Regulation & Policy

GlaxoSmithKline said that the US Food and Drug Administration has approved its combination treatment for benign prostatic hyperplasia, Jalyn. The drug combines dutasteride and tamsulosin in a single capsule.

With the pace of biomedical research accelerating by the day, the need for the Food and Drug Administration to bring pharmaceutical regulation into closer alignment with inventions emerging from the laboratory is greater than ever before, according to Margaret Hamburg, the FDA Commissioner.

An advisory committee of the US Food and Drug Administration has recommended that the multiple sclerosis drug, fingolimod, be approved, according to Novartis, the drug’s manufacturer. The drug is an oral therapy that has a novel mode of action.

AstraZeneca Plc said its treatment for metastatic colorectal cancer, Recentin (cediranib), showed no improvement in overall survival in a Phase 3 trial, the second of two pivotal studies for this indication. A regulatory filing will not be made.

The Novartis Group said that a Phase 3 trial of a drug for ovarian cancer failed to meet its primary endpoint and will not be submitted to the regulatory authorities. The drug, EPO906 (patupilone), did not show a significant overall survival advantage.

The European Medicines Agency has given its backing to data generated by a company which is developing a new cell therapy. It is the first time the regulator has formerly certified early-stage data for an advanced therapy product.

The US Food and Drug Administration has ordered Genzyme Corp to pay the government $175 million as a penalty for selling drugs that were manufactured at a plant in Allston, Massachusetts which had serious quality problems.

NicOx SA’s candidate product for osteoarthritis, naproxcinod, has failed to get the support of a joint US Food and Drug Administration advisory committee which said the French’s company’s new drug application needs more data.

More embryonic stem cell lines approved for US funding

The US Food and Drug Administration has approved a new combination hormonal tablet for use as an oral contraceptive. The drug, Natazia (estradiol valerate and estradiol valerate/dienogest), is manufactured by the US division of Bayer AG.