Roche has secured a new indication for its antibody-drug conjugate Kadcyla (trastuzumab emtansine) that extends the drug’s approved use to early breast cancer in patients who have had surgery but still show residual signs of disease. Treatment would take place after chemotherapy and antibody therapy. Kadcyla was first approved for late-stage breast cancer in 2013. In both cases, patients have tumours that overexpress the HER2 protein.
Promethera Biosciences SA has completed a Series D financing round to support the development of its cell therapies for liver disease, raising €39.7 million from global investors. A total of €10 million of the funding was committed by the Japanese conglomerate Itochu Corp in January.
A new Switzerland-based company, Alentis Therapeutics Ltd, has received CHF 12.5 million (€11.1 million) in Series A funding to develop an antibody drug for the potential treatment of liver fibrosis and hepatocellular carcinoma. The technology is based on research conducted by scientists at the University of Strasbourg and Inserm in France, as well as the Mount Sinai Hospital in the US.
PolyProx Therapeutics Ltd, a spin-out of the University of Cambridge, has secured £3.4 million in seed capital to finance the development of a new class of engineered proteins for treating cancer. The seed round was co-led by Cambridge Innovation Capital Plc, RT Capital Management and Cambridge Enterprise, the commercialisation arm of Cambridge University.
UK-based Congenica Ltd has raised an additional £13.25 million in a Series B round extension, bringing total receipts from the round up to £23.3 million. Led by Parkwalk Advisors with participation from Cambridge Innovation Capital Plc, the funding will enable the genome services group to further develop its technology and expand in the US and China.
The US Food and Drug Administration has issued its first-ever draft guidance on the development of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD), a condition whose symptoms include inattention and high levels of activity. While many of the recommendations are already in practice, the document gives clarification on the agency’s expectations for clinical trial design.
Kite Pharma is to get its own chief executive under a reorganisation initiated by its parent company Gilead Sciences Inc, which has owned Kite since 2017. The move was disclosed on 2 May with Gilead’s first-quarter earnings announcement.
Daniel O’Day, the Gilead CEO, said in a conference call with analysts that Kite will become a separate business unit, according to Reuters.
Novo Nordisk A/S secured a 9% increase in sales to DKK 29.3 billion (€3.9 billion) in the first quarter and a 14% rise in operating profit to DKK 14.2 billion. But a foreign exchange loss of DKK 876 million depressed the net profit which was DKK 10.4 billion, down by 3%. This followed an unsuccessful attempt to hedge against changes in the value of the dollar against the krone.
The European Commission has published proposed rules for electronic commerce that, among other things, would guarantee the validity of e-contracts and e-signatures and introduce measures to combat spam. The proposal has been introduced within the context of ongoing negotiations among World Trade Organization members about making e-commerce more transparent and reliable.
“Despite a fast increase in digital trade, there are currently no multilateral rules in this area,”
the Commission said in a statement issued on 3 May.
AstraZeneca Plc has entered into a research collaboration and exclusive licensing deal with Transgene SA of France to co-develop five oncolytic virus drug candidates for the treatment of cancer. Financial terms of the agreement were not disclosed.
Oncolytic virus therapies are genetically modified viruses that are injected into tumour cells to cause cell death and as a second step, stimulate the immune system. To date, one oncolytic virus product, Amgen Inc’s Imlygic for the treatment of melanoma, has been approved for marketing, but many more are in development.