United States

FDA seeks $5.1B for FY 2017

Wednesday, February 10, 2016

The FDA is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget—an 8% increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the vice president.

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Epizyme’s Tazemetostat granted FDA Orphan designation for malignant rhabdoid tumors

Tuesday, February 9, 2016

The FDA has granted Orphan Drug status to Epizyme’s first-in-class EZH2 inhibitor, tazemetostat, for the treatment of malignant rhabdoid tumors (MRTs). In December 2015, the company initiated a phase II study in adults and a phase I study in children with genetically defined tumors, including MRTs. Tazemetostat is also being investigated in an ongoing five-arm phase II study in patients with non-Hodgkin lymphoma.

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Bipartisan legislation introduced to combat Zika virus

Friday, February 5, 2016

U.S. Representatives G. K. Butterfield (NC-01) and Susan Brooks (IN-05) have introduced H.R. 4400, a bipartisan bill that seeks to add the Zika virus to the list of diseases included in the Tropical Disease Priority Review Voucher Program at the FDA. The Zika virus, which is transmitted to humans by mosquitoes, can infect pregnant women and result in birth defects, including microcephaly and neurological disorders in newborns. The virus also causes skin rashes, conjunctivitis, muscle and joint pain, and headaches in adults. The World Health Organization has labeled Zika a global public health emergency.

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Laura Donohue joins BRANY’s IRB team

Tuesday, February 2, 2016

Laura Donohue has joined Biomedical Research Alliance of New York (BRANY), a national organization providing support services to sponsors and investigators involved in research, as IRB supervisor. She will work with BRANY’s central, AAHRPP-accredited IRB.

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Codiak BioSciences closes $61M series B financing

Thursday, January 28, 2016

Codiak BioSciences Inc., a leading company in the field of exosome biology, announced the closing of its $61 million Series B round, bringing total investment in its combined Series A and B financing, announced in November 2015, to $92 million. Codiak intends to use the proceeds of this round primarily to advance research and clinical development of exosomes for therapeutic and diagnostic purposes. 

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Miami Cancer Institute names Mehta deputy director, radiology chief

Tuesday, January 26, 2016

Minesh Mehta, M.D., an expert in radiation oncology, proton therapy and cancer research, has joined the executive leadership of Miami Cancer Institute at Baptist Health South Florida as deputy director and chief of radiation oncology. Dr. Mehta will position Miami Cancer Institute’s proton therapy center—the only one of its kind in South Florida and one of fewer than two dozen of its kind in the U.S.—as the region’s top destination for this leading-edge treatment.

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FDA Approves BOTOX for lower limb spasticity in adults

Monday, January 25, 2016

Allergan has announced that the FDA has approved BOTOX (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. BOTOX is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers and thumb) and lower limbs that may be impacted by spasticity.

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Eisai’s Lenvatinib receives FDA Priority Review

Friday, January 22, 2016

Eisai has announced that the FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for lenvatinib for the potential treatment of patients with unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with everolimus following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The FDA had previously granted lenvatinib Breakthrough Therapy designation for this investigational indication. Breakthrough Therapy designation is reserved for drugs with preliminary clinical evidence that indicates the drug, alone or in combination, may demonstrate a substantial improvement over existing therapies for the treatment of a serious condition.

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