncologyPharmaceuticalResearch

UK NICE guidance says breast cancer drug Perjeta not value for money

06-08-2013

The UK's National Health Service (NHS) is to be advised that it should not routinely provide Swiss drug…

BiotechnologyEuropeOncologyPerjetaPharmaceuticalPricingRegulationRoche

Cancer drug sales reps find access to oncologist most restricted

31-07-2013

Oncology remains the most restrictive specialty for pharmaceutical sales representative access this year…

BiotechnologyMarkets & MarketingNorth AmericaOncologyPharmaceutical

Bristol-Myers partners with South Korean firm on biopharma production

29-07-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) has entered into a 10-year agreement under which Samsung…

Asia-PacificBiotechnologyBristol-Myers SquibbOncologyPharmaceuticalProductionSamsung BioLogics

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

Quest PharmaTech sets up partnership in South Korea

24-07-2013

Canadian cancer specialist Quest PharmaTech (TSX-V: QPT) has entered into a long term strategic relationship…

AD BiotechBiotechnologyFinancialOncologyPharmaceuticalQuest PharmaTechResearch

UK's NICE calls for more data to consider Roche drug for a type of vasculitis

23-07-2013

UK drug watchdog the National Institute for Health and Care Excellence (NICE) has today (July 23) published…

BiotechnologyEuropeMabTheraOncologyPharmaceuticalPricingRare diseasesRegulationRoche

US Court denies re-hearing of Arzerra patent case

16-07-2013

Danish drugmaker Genmab (OMX: GEN) says that the US Court of Appeals for the Federal Circuit has declined…

ArzerraBiogen IdecBiotechnologyGenentechGenmabGlaxoSmithKlineLegalNorth AmericaOncologyPatentsPharmaceutical

US FDA approves Boehringer Ingelheim's first cancer drug

15-07-2013

In what the family-owned German drug major Boehringer Ingelheim hopes is just the first drug to come…

afatinibBiotechnologyBoehringer IngelheimGilotrifNorth AmericaOncologyPharmaceuticalQiagenRegulation

Conditional EU approval for Roche basal cell carcinoma drug

15-07-2013

The European Commission has granted conditional approval to Swiss drug major Roche's (ROG: SIX) Erivedge…

BiotechnologyCurisErivedgeEuropeGenentechOncologyPharmaceuticalRegulationRoche

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