BioCentury | Jul 2, 2020
Product Development

First Phase III data for an IL-6 mAb in COVID-19 disappoint

A Phase III miss for IL-6 inhibitor Kevzara may not reflect a broader problem with the target or the strengthening theory that immune modulators are the best line of defense against severe forms of COVID-19....
BioCentury | Jun 30, 2020
Regulation

Data Bytes: Drug approvals in Japan

On Monday, Japan’s Ministry of Health, Labour and Welfare announced at least nine drug approvals, five of which are products from Novartis AG (NYSE:NVS; SIX:NOVN). Two of the approvals are for HIF-PH inhibitors to treat...
BioCentury | Jun 27, 2020
Product Development

A mechanistic view of four compounds that disrupt interleukin pathways to treat severe COVID-19

Master protocols for COVID-19 clinical trials are testing half a dozen molecules that aim to prevent respiratory distress in patients with severe disease by targeting the host immune system -- four of these compounds intervene...
BioCentury | Apr 11, 2020
Product Development

COVID-19: closing in on matching therapeutic mechanism to disease stage

In the history of infectious diseases, no single disease has had even remotely as many mechanisms or products tested at the same time as COVID-19. With nearly 50 therapies in clinical trials due to yield...
BioCentury | Mar 24, 2020
Product Development

Biopharma execs highlight regulatory collaboration, call for increased manufacturing, data sharing

Executives at biopharmas developing vaccines and therapeutics to treat COVID-19 provided updates on clinical timelines, the positive impact of regulatory collaboration and the need to dramatically expand manufacturing capacity in order to respond more quickly...
BC Extra | Oct 9, 2019
Company News

With Japan submission nearing in NMOSD, Viela picks Mitsubishi as territorial partner

Just days after completing its IPO, Viela will receive another cash infusion from a partnership giving Mitsubishi Tanabe territorial rights to lead program inebilizumab to treat neuromyelitis optical spectrum disorder. Viela Bio Inc. (NASDAQ:VIE) will...
BC Innovations | Oct 7, 2019
Distillery Therapeutics

Bispecific cytokine fusion for Type II diabetes

DISEASE CATEGORY: Endocrine/metabolic disease INDICATION: Diabetes A chimeric protein derived from two cytokines previously shown to modify food intake, IL-6 and CNTF, could treat Type II diabetes. The chimeric cytokine is based on IL-6, with...
BC Extra | Sep 26, 2019
Preclinical News

Sept. 26 Preclinical Quick Takes: $30M for new lung disease lab; plus AI-derived compounds from Auransa, Atomwise, and diabetes candidates

Bayer, Brigham and Mass General open lung disease-focused lab  Bayer AG (Xetra:BAYN) will invest more than $30 million over five years to fund research into new treatments for chronic lung diseases, such as chronic obstructive...
BC Extra | May 7, 2019
Clinical News

Viela reports detailed Phase II/III data for rare CNS disorder therapy

Viela touted a potential dosing advantage and reiterated its plans to submit mid-year a BLA to FDA for inebilizumab to treat neuromyelitis optica spectrum disorder (NMOSD). The update came during a presentation at AAN on...
BC Extra | Mar 26, 2019
Company News

Japan approvals include Kymriah as Japan's first CAR T therapy

Japanese regulators approved a basket of drugs on Tuesday, including the first CAR T cell therapy in Japan. Novartis AG (NYSE:NVS; SIX:NOVN) said Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Kymriah tisagenlecleucel to...
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