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Novartis files for US approval of meningitis B vaccine Bexsero

Novartis files for US approval of meningitis B vaccine Bexsero

17-06-2014

Swiss pharma major Novartis has submitted a Biologic License Application to the US Food and Drug Administration…

BexseroBiotechnologyNovartisRegulationUSAVaccines

“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

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

Biological E's Japanese Encephalitis vaccine prequalified by WHO

23-07-2013

Indian biopharmaceutical company Biological E (BioE) and European biotech company Valneva (Euronext:…

Biological E LtdBiotechnologyProductionRegulationVaccinesValneva

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine

11-06-2013

US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

Regulatory briefs: Sanofi's Fluzone; Roche' RoActemra; Takeda's Rienso

10-06-2013

French pharma major Sanofi (Euronext: SAN) today (June 10) announced that the US Food and Drug Administration…

Anti-Arthritics/RheumaticsBiotechnologyPharmaceuticalRegulationRocheSanofiTakeda PharmaceuticalsVaccines

FDA delays approval of Dynavax' Heplisav, issuing CRL

26-02-2013

Dynavax Technologies ( Nasdaq: DVAX) saw its shares plunge as much as 38% to $1.84 in pre-market trading…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavNorth AmericaRegulationVaccines

China gains WHO designation for biological products center

20-01-2013

China's Institute for Biological Product Control (IBPC) of the National Institutes for Food and Drug…

Asia-PacificBiotechnologyRegulationVaccines

FDA approves Protein Sciences egg-free flu vaccine Flublok; and Octapharma's Octaplas

18-01-2013

The US Food and Drug Administration revealed it has approved privately-held US biotech firm Protein Sciences…

Anti-viralsBiotechnologyFlublokMergers & AcquisitionsNorth AmericaOctapharmaOctaplasPanblokPharmaceuticalProtein Sciences CorpRegulationVaccines

Health Canada approves Vertex' Kalydeco; and Sanofi Pasteur's Menactra

03-12-2012

Vertex Pharmaceuticals (Nasdaq: VRTX) says that Health Canada has approved Kalydeco (ivacaftor), the…

BiotechnologyKalydecoMenactraNorth AmericaPharmaceuticalRare diseasesRegulationSanofiSanofi PasteurVaccinesVertex

Positive CHMP recommendations for Sanofi and Novartis, but not for Celgene

19-11-2012

There was a batch of good news for two pharma companies and a negative opinion for one last Friday coming…

BexseroBiotechnologyCelgeneDiabetesEuropeIstodaxLyxumiaNovartisOncologyPharmaceuticalRegulationSanofiVaccinesZaltrap

News briefs from Sanofi, Biogen/SOBI and Novartis

01-11-2012

French drug major Sanofi (Euronext: SAN) and subsidiary Genzyme have reported results from pivotal studies…

AgrippalBiogen IdecBiotechnologyFluadLemtradaNeurologicalNovartisPharmaceuticalRegulationResearchSanofiSwedish Orphan BiovitrumVaccines

News briefs from Threshold, Merck KGaA and GSK

18-09-2012

US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) said yesterday that data from a Phase IIb trial…

BiotechnologyErbituxEuropeGlaxoSmithKlineMerck KGaAMerck SeronoOncologyPharmaceuticalRegulationResearchSynflorixTH-302Threshold PharmaceuticalsVaccines

EMA accepts Dynavax' filing for hep B drug Heplisav

23-08-2012

US biotech firm Dynavax Technologies (Nasdaq: DVAX) revealed yesterday that the European Medicines Agency…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

Recalls threaten public confidence in vaccines and immunoglobulins

27-03-2012

Quality defects and donor tissue history must be more carefully monitored to increase public acceptance…

BiotechnologyHealthcareImmunologicalsRegulationVaccines

FDA approves Incytes’ Jakafi, first drug to treat MF; advisory panel backs Pfizer’s Prevnar 13 for adults

17-11-2011

USA-based Incyte (Nasdaq: INCY) saw its shares rise 10% to$13.90 on the news that the Food and Drug Administration…

BiotechnologyIncyteJakafiNorth AmericaNovartisPfizerPharmaceuticalPrevnarRare diseasesRegulationruxolitinibVaccines

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