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Positive EMA/CHMP opinions for Actelion and Lundbeck

Positive EMA/CHMP opinions for Actelion and Lundbeck

27-10-2013

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

18-09-2013

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

AubagioBiotechnologyEuropeGenzymeNeurologicalPharmaceuticalPricingRegulationSanofi

Genzyme's MS drug Lemtrada approved in Europe

17-09-2013

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

AubagioBiotechnologyEuropeGenzymeLemtradaNeurologicalPharmaceuticalRegulationSanofi

Sanofi's MS drug Aubagio gains final European approval

02-09-2013

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

AubagioBiotechnologyEuropeGenzymeNeurologicalPharmaceuticalRegulationSanofi

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

01-08-2013

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

26-07-2013

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

16-07-2013

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

02-07-2013

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

04-06-2013

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

01-05-2013

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

30-04-2013

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

25-04-2013

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

AubagioBiotechnologyGenzymeNeurologicalPharmaceuticalResearchSanofi

Appeals Court rules against EMD Serono over Rebif deal with Pfizer

16-04-2013

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

25-03-2013

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

AubagioBiotechnologyEuropeGenzymeImmunologicalsNeurologicalPharmaceuticalProductionRegulationSanofiTransgene

Cerecor acquires rights to Merck & Co's COMT inhibitors

22-03-2013

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

07-03-2013

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

27-02-2013

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

22-02-2013

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

11-02-2013

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

07-02-2013

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

06-02-2013

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

BiotechnologyLicensingMerck KGaAMerck SeronoNeurologicalOpexa TherapeuticsPharmaceuticalTcelna

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