Biotechnology - Neurological, Regulation

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FDA Breakthrough designation for ACADIA’s Nuplazid for Parkinson’s disease psychosis

FDA Breakthrough designation for ACADIA’s Nuplazid for Parkinson’s disease psychosis

03-09-2014

US biotech firm ACADIA Pharmaceuticals says that the US Food and Drug Administration has granted Breakthrough…

ACADIA PharmaceuticalsBiotechnologyNeurologicalNuplazidpimavanserinRegulationUSA

Alkermes files NDA for aripiprazole lauroxil in schizophrenia

Alkermes files NDA for aripiprazole lauroxil in schizophrenia

26-08-2014

Ireland-headquartered biotech firm Alkermes has submitted a New Drug Application to the US Food and Drug…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyNeurologicalRegulationUSA

Biogen Idec’s Plegridy gains US approval for multiple sclerosis

Biogen Idec’s Plegridy gains US approval for multiple sclerosis

17-08-2014

The US Food and Drug Administration has approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Plegridy…

Biogen IdecBiotechnologyNeurologicalPlegridyRegulationUSA

IQWiG finds no added benefit for Biogen Idec’s Tecfidera

IQWiG finds no added benefit for Biogen Idec’s Tecfidera

08-08-2014

In its early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG)…

Biogen IdecBiotechnologyGermanyMSNeurologicalPricingRegulationTecfidera

NICE issues positive draft FAD guidance on Tecfidera

NICE issues positive draft FAD guidance on Tecfidera

11-07-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

Biogen IdecBiotechnologyMultiple sclerosisNeurologicalPricingRegulationTecfideraUK

US FDA accepts resubmission of Lemtrada sBLA by Genzyme

US FDA accepts resubmission of Lemtrada sBLA by Genzyme

30-05-2014

French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme said today that the US Food and Drug…

BiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

Genzyme gains UK NICE backing for second MS drug Lemtrada

Genzyme gains UK NICE backing for second MS drug Lemtrada

28-05-2014

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance…

AubagioBiotechnologyGenzymeLemtradaNeurologicalPricingRegulationSanofiUK

Positive CHMP opinion for Biogen Idec MS drug Plegridy

25-05-2014

US biotech firm Biogen Idec said on Friday that it had received a positive recommendation from the European…

Biogen IdecBiotechnologyEuropeNeurologicalPlegridyRegulation

FDA issues CRL over Acorda's Plumiaz marketing application

FDA issues CRL over Acorda's Plumiaz marketing application

02-05-2014

There was disappointment for US biotech firm Acorda Therapeutics, which says it has received a complete…

Acorda TherapeuticsBiotechnologyNeurologicalPlumiazRegulationUSA

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

09-04-2014

US biotech firm Alkermes saw its shares spike on Tuesday, after it announced positive top-line results…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyLundbeckNeurologicalOtsukaRegulationResearch

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada

04-04-2014

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…

BiotechnologyGenzymeLemtradaNeurologicalNorthern EuropeRegulationSanofiUK

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

Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab

18-03-2014

Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma…

Asia-PacificAustraliaBiogen IdecBiotechnologyNatalizumabNeurologicalRegulationTysabri

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

Biogen’s MS drug Tecfidera approved in EU

Biogen’s MS drug Tecfidera approved in EU

03-02-2014

US biotech firm Biogen Idec’s Tecfidera (dimethyl fumarate) has been approved by the European Commission…

Biogen IdecBiotechnologyEuropeNeurologicalRegulationTecfidera

NICE recommends Sanofi’s Aubagio as new treatment option for MS

NICE recommends Sanofi’s Aubagio as new treatment option for MS

22-01-2014

In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

AubagioBiotechnologyGenzymeNeurologicalNorthern EuropePricingRegulationSanofiUK

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

05-12-2013

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

BiotechnologyEuropeGenzymeLemtradaNeurologicalPricingRegulationSanofiUK

Biogen prevails in EU exclusivity battle for MS drug Tecfidera

Biogen prevails in EU exclusivity battle for MS drug Tecfidera

25-11-2013

US biotech company Biogen Idec saw its shares leap 10% to an all-time high of nearly $278 on Friday,…

Biogen IdecBiotechnologyEuropeNeurologicalPatentsRegulationTecfidera

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

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

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