Biotechnology - Neurological, North America


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FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy


The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

RedHill Biopharma and IntelGenx respond to CRL on rizatriptan


Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx,…

BiotechnologyIntelGenxNeurologicalNorth AmericaRedHill BiopharmaRegulationUSA

Phase IIb study funding approved for MediciNova's MS drug MN-166


USA-based biopharma company MediciNova (Nasdaq: MNOV), which is also listed in Japan (TYO: 4875) has…

BiotechnologyFinancialibudilastMediciNovaNeurologicalNorth America

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

Biogen Idec files BLA for MS drug Plegridy in USA


US biotech company Biogen Idec (Nasdaq: BIIB) has submitted a Biologics License Application (BLA) to…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulation

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

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

FDA backs NDA filing for ACADIA's Parkinson's candidate pimavanserin


US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) saw its shares leap 42.8% to $7.97 in pre-market…

ACADIA PharmaceuticalsBiotechnologyNeurologicalNorth AmericapimavanserinRegulation

FDA approves Biogen Idec's new multiple sclerosis treatment Tecfidera


The US Food and Drug Administration yesterday (March 27) approved biotech firm Biogen Idec's (Nasdaq:…

BG-12Biogen IdecBiotechnologyNeurologicalNorth AmericaRegulationTecfidera

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

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

Genzyme says Lemtrada sBLA for MS accepted by FDA; reports on Aubagio


French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme says that the US Food and Drug…

AubagioBiotechnologyGenzymeLemtradaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

US FDA approves Merck KGaA's Rebif Rebidose


German drug major Merck KGaA's (MRK: DE) US subsidiary EMD Serono and pharma behemoth Pfizer (NYSE: PFE)…

BiotechnologyEMD SeronoMerck KGaANeurologicalNorth AmericaPfizerPharmaceuticalRebifRegulation

Canada's Pharmascience sets up JV with Korea Kolmar; buys Rivex


Privately-held Canadian drugmaker Pharmascience and Korea Kolmar Holdings, based in Seoul, South Korea,…

Asia-PacificBiotechnologyGenericsHelix BioPharmaKorea KolmarMergers & AcquisitionsNeurologicalNorth AmericaPharmaceuticalPharmascienceRivex Pharma

FDA approvals for Gattex, Adasuve, Varizig and Tamiflu


Ahead of the Christmas holiday period, the US Food and Drug Administration announced a number of regulatory…

Anti-viralsBiotechnologyGastro-intestinalsNeurologicalNorth AmericaPharmaceuticalRegulation

FDA advisory gives thumbs down for Zogenix' Zohydro for chronic pain; EU label extension for Genzyme's Thyrogen


Shares of USA-based Zogenix (Nasdaq: ZGNX) plummeted 33.5% to $1.57 in after-hours trading on Friday…

BiotechnologyEuropeGenzymeMetabolicsNeurologicalNorth AmericaPharmaceuticalRegulationSanofiThyrogenZogenixZohydro

US multiple sclerosis market growth remains centered on Tysabri and Gilenya ahead of Aubagio's launch


The average satisfaction rating for Biogen Idec (Nasdaq: BIIB) and Elan's (NYSE: ELN) Tysabri (natalizumab).…

AubagioBiogen IdecBiotechnologyElanGilenyaMarkets & MarketingNeurologicalNorth AmericaNovartisPharmaceuticalSanofiTysabri

Regulatory briefs: Celgene's pomalidomide; Lundbeck's vortioxetine


US biotech firm Celgene (Nasdaq: CELG) says that the US Food and Drug Administration's Oncologic Drugs…

Asia-PacificBiotechnologyCelgeneLundbeckNeurologicalNorth AmericaOncologyPharmaceuticalpomalidomideRegulationvortioxetine

Alzheimer's disease: From setbacks to stepping stones


The Pharmaceutical Research and Manufacturers of America (PhRMA) last week released two new reports at…

BiotechnologyNeurologicalNorth AmericaPharmaceuticalRegulationResearch

FDA thumbs up for Sanofi's MS drug Aubagio


As has been largely expected, the US Food and Drug Administration yesterday approved marketing of French…

AubagioBiotechnologyGenzymeNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

FDA OKs new indication for Janssen's Nucynta and fast tracks Zytiga sNDA


There were two pieces of good news for US health care giant Johnson & Johnson (NYSE: JNJ) subsidiaries…

BiotechnologyJanssenJohnson & JohnsonNeurologicalNorth AmericaNucyntaOncologyPharmaceuticalRegulationZytiga

FDA calls on Genzyme to re-file Lemtrada sBLA


French drug major Sanofi (Euronext: SAN) revealed yesterday that its US biotech subsidiary has received…

BayerBiotechnologyGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

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