Regulatory Index News w/c 2 December 2019

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


Bladder cancer gene therapy backed by Blackstone gets trial win

A gene therapy for bladder cancer that recently received $400 million in support from the private equity company Blackstone Group helped more than half of treated patients with resistant disease achieve remission.

To read more follow this BioPharmaDive link



EMA to review Amarin’s Vascepa filing

The European Medicines Agency (EMA) has agreed to review its marketing application for Amarin’s cardiovascular (CV) drug, Vascepa (icosapent ethyl).  The regulatory organisation says that it is expected to complete the review for the drug by the end of 2020 .......

To read more follow this PharmaTimes link


Roche’s Tecentriq gets another FDA nod

Roche has announced that Tecentriq (atezolizumab) has garnered US Food and Drug Administration (FDA) approval for adults with metastatic non-squamous non-small cell lung cancer (NSCLC), who have no EGFR or ALK genomic tumour aberrations.

To read more follow this PharmaTimes link



Lilly puts its cancer future in Loxo's hands

Eli Lilly is turning to executives from Loxo Oncology, the biotech it bought in January for $8 billion, to lead a major reorganization of its cancer research efforts.  Josh Bilenker, formerly Loxo's CEO, as well as two members of the biotech's leadership team, Jacob Van Naarden and Nisha Nanda, will head up a merged group that combines Lilly's cancer laboratories with Loxo's.

To read more follow this BioPharmaDive link


After FDA rejection, Immunomedics tries again with breast cancer drug

For a year marked by an FDA rejection, manufacturing problems and a CEO departure, Immunomedics appears to have weathered the storm. Eight months after Immunomedics submitted its application for sacituzumab govitecan, the FDA issued a Complete Response Letter over manufacturing issues, according to the company.

To read more follow this BioPharmaDive link


Astellas, Audentes pen $3bn gene therapy deal

Astellas has announced definitive plans to acquire Audentes Therapeutics, a US-based gene therapy company, at a cost of $3 billion.  As part of the mega-deal Astellas plans to set up a new genetic regulation unit, spearheaded by its late-stage neuromuscular disease gene therapy, AT132, which is set to be ready for both US and EU filing next year.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

06th December 2019

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