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

18-03-2014

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

04-03-2014

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

19-07-2013

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

02-07-2013

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

21-05-2013

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

01-05-2013

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

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

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

11-04-2013

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

28-03-2013

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

07-03-2013

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

11-02-2013

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

28-01-2013

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

04-01-2013

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

03-01-2013

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

27-12-2012

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

10-12-2012

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

28-09-2012

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

21-09-2012

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

16-09-2012

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

13-09-2012

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

30-08-2012

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

28-08-2012

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

BayerBiotechnologyGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

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