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Positive EMA/CHMP opinions for Actelion and Lundbeck

Positive EMA/CHMP opinions for Actelion and Lundbeck


At its October month-end meeting, the European Medicines Agency’s Committee for Medicinal Products…

ActelionBiotechnologyBrintellixEuropeLundbeckNeurologicalOpsumitPharmaceuticalRegulationRespiratory and Pulmonary

UK's NICE calls for more information on MS treatment Aubagio


UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme,…


Genzyme's MS drug Lemtrada approved in Europe


French drug major Sanofi (Euronext: SAN) and its USA-based biotech subsidiary Genzyme revealed this morning…


Sanofi's MS drug Aubagio gains final European approval


Following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products…


Bionomics in $172 million pain treatment deal with US pharma giant


Australian biotech firm Bionomics (ASX: BNO) has entered an agreement with US pharma giant Merck & Co…

BionomicsBiotechnologyLicensingMerck & CoNeurologicalPharmaceuticalResearch

New entrants to multiple sclerosis market will drive 10% pa growth through 2018


The market for disease-modifying multiple sclerosis (MS) therapies will expand at an annual rate of 10%…

AbbVieAubagioBayerBiogen IdecBiotechnologydaclizumabGlobalLemtradaMarkets & MarketingNeurologicalocrelizumabPharmaceuticalRocheSanofiTecfidera

Orphan status for Alexion's Solaris


US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) says that Soliris (eculizumab), the company's first-in-class…

Alexion PharmaceuticalsBiotechnologyEuropeNeurologicalPharmaceuticalRare diseasesRegulationSolaris

US FDA backs news indications for Latuda; grants Priority Review for Perjeta


Sunovion Pharmaceuticals, a US subsidiary of Japan's Dainippon Sumitomo Pharma (TYO: 4506), says that…

BiotechnologyDainippon Sumitomo PharmaLatudaNeurologicalNorth AmericaOncologyPerjetaPharmaceuticalRegulationRocheSunovion

Biotie buys option to acquire Neurelis, and opportunity for epilepsy candidate


Finland-based biotech firm Biotie Therapies (Nasdaq-OMX; BTH1V) says that it has obtained an exclusive…

BiotechnologyBiotie TherapiesMergers & AcquisitionsNeurelisNeurologicalNRL-1Pharmaceutical

US FDA rejects Titan Pharma's Probuphine NDA


California, USA-based Titan Pharmaceuticals (OTCBB: TTNP) has received a Complete Response Letter from…

BiotechnologyBraeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationTitan Pharmaceuticals

GSK returns IPX066 rights to Impax; Merck & Co and Pfizer link up on diabetes drug


US biotech firm Impax Laboratories (Nasdaq: IPXL) saw its shares fall 2% to $17.32 in premarket trading,…

BiotechnologyDiabetesertugliflozinGlaxoSmithKlineImpax LaboratoriesIPX066LicensingMerck & CoNeurologicalPfizerPharmaceuticalResearch

Sanofi's Aubagio delayed onset of clinically definite MS in TOPIC study


French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme announced today positive top-line…


Appeals Court rules against EMD Serono over Rebif deal with Pfizer


Germany's Merck KGaA (MRK: DE) says that a Pennsylvania appeals court has ruled against Merck in deciding…

BiotechnologyEMD SeronoLegalMarkets & MarketingMerck KGaANeurologicalNorth AmericaPfizerPharmaceuticalRebif

Sanofi and Transgene collaborate on immunotherapy treatments; NAS designation of Aubagio disputed


Drug major Sanofi (Euronext: SAN) and fellow France-based biotech firm Transgene SA (NYSE-Euronext: TNG)…


Cerecor acquires rights to Merck & Co's COMT inhibitors


US neuroscience biotech company Cerecor has acquired exclusive, worldwide rights to develop, register…

BiotechnologyCerecorLicensingMerck & CoNeurologicalPharmaceutical

Growing US uptake of Genzyme's Aubagio at three months post-launch


Some 34% of surveyed US neurologists have prescribed French drug major Sanofi (Euronext: SAN) subsidiary…

AubagioBiotechnologyGenzymeMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalSanofi

Jazz Pharma and Concert ink deal on deuterium-modified sodium oxybate


US drugmakers Jazz Pharmaceuticals (Nasdaq: JAZZ) and Concert Pharmaceuticals have entered into an exclusive…

BiotechnologyConcert PharmaceuticalsJazz PharmaceuticalsLicensingNeurologicalPharmaceuticalResearchsodium oxybateZyrem

Positive EU regulatory news for Alexza and Ferrer, but not Gentium


USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) and Spanish partner Grupo Ferrer Internacional have received…

AdasuveAlexza PharmaceuticalBiotechnologydefibrotideEuropeFerrer InternacionalGentiumNephrology and HepatologyNeurologicalPharmaceuticalRegulation

FDA guidance on developing Alzheimer's could ease barriers to research


The US Food and Drug Administration last week issued a proposal designed to assist companies developing…

BiotechnologyNeurologicalNorth AmericaPharmaceuticalRegulationResearch

Elan sells its Tysabri rights to Biogen; posts 2012 financials


Ireland-based drugmaker Elan Corp (NYSE: ELN) said yesterday that partner US biotech firm Biogen Idec…

Biogen IdecBiotechnologyElanFinancialMergers & AcquisitionsNeurologicalPharmaceuticalTysabri

Merck Serono to in-license Opexa's MS drug candidate Tcelna


USA-based Opexa Therapeutics (Nasdaq: OPXA) has entered into an agreement with Merck Serono, a division…

BiotechnologyLicensingMerck KGaAMerck SeronoNeurologicalOpexa TherapeuticsPharmaceuticalTcelna

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