The US Food and Drug Administration has issued its first-ever draft guidance on the development of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD), a condition whose symptoms include inattention and high levels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.
GlaxoSmithKline Plc will focus on building its pharmaceutical pipeline this year while executing a merger of its consumer healthcare business with that of Pfizer Inc. This was the message delivered by Emma Walmsley, the chief executive, following the release of first-quarter results on 1 May which showed a 6% rise in turnover to £7.7 billion and an operating profit of £1.43 billion, up by 15% from a year earlier. The operating margin was 18.6%.
The European Medicines Agency has given a positive opinion to an implant for the treatment opioid addiction which is intended to treat the disorder by giving users a steady but low supply of an opioid drug. Called Sixmo, the implant consists of four small rods that are placed in a patient’s arm by a physician using a local anaesthetic.
Recent acquisitions and strong sales for vaccines and rare disease medicines lifted Sanofi SA in the first quarter after a lacklustre performance in 2018. The French company reported net sales of €8.4 billion for the quarter, up by 6.2% from a year earlier and net income of €1.14 billion, up by 11.9%. This followed a restructuring of its portfolio to focus on specialty medicines and away from insulins. With an operating profit of €1.4 billion, the company delivered an operating margin of 17%.
AstraZeneca Plc delivered higher product sales and an increase in operating profit in the first quarter, continuing a turnaround that took hold in 2018. Product sales rose across the company’s three therapy areas, while operating expenses remained subdued. As a result, the operating margin rose to 20% from 13.4% a year earlier.
A Phase 3 trial investigating a new small molecule drug for advanced fibrosis failed to meet its primary endpoint, sending the developer Gilead Sciences Inc back to the drawing board. The drug, selonsertib, was being investigated in patients with stage 3 fibrosis due to non-alcoholic steatohepatitis (NASH), a progressive liver disease characterised by the accumulation of fat and inflammation in the liver.