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Amgen working on alternative methods for Mapp's Ebola vaccine; Canada sends vaccine vials to WHO

Amgen working on alternative methods for Mapp's Ebola vaccine; Canada sends vaccine vials to WHO

20-10-2014

USA-based Amgen, the world’s leading independent biotech firm, has indicated that it plans to work…

AmgenAntibiotics and Infectious diseasesBiotechnologyCanadaHuman InterestProductionRegulationResearchUSAZMapp

Northwest Bio says DCVax-L hospital exemption program under way in Germany

Northwest Bio says DCVax-L hospital exemption program under way in Germany

15-10-2014

US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for…

BiotechnologyDCVax-LGermanyNorthwest BiotherapeuticsOncologyRegulationResearch

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

08-10-2014

One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive…

BiotechnologyLegalLicensingPatents & Trade marksProductionRegulationResearchSocial IssuesUK

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

22-09-2014

US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

FDA lifts partial clinical hold on OncoMed's ipafricept

05-09-2014

Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and…

BayerBiotechnologyipafriceptOncologyOncoMed PharmaceuticalsRegulationResearchUSA

Positive Ph III data for Amicus’ migalastat as Fabry monotherapy

Positive Ph III data for Amicus’ migalastat as Fabry monotherapy

21-08-2014

US biopharma company Amicus Therapeutics has revealed positive 18-month data from its second Phase III…

Amicus TherapeuticsBiotechnologymigalastatRare diseasesRegulationResearch

Catalyst Pharma updates on Ph III Firdapse study in LEMS

13-08-2014

US rare diseases focussed biotech firm Catalyst Pharmaceutical Partners provided an update on the progress…

BiotechnologyCatalyst Pharmaceutical PartnersFirdapseLambert-Eaton myasthenic syndromeRare diseasesRegulationResearchTreatment of Lambert-Eaton myasthenic syndromeUSA

Harlan aims to provide expertise for biologics and biosimilars

31-07-2014

Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology…

BiosimilarsBiotechnologyContract research servicesHarlanRegulationResearchSwitzerlandToxicology services

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

Vertex leaps on positive Ph III results with lumacaftor

Vertex leaps on positive Ph III results with lumacaftor

24-06-2014

US biotech firm Vertex Pharmaceuticals saw its share price rocket nearly 52% to $101.20 in extending…

BiotechnologyBusiness FinanceCystic fibrosisHealth Medical PharmaKalydecolumacaftorMedicinePhenolsRare diseasesRegulationResearchVertex Pharmaceuticals

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

19-06-2014

RNAi therapeutics company Alnylam Pharmaceuticals and The Alpha-1 Project (TAP), the venture philanthropy…

ALN-AATAlnylam PharmaceuticalsBiotechnologyNephrology and HepatologyRegulationResearchThe Alpha-1 ProjectUSA

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

16-06-2014

US anti-virals major Gilead Sciences has released strong top-line results from a Phase III clinical trial…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationResearchsofosbuvirSovaldi

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

10-06-2014

US drugmaker Achillion has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for…

ACH-3422AchillionAnti-viralsBiotechnologyRegulationResearchsovaprevir

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

10-06-2014

US biotech firm Immunomedics says that IMMU-132, its antibody-drug conjugate (ADC) for solid cancer therapy,…

BiotechnologyIMMU-132ImmunomedicsOncologyRegulationResearchUSA

Halozyme can resume PEGPH20 clinical program in pancreatic cancer

Halozyme can resume PEGPH20 clinical program in pancreatic cancer

05-06-2014

US biotech firm Halozyme Therapeutics saw its shares rise after revealing that the US Food and Drug Administration…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

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

US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

BioLineRx gains orphan status for novel stem cell mobilization treatment

BioLineRx gains orphan status for novel stem cell mobilization treatment

23-01-2014

Israeli drug developer BioLineRx has received notice from the US Food and Drug Administration confirming…

BioLineRxBiotechnologyBL-8040Rare diseasesRegulationResearch

US drug approvals lower than previously reported; new study

10-01-2014

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearchUSA

OncoMed CEO presses for better environment for biopharma innovation, at House hearings

13-12-2013

The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight…

BiotechnologyNorth AmericaOncoMed PharmaceuticalsPoliticsRegulationResearch

New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan

22-11-2013

The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies.…

Asia-PacificBiotechnologyCytori TherapeuticsLegalRegulationResearch

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