Regulatory Index News w/c 29 July 2019

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


Biodesix, Immodulon team up for pancreatic cancer treatment

Biodesix and Immodulon have announced a joint venture into biomarker research. The partnership will focus on the analysis of the circulating proteome of advanced pancreatic cancer patients treated with IMM-101 using the Biodesix Diagnostic Cortex machine learning platform.

To read more follow this PharmaTimes link



Senate advances drug pricing bill, setting up September vote

Legislation limiting drug price increases in Medicare will face a full Senate debate in September after the Finance Committee approved it on a mixed vote Thursday. The pharmaceutical industry is opposing the Senate bill, saying it would impose price controls and divert industry money from research & development.

To read more follow this BioPharmaDive link


European regulators back Bayer, GW drugs, but with caveats

A targeted cancer therapy from Bayer and a seizure medication from GW Pharmaceuticals have won over the committee responsible for recommending what drugs should be cleared for the European market, though with a couple important caveats.

To read more follow this BioPharmaDive link


Nubeqa bags FDA green light

The US Food and Drug Administration (FDA) has approved Eli Lilly’s non-steroidal androgen receptor inhibitor (ARi), Nubeqa (darolutamide), for men with non-metastatic castration-resistant prostate cancer. The drug has been approved under the governing body’s Priority Review designation.

To read more follow this PharmaTimes link


Neuraxpharm launches first products in UK

Neuraxpharm Group has announced the launch of its first products in the United Kingdom, as well as the appointment of the company’s new general manager Craig Bowen, who will run Neuraxpharm UK, based in Reading.

To read more follow this PharmaTimes link


FDA cancels panel review for Intra-Cellular drug, stirring investor confusion

The Food and Drug Administration on Tuesday canceled an advisory committee meeting scheduled to discuss Intra-Cellular Therapeutics' leading drug candidate, creating confusion over the status of the experimental schizophrenia treatment. 

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

02nd 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