Regulatory Index News w/c 1 April 2019

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

 

 

Allergan eye drug fails to impress on safety, upping pressure ahead of key meeting

Allergan on Tuesday disclosed new safety results for an experimental eye drug, abicipar, but a modest improvement in a key inflammation rate failed to convince Wall Street analysts of the drug's commercial prospects.

To read more follow this BioPharmaDive link

 

FDA green light for Merck's Mavenclad

German pharmaceutical giant Merck has announced the US Food and Drug Administration (FDA) approval of its Mavenclad (cladribine) tablets in various forms of multiple sclerosis (MS).

To read more follow this PharmaTimes link

     
 

HPV vaccine to thank for 89% decline in cervical cancer

A new analysis has found that human papillomavirus (HPV) vaccination of 12 and 13 year old girls has led to an 89% decline in cases of cervical cancer in Scotland.

To read more follow this PharmaTimes link

 

FDA warns of potential violations at 21 stem cell clinics, manufacturers

The Food and Drug Administration chastised the stem cell industry for not doing enough to comply with agency regulations, sending out 21 letters to health-care providers and manufacturers.

To read more follow this BioPharmaDive link

     
 

German Merck finally gets yes for MS drug Mavenclad

The Food and Drug Administration has approved Merck KGaA's Mavenclad for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).

To read more follow this BioPharmaDive link

 

FDA gives Fast Track Designation to tebentafusp

Immunocore’s lead asset tebentafusp (IMCgp100) has gained Fast Track Designation for the treatment of metastatic uveal melanoma (mUM).

The T Cell Receptor (TCR) biotechnology company announced the US Food and Drug Administration’s (FDA) decision for patients who are HLA-A*0201-positive with previously untreated mUM.

To read more follow this PharmaTimes link

 

L O

Author

Lorna Osborn

Date Published

05th April 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