Novartis, Amgen Inc and the non-profit organisation Banner Alzheimer’s Institute have stopped two pivotal studies of umibecestat, a candidate Alzheimer’s drug, because a review identified a worsening in some measures of cognitive function among patients. The trial was intended to run until 2025.
Slovakia has been added to the group of European countries whose pharma manufacturing inspections systems are on par with those in the US, enabling the Food and Drug Administration to automatically recognise products produced in the country’s factories.
As a result, all 28 EU member states can now participate in a Mutual Recognition Agreement on good manufacturing practice (GMP) that was initiated in 1998, and slowly brought into force over the past 20 years. The European Commission announced the coming into effect of the full agreement on 11 July.
BioNTech SE has generated substantial financial support for its portfolio of personalised cancer medicines with a Series B financing of $325 million – one of the largest single private financing rounds for a European biotechnology company. The fundraising was led by Fidelity Management & Research Co with participation from both new and existing investors.
Based in Mainz, Germany BioNTech has a portfolio of messenger RNA-based product candidates, chimeric antigen receptor T cell therapies, checkpoint immunomodulators, antibodies and small molecule drugs.
A group of international scientists has successfully repressed the transcription of the mutant gene causing Huntington’s disease, enabling animal models with the disease to show clear improvements in a range of important functions. Results of the research were published online on 1 July in the journal Nature Medicine. The studies were carried out by Sangamo Therapeutics Inc and the CHDI Foundation, a non-profit organisation devoted to Huntington’s disease research.
Evotec SE has announced the launch of a new company, Breakpoint Therapeutics GmbH, to discover compounds modulating the DNA repair pathway as a source of potential treatments for cancer. In so doing, it joins a number of enterprises that see DNA damage response as a way of developing drugs for patients who don’t respond to existing treatments.
A science team from the University of Birmingham in the UK has reformulated the diabetes drug exenatide in order to treat patients with the neurological condition idiopathic intracranial hypertension. With a view to commercialising the discovery, it has assigned intellectual property rights for the reformulated drug to a new Australian-based company – Invex Therapeutics Ltd.
A new medicine for multiple myeloma has been approved by the US Food and Drug Administration giving patients whose disease is resistant to several other drugs, an option for treatment. The small molecule drug, Xpovio (selinexor), can now be used by patients who have received at least four other therapies, but without success. Resistance in these patients has been shown to proteasome inhibitors, immunomodulatory agents and an anti-CD38 monoclonal antibody.
MorphoSys AG has upgraded its financial guidance for 2019 following a decision by GlaxoSmithKline Plc to start Phase 3 trials of one of its antibodies. This triggers a €22 million milestone payment to MorphoSys. The German company now expects revenue this year will be between €65-72 million, up from €43-50 million previously, and its loss before interest and tax to narrow to €105-115 million from €127-137 million previously.
The Belgian drug discovery company Confo Therapeutics NV has linked up with a technology provider in Germany to identify a small molecule compound that could modulate an undisclosed G-protein coupled receptor (GPCR) for the purpose of treating disease. Companies have been working for years to effectively target GPCRs, a family of membrane proteins that are involved in a wide range of biological processes and disorders.
The charity Cancer Research UK is to invest $25 million in a biotechnology fund managed by SV Health Investors as part of a partnership aimed at accelerating the development of new oncology drugs.
Under the arrangement, Cancer Research UK will provide at least $25 million to SV Health Investors’ seventh venture capital fund which is expected to raise $250 million. About 60% of the fund’s new capital will be invested in oncology or oncology-related projects.