United States

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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FDA approves Alkermes ARISTADA treatment for schizophrenia

Wednesday, June 7, 2017

Alkermes announced that the FDA has approved two-month ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is now FDA-approved in four doses and three dosing duration options (441mg, 662mg or 882mg once monthly, 882mg once every six weeks and 1064mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

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FDA approves new hemophilia treatment

Thursday, June 1, 2017

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

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Genentech’s Actemra FDA approved for giant cell arteritis

Friday, May 26, 2017

Genentech, a member of the Roche Group, announced that the FDA has approved Actemra (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.

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Otsuka, Proteus Digital Health resubmit FDA application for first digital medicine

Tuesday, May 23, 2017

Otsuka Pharmaceutical and Proteus Digital Health announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in the fourth quarter of 2017.

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