Ethics/Regulatory

Executives of Juno Therapeutics under investigation

Monday, August 14, 2017

Shareholder and consumer rights law firm Schubert Jonckheer & Kolbe LLP has launched an investigation into whether certain officers and directors of Juno Therapeutics breached their fiduciary duties to Juno and its shareholders by exposing Juno to civil liability for failing to disclose patient deaths in the phase II/ROCKET trial of its leading product candidate, JCAR015, during the period June 24, 2016, to November 22, 2016. 

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CRISPR/Cas9 gene editing appeal filed

Tuesday, August 1, 2017

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics announced that The Regents of the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively UC), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, submitted an appellate brief to the U.S. Court of Appeals for the Federal Circuit seeking reversal of a decision by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) in an interference proceeding relating to CRISPR/Cas9 gene editing technology. In the appeal, UC requests reversal of the PTAB’s decision terminating the interference between certain CRISPR/Cas9 patent claims owned by UC and claims of the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, Broad).

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FDA to eliminate Orphan designation backlog

Thursday, June 29, 2017

The FDA has unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.

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Colorado passes Bill that allows medical cannabis treatments for PTSD

Monday, June 12, 2017

The Colorado General Assembly recently approved SB 17-17 to add Post-Traumatic Stress Bill to the list of approved medical conditions for the use of medical cannabis. That became Colorado law June 5th with Governor John Hickenlooper’s signature. This is the final step of what has been a long journey to justice. Military veterans and all suffering from this debilitating condition can finally have access to medical cannabis in order to effectively supplement their treatment regimen under the supervision of trusted physicians. Related Colorado Appeals and Denver District court cases were handled pro bono by Hoban Law Group on behalf of Plaintiffs Curtis Bean, Larisa Bolivar, Matthew Kahl, Stephen Otero and Zachary Phillips.

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FDA requests removal of Opana ER for risks related to abuse

Monday, June 12, 2017

The FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

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