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EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

Boehringer Ingelheim pulls out of hepatitis C drug development

Boehringer Ingelheim pulls out of hepatitis C drug development

23-06-2014

German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

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

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

06-03-2014

German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

“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

IN FOCUS: Viiv Healthcare’s Tivicay offers new HIV treatment option for patients

IN FOCUS: Viiv Healthcare’s Tivicay offers new HIV treatment option for patients

03-02-2014

Global HIV company Viiv Healthcare has launched its first new treatment option for people with HIV today.

Anti-viralsAtriplaInterviewsIsentressPharmaceuticalPrezistaRegulationResearchTivicayUKViiV Healthcare

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

06-01-2014

The UK House of Commons Public Accounts Committee is calling for all data on drugs being prescribed in…

Anti-viralsNorthern EuropePharmaceuticalRegulationResearchRocheTamifluUK

Vertex slumps as FDA delays hepatitis C trial

26-07-2013

US drug maker Vertex Pharmaceuticals (Nasdaq: VRTX) saw its shares drop 11% to $78 a share, in after-hours…

Anti-viralsBiotechnologyNorth AmericaPharmaceuticalRegulationResearchVertexVX-135

Annual approvals of new drugs for neglected diseases nearly doubled since early 2000s and 2009-12; Tufts

14-07-2013

The annual number of new drug approvals worldwide to treat neglected diseases has nearly doubled in recent…

Anti-viralsPharmaceuticalRegulationResearchTropical diseases

US FDA grants "Breakthrough" status for AbbVie's HCV regimen

06-05-2013

US drugmaker AbbVie (NYSE: ABBV) says that its investigational direct-acting antiviral (DAA) combination…

AbbVieAnti-viralsPharmaceuticalRegulationResearch

AHF demands FDA reversal on use of Gilead's HIV prevention pill for women

06-03-2013

Citing another failed clinical trial in women of the use of Gilead Sciences' (Nasdaq: GILD) AIDS drug…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationResearchTruvada

BioCryst withdraws BCX5191 lND following discussion with FDA

04-11-2012

US biotech firm BioCryst Pharmaceuticals (Nasdaq: BCRX) says it is withdrawing its Investigational New…

Anti-viralsBCX5191BioCryst PharmaceuticalsBiotechnologyNorth AmericaRegulationResearch

Shionogi-Viiv Healthcare to start regulatory filing of dolutegravir by year-end

08-10-2012

Shionogi-ViiV Healthcare, a joint venture between Japan's Shionogi (TYO: 4507) and ViiV Healthcare, a…

Anti-viralsdolutegravirGlaxoSmithKlinePfizerPharmaceuticalRegulationResearchShionogiShionogi-ViiV HealthcareViiV Healthcare

FDA approves initiation of a Phase IIb study of Genfit's GFT505

05-09-2012

French biotech firm Genfit (Alternext: ALGFT) says that the US Food and Drug Administration has approved…

Anti-viralsBiotechnologyGenfitGFT505RegulationResearch

Bristol-Myers drops hep C pill on patient safety issues

24-08-2012

US drug major Bristol-Myers Squibb (NYSE: BMY) has discontinued development of BMS-986094 (formerly known…

Anti-viralsBiotechnologyBMS-986094Bristol-Myers SquibbPharmaceuticalRegulationResearch

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