The US Food and Drug Administration’s (FDA) regulations tell us that we must identify the environmental conditions that can affect the strength, identity, safety, quality and purity of our regulated products, whether they are pharmaceuticals, medical devices or biologic products. The FDA regulations also say we must be able to demonstrate that we have maintained our product storage spaces such that the required storage conditions for our products have been met. [ + ]

Bionomics (ASX:BNO) has entered a small molecule pain drug research and option agreement with pharmaceutical giant Merck that could be worth up to US$172m. [ + ]

The results of clinical trial using cellular therapy in patients with Crohn’s disease were so encouraging the research was published before the trail had been completed. [ + ]

Macquarie Graduate School of Management (MGSM) has launched a new unit for MBA students, ‘Healthcare Management and Leadership’, which will be offered for the first time in term four 2013 to those that wish to lead, govern or manage within the healthcare sector. [ + ]

Phosphagenics (ASX:POH) will move on to phase II trials of its oxycodone patch product, after demonstrating sustained delivery in phase I. [ + ]

Combining the Standard Model of particle physics with Einstein’s general theory of relativity is a Holy Grail that is now being probed. [ + ]

Researchers have found that rather than just one mutation causing enhanced survival, about five to seven mutations are required. These extra mutations are termed ‘genetic hitchhikers’ because they don’t appear to contribute to the enhanced fitness of the organism. [ + ]

BioDiem (ASX: BDM) has announced its hepatitis vaccine program is making good progress. [ + ]

Running a lab, directing a CRC and now a WHO Centre, Anne Kelso discusses her accomplished research career in microbiology, immunology and virology. [ + ]

When Alan Shepard, the first American to fly in space (5 May 1961) was forced to wee in his spacesuit, his urine short-circuited his electronic biosensors. Eight hours of launch delays had not been factored into his 15-minute spaceflight and there was no provision for him to urinate once kitted out in his spacesuit. [ + ]

Interim results look promising for Viralytic’s lead compound Cavatak. [ + ]

Fatty acids derived from fatty fish and fish-oil supplements, usually lauded as ‘cure-alls’, have been found to increase the risk of developing aggressive prostate cancer. [ + ]

Debate continues about the claim that proteins interact with 80% of the human genome and whether this much regulation is required for a functional human being. [ + ]

Bioniche (ASX:BNC) has secured regulatory approval for Folltropin - its FSH product for stimulating superovulation in cows - in seven more European markets. [ + ]

AusBiotech, supported by the Victorian Government, has been working with an advisory committee to develop the Guide for Life Science Company Directors as a supporting document to the newly revised Code of Best Practice for Reporting by Life Sciences Companies (Ed 2). A draft is now available for comment until 15 August. [ + ]