News

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 21^st Century Cures Act to add an exception to the consent requirement.

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.

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.

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.

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.

MorphoSys AG expects revenue this year to be on the upper end of a range announced in August, while earnings before interest and taxes (EBIT) will show a loss, but smaller than that reported for 2017. This follows higher third quarter sales which were boosted by a €47.5 million upfront payment from Novartis for rights to a candidate drug for atopic dermatitis.

The European institutions are a fertile source of funding for small and medium-sized life science enterprises, (SMEs), but gaining access to this capital requires a different set of skills than pitching for venture capital. This was one of the conclusions of a discussion at the BioEurope conference in Copenhagen on 6 November which featured presentations by Laszlo Helmle of the European Commission; Pierre Meulien of the Innovative Medicines I

SwedenBIO, which represents more than 250 companies in the life science sector in Sweden, is stepping up efforts to introduce biopharma and medical technology companies to US investors as the sector becomes increasingly important to the national economy.