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Second collaboration between FORMA Therapeutics and Celgene

02-04-2014

Privately-held drug discovery firm FORMA Therapeutics has entered a second strategic collaboration and…

BiotechnologyCelgeneFORMA TherapeuticsLicensingMergers & AcquisitionsResearch

European generic drug makers sets out priorities for EU Trade Policy

European generic drug makers sets out priorities for EU Trade Policy

02-04-2014

European Generic Medicines Association (EGA) revealed this morning that its president, Nick Haggar, has…

EuropeGenericsPoliticsRegulationRest of the World

US FDA approves Stallergenes’ allergy tablet Oralair

US FDA approves Stallergenes’ allergy tablet Oralair

02-04-2014

The US Food and Drug Administration has approved Oralair immunotherapy tablet from French allergen specialist…

ImmunologicalsOralairPharmaceuticalRegulationStallergenesUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Amarin and Kowa Pharma to co-promote Vascepa in USA

01-04-2014

US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an…

AmarinBiotechnologyCardio-vascularKowa PharmaceuticalsMarkets & MarketingNorth AmericaUSAVascepa

Paul Sekhri joins Sanofi as Senior Vice President

Paul Sekhri joins Sanofi as Senior Vice President

01-04-2014

Paul Sekhri has joined French drug major Sanofi as Senior Vice President, Integrated Care effective…

BiotechnologyBoardroomPharmaceuticalSanofiUSA

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

01-04-2014

The global pancreatic cancer treatment market value in the six major countries (6MM: the USA, France,…

AbraxaneBiotechnologyCelgeneEuropeMarkets & MarketingOncologyUSA

Janssen files new NDA for combination HIV drug containing darunavir

Janssen files new NDA for combination HIV drug containing darunavir

01-04-2014

US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a New Drug Application…

Anti-viralsDarunavirJanssenPharmaceuticalPrezistaRegulationUSA

Executive Q&A: Epigenomics’ chief executive Dr Thomas Taapken

Executive Q&A: Epigenomics’ chief executive Dr Thomas Taapken

01-04-2014

The Pharma Letter interviewed chief executive Dr Thomas Taapken about Epigenomics’ lead product, increasing…

BiotechnologyEpi proColonEpigenomicsGermanyInterviewsOncology

SOBI assumes direct responsibility for rare disease drug Orfadin in the USA and Canada

SOBI assumes direct responsibility for rare disease drug Orfadin in the USA and Canada

01-04-2014

Biotech firm Swedish Orphan Biovitrum has assumed direct responsibility for the distribution of its proprietary…

BiotechnologyMarkets & MarketingNorthern EuropeOrfadinRare diseasesSobi

Fairjourney Biologics signs agreement to develop therapeutic antibodies for heparanase

01-04-2014

Portuguese antibody solutions company Fairjourney Biologics has signed a research and option agreement…

BiotechnologyOncologyPortugalResearch

US FTC releases 2013 highlights, including action against Actavis and Mylan

US FTC releases 2013 highlights, including action against Actavis and Mylan

01-04-2014

The US Federal Trade Commission chairwoman Edith Ramirez has released the agency’s 2013 Annual Highlights,…

ActavisMylan LaboratoriesPharmaceuticalRegulationUSA

Bayer’s Adempas gains EU clearance for two forms of PAH

Bayer’s Adempas gains EU clearance for two forms of PAH

31-03-2014

Following a previous positive opinion from the European Medicines Agency’s advisory committee, the…

AdempasBayerEuropePharmaceuticalRegulationRespiratory and Pulmonary

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

31-03-2014

UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a…

GlaxoSmithKlineOncologyPharmaceuticalRegulationUKVotrientWomen's Health

Tiziana Pharma plans listing via reverse takeover

Tiziana Pharma plans listing via reverse takeover

31-03-2014

Tiziana Pharma, a recently-established UK biotech company that has licensed technology for a potential…

BiotechnologyMergers & AcquisitionsOncologyTiziana

Convergence Pharma and Evotec collaborate on chronic pain drugs

Convergence Pharma and Evotec collaborate on chronic pain drugs

31-03-2014

Independent UK biotech firm Convergence Pharmaceuticals has entered into a research alliance with Germany’s…

BiotechnologyConvergence PharmaceuticalsEvotecNeurologicalResearch

Sanofi appoints Dr Anne Beal as chief patient officer

Sanofi appoints Dr Anne Beal as chief patient officer

31-03-2014

French drug major Sanofi has announced the appointment of Anne Beal to the newly created position of…

BiotechnologyBoardroomFrancePharmaceuticalSanofiUSA

aTyr Pharma appoints David Weiner as Chief Medical Officer

aTyr Pharma appoints David Weiner as Chief Medical Officer

31-03-2014

aTyr Pharma, a rare disease biotherapeutics enterprise, has announced the appointment of David Weiner…

aTyrBiotechnologyBoardroomUSA

ACC 2014: Amgen’s evolocumab reduces cholesterol by up to 66%

ACC 2014: Amgen’s evolocumab reduces cholesterol by up to 66%

31-03-2014

USA-based Amgen announced data at the American College of Cardiology 63rd Annual Scientific Session this…

AmgenBiotechnologyCardio-vascularevolocumabResearchUSA

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

EU approval for Dainippon Sumitomo and Takeda’s Latuda

EU approval for Dainippon Sumitomo and Takeda’s Latuda

28-03-2014

Japanese drug majors Dainippon Sumitomo Pharma and Takeda Pharmaceutical have received European Commission…

Dainippon Sumitomo PharmaEuropeLatudaNeurologicalPharmaceuticalRegulationSunovionTakeda Pharmaceuticals

European biotech RDI incentives need to ensure greater economic growth

European biotech RDI incentives need to ensure greater economic growth

28-03-2014

European governments must remain committed to biotech research, development and innovation (RDI) incentives…

BiotechnologyEuropeFinancialPoliticsResearch

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