Regulatory Index News w/c 12 August 2019

Here is a selection of this week's news from around the world



Study success strengthens case for Lynparza in ovarian cancer

Adding AstraZeneca's Lynparza to Roche's older cancer drug Avastin helped women with advanced ovarian cancer live longer without their tumors growing, according to results from a Phase 3 study disclosed Wednesday by AstraZeneca.

To read more follow this BioPharmaDive link


‘Probe’ could help make prostate cancer surgery more accurate

The National Institute for Health Research (NIHR) has announced that a new ‘probe’ that detects prostate cancer could help make surgery more accurate.  The organisation stated researchers, funded by the NIHR Invention for Innovation (i4i) programme ....

To read more follow this PharmaTimes link


Taltz trumps Tremfya in plaque psoriasis study

Eli Lilly has announced that Taltz (ixekizumab) has met the primary and all major secondary endpoints up to week 12 in the Phase IV IXORA-R study.  The company’s moderate to severe plaque psoriasis drug was evaluated against Tremfya (guselkumab) in people living with the skin disorder ....

To read more follow this PharmaTimes link


Nonprofit under pressure to make new TB drug affordable

The Food and Drug Administration has approved a new drug for hard-to-treat tuberculosis infections, creating another option for one of the world's 10 most common causes of death.

To read more follow this BioPharmaDive link



Regeneron gets cholesterol drug win where Praluent won't go

Regeneron Pharmaceuticals said its experimental drug evinacumab significantly lowered "bad" cholesterol levels 49% compared to placebo in a Phase 3 study of patients with homozygous familial hypercholesterolemia (HoFH), a severe form of disease resistant to treatment.

To read more follow this BioPharmaDive link


Imbruvica bags EU expansion for two indications

Janssen has announced the European Commission (EC) approval of Imbruvica (ibrutinib) for expanded use in two indications. The regulator has approved expanding the scope of the drug to include its use in combination with obinutuzumab in adults with previously untreated chronic lymphocytic leukaemia (CLL) ....

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

16th August 2019

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