News

Shares in Vivus were on the rise yesterday as investors welcomed news that its erectile dysfunction (ED) drug Spedra has won European approval.

The European Commission has granted the US an export waiver, which means that, from July 1, US companies will no longer need to obtain an export certificate from the Food and Drug Administration (FDA) before shipping certain pharmaceutical products to the European Union (EU).

Days after regulators in Europe approved Astellas and Medivation’s prostate cancer drug Xtandi, the companies have begun a mid-stage trial of the therapy in breast cancer.

The National Institute for Health and Care Excellence (NICE) has published a stream of final guidances approving Forxiga for diabetes, Betmiga for overactive bladder and Xarelto for pulmonary embolism, but turning down Jakavi for enlarged spleen and Krystexxa for gout.

Novartis has presented late-stage data on omalizumab, already approved for asthma and sold as Xolair, which shows that it significantly improved itch in patients with a debilitating form of hives.

Eisai is to suspend commercial distribution of its new epilepsy drug Fycompa in Germany, saying it continues to disagree with the country’s reimbursement regulatory body’s rejection of the therapy.

The European Medicines Agency (EMA) has put out for consultation a draft policy on access to clinical-trial data that includes three different levels of access, together with corresponding conditions for publication and use, depending on the type of data involved.

Thousands of women with a family history of breast cancer are being given access to medicines to help prevent the disease under ground-breaking new guidance from NHS cost regulator the National Institute for Health and Care Excellence.

While the full impact of the Health and Social Care Act has yet to be felt, the government’s response so far to the problems facing the NHS has been “inadequate and divisive,” and cost improvement programmes are “cutting resources to the bone,” according to the BMA’s chair of council, Dr Mark Porter.

The report from the Parliamentary Commission on Banking Standards will have made uncomfortable reading for government ministers and Treasury officials. But the news that the Care Quality Commission stood accused of covering up its own failure to investigate a maternity unit where babies died through neglect was a real shocker. Faith in the way healthcare organisations operate is a precious commodity. Patients, taxpayers and industry professionals have a common interest in making sure that steps are taken to reinforce the system’s natural safeguards and its intrinsic strengths.

Another set of late stage data for GlaxoSmithKline’s experimental diabetes drug albiglutide has failed to excite analysts.

Almost 70% of Americans are taking at least one prescription drug, more than half take two, and 20% are on five or more, according to new research.

Sanofi chief executive Christopher Viehbacher has officially begun his two-year term as president of the European Federation of Pharmaceutical Industries and Associations, saying that the old continent needs a different approach to healthcare.

Responding to growing demand in contract research and development for flexible, tailored service relationships below the level of comprehensive strategic partnerships, Parexel International has launched a functional-services unit within its Clinical Research Services segment.

Takeda UK and Nipro Diagnostics have entered into a long-term pact to co-promote a range of the latter group’s blood glucose monitoring systems within the UK.