Regulatory Index News w/c 19 August 2019

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


Priority Review awarded to Xtandi for prostate cancer

The US Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for Astellas and Pfizer’s Xtandi (enzalutamide), the companies have announced.

To read more follow this PharmaTimes link


Celgene wins approval for drug key to Bristol buyout

Celgene on Friday won U.S. approval for Inrebic, a treatment for myelofibrosis that is one of five drugs Bristol-Myers Squibb regarded as particularly valuable in its $74 billion deal to buy Celgene. 

To read more follow this BioPharmaDive link


FDA boxed warning for AbbVie's JAK inhibitor clouds Gilead's

The Food and Drug Administration's decision to approve a new rheumatoid arthritis treatment with a boxed safety warning could limit the potential for the entire drug class, one Wall Street analyst cautioned in a Sunday note to investors. 

To read more follow this BioPharmaDive link


‘Unhappy’ pupils more likely to be smokers and drinkers

Specifically, 51% of young people aged 11 to 15 who had recently drunk alcohol, smoked cigarettes and taken drugs reported experiencing low levels of happiness compared to 36% who had recently done just one of these things, and 22% who hadn’t recently smoked, drank or taken drugs.

To read more follow this PharmaTimes link


Sarepta’s DMD drug hit with FDA Complete Response Letter

Sarepta Theraputics has announced the reception of a Complete Response Letter (CRL) from the US Food and Drug Administration, (FDA) regarding accelerated approval of golodirsen injection.

To read more follow this PharmaTimes link


Nabriva wins FDA's favor on pneumonia antibiotic

Nabriva Therapeutics on Monday gained U.S. approval for its pneumonia treatment lefamulin, bringing a new antibiotic option to a commercially difficult market. 

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

22nd August 2019

Come and join our community!

We are ready and waiting for you

We use cookies. By continuing to browse the site or closing this message you are agreeing to our Terms and Privacy Policy

ACCEPT and Hide This Message