Novartis has reported positive Phase 3 data from a trial investigating a new treatment for breast cancer targeting a protein in the PI3K pathway, a signalling pathway for human cancers. The compound, BYL719 (alpelisib), showed an improvement in progression-free survival.
AstraZeneca Plc’s treatment for chronic obstructive pulmonary disease (COPD), Bevespi Aerosphere, has shown non-inferiority but not superiority, on one respiratory measure in a Phase 3b trial in which it was compared with a similar treatment from GlaxoSmithKline Plc.
On a second respiratory measure, it failed to show non-inferiority.
Novo Nordisk A/S has entered a research alliance with Evotec AG to discover and develop new small molecule therapies for diabetes and obesity, diseases that affect an estimated one billion people worldwide. Financial terms of the agreement weren’t disclosed.
Novo Nordisk A/S has acquired a UK university spin-out with technology for a new generation of insulins that would be released automatically into the bloodstream in response to a rise in blood glucose levels. In principle this would make it easier for people with diabetes to manage their disease and achieve tight control over blood glucose levels.
China-based Zhejiang Tianyu Pharmaceutical Co Ltd has had its regulatory clearance for the supply of the active ingredient valsartan to the European market suspended following an inspection showing the presence of N-nitrosodimethylamine (NDMA), a suspected carcinogen. NDMA is classified as a probable human cardinogen based on the results of laboratory tests.
The private equity group Welsh, Carson, Anderson & Stowe (WCAS) is to acquire Abzena Plc, a service company based in Cambridge UK, that has built up an international business in antibody discovery and chemistry services with subsidiaries in two locations in the US.
The acquisition values Abzena at 16 pence per share or approximately £34.4 million, which is more than double the closing price of the company’s shares on the AIM market in London on 15 August. The price is about 1.5 times the company’s revenue of £22 million in the fiscal year ended 31 March 2018.
Germany-based BioNTech AG is to expand its portfolio of individualised therapies beyond cancer to include infectious disease. Under a new collaboration with Pfizer Inc, the two companies will develop messenger RNA-based vaccines for the prevention of influenza.
The agreement involves an initial payment of $120 million to BioNTech plus potential development, regulatory and commercial milestones of up to up to $305 million.
Crescendo Biologics Ltd has reached a new milestone in a strategic collaboration with Takeda Pharmaceutical Company Ltd which is directed at developing novel drugs for cancer. The drugs are biologics which are based on the human variable domain of an antibody. The size of the milestone payment wasn’t disclosed but it is the second to be achieved this year under a 2016 collaboration between the two companies, Crescendo announced on 15 August.
A new two-drug monthly regimen for the treatment of HIV-1 infected adults has generated positive data in a pivotal Phase 3 study, ViiV Healthcare Ltd announced on 15 August.
The study, ATLAS, met its primary endpoint showing similar efficacy for the once-a-month injectable two-drug treatment compared with a standard of care, daily, oral three-drug regimen.
A Phase 2a study that was evaluating a potential treatment for paediatric patients with non-alcoholic fatty liver disease was stopped early in August after the first three patients showed an increase in liver fat and elevations in serum alanine transaminase (ALT) levels, raising concerns about liver toxicity.