Five-year follow-up data from a pioneering trachea transplantation using tissue-engineered materials has confirmed that the procedure is safe and effective, according to a report in The Lancet. The follow-up report takes into account a stent procedure carried out in the recovery period to address scarring.
Shire Plc, the Dublin-headquartered specialty pharmaceutical company, reported sharply higher revenue and earnings in the third quarter as the result of a 13% rise in product sales and lower costs following a merger of its three autonomous R&D divisions into one in May.
AstraZeneca Plc has selected a microRNA target from a collaboration with California-based Regulus Therapeutics Inc which will be used to develop a new oncology therapeutic. The target is one of three being investigated under a 2012 collaboration between the two companies.
Sygnis AG of Germany has raised gross proceeds of €2.7 million from a rights offering and private placement to support its growth as a service provider of DNA amplification and sequencing products.
Since 2007, legislation known as the Advanced Therapy Medicinal Products Regulation (ATMP) has been in place to set regulatory standards for assessing gene, cell and tissue-engineered products. Yet in this time only four ATMPs have been approved for marketing.
The Committee for Medicinal Products for Human Use has given positive opinions to a new drug for depression developed by H. Lundbeck A/S, and one for pulmonary arterial hypertension (PAH) by Actelion Ltd. The decisions were announced on 25 October.
A group of venture capitalists is providing €9.4 million to a new company that will hold exclusive licences to oncology assets originated by F-Star Biotechnology Ltd, a discoverer of bispecific antibodies. The Series A round is supported by Atlas Venture.
The European Medicines Agency’s main scientific committee has recommended that patients with chronic hepatitis C virus infection before or after a liver transplantation be given the opportunity to be treated with the experimental drug sofosbuvir.
MorphoSys AG has revised upward its profit forecast for 2013 in light of stronger than anticipated revenue, and lower than expected costs for the development of a therapeutic antibody for cancer which is partnered with Celgene Inc.
An advisory panel of the US Food and Drug Administration has unanimously recommended approval of the Johnson & Johnson/Medivir AB treatment for patients infected with hepatitis C virus, simeprevir, in combination with interferon and ribavirin.