United States

Pfizer breaks ground on new R&D facility in Missouri, to hire 80

Thursday, June 29, 2017

Pfizer, a biopharmaceutical company, broke ground on a state-of-the art Research and Development (R&D) and process development facility at 875 W. Chesterfield Parkway, Chesterfield, MO. The new campus will be owned by Pfizer and will bring together more than 450 employees who currently work at multiple locations which the company leases in the St. Louis area. Pfizer expects to hire an additional 80 employees over the coming years to support research at the site. Construction is expected to be complete by mid-2019.

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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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Irvine Scientific adds new R&D center of excellence

Wednesday, June 14, 2017

Irvine Scientific, a leader in the development and manufacture of cell culture media, announced the expansion of its Orange County, California, offices and laboratories, with the addition of a 40,000 square foot purpose-built R&D center at 17112 Armstrong Ave, Irvine, California. The growth of the company is in response to increased customer demand for Irvine Scientific’s cell culture and media reagents, and follows the significant expansion of its R&D facilities less than five years ago.

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Pfizer and Lilly receive FDA Fast Track designation for Tanezumab

Tuesday, June 13, 2017

Pfizer and Eli Lilly announced that the FDA has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP). Tanezumab is an investigational humanized monoclonal antibody that selectively targets, binds to and inhibits nerve growth factor (NGF). It is the first NGF inhibitor to receive Fast Track designation, a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

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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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