research and development news

A US advisory committee has rejected an investigational compound for type II diabetes sufferers, throwing its future into doubt.

Dapagliflozin, developed by AstraZeneca and Bristol-Myers Squibb, was given the thumbs down by nine votes to six during a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

The primary concern was over instances of breast and bladder cancer in patients, raising the possibility of further trials being needed, which could greatly delay – or even halt - the drug’s progress.

M&A abounds in the CRO sector with INC completing its purchase of Kendle, inVentiv snappig up Pharmanet and ICON buying Firecrest, plus new contracts for OpenClinica and Clinilabs.

INC Research completed its takeover of fellow contract research organisation Kendle in a $232 million deal that was first announced in May. The companies say the merger has created a global CRO with 5,000 employees operating in 100 countries and will rank among the top-tier CROs in terms of size and scale.

France’s health minister Xavier Bertrand: pharma must be kept at a distance

France has unveiled sweeping changes to how it regulates prescription medicines following the scandal surrounding Servier’s Médiator.

Health minister Xavier Bertrand says new regulation will strengthen pharmacovigilance, create greater transparency and more declaration of interests at all levels of regulation and government.

The controversy has generated considerable distrust of pharma industry practices in France, with Servier’s alleged close connections with doctors and regulators blamed for the drug staying on the market.

Sanofi is poised to move sarilumab into phase III trials for rheumatoid arthritis after the monoclonal antibody showed positive results in a mid-stage study.

But the company and its development partner Regeneron have no such plans for sarilumab in another autoimmune disease after it disappointed in a separate ankylosing spondylitis trial.

In the phase IIb MOBILITY trial rheumatoid arthritis patients treated with sarilumab and standard RA treatment methotrexate (MTX), saw a significant improvement in signs and symptoms compared to MTX alone.

In the US the FDA is seeking comments on its new policy for companion diagnostics

Pharma regulators in the US and Europe have put out separate consultations on issues affecting how medicines are developed.

The FDA is seeking comment on its proposed policy for diagnostic tests, while the European Medicines Agency wants views on genomic markers in medicine development.

The FDA has issued draft guidance for companies on the US regulator’s policy for reviewing a companion diagnostic and the medicine which goes with it.

Amgen has teamed up with German biotech Micromet to develop tumour-destroying antibodies in a two-year deal that could net Micromet €695 million.

The agreement focuses on BITE antibodies, which are designed to direct the body’s cell-destroying T cells against tumour cells, and have been shown to induce a self-destruction process.

Sanofi has signed a research collaboration with Rib-X Pharmaceuticals to investigate new types of antibiotics.

The French pharma company has taken an option to licence Rib-X’s novel classes of antibiotics in return for an upfront payment of $10 million and further milestones that could be worth more than $186 million per product developed.

The partners aim to produce treatments for multi-drug resistant bacteria, infections from which are responsible for at least 25,000 patient deaths in the European Union each year.

Quintiles helps fund Alzheimer's drug programme, Toxikon starts building a new facility, plus updates from Jubilant, CIToxLAB and PupPharma.

Quintiles has bought another $1 million-stake in Australian drugmaker Prana Biotechnology to help fund development of a new drug for Alzheimer's and Huntington's disease called PBT2 which is currently in phase II trials. The contract research organisation, which has provided CRO services to the Australian firm over a number of years, bought $1 million in Prana shares in June 2010.