Navidea (NYSE:NAVB) is getting a loan of up to $60 million it plans to use to retire debt and spur wider use of its Lymphoseek cancer imaging agent.
Navidea Biopharmaceuticals
Navidea eyes China with partnership for Lymphoseek imaging agent
Navidea Biopharmaceuticals (NYSE:NAVB) is preparing major moves in China with a new alliance that aims to bring its Lymphoseek imaging agent to the country.
Press Release: FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region.
FDA expands approval for Navidea’s Lymphoseek for head and neck cancers
Navidea Biopharmaceuticals landed FDA approval to expand use for its Lymphoseek imaging agent to help track cancers spreading in the head and neck.
Lymphoseek is the "1st and only FDA-approved radiopharmaceutical application for sentinel lymph node detection," according to Navidea, which originally won FDA approval for Lymphoseek in March 2013.
Cancer: FDA approves Navidea’s Lymphoseek imaging agent
The FDA approved Navidea Biopharmaceuticals’ Lymphoseek radioactive imaging agent, an injectable drug that helps physicians isolate lymph nodes in patients with breast cancer or melanoma.
The Lymphoseek approval marks the 1st time in more than 30 years that the FDA has approved a lymph node mapping drug, according to an agency notice.
FDA lets Cooper’s Avaira Toric back on the market | Regulatory Roundup
Cooper Cos. (NYSE:COO) today announced that the U.S. Food and Drug Administration has granted a Special 510(k) clearance for CooperVision’s Avaira Toric two-week silicone hydrogel contact lenses for astigmatism.
CooperVision will re-launch Avaira Toric with shipments available for select distribution beginning in early May 2012.
St. Jude lands FDA win for 2 next-gen cardiac ablation catheters | Regulatory Roundup
St. Jude Medical Inc. (NYSE:STJ) won pre-market approval for 2 next-generation cardiac ablation systems this month, the Therapy Cool Path Duo and Safire Blu Duo catheters.
Both ablation systems use radiofrequency energy to freeze small areas of faulty cardiac tissue in patients with typical trial flutter, a type of arrhythmia in which patients experience abnormal heart rhythms or an abnormally fast heartbeat in the upper chambers of the heart.
Thoratec taps ex-Medtronic CEO Hawkins for board | Personnel Moves
Survey: Docs have mixed feelings about Obamacare | MassDevice.com On Call
MASSDEVICE ON CALL — Doctors are split when it comes to health care reform, according to a new survey from the Deloitte Center for Health Solutions.
Of the 501 doctors surveyed, 44 percent said the law was "a good start," while another 44 percent said health care reform was "a step in the wrong direction."
Overall, the doctors worried that the new system would increase access to government insurance programs without reducing costs, leaving fewer people uninsured but increasing emergency room wait times and lowering the total quality of care.
Diabetes: FDA clears iPhone glucose meter | MassDevice.com On Call
MASSDEVICE ON CALL — Sanofi’s (NYSE:SNY) iPhone glucose meter, the iBGStar, landed 510(k) clearance from the FDA, making it the first iPhone glucose meter to win a nod from the federal watchdog agency.
The company’s website describes the meter as "is the first available blood glucose meter that seamlessly connects to the Apple iPhone and iPod touch for the flexibility to manage your diabetes whenever, wherever."
Zimmer slides despite beating The Street | Earnings Roundup
Zimmer Holdings (NYSE:ZMH) shares are down this morning in early trading after the orthopedics giant lowered its sales and earnings guidance for 2011 – despite beating analysts’ expectations with its third-quarter earnings.
Warsaw, Ind.-based Zimmer said third-quarter profits were $192 million, or $1.01 per share, on sales of $1.03 billion for the three months ended Sept. 30, up 5.2 percent and 6.9 percent, respectively, compared with the same period last year.