Ethics/Regulatory

U.S. District Court issues Restasis patents trial decision

Wednesday, October 18, 2017

Allergan, a global biopharmaceutical company, acknowledged that the U.S. District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% are invalid. The company will appeal the Court’s ruling.

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Global clinical trials database GlobalClinicalTrialsData.com launches

Monday, September 11, 2017

OZMOSI, an emerging leader in competitive intelligence and forecasting solutions for global pharmaceutical, biotech, and investment companies, announces the launch of a new global website which consolidates clinical trial data from all around the world into a single searchable database, GlobalClinicalTrialsData.com. Now anyone can use this free, real-time, global resource to search more than 280,000 trials covering over 3,700 disease areas to better understand and explore clinical trials in the pharmaceutical industry.

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Abbott addresses pacemaker hacking fears

Tuesday, September 5, 2017

On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the pacemaker).

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Omeros responds to Statnews.com story

Tuesday, August 29, 2017

Omeros stated that it continues to pursue legal action to hold responsible those behind a series of defamatory reports about the company posted online under the pseudonym “Art Doyle,” an entity or group that self-identifies as having a short position in Omeros’ stock. Because of its ongoing legal action, including a number of steps aimed at unmasking the identity of the individual(s) responsible, Omeros elected not to respond to queries from a writer for statnews.com who evidently had early access to and commented through Twitter on the initial “Art Doyle” false report before it was broadly made public.

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FDA to enforcement oversight of stem cell therapies and regenerative medicine

Monday, August 28, 2017

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes among many others.

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