The antibody-drug conjugate Adcetris (brentuximab vedotin) has received a new lymphoma indication from the US Food and Drug Administration under a procedure that allows the agency to study key clinical data for the compound prior to its formal regulatory application.
AstraZeneca Plc’s Phase 3 trial of the Imfinzi and tremelimumab checkpoint antibodies did not meet the primary endpoint of improving overall survival compared with standard-of-care chemotherapy in previously untreated patients with Stage IV metastatic non-small cell lung cancer, the company announced on 16 November. This follows the failure of the same combination in July 2017 to reach statistical significance in progression-free survival.
The UK artificial intelligence company Exscientia Ltd has expanded its drug discovery resource with the acquisition of Kinetic Discovery Ltd, a protein engineering specialist. The transaction follows Exscientia’s expansion in Oxford where it is bringing computer scientists, drug designers and biologists under one roof to work on algorithm development for drug discovery. Financial terms of the deal were not disclosed.
The US Food and Drug Administration is proposing a waiver to the legal requirement on pharma companies to obtain informed patient consent for certain low-risk clinical trials. The proposal would amend a provision of the 21st Century Cures Act to add an exception to the consent requirement.
The proposed rule, if finalized, would allow the institutional review board (IRB) responsible for the review and approval of clinical research to waive or alter certain elements of informed consent, or to waive the requirement entirely, under limited circumstances.
Swedish Orphan Biovitrum AB (Sobi) has agreed to pay up to $1.5 billion upfront to AstraZeneca Plc for US rights to Synagis (palivizumab), an off-patent medicine for the prevention of serious lower respiratory tract infection caused by the respiratory syncytial virus (RSV) in infants and young children.
The upfront payment consists of cash and newly issued Sobi shares which will give AstraZeneca an equity interest in the Swedish company of about 8%.
Evotec AG powered ahead in the first nine months of 2018 as its contract service provision generated €254.3 million in revenue, up by 53% from a year earlier, and its discovery alliances produced €51.3 million, up by 55%. The discovery business realized more milestone payments during the period, including a €60 million payment from Sanofi SA for taking over development of the French’s company’s infectious disease portfolio.
AstraZeneca Plc has reported positive outcome data for its licensed diabetes medicine Farxiga (dapagliflozin) showing that the drug significantly reduces the risk of hospitalisation for heart failure or cardiovascular death among patients with Type 2 diabetes. In a Phase 3 trial, the reduction of risk was 17% compared with a placebo.
The neuroscience specialist H. Lundbeck A/S has raised its profit forecast for 2018 on the back of revenue and earnings gains in the first nine months and a significant improvement in its operating margin.
“Lundbeck remains on track to deliver the best-ever financial results, creating the foundation to work to strengthen the pipeline for future growth,” said Deborah Dunsire, the company’s new chief executive. Dr Dunsire joined Lundbeck on 1 September having previously managed biopharmaceutical companies in the areas of oncology and central nervous system disorders.
Curetis NV’s proposed private placement, intended to raise up to €18.4 million, has attracted less than half this amount, or €8.9 million, from investors. As a result, the molecular diagnostics company said it plans to reassess its strategic priorities.
This will entail re-evaluating funding for the commercialisation of Unyvero, a cartridge-based diagnostic for detecting pathogens and antimicrobial resistance markers in infectious disease indications; its European commercialisation activities, working capital requirements and research and development programmes.
Sales of new products at AstraZeneca Plc increased faster, and generated more revenue than legacy medicines in the third quarter and 2018 first nine months, leading the UK company to declare it had reached a turning point on the way towards sustainable growth.
“This is the start of a period of sustained growth in the years to come,” Pascal Soriot, the chief executive, told journalists during a quarterly news conference on 8 November. He confirmed the company’s forecast for a low single-digit percentage increase in product sales this year.