News

Regulatory wins for AZ

Thursday 10 November 2022
Country
United Kingdom

AstraZeneca Plc won 19 regulatory approvals for its portfolio of biopharmaceuticals in the four months to early November representing a step-change from the recent past. Approvals were evenly distributed across geographies and reflected the company’s global ambitions.

At the company’s third quarter press briefing on 10 November, Pascal Soriot, the chief executive, said AstraZeneca intends to spend a significant proportion of its revenue on R&D going forward as it has in the recent past.

Jardiance gives heart and kidney benefit

Thursday 10 November 2022
Country
Germany

New data have been reported for Jardiance (empagliflozin), a medicine approved to treat Type 2 diabetes in 2014 and subsequently also authorised to treat heart failure. A Phase 3 trial in 6,609 adults with chronic kidney disease has now shown that Jardiance can confer a significant kidney and cardiovascular benefit. When treated with the medicine, the risk of kidney disease progression or cardiovascular death was reduced by 28% compared with a placebo, according to the trial’s sponsors Eli Lilly and Co and Boehringer Ingelheim GmbH.

Early data are positive for HIV therapeutic vaccine

Thursday 10 November 2022
Country
Spain

An experimental therapeutic vaccine for HIV that has been designed for use with other therapies to suppress the virus in the absence of antiretroviral medication has reported positive data from a Phase 1 study. The trial results were published online on 27 October in Nature Medicine. The vaccine’s developer is AELIX Therapeutics SL in Spain which collaborated on the study with Gilead Sciences Inc of the US and the IrsiCaixa AIDS Research Institute in Badalona, Spain.

Heart failure study stopped early

Wednesday 9 November 2022
Country
Switzerland

A study of patients hospitalised for acute heart failure has shown that a strategy involving the rapid up-titration of medications and close follow-up resulted in a significant reduction in all cause death and hospital readmissions. The trial was stopped early for efficacy. The results of the study were published on line in The Lancet on 7 November. Separately, Roche announced that the trial had used one of its diagnostics to identify individuals suspected of having congestive heart failure.

Evotec had operating loss for first nine months

Wednesday 9 November 2022
Country
Germany

Evotec SE reported an operating loss for the first nine months of the year as costs associated with biologics manufacturing, drug research and development, and staff recruitment outpaced gains in revenue. The German drug developer and service provider had revenue of €510.8 million for the nine-month period, up by 19% from a year earlier. But the cost of sales and other expenses left it with an operating loss of €16.8 million. This compared with a year-earlier profit of €26.1 million.

Blenrep fails to meet endpoint in myeloma trial

Wednesday 9 November 2022
Country
United Kingdom

The antibody-drug conjugate Blenrep (belantamab mafodotin), which was given an accelerated approval in the US for multiple myeloma in 2020, has failed to show superiority against a competitor molecule in a follow-up Phase 3 study. Announcing the trial results on 7 November, GSK Plc said the ADC did not meet its primary endpoint of progression-free survival. Blenrep was being tested against pomalidomide in combination with low dose dexamethasone.

New direction for Galapagos

Monday 7 November 2022
Country
Belgium

Galapagos NV is to embark on a new strategic path that will combine its experience in immunology with a bold approach to cell-based therapies for cancer. The strategy was outlined by Paul Stoffels, the chief executive on 4 November, and involves changes to the company’s portfolio and its approach to commercialisation. Dr Stoffels is a former chief scientific officer at Johnson & Johnson Inc who became the Galapagos CEO on 1 April.

The strategy addresses both setbacks and opportunities.

Demand for Novo’s GLP-1 products strong

Sunday 6 November 2022
Country
Denmark

Demand for Novo Nordisk A/S’s glucagone-like peptide-1 (GLP-1) medicines for diabetes remained strong in the first nine months of the year, leading the Danish company to upgrade its financial forecast for 2022. Sales at constant exchange are now expected to increase by 14% to 17% this year, instead of the earlier predicted rise of 12% to 16%. In its latest financial report, Novo said the outlook takes into account periodic supply constraints at some of its manufacturing sites.

Santhera looks toward DMD approval

Sunday 6 November 2022
Country
Switzerland

Two years after abandoning an experimental treatment for Duchenne muscular dystrophy (DMD), Santhera Pharmaceuticals AG is close to achieving its treatment goal – this time with a different molecule. The Swiss rare disease company has completed regulatory applications in both the US and Europe for its newest DMD treatment vamorolone, an anti-inflammatory drug that is being positioned as a potential alternative to corticosteroids for treating the disease.

Gene therapy company launch

Sunday 6 November 2022
Country
United Kingdom

A new gene therapy company has been launched in the US and UK by a group of academic-entrepreneurs who aim to treat genetic diseases of the eye with therapies delivered by a herpes simplex virus (HSV) vector. The company, Eudora, plans to employ an HSV-1 vector as a delivery vehicle instead of the commonly used adeno-associated virus (AAV) vector. In an announcement on 31 October, Eudora said its HSV vehicle could deliver more drug than an AAV vector, one of the most widely used virus vectors in the industry.