AstraZeneca Plc has received a complete response letter (CRL) from the US Food and Drug Administration rejecting its application to market a new drug for hyperkalaemia called ZS-9. The CRL relates to an unspecified manufacturing issue.
Aleva Neurotherapeutics SA, a Swiss company with a candidate device for deep brain stimulation, has obtained $18 million in Series C financing enabling it to prepare for the registration of its product in Europe in 2017.
The shareholders of Shire Plc have voted to approve management’s proposed merger with Baxalta Inc to create a global company focused on developing drugs for rare diseases and other specialised conditions. The $32 billion deal comprises cash and shares.
Angle Plc, a specialist medical technology company listed on the AIM market in London, has placed about 15.8 million new shares with institutional investors raising £10.2 million in order to commercialise a liquid biopsy test for cancer based on the detection of circulating tumour cells.
Sanofi SA has filed papers with the US Securities and Exchange Commission (SEC) in an effort to remove and replace the board of Medivation Inc following that company’s rejection in late April of the French company’s unsolicited $9.3 billion takeover bid.
MorphoSys AG has joined forces with the MD Anderson Cancer Center in Texas to discover and develop potential antibody therapies against cancer. The German company will use its technology platform to generate antibodies against jointly selected targets.
Jörg Vollmer, a veteran biotechnology executive, is to lead a new technology advisory board at Silence Therapeutics Plc, which is developing therapeutics based on ribonucleic acid (RNA) for cancer and other diseases.
The Roche Group subsidiary Genentech has extended a discovery alliance with Evotec AG that began in May 2010 for another three years to 2019 in order to continue work in identifying new small molecule drugs against targets identified by Genentech. Financial details were not disclosed.
Three executive vice presidents at Sanofi SA have decided to step down resulting in a reorganisation of the company’s executive committee which is led by Olivier Brandicourt, chief executive of the company since April 2015.
In a bid to highlight oncology, Novartis has split its pharmaceuticals division into two new business units, one of which will be devoted exclusively to cancer medicines including cell and gene therapies. Bruno Strigini will head the new unit, reporting directly to Joseph Jimenez, the chief executive.