research and development news

Research into dementia, cancer, diabetes and heart disease are among the activities to benefit from a new £800 government funding package.

The money comes in the shape of 31 awards which will be paid out over the next five years for projects aiming to turn cutting-edge science into treatments which can be used by the NHS.

The translational research brings together the pharma industry, NHS, universities and charities under the auspices of the National Institute for Health Research (NIHR), which oversees NHS research.

GlaxoSmithKline has taken a £1.3 million stake in a new UK biotech spin-out that will develop pharmacological treatments for hearing loss.

Autifony Therapeutics has been set up by a trio of senior research executives at GSK and starts life with a number of pre-candidate assets from the big pharma company.

These are voltage-gated ion channel modulator compounds, which are thought to have potential in the treatment of hearing disorders, including noise-induced hearing loss and tinnitus.

Our round-up of news from the contract research sector includes the rejection of a cancer drug by the FDA because of procedural problems at a CRO-run study, plus updates from Criterium, Eurofins Optimed/Spaulding, Synexus and Covance.

US drugmaker Adventrx has had its lead drug for cancer - Exelbine (vinorelbine injectable emulsion) - rejected by the US FDA because of mistakes in a clinical trial carried out by an Argentinian contractor.

India's Ipca Laboratories has bought UK chemistry services firm Onyx Scientific for around £4.6 million ($7.5m).

The Mumbai-based company, a contract manufacturer that produces finished dosage forms and active pharmaceutical ingredients, said Onyx Scientific will continue to operate out of its facility in Sunderland, which offers custom synthesis, solid-state chemistry, scale-up and kilo-scale GMP manufacturing.

GlaxoSmithKline’s new drug IPX066 has helped Parkinson’s disease patients retain their motor skills after their medication wore off.

IPX066, which GSK licensed from Impax Pharmaceuticals, is an extended release capsule formulation of carbidopa-levodopa.

In a phase III trial it significantly extended a patients ‘off time’ when compared to Novartis/Orion’s standard treatment Stalevo (carbidopa, levodopa and entacapone - or CLE).

New trials for MannKind’s investigational inhaled insulin drug Afrezza have been given the go-ahead by the FDA, potentially breathing new life into the market.

The US regulator has cleared MannKind’s design for two clinical studies to evaluate the efficacy and safety of Afrezza (insulin human [rDNA origin]), an ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler.

New genetic links to the immune system have been identified as a possible trigger for multiple sclerosis.

The exact causes of multiple sclerosis have been under intense scientific scrutiny for years, but this new piece of research has found 57 new genetic factors that researchers believe are primary triggers for the disease.

PPD plays down sell-off rumours, Icon sees a steep profit decline, plus updates from Beaufort, PharmaNet, ClinStar and Biofocus/IMD.

PPD has played down speculation that it may be putting itself up for sale, but said in a statement that its board of directors "has asked management to review PPD's strategic plan and capital structure with a focus on unlocking value for shareholders".

Bristol-Myers Squibb is to plug gaps in its pipeline by buying private biotech company Amira Pharmaceuticals for $325 million in cash.

San Diego-based Amira specialises in developing drugs to treat inflammatory and fibrotic diseases, and the latter area has particularly piqued BMS’ interest.

“Bristol-Myers Squibb has identified fibrotic diseases as an area of high unmet medical need that complements our research efforts in several of our therapeutic areas,” explained Elliott Sigal, BMS president of R&D.

Lilly has presented a review of data from semagacestat, the Alzheimer’s drug it dropped last year after disappointing results.

Phase II trials were halted in August 2010 when early signs suggested that semagacestat did not slow Alzheimer’s disease progression, but in fact made the patients’ condition worse.

To help understand what was happening, Lilly continued to gather data for another 32 weeks after dosing was stopped.